Lupus Erythematosus, SystemicPhase 3LUPUZORNCT02504645
A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus
A Phase 3 study testing IPP-201101 in people with Lupus Erythematosus, Systemic, run by ImmuPharma at 30 sites in 8 countries.
Trial summary
This current Phase 3 study will evaluate the efficacy and safety of administration of subcutaneous (sc) IPP-201101 in patients with active SLE. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- IPP-201101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 30 sitesin 8 countries
- Study dates
- Mar 2015to Jan 2018
- Phase
- Phase 3
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
- The patient is a man or woman between 18 and 70 years of age with an established diagnosis of SLE as defined by ACR Classification Revised Criteria. The diagnosis is fulfilled provided that at least 4 criteria are met.
- The patient has a positive test result for ANA at screening (titer must be at least 1:80 [by human epithelial cell tumor line (HEp-2) ANA assay]) and/or a positive test result for anti-dsDNA Ab at screening (value must be 30 IU/mL or more by enzyme-linked immunosorbent assay [ELISA]).
- Written informed consent is obtained.
- Women must be surgically sterile, 2 years postmenopausal, or, if of childbearing potential, using a medically accepted method of contraception, and must agree to continued use of this method for the duration of the study and for 30 days after discontinuation of study drug treatment. Acceptable methods of contraception include barrier method with spermicide, abstinence (when this is in line with the preferred and usual lifestyle of the subject), intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method.
- The patient has a SLEDAI-2K clinical score of at least 6 points during screening. A SLEDAI-2K clinical score is the calculated score without inclusion of the points that may be contributed by having a positive titer for anti-dsDNA Ab or decreased serum complement levels.
- The patient does not have an "A" score on the BILAG-2004 scale. If the patient is using oral corticosteroids, the weekly cumulative dose must not exceed 80 mg of prednisone equivalent; the weekly dose must be stable over the 4 weeks preceding the 1st dose of study drug.
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- If the patient is using antimalarials, methotrexate, leflunomide, mycophenolate mofetil (MMF), or azathioprine, the start date must be at least 3 months prior to the 1st dose of study drug, and the daily dose must be stable over the 4 weeks preceding the 1st dose of study drug.
- If the patient is not currently using corticosteroids, antimalarials, methotrexate, MMF, or azathioprine, the last dose (in case of previous use) must be at least 4 weeks prior to the 1st dose of study drug. For leflunomide, the stop date must be at least 8 weeks before the 1st dose of study drug unless an adequate cholestryamine washout has been performed. If cholestyramine washout is performed, the last use of leflunomide must be at least 4 weeks before the 1st dose of study drug.
- The patient must be willing and able to comply with study restrictions, to remain at the study center for the required duration during each study visit, and to return to the study center for the final assessment as specified in this protocol.
Who cannot join
- The patient has been treated with intramuscular or intravenous (iv) pulse steroids (ie, 250 to 1000 mg iv total daily dose of methylprednisolone) within 4 weeks of the 1st dose of study drug. The use of intra-articular steroids may be allowed after consultation with the medical expert.
- The patient has received tacrolimus, cyclosporin A, or iv immunoglobulins (IVIG) within 3 months of the 1st dose of study drug.
- The patient has received cyclophosphamide within 6 months prior to the 1st dose of study drug.
- The patient has been treated for SLE with agents such as fusion proteins, therapeutic proteins, or monoclonal antibodies or antibody fragments, within 6 months of the 1st dose of study drug.
- The patient has received B-cell depleting agents such as rituximab, belimumab or epratuzumab within one year of the 1st dose and has not yet normalized the B-cell count (ie, CD20+ B-cell count is less than normal range and the absolute lymphocyte count [ALC] is less than normal range).
- The patient has New York Heart Association (NYHA) Class III or IV congestive heart failure.
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- The patient has an estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73 m2 (via Modification of Diet in Renal Disease [MDRD] equation).
- The patient has an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value greater than 2 times the upper limit of the normal range (ULN) or a total bilirubin level greater than 1.5 times ULN.
- The patient has a planned immunization with a live or live attenuated vaccine within 3 months prior to administration of the 1st dose of study drug and for 3 months after administration of the last dose of study drug.
- The patient has any clinically significant abnormalities on ECG that are not related to SLE, as determined by the investigator. Patients with stable ECG changes without evidence of active cardiovascular disease may participate at the discretion of the investigator and medical monitor.
- The patient has an ongoing active systemic infection requiring treatment or a history of severe infection, such as hepatitis or pneumonia, in the 3 months prior to administration of the 1st dose of study drug. Less severe infections in the 3 months prior to administration of the 1st dose of study drug are permitted at the discretion of the investigator and medical monitor.
- The patient has any concomitant medical condition unrelated to SLE that may interfere with his or her safety or with evaluation of the study drug, as determined by the investigator.
- The patient has a history of a medical condition other than SLE that has required treatment with oral corticosteroids in excess of 80 mg of prednisone equivalent/week within 3 months of the 1st dose of study drug.
- The patient has a positive test result for hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab).
- The patient has a known positive history of antibodies to human immunodeficiency virus (HIV) or HIV disease or other immunosuppressive state (eg, agammaglobulinemia, etc).
- The patient has a history of alcohol or substance dependence or abuse (with the exception of nicotine),according to the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association, Fourth Edition, Text Revision (DSM-IV-TR), within 3 months of the screening visit or has current substance abuse.
- The patient has a history of severe allergic reactions to or hypersensitivity to any component of the study drug or placebo.
- The patient has undergone or is undergoing treatment with another investigational drug for the treatment of lupus within 6 months prior to the 1st dose of study drug or has received any other investigational drug for any other condition within 4 weeks prior to the 1st dose of study drug.
- The patient has previously participated in a ImmuPharma- or ImmuPharma-sponsored clinical study with IPP-201101.
- The patient is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
- The patient is unlikely to comply with the study protocol or is unsuitable for any other reason, as judged by the investigator or medical monitor.
Trial locations and contacts
30 sites in 8 countries.
30 sites in 8 countries
United States9 sites
Arthritis and Rheumatic Disease Specialties
Aventura, Florida
Thurston Arthritis Research Center
Chapel Hill, North Carolina
DJL Clinical Research, PLLC
Charlotte, North Carolina
Denver Arthritis Clinic
Denver, Colorado
Innovative Health Research
Las Vegas, Nevada
WALLACE
Los Angeles, California
East Bay Rheumatology Medical
San Leandro, California
Arthritis Research & Treatment Center
Stockbridge, Georgia
McILwain Medical Group
Tampa, Florida, 33614
France7 sites
Hopital Haut Lévêque
Bordeaux
Hôpital européen
Marseille
GHR Mulhouse Sud-Alsace
Mulhouse
Hôpital Cochin
Paris
CHU Felix Guyon
Saint-Denis, La Réunion
CHU Strasbourg Hôpital de Hautepierre
Strasbourg
CHU Strasbourg Nouvel Hôpital Civil
Strasbourg
Hungary4 sites
Egyesitett Szt.István és Szt. László Kórház
Budapest, 1097
University of Debrecen Medical Center Department of Clinical Immunology
Debrecen
Synexus Gyula AS
Gyula, 5700
Mentaház Magánorvosi Központ Kft.
Székesfehérvár, 8000
Poland4 sites
Centrum Medyczne Plejady
Krakow
Krakowskie Centrum Medyczne
Krakow
Centrum Medyczne Hetmańska
Poznan
Centrum Medyczne Oporow
Wroclaw
Czechia2 sites
Revmatologie s.r.o.
Brno
Revmatologický ústav v Praze
Prague, 128 50
Germany2 sites
Schlosspark-Klinik Berlin
Berlin
Clinic for Rheumatology and Internal Medicine
Freiburg im Breisgau
About this study
This current Phase 3 study will evaluate the efficacy and safety of administration of subcutaneous (sc) IPP-201101 in patients with active SLE.
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- IPP-201101, Placebo, Standard of Care
- 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.
IPP-201101Drug
Also called Lupuzor, regiremod
PlaceboDrug
Standard of CareOther
| Study group | Role | What they receive |
|---|---|---|
| IPP-201101 200-mcg plus SOC | Active comparator | Patients randomly assigned to IPP-201101 will be administered a dosage of 200 mcg subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered). Receives: Drug: IPP-201101; Other: Standard of Care |
| PLACEBO plus SOC | Placebo comparator | Patients randomly assigned to placebo will be administered placebo subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered). Receives: Drug: Placebo; Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Systemic Lupus Erythematosus Responder Index (SRI) at Week 52
A Systemic lupus erythematosus Responder Index (SRI) response is defined as a reduction from baseline in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of at least 4 points, no worsening in Physician's Global Assessment (PhGA) (with worsening defined as an increase in PhGA of more than 0.30 point from baseline), no new British Isles Lupus Assessment Group A (BILAG A) body system score, and no more than 1 new BILAG B body system score from baseline.
The decrease of 4 points of the SRI is considered as better ouctome.
Measured: At week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startMar 2015
- Primary completionJan 2018
- Study completionJan 2018
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.
- Other trials for Lupus Erythematosus, SystemicStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmuPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel WALLACE, Principal investigator, Wallace Rheumatic Studies Center LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02504645
- Sponsor's protocol ID
- IPP-201101/005
- Acronym
- LUPUZOR
- Status last verified
- Apr 2019
- First submitted
- 17 Jul 2015
- Last updated
- 11 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No