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NCT05327114 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, sponsored by Janssen Research & Development.

Recruiting
Registry status
Phase 2
Development phase
201
Enrollment target
20
Study locations

NCT05327114: Recruiting Phase 2 study of Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, sponsored by Janssen Research & Development.

NCT05327114 is a Phase 2 study of Polyradiculoneuropathy, Chronic Inflammatory Demyelinating that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 201 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05327114, a Phase 2 study of Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, is actively recruiting participants, sponsored by Janssen Research & Development.

RECRUITING
Registry status
Phase 2
Development phase
201 participants
Enrollment target
20
Study locations

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.

Primary Outcome

Stage B time to first occurrence of a relapse event will be reported.

Interventions

  • DRUG Placebo
  • DRUG Nipocalimab

Study Locations (20)

Other

  • Hospital Italiano de Buenos Aires - Buenos Aires
  • Hospital Gral Agudos Ignacio Pirovano - Buenos Aires
  • The Alfred Hospital - Melbourne
  • Gold Coast University Hospital - Parkwood
  • Peking University First Hospital - Beijing
  • Xuanwu Hospital ,Capital Medical University - Beijing
  • Beijing Tiantan Hospital, Capital Medical University - Beijing

Florida

  • Healthcare Innovations Institute Inc - Coral Springs
  • Neurology Associates PA - Maitland

New York

  • The Neurological Institute of New York - New York
  • South Shore Neurologic Associates - Patchogue - Patchogue

Colorado

  • IMMUNOe Health and Research Centers - Centennial

Kansas

  • University of Kansas Medical Center - Kansas City

Maryland

  • Johns Hopkins Hospital - Baltimore

Massachusetts

  • Boston Clinical Trials - Boston

Michigan

  • Beaumont Hospital Royal Oak - Royal Oak

Trial Details

FieldValue
Enrollment Target 201 participants
Start Date 2022-09-23
Est. Completion 2028-07-11
Phase Phase 2
Janssen Research & Development

593 total trials

What NCT05327114 shows while recruiting

NCT05327114 is an interventional study that assigns participants to a tested intervention. The registered 201 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% higher).

The record links to 1 condition, with Polyradiculoneuropathy, Chronic Inflammatory Demyelinating appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05327114 names 20 study sites across 12 states, led by Other, Florida, New York.

Frequently Asked Questions

What is clinical trial NCT05327114 about?

NCT05327114 is a clinical study titled "Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)". 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.

What is the current status of trial NCT05327114?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 201 participants. The study started on 2022-09-23. Estimated completion is 2028-07-11.

What conditions does trial NCT05327114 study?

This clinical trial studies the following conditions: Polyradiculoneuropathy, Chronic Inflammatory Demyelinating.

What interventions are being tested in trial NCT05327114?

The interventions under investigation include: Placebo (DRUG), Nipocalimab (DRUG).

Who is sponsoring clinical trial NCT05327114?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05327114 being conducted?

This trial has 20 study locations across Colorado, Florida, Kansas, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05327114's enrollment target sits among peer trials

201 302nd of 2000 higher than 1,697 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05327114, the US trial registry maintained by the National Library of Medicine. NCT05327114 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.