Systemic Lupus ErythematosusPhase 1/2NCT03371251
Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care
A Phase 1/2 study testing BOS161721 in people with Systemic Lupus Erythematosus, run by Boston Pharmaceuticals at 68 sites in 12 countries.
Trial summary
This study will be conducted to assess the safety, tolerability, and immunogenicity of repeat doses of BOS161721 (20 milligrams [mg], 60 mg, and 120 mg) administered subcutaneously in adult participants with moderately to severely active Systemic Lupus Erythematosus (SLE) on limited background standard of care… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- BOS161721
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- 68 sitesin 12 countries
- Study dates
- 10 Jan 2018to 26 Nov 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, ages 18 to 70 years, inclusive
- Participants must be mentally capable of giving consent and there must be evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study
- Participants must have Systemic Lupus Erythematosus (SLE) as defined by meeting 4 of the Systemic Lupus International Collaborating Clinics classification criteria for SLE (with at least 1 clinical and 1 immunologic criterion OR Lupus nephritis as the sole clinical criterion in the presence of anti-nuclear antibodies (ANA) or anti-double stranded deoxyribonucleic acid (dsDNA) antibodies), either sequentially or simultaneously
- At screening, participants must have at least 1 of the following:
- Elevated ANA ≥ 1:80 via immunofluorescent assay at the central laboratory
- Positive anti-dsDNA or anti-Smith (anti-Sm) above the normal level as determined by the central laboratory
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- At screening, the total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score must be ≥ 8, including points from at least 1 of the following clinical components:
- Arthritis, rash, myositis, mucosal ulcers, pleurisy, pericarditis, and vasculitis Note: Points from lupus headache and organic brain syndrome will also be excluded from qualifying total and clinical SLEDAI-2K scores at screening and Day 0.
- A clinical SLEDAI-2K score of ≥ 6 at screening at Day 0. Clinical SLEDAI-2K score is defined as follows:
- Contains points from arthritis, rash, myositis, mucosal ulcers, pleurisy, pericarditis, or vasculitis
- Excludes parameters which require central laboratory results: hematuria, pyuria, urinary casts, proteinuria, positive anti-dsDNA, decreased complement, thrombocytopenia, and leukopenia Note: Points from lupus headache and organic brain syndrome will also be excluded from qualifying total and clinical SLEDAI-2K scores at screening and Day 0.
- Participants must have at least 1 qualifying A or 2Bs from the following manifestations of SLE, as defined by the British Isles Lupus Assessment Group (BILAG) criteria as modified for use in this study, which must be confirmed by the central data reviewer:
- BILAG A or B score in the mucocutaneous body system. If a BILAG B score is due to BILAG number 6, mild skin eruption, the CLASI activity score including erythema and scale/hypertrophy must be ≥ 3 excluding points from mucosal ulcers and alopecia.
- BILAG A or B score in the musculoskeletal body system due to active polyarthritis Note: Hips, shoulders, back, neck, and temporomandibular joints do not count towards the total number of joints with active synovitis.
- If only one "B" and no "A" score is present in the mucocutaneous body system or in the musculoskeletal body system due to arthritis, then at least 1 "B" must be present in at least 1 other body system for a total of 2 "B" BILAG body system scores.
- Participants must be currently receiving at least 1 of the following:
- Administration for a minimum of 12 weeks, and a stable dose for at least 56 days (8 weeks prior to Day 0) of the following permitted steroid sparing agents: azathioprine (AZA), mycophenolate mofetil or mycophenolic acid, chloroquine, hydroxychloroquine, or methotrexate
- If AZA, myocophenolate mofetil, mycophenolic acid, hydroxychloroquine, or MTX were discontinued prior to screening, the washout period must be ≥ 12 weeks.
- Corticosteroids (CSs) (prednisone or prednisone-equivalent) at a stable dose of up to 30 mg/day for at least 6 weeks prior to Day 0
- For participants whose only SLE treatment is CSs, the stable CS dose must be ≥ 10 mg/day for at least 6 weeks prior to Day 0 and no more than 30 mg/day at the time of randomization.
- Topical steroids may be used, but the dose must be stable for at least 6 weeks prior to Day 0. PRN topical steroids are not permitted.
- Women of childbearing potential (WOCBP):
- Must have a negative serum pregnancy test at screening. Urine pregnancy test must be negative prior to first dose
- Must not be breastfeeding
- Must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 52 weeks
- Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 52 weeks
- Participants must demonstrate willingness and ability to comply with the scheduled study visits, treatment plans, laboratory tests, and other procedures
Who cannot join
- Participants presenting with any of the following will not be included in this study:
- Drug-induced SLE, rather than "idiopathic" SLE
- Other systemic autoimmune disease (eg, erosive arthritis, rheumatoid arthritis [RA], multiple sclerosis [MS], systemic sclerosis, or vasculitis not related to SLE). RA-Lupus overlap (Rupus), and secondary Sjogren syndrome are allowed.
- Any major surgery within 6 weeks of study drug administration (Day 0) or any elective surgery planned during the course of the study
- Any history or risk for tuberculosis (TB), specifically those with:
- Current clinical, radiographic, or laboratory evidence of active TB
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- History of active TB
- Latent TB defined as positive QuantiFERON-TB Gold In Tube or other diagnostic test in the absence of clinical manifestations. Latent TB is not excluded if the participant has documented completion of adequate course of prophylactic treatment with regimen recommended by local health authority guideline, or the participant has started treatment with isoniazid, or other regimen recommended by local health authority guidelines for at least 1 month before Day 0 and continues to receive the prophylactic treatment during study until the treatment course is completed
- Active or unstable lupus neuropsychiatric manifestations, including but not limited to any condition defined by BILAG A criteria, with the exception of mononeuritis multiplex and polyneuropathy, which are allowed
- Severe proliferative lupus nephritis (World Health Organization Class III, IV), which requires or may require induction treatment with cytotoxic agents or high dose CSs
- Concomitant illness that, in the opinion of the investigator or the Sponsor or their designee, is likely to require additional systemic glucocorticosteroid therapy during the study, (eg, asthma), is exclusionary. However, treatment for asthma with inhalational CSs therapy is allowed.
- Use or planned use of concomitant medication outside of standard of baseline treatment for SLE from Day -1 or for any time during the study
- Active and clinically significant infection (bacterial, fungal, viral, or other) within 60 days prior to first dose of study drug. Clinically significant is defined as requiring systemic parenteral antibiotics or hospitalization
- A history of opportunistic infection, or a history of recurrent or severe disseminated herpes zoster or disseminated herpes simplex within the last 3 years
- Chronic viral hepatitis B (HBV) and hepatitis C (HCV), unless participant received curative treatment for HCV and has a documented negative viral load, known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness
- Cryptosporidium in the stool sample at screening
- White blood cells < 1,200/millimeters cubed (mm^3) (1.2 × 10^9/Liter [L]) at screening
- Absolute neutrophil count < 500/mm^3 at screening
- CD4+ count < 150/microliter (µL) at screening
- Platelets < 50,000/mm^3 (50 × 10^9/L) or < 35,000/mm^3 (35 × 10^9/L) if related to SLE, at screening
- Hemoglobin < 8 grams per deciliter (g/dL) or < 7 g/dL at screening if related to SLE
- Proteinuria > 3.0 g/day (3000 milligrams per day [mg/day]) at screening or equivalent level of proteinuria as assessed by protein/creatinine ratio (3 mg/mg or 339 milligrams per millimole [mg/mmol])
- Serum creatinine > 2.0 mg/dL at screening or creatinine clearance < 40 milliliters per minute (mL/minute) based on Cockcroft-Gault calculation
- Serum alanine aminotransferase and/or serum aspartate aminotransferase > 2 × the upper limit of normal (ULN) at screening, unless explicitly related to lupus based on the investigator's judgment
- Creatinine kinase > 3.0 × ULN at screening unless related to lupus myositis
- Total bilirubin > 1.5 × ULN at screening (unless related to Gilbert's syndrome)
- Any other laboratory test results that, in the opinion of the Investigator or the Sponsor or Sponsor's designee, might place a participant at unacceptable risk for participating in this study
- History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibodies (mAb) (eg, IgG protein) or molecules made of components of mAbs
- History substance and/or alcohol abuse, or dependence within the past 1 year, at the investigator's judgment
- History of cancer within the last 5 years (except for cutaneous basal cell or squamous cell cancer, or cervical cancer in situ resolved by excision)
- Any other severe acute or chronic medical or psychiatric condition, including recent (within the past year) medical conditions (eg, cardiovascular conditions, respiratory illnesses) that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, Sponsor, or Sponsor's designee, would make the participant inappropriate for entry into this study
- Investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the investigator, or participants who are employees of the sponsor or directly involved in the conduct of the trial
- Currently participating in, or who have participated in other interventional (drug or device) clinical study within 30 days or 5 half-lives of baseline, whichever is longer
- Recent (within the past 12 months) or active suicidal ideation or behavior based on participant responding "yes" to question 3, 4, or 5 on the Columbia Suicide severity Rating Scale
- Current or pending incarceration
- Current or pending compulsory detainment for treatment of either a psychiatric or physical (eg, infectious disease) illness
- Currently taking a total daily dose of > 30 mg morphine or morphine equivalent
- Body mass index (BMI) ≥ 40.0
Trial locations and contacts
68 sites in 12 countries.
68 sites in 12 countries
United States17 sites
Pinnacle Research Group
Anniston, Alabama, 36207
Joint and Muscle Research Institute
Charlotte, North Carolina, 28204-3130
Clinical Research of West Florida
Clearwater, Florida, 33765-2616
Omega Research Consultants
DeBary, Florida, 32713-2260
TriWest Research Associates
El Cajon, California, 92020-4124
Centre for Rheumatology Immunology and Arthritis
Fort Lauderdale, Florida, 33309-1715
Aa Mrc Llc
Grand Blanc, Michigan, 48439
Accurate Clinical Research Inc
Houston, Texas, 77089
Indiana University School of Medicine
Indianapolis, Indiana, 46202
June DO PC
Lansing, Michigan, 48910-8595
Valerius Medical Group and Research Center
Los Alamitos, California, 90720-5403
Ramesh C. Gupta M.D.
Memphis, Tennessee, 38119-5214
Millennium Research
Ormond Beach, Florida, 32174
The Arthritis Center
Palm Harbor, Florida, 34684
Clinic of Robert Hozman/Clinical Investigation Specialists, Inc.
Skokie, Illinois, 60076-1238
Clinical Research of West Florida
Tampa, Florida, 33603
Westlake Medical Research
Thousand Oaks, California, 91360-3994
Poland8 sites
Centrum Kliniczno - Badawcze J. Brzezicki, B. Gronkiewicz Brzezicka Spółka Lekarska
Elblag, 82-300
Centrum Medyczne Plejady
Krakow, 30-363
Centrum Nowoczesnych Terapii Dobry Lekarz sp. z o.o
Krakow, 31-011
Centrum Medyczne AMED oddział w Łodzi
Lodz, 91-363
NZOZ Lecznica MAK-MED
Nadarzyn, 05-830
Prywatna Praktyka Lekarska Prof. UM dr hab. med Pawel Hrycaj
Poznan, 61-397
SANUS Szpital Specjalistyczny sp. z o.o
Stalowa Wola, 37-450
Reumatika-Centrum Reumatologii
Warsaw, 02-691
Colombia6 sites
Centro Integral de Reumatologia del Caribe CIRCARIBE S.A.S
Barranquilla, 080002
Preventive Care S.A.S.
Bogotá, 110311
Medicity S.A.S.
Bucaramanga, 680003
Servimed S.A.S.
Bucaramanga, 680003
Clinica de Artritis Temprana
Cali, 760043
Hospital Pablo Tobon Uribe
Medellín, 050034
Georgia6 sites
V. Tsitlanadze Scientifically-Practical Rheumatology Center Ltd
Tbilisi, 0102
Research Institute of Clinical Medicine Ltd
Tbilisi, 0112
LTD New Hospitals
Tbilisi, 0114
Mtskheta Street Clinic Ltd
Tbilisi, 0179
First Medical Center
Tbilisi, 0180
Multiprofile Clinic Consilium Medulla Ltd
Tbilisi, 0186
Peru5 sites
Hogar Clinica San Juan De Dios
Cayma, 04000
Centro de Investigación Clínica Trujillo E.I.R.L.
La Libertad, 13001
Hospital Nacional Cayetano Heredia
Lima, 15102
Clinica San Juan Bautista
Lima, 15431
Instituto de Ginecología y Reproducción
Santiago de Surco, 15023
Philippines5 sites
Angeles University Foundation Medical Center
Angeles City, 2009
Southern Philippines Medical Center
Davao City, 8000
Mary Mediatrix Medical Center
Lipa City, 4217
Philippine General Hospital
Manila, 1000
University of Santo Tomas Hospital
Manila, 1015
Ukraine5 sites
National Scientific Center at Institute of Cardiology named after acad. M.D. Strazhesko
Kyiv, 03680
Kyiv Regional Clinical Hospital
Kyiv, 04107
Odesa Regional Clinical Hospital
Odesa, 65025
Communal Non-Profit Enterprise "Ternopil University Clinic" of Ternopil Regional Council
Ternopil, 46002
Vinnytsia Regional Clinical Hospital
Vinnytsia, 21018
Argentina4 sites
Hospital Militar Central - Servicio de Reumatología
Buenos Aires, C1426BOR
Framingham Centro Medico
La Plata, B1902COS
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, T4000AXL
Centro de Investigaciones Reumatologicas
San Miguel de Tucumán, T4000BRD
Bulgaria3 sites
Diagnostic Consultative Center Sveti Georgi EOOD
Plovdiv, 4000
University Multiprofile Hospital for Active Treatment Plovdiv
Plovdiv, 4001
Medical Center - 1 - Sevlievo EOOD
Sevlievo, 5400
Hungary3 sites
Qualiclinic Kft.
Budapest, 1036
DE Klinikai Központ
Debrecen, 4032
Békés Megyei Központi Kórház Pándy Kálmán Tagkórház
Gyula, 5700
Mexico3 sites
Centro Integral en Reumatología S.A. de C.V. (CIRSA)
Guadalajara, 44160
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, 44280
CLIDITER S.A. de C.V. (Centro de Investigación y Tratamiento de las Enfermedades Reumaticas)
Mexico City, 06700
Romania3 sites
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed SRL
Brasov, 500283
Spitalul Clinic Judetean De Urgenta Cluj Napoca
Cluj-Napoca, 400006
Spitalul Clinic de Recuperare Iasi #2
Iași, 700661
About this study
Official title: A Randomized Double-Blind Phase 1b/2 Combined Staggered Multiple Dose Escalation Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care
This study will be conducted to assess the safety, tolerability, and immunogenicity of repeat doses of BOS161721 (20 milligrams [mg], 60 mg, and 120 mg) administered subcutaneously in adult participants with moderately to severely active Systemic Lupus Erythematosus (SLE) on limited background standard of care treatment, in order to estimate the optimal dose.
BOS161721 at the chosen dose will be compared to placebo for response on the SLE Responder Index 4, with sustained reduction of oral corticosteroids, in the same participant population.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- BOS161721, Placebo
- Keywords
- Adults, BOS161721, standard of care, moderately to severely active Systemic Lupus Erythematosus
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOS161721Drug
SC administration
PlaceboDrug
SC administration
| Study group | Role | What they receive |
|---|---|---|
| Phase 1b: BOS161721 20, 60, 120 mg | Experimental | Participants will be randomized to receive a 20 milligram (mg), 60 mg, or 120 mg subcutaneous (SC) dose of BOS161721. Participants may receive a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270. Receives: Drug: BOS161721 |
| Phase 1b: Placebo 20, 60, 120 mg | Placebo comparator | Participants will be randomized to receive a 20 mg, 60 mg, or 120 mg SC dose of placebo. Participants may receive a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270. Receives: Drug: Placebo |
| Phase 2: BOS161721 | Experimental | Participants will be randomized to receive a 120 mg SC dose of BOS161721 (as determined from Phase 1b of the study). Participants may receive a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270. Receives: Drug: BOS161721 |
| Phase 2: Placebo | Placebo comparator | Participants will be randomized to receive a 120 mg SC dose of placebo (as determined from Phase 1b of the study). Participants may receive a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1b: Number of Participants With Adverse Events (AEs)
The safety, tolerability, and immunogenicity of repeat doses of BOS161721 (20, 60, and 120 mg) administered SC were assessed in adult participants with moderate to severe SLE on limited background standard of care treatment, in order to estimate the optimal dose.
Measured: Up to Day 270
Phase 2: Number of Participants With an SLE Responder Index 4 (SRI-4) Response at Day 210
The SRI-4 is a composite index of SLE disease improvement that consists of scores derived from the SLE Disease Activity Index 2000 (SLEDAI-2K), the British Isles Lupus Assessment Group (BILAG) 2004 Index and the Physician's Global Assessment (PGA). Response based on the SRI-4 is defined by: 1) ≥ 4-point reduction in the SLEDAI-2K total score; 2) no new severe disease activity (BILAG A organ score) or more than 1 new moderate organ score (BILAG B) compared with baseline; and 3) no deterioration from baseline in the PGA by ≥ 30 millimeters. The SLEDAI-2K total score falls between 0 and 105, with higher scores representing increased disease activity.The SRI-4 response in participants with moderate to severe SLE is associated with broad improvements in clinical and participant-reported outcomes.
Measured: Day 210
Secondary outcomes (31)
Phase 1b: Maximum Observed Concentration (Cmax)
The PK of BOS161721 was characterized and the optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE.
Measured: Pre-dose: Days 0, 30, 60, 90, 120, 150, and 180. Post-dose: Days 0, 7, 15, 30, 180, 187, 195, 210, 240, and 270. Post-dose samples were collected at 4, 8, and 24 hours after study drug administration on Days 0, 30, and 180
Phase 1b: First Time to Maximum Concentration (Tmax)
The PK of BOS161721 was characterized and the optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE.
Measured: Pre-dose: Days 0, 30, 60, 90, 120, 150, and 180. Post-dose: Days 0, 7, 15, 30, 180, 187, 195, 210, 240, and 270. Post-dose samples were collected at 4, 8, and 24 hours after study drug administration on Days 0, 30, and 180
Phase 1b: The Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Quantifiable Concentration (AUClast)
The PK of BOS161721 was characterized and the optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE.
Measured: Pre-dose: Days 0, 30, 60, 90, 120, 150, and 180. Post-dose: Days 0, 7, 15, 30, 180, 187, 195, 210, 240, and 270. Post-dose samples were collected at 4, 8, and 24 hours after study drug administration on Days 0, 30, and 180
Phase 1b: Terminal Elimination Half-life (t1/2)
The PK of BOS161721 was characterized and the optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE.
Measured: Pre-dose: Days 0, 30, 60, 90, 120, 150, and 180. Post-dose: Days 0, 7, 15, 30, 180, 187, 195, 210, 240, and 270. Post-dose samples were collected at 4, 8, and 24 hours after study drug administration on Days 0, 30, and 180
Phase 1b: Apparent Plasma Clearance After Extravascular Administration (CL/F)
The PK of BOS161721 was characterized and the optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE.
Measured: Pre-dose: Days 0, 30, 60, 90, 120, 150, and 180. Post-dose: Days 0, 7, 15, 30, 180, 187, 195, 210, 240, and 270. Post-dose samples were collected at 4, 8, and 24 hours after study drug administration on Days 0, 30, and 180
Phase 1b: Apparent Volume of Distribution After Extravascular Administration (Vz/F)
The PK of BOS161721 was characterized and the optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE.
Measured: Pre-dose: Days 0, 30, 60, 90, 120, 150, and 180. Post-dose: Days 0, 7, 15, 30, 180, 187, 195, 210, 240, and 270. Post-dose samples were collected at 4, 8, and 24 hours after study drug administration on Days 0, 30, and 180
Phase 1b: Mean Change From Baseline in Phosphorylated Signal Transducer and Activator of Transcription 3 (pSTAT3)
The optimal dose of BOS161721 was selected based on safety, tolerability, PK and pharmacodynamic (PD) data in participants with moderate to severe SLE.
Measured: Baseline (Day 0); Days 30, 44, 60, and 90 (pre-dose [trough] samples only)
Phase 1b: Mean Change From Baseline in Complement 3 (C3) and Complement (C4) Levels
The optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE.
Measured: Baseline (Day 0); Day 210
Phase 1b: Mean Change From Baseline in Leukocyte Immunophenotype
The optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE.
Measured: Baseline (Day 0); Day 180
Phase 1b: Mean Change From Baseline in Anti-double-stranded DNA (dsDNA) Autoantibodies at Each Visit
The optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE..
Measured: Baseline (Day 0); Days 30, 60, 90, 120, 150, 180, 210, 240, and 270
Phase 1b: Mean Change From Baseline in Anti-Sjögren's Syndrome A and B (SSA, SSB)
The optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in subjects with moderate to severe SLE.
Measured: Baseline (Day 0); Day 180
Phase 1b: Mean Change From Baseline in Anti-Smith Antibody (Sm)
The optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in subjects with moderate to severe SLE.
Measured: Baseline (Day 0); Day 180
Phase 1b: Mean Change From Baseline in Antiphospholipid (APL) Autoantibodies (Beta 2 Glycoprotein, Cardiolipin IgG)
The optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE.
Measured: Baseline (Day 0); Day 180
Phase 1b: Mean Change From Baseline in Abrogation of IL-21 Gene Signature
The optimal dose of BOS161721 was selected based on safety, tolerability, PK and PD data in participants with moderate to severe SLE.
Measured: Baseline (Day 0); Days 15, 90, 180, and 270
Phase 2: Number of Participants With an SRI-4, SRI-5, and SRI-6 Response at Each Visit
The SRI-4 is a composite index of SLE disease improvement that consists of scores derived from the SLE Disease Activity Index 2000 (SLEDAI-2K) and the British Isles Lupus Assessment Group (BILAG) 2004 Index. Response based on the SRI-4 is defined by: 1) ≥ 4-point reduction in the SLEDAI-2K global score; 2) no new severe disease activity (BILAG A organ score) or more than 1 new moderate organ score (BILAG B); and 3) no deterioration from baseline in the Physician's Global Assessment (PGA) by ≥ 30 millimeters. The SRI-4 response in participants with moderate to severe SLE is associated with broad improvements in clinical and participant-reported outcomes. SRI-5 and SRI-6 are composite indices of SLE disease improvement that consist of scores derived from the SLEDAI-2K and the BILAG 2004 Index. The SRI-5 and SRI-6 are computed with a minimal five-point or six-point improvement in SLEDAI-2K being required, respectively.
Measured: Days 30, 60, 90, 120, 150, 180, 210, 240, and 270
Phase 2: Number of Participants With a Sustained Reduction From Baseline of Oral Corticosteroid (CS) (≤ 7.5 mg/Day and < Day 0 Dose) Between Day 150 and Day 210
Effect of BOS161721 compared with placebo for response on clinical indicators of SLE activity was assessed in adult participants with moderate to severe SLE on limited background standard of care treatment.
Measured: Day 150 to Day 210
Phase 2: Number of Participants With New or Recurrent BILAG Flares (≥ 1 Qualifying BILAG A or > 1 Qualifying BILAG B) Through Day 210
The BILAG-2004 index is an organ-specific 97-question assessment based on the principle of the doctor's intent to treat. Only clinical features attributable to SLE disease activity were recorded and based on the participant's condition in the last 4 weeks compared with the previous 4 weeks. It was scored as not present (0), improved (1), the same (2), worse (3), or new (4). Disease activity was graded separately for 9 body systems to 5 different grades (A to E) as follows: A is very active disease, B is moderate activity, C is mild stable disease, D is inactive now but previously active, and E indicates the organ was never involved. A shift from BILAG-2004 Grade A or B to a lower grade indicates a clinically relevant change in disease activity as the BILAG-2004 grades mirror the decision points for treatment interventions.
Measured: Days 30, 60, 90, 120, 150, 180, 210
Phase 2: Number of Participants With Physician's Global Assessment (PGA) Worsening
The PGA is used to assess Investigator's general impression on the patient's overall status of SLE disease activity via visual analogue scale (100 mm) with 0 being "very good, asymptomatic and no limitation of normal activities" with 100 mm being "most severe possible disease ever seen in all SLE patients". PGA worsening is defined as an increase of ≥ 30 mm from baseline.
Measured: Days 30, 60, 90, 120, 150, 180, and 210
Phase 2: Number of Participants With a BILAG-based Composite Lupus Assessment (BICLA) Response at Day 210
The BICLA is a responder index developed to measure response to therapy, and it includes scores from the BILAG, SLEDAI-2K, and Physician's Global Assessment (PGA). BICLA response is defined as: 1) at least 1 gradation of improvement in baseline BILAG 2004 scores in all body systems with moderate disease activity at entry (eg, all B [moderate disease] scores falling to C [mild], or D [no activity]); 2) no new BILAG A or more than 1 new BILAG B scores; 3) no worsening of total SLEDAI-2K score from baseline; 4) ≤ 10% deterioration in PGA score; and 5) no treatment failure. The PGA is measured on a 0 to 100 mm scale with score 0 to be No Disease Activity and score 100 to be the most Severe Disease Activity.
Measured: Day 210
Phase 2: Number of Participants With a Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Response at Day 210
The CLASI is a comprehensive tool for assessment of disease activity (CLASI-A) in cutaneous lupus, shown to be valid, reliable, and sensitive to changes in disease activity. Response is defined as at least 50% improvement from baseline in "A" scores. This assessment was applied to all participants as all were required to have cutaneous disease activity. The total score represents the sum of the individual scores and ranges from 0 to 70. Higher scores are awarded for more severe manifestations.
Measured: Day 210
Phase 2: Number of Participants With Medication Failures
Effect of BOS161721 compared with placebo for response on clinical indicators of SLE activity was assessed in adult participants with moderate to severe SLE on limited background standard of care treatment.
Measured: Days 30, 60, 90, 120, 150, 180, and 210
Phase 2: Mean Change From Baseline in CLASI at Day 210
The CLASI is a comprehensive tool for the assessment of disease activity (CLASI-A) and damage (CLASI-B) in cutaneous lupus, shown to be valid, reliable, and sensitive to changes in disease activity. Response is defined as 50% improvement from baseline in "A" or "B" scores. This assessment was applied to all participants as all were required to have cutaneous disease activity. The total score represents the sum of the individual scores and ranges from 0 to 70 (CLASI-A) and 0 to 58 (CLASI-B). Higher scores are awarded for more severe manifestations. Change from baseline was calculated as the post-baseline value minus the baseline value.
Measured: Baseline, Day 210
Phase 2: Mean Change From Baseline in PGA
The PGA is used to assess Investigator's general impression on the patient's overall status of SLE disease activity via visual analogue scale (100 mm) with 0 being "very good, asymptomatic and no limitation of normal activities" with 100 mm being "most severe possible disease ever seen in all SLE patients".
Measured: Baseline, Day 210
Phase 2: Mean Change From Baseline in the Total Number of Swollen Joints, Tender Joints, and Active Joints (Swelling and Tenderness in the Same Joint) in the American College of Rheumatology-28 (ACR-28) Joint Count
The ACR-28 joint count evaluated the number of tender and swollen joints in the shoulder, elbow, wrist, hand, and knee joints. Joints of the feet were excluded. Change from baseline was calculated as the post-baseline value minus the baseline value.
Measured: Baseline, Day 210
Phase 2: Mean Change From Baseline in SLEDAI-2K at Day 210
The SLEDAI-2K is a validated instrument that measures disease activity in SLE participants at the time of the visit and in the previous 30 days. It is a global index and includes 24 clinical and laboratory variables that are weighted by the type of manifestation, but not by severity. The total score falls between 0 and 105, with higher scores representing increased disease activity. A SLEDAI -2K of 6 or more generally represents moderately to severely active disease.
Change from baseline was calculated as the post-baseline value minus the baseline value.
Measured: Baseline, Day 210
Phase 2: Mean Change From Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index
The SLICC/ACR damage index is a validated instrument to assess damage, defined as irreversible impairment, continuously persistent for 6 months (ascertained by clinical assessment), occurring since the onset of lupus, and it is based on a weighted scoring system. This index records damage occurring in participants with SLE regardless of cause, with demonstrated content, face, criterion, and discriminant validity. A score of 0=no damage. Total maximum score is 47 and increasing score indicates increasing disease severity.
Measured: Baseline; Day 180
Phase 2: Time to Medication Failure
Participants who received prohibited medications or undergo unallowable corticosteroid (CS) usage were considered "medication failures".
Measured: Up to Day 270
Mean Percent Change in CS Administration From the Baseline Day 0 Dose Through Day 210 in Participants Receiving ≥ 7.5 mg/Day Prednisone Equivalent at Day 0
The percent reduction in CS administration from Day 0 through Day 210 was determined based on the average daily CS usage.
Measured: Baseline; Day 210
Phase 2: Duration of Longest SRI-4 Response
The SRI-4 is a composite index of SLE disease improvement that consists of scores derived from SLEDAI-2K, BILAG 2004 Index and PGA. Response based on the SRI-4 is defined by: 1) ≥ 4-point reduction in the SLEDAI-2K total score; 2) no new severe disease activity (BILAG A organ score) or more than 1 new moderate organ score (BILAG B) compare with baseline; and 3) no deterioration from baseline in the PGA by ≥ 30 millimeters. The total SLEDAI-2K score falls between 0 and 105, with higher scores representing increased disease activity. The PGA is used to assess Investigator's general impression on the patient's overall status of SLE disease activity via visual analogue scale (100 mm) with 0 being "very good, asymptomatic and no limitation of normal activities" with 100 mm being "most severe possible disease ever seen in all SLE patients". The SRI-4 response in participants with moderate to severe SLE is associated with broad improvements in clinical and participant-reported outcomes.
Measured: Up to Day 270
Phase 2: Time to First BILAG Flare (≥ 1 New or Recurrent BILAG A or > 1 New or Recurrent BILAG B) Relative to Baseline Through Day 210
The BILAG-2004 index is an organ-specific 97-question assessment based on the principle of the doctor's intent to treat. Only clinical features attributable to SLE disease activity were recorded and based on the participant's condition in the last 4 weeks compared with the previous 4 weeks. It was scored as not present (0), improved (1), the same (2), worse (3), or new (4). Disease activity was graded separately for 9 body systems to 5 different grades (A to E) as follows: A is very active disease, B is moderate activity, C is mild stable disease, D is inactive now but previously active, and E indicates the organ was never involved. A shift from BILAG-2004 Grade A or B to a lower grade indicates a clinically relevant change in disease activity as the BILAG-2004 grades mirror the decision points for treatment interventions.
Measured: Baseline; Day 210
Phase 2: Number of Participants With AEs
The safety and tolerability of repeat doses of BOS161721 (120 mg) administered SC were assessed in adult participants with moderate to severe SLE on limited background standard of care treatment.
Measured: Up to Day 270
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start10 Jan 2018
- Primary completion26 Nov 2020
- Study completion26 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371251
- Sponsor's protocol ID
- BOS161721-02
- Status last verified
- Feb 2022
- First submitted
- 8 Dec 2017
- Last updated
- 14 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Ahmad SB, Jefferson JA. Targeting B Cells and Plasma Cells in Glomerular Disease. J Am Soc Nephrol. 2025 Jun 4;36(9):1844-1857. doi: 10.1681/ASN.0000000772.
PubMed 40465397
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Phase 1b/2 Combined Staggered Multiple Dose Escalation Study of BOS161721 in Systemic Lupus Erythematosus (SLE) Patients on a Background of Limited Standard of Care
- ClinicalTrials.gov ID
- NCT03371251
- Acronym / sponsor ID
- BOS161721-02
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Adults, BOS161721, standard of care, moderately to severely active Systemic Lupus Erythematosus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Boston PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 26 Nov 2020 (actual)
- Study completion
- 26 Nov 2020 (actual)
- First posted
- 13 Dec 2017 (actual)
- Results
- Posted 14 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be conducted to assess the safety, tolerability, and immunogenicity of repeat doses of BOS161721 (20 milligrams [mg], 60 mg, and 120 mg) administered subcutaneously in adult participants with moderately to severely active Systemic Lupus Erythematosus (SLE) on limited background standard of care treatment, in order to estimate the optimal dose.
BOS161721 at the chosen dose will be compared to placebo for response on the SLE Responder Index 4, with sustained reduction of oral corticosteroids, in the same participant population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 1b: BOS161721 20, 60, 120 mg | Experimental | Drug: BOS161721Participants will be randomized to receive a 20 milligram (mg), 60 mg, or 120 mg subcutaneous (SC) dose of BOS161721. Participants may receive a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270. |
| Phase 1b: Placebo 20, 60, 120 mg | Placebo comparator | Drug: PlaceboParticipants will be randomized to receive a 20 mg, 60 mg, or 120 mg SC dose of placebo. Participants may receive a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270. |
| Phase 2: BOS161721 | Experimental | Drug: BOS161721Participants will be randomized to receive a 120 mg SC dose of BOS161721 (as determined from Phase 1b of the study). Participants may receive a total of 7 SC monthly doses of BOS161721 on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270. |
| Phase 2: Placebo | Placebo comparator | Drug: PlaceboParticipants will be randomized to receive a 120 mg SC dose of placebo (as determined from Phase 1b of the study). Participants may receive a total of 7 SC monthly doses of placebo on Days 0, 30, 60, 90, 120, 150, and 180, followed by safety follow-up visits on at Days 210, 240, and 270. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Men and women, ages 18 to 70 years, inclusive
- Participants must be mentally capable of giving consent and there must be evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study
- Participants must have Systemic Lupus Erythematosus (SLE) as defined by meeting 4 of the Systemic Lupus International Collaborating Clinics classification criteria for SLE (with at least 1 clinical and 1 immunologic criterion OR Lupus nephritis as the sole clinical criterion in the presence of anti-nuclear antibodies (ANA) or anti-double stranded deoxyribonucleic acid (dsDNA) antibodies), either sequentially or simultaneously
- At screening, participants must have at least 1 of the following:
- At screening, the total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score must be ≥ 8, including points from at least 1 of the following clinical components:
Key exclusion criteria (38 listed)
- Drug-induced SLE, rather than "idiopathic" SLE
- Other systemic autoimmune disease (eg, erosive arthritis, rheumatoid arthritis [RA], multiple sclerosis [MS], systemic sclerosis, or vasculitis not related to SLE). RA-Lupus overlap (Rupus), and secondary Sjogren syndrome are allowed.
- Any major surgery within 6 weeks of study drug administration (Day 0) or any elective surgery planned during the course of the study
- Any history or risk for tuberculosis (TB), specifically those with:
- Active or unstable lupus neuropsychiatric manifestations, including but not limited to any condition defined by BILAG A criteria, with the exception of mononeuritis multiplex and polyneuropathy, which are allowed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BOS161721SC administration | Drug | Phase 1b: BOS161721 20, 60, 120 mg, Phase 2: BOS161721 |
| PlaceboSC administration | Drug | Phase 1b: Placebo 20, 60, 120 mg, Phase 2: Placebo |
Primary outcome
Phase 1b: Number of Participants With Adverse Events (AEs)
Time frame: Up to Day 270
The safety, tolerability, and immunogenicity of repeat doses of BOS161721 (20, 60, and 120 mg) administered SC were assessed in adult participants with moderate to severe SLE on limited background standard of care treatment, in order to estimate the optimal dose.
Phase 2: Number of Participants With an SLE Responder Index 4 (SRI-4) Response at Day 210
Time frame: Day 210
The SRI-4 is a composite index of SLE disease improvement that consists of scores derived from the SLE Disease Activity Index 2000 (SLEDAI-2K), the British Isles Lupus Assessment Group (BILAG) 2004 Index and the Physician's Global Assessment (PGA). Response based on the SRI-4 is defined by: 1) ≥ 4-point reduction in the SLEDAI-2K total score; 2) no new severe disease activity (BILAG A organ score) or more than 1 new moderate organ score (BILAG B) compared with baseline; and 3) no deterioration from baseline in the PGA by ≥ 30 millimeters. The SLEDAI-2K total score falls between 0 and 105, with higher scores representing increased disease activity.The SRI-4 response in participants with moderate to severe SLE is associated with broad improvements in clinical and participant-reported outcomes.
31 secondary outcomes
Phase 1b: Maximum Observed Concentration (Cmax)
Time frame: Pre-dose: Days 0, 30, 60, 90, 120, 150, and 180. Post-dose: Days 0, 7, 15, 30, 180, 187, 195, 210, 240, and 270. Post-dose samples were collected at 4, 8, and 24 hours after study drug administration on Days 0, 30, and 180
Phase 1b: First Time to Maximum Concentration (Tmax)
Time frame: Pre-dose: Days 0, 30, 60, 90, 120, 150, and 180. Post-dose: Days 0, 7, 15, 30, 180, 187, 195, 210, 240, and 270. Post-dose samples were collected at 4, 8, and 24 hours after study drug administration on Days 0, 30, and 180
Phase 1b: The Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Quantifiable Concentration (AUClast)
Time frame: Pre-dose: Days 0, 30, 60, 90, 120, 150, and 180. Post-dose: Days 0, 7, 15, 30, 180, 187, 195, 210, 240, and 270. Post-dose samples were collected at 4, 8, and 24 hours after study drug administration on Days 0, 30, and 180
Phase 1b: Terminal Elimination Half-life (t1/2)
Time frame: Pre-dose: Days 0, 30, 60, 90, 120, 150, and 180. Post-dose: Days 0, 7, 15, 30, 180, 187, 195, 210, 240, and 270. Post-dose samples were collected at 4, 8, and 24 hours after study drug administration on Days 0, 30, and 180
Phase 1b: Apparent Plasma Clearance After Extravascular Administration (CL/F)
Time frame: Pre-dose: Days 0, 30, 60, 90, 120, 150, and 180. Post-dose: Days 0, 7, 15, 30, 180, 187, 195, 210, 240, and 270. Post-dose samples were collected at 4, 8, and 24 hours after study drug administration on Days 0, 30, and 180
Phase 1b: Apparent Volume of Distribution After Extravascular Administration (Vz/F)
Time frame: Pre-dose: Days 0, 30, 60, 90, 120, 150, and 180. Post-dose: Days 0, 7, 15, 30, 180, 187, 195, 210, 240, and 270. Post-dose samples were collected at 4, 8, and 24 hours after study drug administration on Days 0, 30, and 180
Phase 1b: Mean Change From Baseline in Phosphorylated Signal Transducer and Activator of Transcription 3 (pSTAT3)
Time frame: Baseline (Day 0); Days 30, 44, 60, and 90 (pre-dose [trough] samples only)
Phase 1b: Mean Change From Baseline in Complement 3 (C3) and Complement (C4) Levels
Time frame: Baseline (Day 0); Day 210
Phase 1b: Mean Change From Baseline in Leukocyte Immunophenotype
Time frame: Baseline (Day 0); Day 180
Phase 1b: Mean Change From Baseline in Anti-double-stranded DNA (dsDNA) Autoantibodies at Each Visit
Time frame: Baseline (Day 0); Days 30, 60, 90, 120, 150, 180, 210, 240, and 270
Phase 1b: Mean Change From Baseline in Anti-Sjögren's Syndrome A and B (SSA, SSB)
Time frame: Baseline (Day 0); Day 180
Phase 1b: Mean Change From Baseline in Anti-Smith Antibody (Sm)
Time frame: Baseline (Day 0); Day 180
Phase 1b: Mean Change From Baseline in Antiphospholipid (APL) Autoantibodies (Beta 2 Glycoprotein, Cardiolipin IgG)
Time frame: Baseline (Day 0); Day 180
Phase 1b: Mean Change From Baseline in Abrogation of IL-21 Gene Signature
Time frame: Baseline (Day 0); Days 15, 90, 180, and 270
Phase 2: Number of Participants With an SRI-4, SRI-5, and SRI-6 Response at Each Visit
Time frame: Days 30, 60, 90, 120, 150, 180, 210, 240, and 270
Phase 2: Number of Participants With a Sustained Reduction From Baseline of Oral Corticosteroid (CS) (≤ 7.5 mg/Day and < Day 0 Dose) Between Day 150 and Day 210
Time frame: Day 150 to Day 210
Phase 2: Number of Participants With New or Recurrent BILAG Flares (≥ 1 Qualifying BILAG A or > 1 Qualifying BILAG B) Through Day 210
Time frame: Days 30, 60, 90, 120, 150, 180, 210
Phase 2: Number of Participants With Physician's Global Assessment (PGA) Worsening
Time frame: Days 30, 60, 90, 120, 150, 180, and 210
Phase 2: Number of Participants With a BILAG-based Composite Lupus Assessment (BICLA) Response at Day 210
Time frame: Day 210
Phase 2: Number of Participants With a Cutaneous Lupus Erythematosus Area and Severity Index (CLASI) Response at Day 210
Time frame: Day 210
Phase 2: Number of Participants With Medication Failures
Time frame: Days 30, 60, 90, 120, 150, 180, and 210
Phase 2: Mean Change From Baseline in CLASI at Day 210
Time frame: Baseline, Day 210
Phase 2: Mean Change From Baseline in PGA
Time frame: Baseline, Day 210
Phase 2: Mean Change From Baseline in the Total Number of Swollen Joints, Tender Joints, and Active Joints (Swelling and Tenderness in the Same Joint) in the American College of Rheumatology-28 (ACR-28) Joint Count
Time frame: Baseline, Day 210
Phase 2: Mean Change From Baseline in SLEDAI-2K at Day 210
Time frame: Baseline, Day 210
Phase 2: Mean Change From Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index
Time frame: Baseline; Day 180
Phase 2: Time to Medication Failure
Time frame: Up to Day 270
Mean Percent Change in CS Administration From the Baseline Day 0 Dose Through Day 210 in Participants Receiving ≥ 7.5 mg/Day Prednisone Equivalent at Day 0
Time frame: Baseline; Day 210
Phase 2: Duration of Longest SRI-4 Response
Time frame: Up to Day 270
Phase 2: Time to First BILAG Flare (≥ 1 New or Recurrent BILAG A or > 1 New or Recurrent BILAG B) Relative to Baseline Through Day 210
Time frame: Baseline; Day 210
Phase 2: Number of Participants With AEs
Time frame: Up to Day 270
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40465397Ahmad SB, Jefferson JA. Targeting B Cells and Plasma Cells in Glomerular Disease. J Am Soc Nephrol. 2025 Jun 4;36(9):1844-1857. doi: 10.1681/ASN.0000000772.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
68 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BOS161721 in people with Systemic Lupus Erythematosus, run by Boston Pharmaceuticals at 68 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in United States, Poland, Colombia, Georgia, Peru and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1b: Number of Participants With Adverse Events (AEs) (time frame: Up to Day 270). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03371251, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.