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Monoclonal Antibodies

Nipocalimab for CIDP

Phase 2 & 3
Recruiting
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) according to criteria of the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) 2021, progressing or relapsing forms. CIDP diagnosis to be adjudicated by independent committee during screening period
Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score between 2 and 9 (a score of 2 has to be exclusively from leg disability)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up stage a: 12 weeks; stage b: up to 52 weeks
Awards & highlights

Study Summary

This trial is testing if nipocalimab can help people with CIDP who respond to the drug in Stage A, by delaying relapse.

Who is the study for?
Adults over 18 with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) as per EAN/PNS criteria, showing active disease. They must have an INCAT disability score of 2-9 and be willing to stop or taper current treatments like corticosteroids or immunoglobulins. Excluded are those with severe disorders, pure sensory CIDP, other diseases that explain symptoms better, known allergies to nipocalimab or its components.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Nipocalimab in preventing relapse in adults with CIDP who responded initially to the drug during Stage A. Participants will either receive Nipocalimab or a placebo to compare outcomes.See study design
What are the potential side effects?
While specific side effects for Nipocalimab aren't listed here, common ones for similar drugs include allergic reactions at the infusion site, potential organ inflammation due to immune response changes, and general discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with CIDP that is getting worse or coming back.
Select...
My INCAT score is between 2 and 9, with any score of 2 due to leg issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~stage a: 12 weeks; stage b: up to 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and stage a: 12 weeks; stage b: up to 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Stage B: Time to First Occurrence of a Relapse Event
Secondary outcome measures
Change from Baseline in Total Serum Immunoglobulin (IgG) Concentrations Levels Over Time
Number of Participants with Anti-drug Antibodies (ADA) to Nipocalimab
Number of Participants with Change in Clinical Laboratory Values Over Time
+26 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: NipocalimabExperimental Treatment1 Intervention
Participants in Stage A (Open-label) will receive a loading dose of nipocalimab (Dose 1) intravenous (IV) infusion on Day 1, followed by nipocalimab (Dose 2) IV infusion once every 2 weeks (q2w) from Week 2 to Week 12. Participants who demonstrate evidence of clinical improvement in Stage A (responders) will enter Stage B (Double-blind) and receive nipocalimab (Dose 2) IV infusion q2w starting on Day 1 up to Week 52. After completion of Stage B or discontinuation from Stage B due to relapse, participants will have the option to enter the open label extension (OLE) phase and receive nipocalimab (Dose 2) IV infusion q2w starting on OLE Day 1 until 2 years after marketing authorization in a participant's local country or until nipocalimab becomes available commercially or via other continued access program, whichever comes first.
Group II: PlaceboPlacebo Group1 Intervention
Participants receiving nipocalimab in Stage A and who demonstrate evidence of clinical improvement in Stage A (responders) will enter Stage B (Double-blind) and receive placebo IV infusion q2w starting on Day 1 up to Week 52. After completion of Stage B or discontinuation from Stage B due to relapse, participants will have the option to enter the open label extension (OLE) phase and receive nipocalimab (Dose 2) IV infusion q2w starting on OLE Day 1 until 2 years after marketing authorization in a participant's local country or until nipocalimab becomes available commercially or via other continued access program, whichever comes first.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nipocalimab
2022
Completed Phase 2
~260

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
974 Previous Clinical Trials
6,384,085 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,704 Total Patients Enrolled

Media Library

Nipocalimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05327114 — Phase 2 & 3
Chronic Inflammatory Demyelinating Polyradiculoneuropathy Research Study Groups: Nipocalimab, Placebo
Chronic Inflammatory Demyelinating Polyradiculoneuropathy Clinical Trial 2023: Nipocalimab Highlights & Side Effects. Trial Name: NCT05327114 — Phase 2 & 3
Nipocalimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05327114 — Phase 2 & 3
Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patient Testimony for trial: Trial Name: NCT05327114 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this a full or closed clinical trial?

"The trial, which is currently recruiting patients, was first announced on September 15th, 2022. The most recent update to the posting was on September 8th, 2022."

Answered by AI

Could you tell me how many active locations are conducting this research?

"In total, there are 14 sites enrolling patients for this study. Some notable locations include University of Kansas Medical Center in Kansas City, Kansas, The Neurological Institute of New york in New York, New York, and University of Alberta Hospital in Edmonton, Alberta."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
Arizona
Texas
Other
How old are they?
18 - 65
What site did they apply to?
Augusta University
University of Kansas Medical Center
University of Colorado
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0
2

What questions have other patients asked about this trial?

How do I become part of this trial?
PatientReceived no prior treatments

Why did patients apply to this trial?

the treatment havnt seen any signs of improvement. I'm looking for the experience and pay.and also for the benefit of this.
PatientReceived 1 prior treatment
I live in south Texas in the heat is unbearable. I feel like this location would be better for my chronic inflammation.
PatientReceived no prior treatments
I have tried all possible drugs available in India nothing worked now my daily movement is getting difficult and completely hopeless seeking help.
PatientReceived no prior treatments
I have done IVIG, high steroids, currently taking Azathioprine 150 MG. Looking for a treatment that could potentially help me or others with CIDP.
PatientReceived 2+ prior treatments

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. University of Kansas Medical Center: < 48 hours
~134 spots leftby May 2027