Your session is about to expire
← Back to Search
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ stage a: 12 weeks; stage b: up to 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~stage a: 12 weeks; stage b: up to 52 weeks
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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My INCAT score is between 2 and 9, with any 2 being due to leg issues.I am on low-dose steroids, willing to adjust my treatment, or have not started treatment.There are other requirements you need to meet as determined by the study protocol.I do not have severe health issues that could affect my participation in the study.I have been diagnosed with a specific type of chronic nerve disorder.My symptoms are not caused by another disease like a stroke or lupus.I have been diagnosed with CIDP that is getting worse or coming back.I am 18 years old or older.I have been diagnosed with CIDP that is getting worse or coming back.My CIDP condition is active with a CDAS score of 3 or higher.I have a confirmed diagnosis of CIDP despite having other types of nerve damage.I am willing to stop or reduce my current steroid or immunoglobulin treatment, or I haven't started any treatment yet.My nerve disease affects my legs and my INCAT score is between 2 and 9.My INCAT score is between 2 and 9, with any score of 2 due to leg issues.My disability score is between 2 and 9, with leg issues being a factor.My CIDP condition is active with a CDAS score of 3 or higher.I have been diagnosed with CIDP that is getting worse or coming back.There are other requirements that you must meet to participate in this study.
Research Study Groups:
This trial has the following groups:- Group 1: Nipocalimab
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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:
- University of Kansas Medical Center: < 48 hours
Share this study with friends
Copy Link
Messenger