Status:
COMPLETED
A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active systemic lupus erythematosus (SLE).
Detailed Description
SLE is a complex, immune-mediated inflammatory disorder of unknown etiology that can affect almost any organ system and follows a waxing and waning disease course. In SLE, the immune system attacks th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 26 2024
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT04882878
Start Date
August 20 2021
End Date
December 26 2024
Last Update
December 8 2025
Active Locations (86)
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1
Valerius Medical Group & Research Center
Los Alamitos, California, United States, 90720
2
Desert Medical Advances
Rancho Mirage, California, United States, 92270
3
Wolverine Clinical Trials
Santa Ana, California, United States, 92705
4
Millennium Clinical Trials LLC
Westlake Village, California, United States, 91361