Clinical trial NCT04883619: A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Nipocalimab in Adult Participants With Active Lupus Nephritis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Lupus Nephritis
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-05-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active Lupus Nephritis (LN).

Detailed description: LN is a heterogeneous autoimmune disease that includes a broad spectrum of clinical forms, ranging from those with lesions confined to the skin (cutaneous lupus erythematosus \[CLE\]) to others that involve one or more vital internal organs (systemic lupus erythematosus \[SLE\]). Renal involvement due to SLE is termed LN. Nipocalimab (also referred to as JNJ-80202135 or M281) is a fully human aglycosylated immunoglobulin (Ig) G1 monoclonal antibody designed to selectively bind, saturate, and block the IgG binding site on the endogenous neonatal fragment crystallizable receptor (FcRn). By targeting the IgG binding site on FcRn, nipocalimab is expected to block the binding and, hence, recycling of IgG into circulation, resulting in a decrease in circulating IgG antibody levels, including pathogenic IgG autoantibodies and alloantibodies. The study will consist of a screening period (less than or equal to \[\<=\] 8 Week), double-blind treatment period (52 Week), and a safety follow-up period (6 Week). Safety assessment will include adverse events (AEs), serious adverse events (SAEs), laboratory parameters (hematology and chemistry) and vital signs. The total duration of the main study is up to 66 weeks.

Eligibility criteria: Inclusion Criteria:

* Kidney biopsy documentation of International Society of Nephrology (ISN)/Renal Pathology Society (RPS) proliferative nephritis: Class III or IV (with or without concomitant Class V) within the last 6 months prior to screening or performed during screening
* Urine Protein to Creatinine Ratio (UPCR) greater than or equal to (\>=) 1.0 milligram/milligram (mg/mg) measured twice during screening
* Currently receiving prednisone equivalent dose of 1 milligram/kilogram/day (mg/kg/day) or less than or equal to (\<=) 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
* If receiving angiotensin-converting enzyme (ACE) inhibitor/angiotensin II receptor blockers (ARB), a stable dose for at least 2 weeks prior to first administration of study intervention
* Is recommended to be up-to-date on all age-appropriate vaccinations prior to screening per routine local medical guidelines. For study participants who received locally-approved (and including emergency use-authorized) coronavirus disease 2019 (COVID-19) vaccines recently prior to study entry, follow applicable local vaccine labelling, guidelines, and standards-of-care for patients receiving immune-targeted therapy when determining an appropriate interval between vaccination and study enrolment

Exclusion Criteria:

* Comorbidities (other than Lupus Nephritis, example, asthma, chronic obstructive pulmonary disease) which have required 3 or more courses of systemic glucocorticoids within the previous 12 months
* Has other inflammatory diseases that might confound the evaluations of efficacy, including but not limited to rheumatoid arthritis (RA), psoriatic arthritis (PsA), RA/lupus overlap, psoriasis, Crohn's disease, or active Lyme disease
* Has received oral cyclophosphamide within 3 months or intravenous (IV) cyclophosphamide within 6 months prior to first administration of study intervention
* Has a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, before screening
* COVID-19 infection: During the 6 weeks prior to baseline, have had any of the following (a) confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (test positive), or (b) suspected SARS-CoV-2 infection (clinical features of COVID-19 without documented test results), or (c) close contact with a person with known or suspected SARS-CoV-2 infection

Primary outcomes:
measure: Percentage of Participants Achieving Complete Renal Response (CRR)
timeFrame: Week 52
Secondary outcomes:
measure: Percentage of Participants Achieving CRR
timeFrame: Week 24
measure: Percentage of Participants Achieving at Least 50 Percent (%) Decrease in Proteinuria from Baseline, Week 24 and Week 52
timeFrame: Baseline, Week 24 and Week 52
measure: Percentage of Participants Achieving a Sustained Reduction in Steroid Dose Less Than or Equal to (<=)10 milligram (mg)/day of Prednisone or Equivalent
timeFrame: Week 16 to Week 52
measure: Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to Week 66
measure: Percentage of Participants with Treatment-emergent Serious Adverse Events (TESAEs)
timeFrame: Up to Week 66
measure: Percentage of Participants with Treatment-emergent AEs Leading to Discontinuation of Study Intervention
timeFrame: Up to Week 52
measure: Percentage of Participants with Treatment-emergent Adverse Events of Special Interests (AESIs)
timeFrame: Up to Week 58
measure: Percentage of Participants with Change from Baseline in Laboratory Parameters Over Time
timeFrame: Up to week 58
measure: Percentage of Participants with Change from Baseline in Vital Sign Parameters Over Time
timeFrame: Up to week 58
measure: Serum Concentration of Nipocalimab Over Time
timeFrame: Up to Week 58
measure: Number of Participants with Antibodies to Nipocalimab (Anti-Drug Antibodies [ADAs] and Neutralizing Antibodies [Nabs])
timeFrame: Up to Week 58
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC
state: Arizona
city: Canyon Country
country: United States
facility: Clearview Medical Research, LLC
state: California
city: La Palma
country: United States
facility: Arthritis & Osteoporosis Medical Center - La Palma
state: California
city: Los Alamitos
country: United States
facility: Valerius Medical Group & Research Center
state: California
city: Palm Springs
country: United States
facility: Respire Research, LLC
state: California
city: DeBary
country: United States
facility: Omega Research Consultants
state: Florida
city: Gainesville
country: United States
facility: University of Florida Health Jacksonville - Rheumatology
state: Florida
city: Miami
country: United States
facility: Reliant Medical Research
state: Florida
city: Plantation
country: United States
facility: Integral Rheumatology & Immunology Specialists
state: Florida
city: El Paso
country: United States
facility: Davita Clinical Research
state: Texas
city: Houston
country: United States
facility: Next Innovative Clinical Research
state: Texas
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: