A Clinical Study of Nipocalimab in Adult Participants with Active Lupus Nephritis

Phase 1

• Conditions: Active Lupus Nephritis; MedDRA version: 21.1Level: PTClassification code 10025140Term: Lupus nephritisSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2020-005568-79-PT
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-14
• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

-Male or female, 18 to 75 years of age (inclusive) at the time of consent
-Meets classification for SLE by the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria.
-Kidney biopsy documentation of ISN/RPS proliferative nephritis: Class III-IV (with or without concomitant Class V) within the last 6 months prior to screening or performed during screening.
-UPCR =1.0 mg/mg assessed on 2 first morning urine void specimens during screening.
-Must have received MMF or MPA for at least 8 weeks at the time of randomization, and currently receiving MMF at a dose of =3g/day or MPA at dose of =2.2 g/day with stable dose for at least 4 weeks prior to first administration of study intervention.
-Currently receiving prednisone equivalent dose of 1 mg/kg/day or =60 mg/day whichever is lower, or less. Must be receiving prednisone equivalent of 10 mg/day or more at screening and randomization. Treated for =6 weeks with stable dosing = 2 weeks prior to first administration of study intervention.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

-Current or history of, severe, progressive, or uncontrolled renal disease, with the exception of active LN.
-Anticipated to require dialysis within 6 months.
-Comorbidities (other than LN, eg, asthma, chronic obstructive pulmonary disease) which have required 3 or more courses of systemic glucocorticoids within the previous 12 months.
-Has any unstable or progressive manifestation of SLE
-Isolated Class V LN (ie, without coexistent/majority Class III or IV nephritis).
-Has other inflammatory diseases that might confound the evaluations of efficacy, including but not limited to RA, PsA, RA/lupus overlap, psoriasis, Crohn’s disease, or active Lyme disease.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified