A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis

• Register: ClinicalTrials.gov
• Last refreshed on: 13 September 2021
• Main ID: NCT04883619
• Date of registration: 11/05/2021
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: A Study of Nipocalimab in Adult Participants With Active Lupus Nephritis
• Scientific title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Nipocalimab in Adult Participants With Active Lupus Nephritis
• Date of first enrolment: October 18, 2021
• Target sample size: 80
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT04883619
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

France, Germany, Hong Kong, Israel, Italy, Japan, Korea, Republic of, Panama, Portugal, South Africa, Taiwan, Ukraine, United States

Contacts

• Name: Study Contact

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lupus Nephritis

Intervention(s)

Drug: Nipocalimab

Drug: Standard-of-care treatment

Other: Placebo

Primary Outcome(s)

Percentage of Participants Achieving Complete Renal Response (CRR) [Time Frame: Week 52]

Secondary Outcome(s)

Number of Participants with Antibodies to Nipocalimab (Anti-Drug Antibodies [ADAs] and Neutralizing Antibodies [Nabs]) [Time Frame: Up to Week 58]

Percentage of Participants Achieving a Sustained Reduction in Steroid Dose Less Than or Equal to (<=)10 milligram (mg)/day of Prednisone or Equivalent [Time Frame: Week 16 to Week 52]

Percentage of Participants Achieving at Least 50 Percent (%) Decrease in Proteinuria from Baseline, Week 24 and Week 52 [Time Frame: Baseline, Week 24 and Week 52]

Percentage of Participants Achieving CRR [Time Frame: Week 24]

Percentage of Participants with Change from Baseline in Laboratory Parameters Over Time [Time Frame: Up to week 58]

Percentage of Participants with Change from Baseline in Vital Sign Parameters Over Time [Time Frame: Up to week 58]

Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) [Time Frame: Up to Week 66]

Percentage of Participants with Treatment-emergent Adverse Events of Special Interests (AESIs) [Time Frame: Up to Week 58]

Percentage of Participants with Treatment-emergent AEs Leading to Discontinuation of Study Intervention [Time Frame: Up to Week 52]

Percentage of Participants with Treatment-emergent Serious Adverse Events (TESAEs) [Time Frame: Up to Week 66]

Serum Concentration of Nipocalimab Over Time [Time Frame: Up to Week 58]

Secondary ID(s)

2020-005568-79

80202135LUN2001

CR109008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors