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RECRUITING Phase 2

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

NCT05327114 · View on ClinicalTrials.gov ↗

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.

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

Sponsor

Janssen Research & Development

442 total trials

Interested in This Trial?

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05327114

The ClinicalTrials.gov registry entry for NCT05327114 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 201 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05327114 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, Florida, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05327114?

The interventions under investigation include: Placebo (DRUG), Nipocalimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05327114?

This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial