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A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus

NCT04882878 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2025-12-08

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active systemic lupus erythematosus (SLE).

Conditions

Interventions

OTHER

Placebo

Placebo will be administered intravenously.

DRUG

Nipocalimab

Nipocalimab dose 1 and dose 2 will be administered intravenously.

DRUG

Standard-of-care treatment

Standard-of-care treatment including immunomodulators, antimalarial drugs and GCs will be administered orally.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-20
Primary Completion
2024-04-30
Completion
2024-12-26
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Bulgaria
  • Colombia
  • Germany
  • Hungary
  • Japan
  • Poland
  • South Africa
  • Spain
  • Taiwan
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04882878 on ClinicalTrials.gov