Recruiting NCT07438496

A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

Phase III Interventional Lupus Erythematosus, Systemic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Nipocalimab, Placebo, Standard of care treatment.
Who it may be relevant to: Registry conditions: Lupus Erythematosus, Systemic. Basic parameters: 18 years — 75 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Brazil, Bulgaria +24
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus

Overview

The purpose of this study is to evaluate how well nipocalimab works as compared to placebo in participants with moderate to severe Systemic lupus erythematosus (SLE, a long-term disease where the immune system mistakenly attacks its own healthy tissues, causing swelling and redness in various organs).

Interventions

Drug Nipocalimab
Nipocalimab will be administered.
Drug Placebo
Placebo will be administered.
Drug Standard of care treatment
Protocol-defined topical and systemic standard of care background treatments.

Primary outcome measures

Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI)-4 Composite Response at Week 52 [Time frame: Week 52]

Secondary outcome measures (9)

Percentage of Participants Achieving SRI-4 Composite Response at Week 52 with High Baseline IFN Gene Signature (Interferon [IFN] high) [Time frame: Week 52]
Percentage of Participants Achieving SRI-4 Composite Response at Week 52 with Sustained Reduction in Oral Glucocorticoid (GC) Dose [Time frame: Week 52]
Percentage of Participants Who Achieve Lupus Low Disease Activity State (LLDAS) At Week 52 [Time frame: Week 52]
Percentage of Participants with < 2 Active Joints at Week 52 in Participants with >= 2 Active Joints at Baseline [Time frame: Week 52]
Change From Baseline in Lupus Symptoms Joint Pain Score at Week 52 [Time frame: Baseline, Week 52]
Percentage of Participants Achieving Sustained Reduction in Oral GC Dose at Week 52 in Participants Treated with Oral GC >5 mg/Day Prednisone (or equivalent) at Baseline [Time frame: Week 52]
Change from Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT) Fatigue Score at Week 52 [Time frame: Baseline, Week 52]
Percentage of Participants With BILAG Flare Free Status Through Week 52 [Time frame: Up to Week 52]
Percentage of Participants Achieving SRI-4 Composite Response at Week 52 with High Baseline Autoantibodies (Autoantibody High) [Time frame: Week 52]

Eligibility criteria

Inclusion Criteria:-

Medically stable on the basis of physical examination, medical history, vital signs and 12-lead electrocardiogram (ECG) performed at screening
Clinical diagnosis of systemic lupus erythematosus (SLE) for more than or equal to (>=) 24 weeks prior to screening and meeting european league against rheumatism/american college of rheumatology (EULAR/ACR) classification criteria
Must have a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score >= 6 and a clinical SLEDAI-2K >= 4 at screening, AND a clinical SLEDAI-2K score >= 4 points at Week 0. For eligibility, points attributed to "lupus headache," "alopecia," and "organic brain syndrome" are excluded
Participants of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-hCG) test at screening and a negative urine (β- hCG) test at Week 0 prior to randomization
Has at least 1 BILAG-2004 A score or 2 BILAG-2004 B scores observed at screening

Exclusion criteria

History of severe, progressive and/or uncontrolled hepatic, gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension, and/or any other medical or uncontrolled autoimmune disorder (s) or clinically significant abnormalities in screening laboratory
Any unstable or progressive manifestation of SLE that is likely to warrant escalation in therapy beyond permitted background medications
Confirmed or suspected clinical immunodeficiency syndrome not related to treatment of SLE or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins
Suspected or known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients, or excipients used in the placebo formulation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Double blind
Primary purpose: Treatment

Study locations

United States · 35 centers

David S Hallegua MD A Professional Corporation — Beverly Hills
Providence Medical Foundation — Fullerton
Southland Arthritis and Osteoporosis Medical Center Inc dba Southland Arthritis — Hemet
Advanced Medical Research — La Palma
Medvin Clinical Research San Leandro — San Leandro
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance
Solace Clinical Research California — Tustin
Inland Rheumatology Clinical Trials Inc. — Upland
… and 27 more centers

China · 18 centers

Peking University People's Hospital — Beijing
West China School of Medicine/West China Hospital, Sichuan University — Cheng Du Shi
Dongguan People s Hospital — Dongguan
The First Affiliated Hospital Sun Yat-Sen University — Guangzhou
The Second Affiliated Hospital of Zhejiang University College of Medicine — Hangzhou
Anhui Provincial Hospital — Hefei
Jinhua municipal central hospital — Jinhua
Shandong Jining No.1 People's Hospital — Jining
… and 10 more centers

Japan · 18 centers