Systemic Lupus ErythematosusPhase 2NCT02908100
A Study of the Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
A Phase 2 study testing GDC-0853 in people with Systemic Lupus Erythematosus, run by Genentech, Inc. at 70 sites in 12 countries.
Trial summary
This is a study to evaluate the safety and efficacy of GDC-0853 in combination with standard of care therapy in participants with moderate to severe active systemic lupus erythematosus (SLE). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- GDC-0853
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 70 sitesin 12 countries
- Study dates
- 19 Jan 2017to 16 Jul 2019
- Phase
- Phase 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fulfillment of SLE classification criteria according to either American College of Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics (SLICC) criteria at any time prior to or at screening
- At least one serologic marker of SLE at screening as follows: positive antinuclear antibody (ANA) test by immunofluorescent assay with titer >/= 1:80; or positive anti-double-stranded DNA (anti-dsDNA) antibodies; or positive anti-Smith antibody
- At both screening and Day 1, moderate to severe active SLE, defined as meeting all of the following unless indicated otherwise: Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 8 (at screening only) with clinical SLEDAI-2K score >/= 4.0 (at both screening and Day 1), Physician's Global Assessment >/= 1.0 (out of 3), and currently receiving at least one standard oral treatment for SLE
- If on oral corticosteroids (OCS), the dose must be </= 40 mg/day prednisone (or equivalent)
- Stable doses of anti-malarial or immunosuppressive therapies
- Participants must be willing to avoid pregnancy
Who cannot join
- Proteinuria > 3.5 g/24 h or equivalent using urine protein-to-creatinine ratio (uPCR) in a first morning void urine sample
- Active proliferative lupus nephritis (as assessed by the investigator) or histological evidence of active Class III or Class IV lupus nephritis on renal biopsy performed in the 6 months prior to screening (or during the screening period)
- History of having required hemodialysis or high dose corticosteroids (>100 mg/d) prednisone or equivalent) for the management of lupus renal disease within 90 days of Day 1
- Neuropsychiatric or central nervous system lupus manifestations
- Serum creatinine > 2.5 mg/dL, or estimated glomerular-filtration rate < 30 milliliter per minute (mL/min) or on chronic renal replacement therapy
- History of receiving a solid organ transplant
Show all 11Show fewer
- Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis (TB)
- Significant and uncontrolled medical disease within the 12 weeks prior to screening in any organ system (e.g., cardiac, neurologic, pulmonary, renal, hepatic, endocrine, metabolic, gastrointestinal, or psychiatric) not related to SLE, which, in the investigator's or Sponsor's opinion, would preclude study participation
- History of cancer, including hematological malignancy and solid tumors, within 10 years of screening
- Need for systemic anticoagulation with warfarin, other oral or injectable anticoagulants, or anti-platelet agents
- Evidence of chronic and/or active hepatitis B or C
Trial locations and contacts
70 sites in 12 countries.
70 sites in 12 countries
United States19 sites
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102
Tekton Research Inc
Austin, Texas, 78745
Ochsner Clinic Foundation
Baton Rouge, Louisiana, 70809
University of Alabama at Birmingham
Birmingham, Alabama, 35294
RASF-Clinical Research Center
Boca Raton, Florida, 33486
Bay Area Arthritis and Osteoporosis
Brandon, Florida, 33511
Saint Lawrence Health System
Canton, New York, 13617
Ohio State University Clinical Trials Management Office
Columbus, Ohio, 43210
Accurate Clinical Research
Houston, Texas, 77058-3675
Accurate Clinical Research
Houston, Texas, 77089
Institute of Arthritis Research
Idaho Falls, Idaho, 83404
Valerius Medical Group & Research Ctr of Greater Long Beach
Los Alamitos, California, 90720
The Arthritis & Diabetes Clinic, Inc.; Research
Monroe, Louisiana, 71203
New York University School of Medicine
New York, New York, 10016
Omega Research Consultants
Orlando, Florida, 32810
Shanahan Rheumatology & Immunology, PLLC
Raleigh, North Carolina, 27617
Arthritis Clinic Of Central Texas
San Marcos, Texas, 78666
Clinical Research of West Florida
Tampa, Florida, 33603
Via Christi Research, a division of Via Christi Hospitals Wichita, Inc.
Wichita, Kansas, 67208
Brazil11 sites
Hospital das Clinicas - UFMG
Belo Horizonte, Minas Gerais, 31270-901
Edumed - Educação e Saúde SA
Curitiba, Paraná, 80440-080
CIP - Centro Internacional de Pesquisa X; Pesquisa Clinica
Goiânia, Goiás, 74110-120
Clinica de Neoplasias Litoral
Itajaí, Santa Catarina, 88301-220
CMiP - Centro Mineiro de Pesquisa*X*
Juiz de Fora, Minas Gerais, 36010-570
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90035-001
Centro de Pesquisas em Diabetes - CPD
Porto Alegre, Rio Grande do Sul, 90035-170
Faculdade de Medicina do ABC - FMABC
Santo André, São Paulo, 09060-650
Hospital Estadual Mario Covas
Santo André, São Paulo, 09190-610
Hospital Abreu Sodré - AACD
São Paulo, São Paulo, 04023-000
CEDOES - Diagnóstico e Pesquisa
Vitória, Espírito Santo, 29055-450
Bulgaria6 sites
MHAT Plovdiv
Plovdiv, 4003
Medical Center "Teodora", EOOD
Rousse, 7000
Medical Center Excelsior OOD
Sofia, 1000
UMHAT "Sv. Ivan Rilski", EAD
Sofia, 1431
MC "Synexus - Sofia", EOOD
Sofia, 1784
Medical Center "Nov Rehabilitatsionen Tsentar", EOOD
Stara Zagora, 6000
Colombia6 sites
CEQUIN - Fundación Cardiomet Eje Cafetero
Armenia, 00000
Centro Integral de Reumatologia del Caribe SAS CIRCARIBE SAS
Barranquilla, 00000
Centro de Reumatologia y Ortopedia
Barranquilla, 80020
Medicity S.A.S.
Bucaramanga, 680003
Servimed S.A.S.
Bucaramanga, 680003
Hospital Pablo Tobon Uribe
Medellín, 050034
Mexico6 sites
Consultorio Particular del Dr. Miguel Cortes Hernandez
Cuernavaca, 62290
Unidad de Atencion Medica e Investigacion en Salud S.C.
Mérida, Yucatán, 97000
Hospital Angeles Lindavista
México, 07760
Hospital Universitario de Saltillo
Saltillo, 25000
Hospital Central Dr Ignacio Morones Prieto
San Luis Potosí City, 78240
Centro de Investigacion Alberto Bazzoni S.A. de C.V.
Torreón, Coahuila, 27000
Argentina5 sites
Organizacion Medica de Investigacion
Buenos Aires, C1015ABO
APRILLUS
Buenos Aires, C1194AAO
Hospital Italiano de La Plata
La Plata, 1900
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
San Juan, 5400
Centro Medico Privado de Reumatologia; Reumathology
San Miguel, T4000AXL
Chile5 sites
CTR Estudios SPA
Providencia, 7500571
Dermacross
Santiago, 66901
Centro de Estudios Reumatológicos
Santiago, 7501126
SOMEAL
Santiago, 7510186
Biomedica
Santiago
Spain4 sites
Complejo Hospitalario Universitario A Coruña
A Coruña, LA Coruña, 15006
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital General Universitario Gregorio Marañon
Madrid, 28007
Hospital Clinico Universitario de Valladolid; Servicio de Reumatologia
Valladolid, 47005
Taiwan3 sites
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 00833
National Taiwan University Hospital
Taipei, 10002
Chang Gung Memorial Hospital - Linkou
Taoyuan, 333
South Korea2 sites
Konkuk University Medical Center
Seoul, 05030
The Catholic University of Korea St.Mary's Hospital
Seoul, 150-713
United Kingdom2 sites
University College London Hospital
London, NW1 - 2PG
Guy's Hospital; Louise Coote Lupus Unit
London, SE1 9RT
Germany1 site
Charite Research Organisation GmbH; Phase - I Unit of Hematology and Oncology
Berlin, 12200
About this study
Official title: A Phase II, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus
This is a study to evaluate the safety and efficacy of GDC-0853 in combination with standard of care therapy in participants with moderate to severe active systemic lupus erythematosus (SLE).
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- GDC-0853, Placebo
- 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.
GDC-0853Drug
Also called RO7010939
Participants received GDC-0853 at dosages of 150 or 200mg as per the dosing schedules described above.
PlaceboDrug
Participants received matching placebo to GDC-0853 at dosages of 150 and 200mg as per the dosing schedules described above.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received matching placebo to GDC-0853 orally starting on Day 1 and ending at Week 48, in combination with background standard of care therapy. Receives: Drug: Placebo |
| GDC-0853 (150mg) QD | Experimental | Participants received GDC-0853 (150mg) orally once daily (QD) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy. Receives: Drug: GDC-0853 |
| GDC-0853 (200mg) BID | Experimental | Participants received GDC-0853 (200mg) orally twice daily (BID) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy. Receives: Drug: GDC-0853 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic Lupus Erythematosus Responder Index (SRI)-4 Response at Week 48
The Systemic Lupus Erythematosus Responder Index (SRI)-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points [10 mm] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity.
Measured: Week 48
Secondary outcomes (9)
SRI-4 Response at Week 48 With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to Less Than (<)10 Milligrams Per Day (mg/Day) and Less Than or Equal to (</=) Day 1 Dose During Week 36 Through Week 48
The SRI-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points [10 mm] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity. OCS tapering requires a sustained reduction of OCS from Week 36 through Week 48 [less than 10 milligram per day (mg/day) and less or equal to the dose received on Day 1].
Measured: Week 48
SRI-4 Response at Week 24 With a Sustained Reduction of OCS Dose to < 10 mg/Day and </= Day 1 Dose During Week 12 Through Week 24
The SRI-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points [10 mm] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity. OCS tapering requires a sustained reduction of OCS from Week 12 through Week 24 [less than 10 milligram per day (mg/day) and less or equal to the dose received on Day 1].
Measured: Week 24
SRI-4 Response at Week 24
The SRI-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points [10 mm] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity.
Measured: Week 24
SRI-4 Response at Week 48 in Patients With High vs. Low Plasmablast Signature Levels
The SRI-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points [10 mm] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity. The Plasmablast Signature (PB) is a Bruton's Tyrosine Kinase (BTK)-dependent blood RNA signature comprised of three genes (IgJ, MZB1 and TXNDC5). Q1/2/3/4 = Quartile 1/2/3/4.
Measured: Week 48
SRI-4 Response With a Sustained Reduction of OCS Dose to ≤ 10 mg/Day and ≤ Day 1 Dose During Week 36 Through 48 in Patients With High vs. Low Plasmablast Signature Levels
The SRI-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points [10 mm] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity. The Plasmablast Signature (PB) is a Bruton's Tyrosine Kinase (BTK)-dependent blood RNA signature comprised of three genes (IgJ, MZB1 and TXNDC5). Q1/2/3/4 = Quartile 1/2/3/4.
Measured: Week 48
SRI-6 Response at Week 24 and 48
The Systemic Lupus Erythematosus Responder Index (SRI)-6 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥6 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points [10 mm] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity.
Measured: Week 24, 48
BILAG-based Composite Lupus Assessment (BICLA) Response at Week 24 and 48
The BICLA is a composite index that is defined as follows: [1] At least one gradation of improvement in baseline BILAG scores in all body systems with moderate or severe disease activity at entry (e.g., all A (severe disease) scores falling to B (moderate), C (mild), or D (no activity) and all B scores falling to C or D; [2] No new BILAG A or more than one new BILAG B scores; [3] No worsening of total SLEDAI-2K score from baseline; [4] No significant deterioration (=<10%) in physician's global assessment and [5] No treatment failure (initiation of non-protocol treatment).
Measured: Week 24, 48
Percentage of Participants With Adverse Events (AEs)
An Adverse Event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Measured: Baseline up to 8 weeks after the last dose of study drug (up to Week 56).
Plasma Concentrations of Fenebrutinib at Specified Timepoints
The PK analyses includes tabulation of plasma concentration data and summarisation of plasma concentrations by visits with participants grouped according to treatment received. Descriptive summary statistics for the Arithmetic Mean and Standard Deviation are presented below.
Measured: Baseline (Pre-dose), Week 24 (Pre-dose and Post-dose) and Week 48 (Pre-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start19 Jan 2017
- Primary completion28 May 2019
- Study completion16 Jul 2019
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.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908100
- Sponsor's protocol ID
- GA30044
- Other IDs
- 2016-001039-11, 2016
- Status last verified
- May 2024
- First submitted
- 14 Sep 2016
- Last updated
- 8 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Isenberg D, Furie R, Jones NS, Guibord P, Galanter J, Lee C, McGregor A, Toth B, Rae J, Hwang O, Desai R, Lokku A, Ramamoorthi N, Hackney JA, Miranda P, de Souza VA, Jaller-Raad JJ, Maura Fernandes A, Garcia Salinas R, Chinn LW, Townsend MJ, Morimoto AM, Tuckwell K. Efficacy, Safety, and Pharmacodynamic Effects of the Bruton's Tyrosine Kinase Inhibitor Fenebrutinib (GDC-0853) in Systemic Lupus Erythematosus: Results of a Phase II, Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis Rheumatol. 2021 Oct;73(10):1835-1846. doi: 10.1002/art.41811. Epub 2021 Aug 24.
PubMed 34042314
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT02908100
- Acronym / sponsor ID
- GA30044
- Conditions
- Systemic Lupus Erythematosus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Jan 2017 (actual)
- Primary completion
- 28 May 2019 (actual)
- Study completion
- 16 Jul 2019 (actual)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Posted 7 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to evaluate the safety and efficacy of GDC-0853 in combination with standard of care therapy in participants with moderate to severe active systemic lupus erythematosus (SLE).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants received matching placebo to GDC-0853 orally starting on Day 1 and ending at Week 48, in combination with background standard of care therapy. |
| GDC-0853 (150mg) QD | Experimental | Drug: GDC-0853Participants received GDC-0853 (150mg) orally once daily (QD) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy. |
| GDC-0853 (200mg) BID | Experimental | Drug: GDC-0853Participants received GDC-0853 (200mg) orally twice daily (BID) starting on Day 1 and ending at Week 48, in combination with background standard of care therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Fulfillment of SLE classification criteria according to either American College of Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics (SLICC) criteria at any time prior to or at screening
- At least one serologic marker of SLE at screening as follows: positive antinuclear antibody (ANA) test by immunofluorescent assay with titer >/= 1:80; or positive anti-double-stranded DNA (anti-dsDNA) antibodies; or positive anti-Smith antibody
- At both screening and Day 1, moderate to severe active SLE, defined as meeting all of the following unless indicated otherwise: Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 8 (at screening only) with clinical SLEDAI-2K score >/= 4.0 (at both screening and Day 1), Physician's Global Assessment >/= 1.0 (out of 3), and currently receiving at least one standard oral treatment for SLE
- If on oral corticosteroids (OCS), the dose must be </= 40 mg/day prednisone (or equivalent)
- Stable doses of anti-malarial or immunosuppressive therapies
Key exclusion criteria (11 listed)
- Proteinuria > 3.5 g/24 h or equivalent using urine protein-to-creatinine ratio (uPCR) in a first morning void urine sample
- Active proliferative lupus nephritis (as assessed by the investigator) or histological evidence of active Class III or Class IV lupus nephritis on renal biopsy performed in the 6 months prior to screening (or during the screening period)
- History of having required hemodialysis or high dose corticosteroids (>100 mg/d) prednisone or equivalent) for the management of lupus renal disease within 90 days of Day 1
- Neuropsychiatric or central nervous system lupus manifestations
- Serum creatinine > 2.5 mg/dL, or estimated glomerular-filtration rate < 30 milliliter per minute (mL/min) or on chronic renal replacement therapy
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 |
|---|---|---|
| GDC-0853Also: RO7010939Participants received GDC-0853 at dosages of 150 or 200mg as per the dosing schedules described above. | Drug | GDC-0853 (150mg) QD, GDC-0853 (200mg) BID |
| PlaceboParticipants received matching placebo to GDC-0853 at dosages of 150 and 200mg as per the dosing schedules described above. | Drug | Placebo |
Primary outcome
Systemic Lupus Erythematosus Responder Index (SRI)-4 Response at Week 48
Time frame: Week 48
The Systemic Lupus Erythematosus Responder Index (SRI)-4 measures reduction in SLE disease activity and is a composite measure that includes the SLE Disease Activity Index (SLEDAI-2K), British Isles Lupus Activity Group (BILAG) 2004 and Physician Global Assessment. It is defined as: 1) Reduction of ≥4 points from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score; 2) no new British Isles Lupus Assessment Group (BILAG) A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points [10 mm] from baseline) in the Physician's Global Assessment of Disease Activity. The score range is from 0 to 100, with higher scores indicating greater disease activity.
9 secondary outcomes
SRI-4 Response at Week 48 With a Sustained Reduction of Oral Corticosteroids (OCS) Dose to Less Than (<)10 Milligrams Per Day (mg/Day) and Less Than or Equal to (</=) Day 1 Dose During Week 36 Through Week 48
Time frame: Week 48
SRI-4 Response at Week 24 With a Sustained Reduction of OCS Dose to < 10 mg/Day and </= Day 1 Dose During Week 12 Through Week 24
Time frame: Week 24
SRI-4 Response at Week 24
Time frame: Week 24
SRI-4 Response at Week 48 in Patients With High vs. Low Plasmablast Signature Levels
Time frame: Week 48
SRI-4 Response With a Sustained Reduction of OCS Dose to ≤ 10 mg/Day and ≤ Day 1 Dose During Week 36 Through 48 in Patients With High vs. Low Plasmablast Signature Levels
Time frame: Week 48
SRI-6 Response at Week 24 and 48
Time frame: Week 24, 48
BILAG-based Composite Lupus Assessment (BICLA) Response at Week 24 and 48
Time frame: Week 24, 48
Percentage of Participants With Adverse Events (AEs)
Time frame: Baseline up to 8 weeks after the last dose of study drug (up to Week 56).
Plasma Concentrations of Fenebrutinib at Specified Timepoints
Time frame: Baseline (Pre-dose), Week 24 (Pre-dose and Post-dose) and Week 48 (Pre-dose)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34042314Isenberg D, Furie R, Jones NS, Guibord P, Galanter J, Lee C, McGregor A, Toth B, Rae J, Hwang O, Desai R, Lokku A, Ramamoorthi N, Hackney JA, Miranda P, de Souza VA, Jaller-Raad JJ, Maura Fernandes A, Garcia Salinas R, Chinn LW, Townsend MJ, Morimoto AM, Tuckwell K. Efficacy, Safety, and Pharmacodynamic Effects of the Bruton's Tyrosine Kinase Inhibitor Fenebrutinib (GDC-0853) in Systemic Lupus Erythematosus: Results of a Phase II, Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis Rheumatol. 2021 Oct;73(10):1835-1846. doi: 10.1002/art.41811. Epub 2021 Aug 24.
Related trials for Systemic Lupus Erythematosus
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
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.
Clinical Trials study director
Hoffmann-La Roche
70 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GDC-0853 in people with Systemic Lupus Erythematosus, run by Genentech, Inc. at 70 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 6 inclusion and 11 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 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 sites in United States, Brazil, Bulgaria, Colombia, Mexico 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 phase mean?
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 7 Jul 2020). 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?
Systemic Lupus Erythematosus Responder Index (SRI)-4 Response at Week 48 (time frame: Week 48). 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 NCT02908100, 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 8 May 2024.