Clinical trial
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus
Name
CR109011
Description
The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active systemic lupus erythematosus (SLE).
Trial arms
Trial start
2021-08-20
Estimated PCD
2024-05-02
Trial end
2024-12-26
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Placebo
Placebo will be administered intravenously.
Arms:
Group 1: Placebo
Nipocalimab
Nipocalimab dose 1 and dose 2 will be administered intravenously.
Arms:
Group 2: Nipocalimab Dose 1, Group 3: Nipocalimab Dose 2
Other names:
JNJ-80202135, M281
Standard-of-care treatment
Standard-of-care treatment including immunomodulators, antimalarial drugs and GCs will be administered orally.
Arms:
Group 1: Placebo, Group 2: Nipocalimab Dose 1, Group 3: Nipocalimab Dose 2
Size
228
Primary endpoint
Percentage of Participants Achieving an Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 Composite Response at Week 24
Week 24
Eligibility criteria
Inclusion Criteria:
* Has a clinical diagnosis of systemic lupus erythematosus (SLE) greater than or equal to (\>=) 6 months prior to the screening visit and according to Systemic Lupus International Collaborating Clinics (SLICC)-2012 classification criteria: at least 4 criteria fulfilled, with at least 1 clinical criterion and 1 immunologic criterion
* Has at least 1 BILAG (british isles lupus assessment group) A and/or 2 BILAG B scores observed during screening
* Must have at least moderately active SLE, as defined as systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score \>= 6 at screening visit. Must also have SLEDAI 2K \>= 4 for clinical features (that is, SLEDAI-2K score excluding headache and laboratory abnormalities) present at Week 0 prior to randomization
* Has a CLASI (cutaneous lupus erythematosus disease area and severity index) activity score of at least 6 (excluding diffuse non-inflammatory alopecia) or at least 4 joints with pain and signs of inflammation (active joints) at screening or at Week 0, or both
* At least 1 unequivocally positive autoantibody test including antinuclear antibodies (ANA) (\>= 1:80) and/or anti-double stranded deoxyribonucleic acid (dsDNA) antibodies (level \>= 75 international units/milliliter \[IU/mL\]) and/or anti-Smith antibodies (\>120 Absorbance unit/milliliter \[AU/mL\]) detected during screening
* Must be receiving 1 or more of the following protocol-permitted, systemic standard-of-care treatments prior to first administration of study intervention at a stable dose: oral glucocorticoids, antimalarial or up to 2 immunomodulatory drugs
Exclusion Criteria:
* Current or history of, severe, progressive, or uncontrolled renal disease, with the exception of active lupus nephritis (LN). Have severe active LN as determined by sponsor (or designee) adjudication. Control of renal disease must be documented with at least 2 measurements of proteinuria or urine protein/creatinine ratio (UPCR) over the 6 months prior to screening
* Has any unstable or progressive manifestation of SLE that is likely to warrant escalation in therapy beyond permitted background medications
* Confirmed or suspected inflammatory diseases that might confound the evaluations of efficacy
* Has a severe infection including opportunistic infections requiring parenteral anti-infectives, and/or hospitalization within 8 weeks prior to screening
* Has received a single B-cell targeting agent within 3 months prior to first administration of study intervention
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 228, 'type': 'ACTUAL'}}
Updated at
2024-05-28
1 organization
2 products
1 indication
Organization
Janssen Research & DevelopmentProduct
NipocalimabIndication
Systemic Lupus ErythematosusProduct
Standard-of-care treatment