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Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

NCT05327114 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2026-05-08

No results posted yet for this study

Summary

The main purpose of this study is to evaluate the safety and efficacy of nipocalimab compared to placebo in delaying relapse in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) who initially respond to nipocalimab in Stage A.

Conditions

  • Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Interventions

DRUG

Nipocalimab

Nipocalimab will be administered intravenously.

DRUG

Placebo

Placebo will be administered intravenously.

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
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-23
Primary Completion
2027-05-14
Completion
2029-06-18
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Canada
  • China
  • Colombia
  • Czechia
  • France
  • Germany
  • Greece
  • Italy
  • Japan
  • Mexico
  • Poland
  • Portugal
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT05327114 on ClinicalTrials.gov