201 Participants Needed

Nipocalimab for CIDP

Recruiting at 137 trial locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Janssen Research & Development, LLC
Must be taking: Corticosteroids
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing nipocalimab, a medicine that helps the immune system, in adults with CIDP who initially respond to it. The goal is to see if it can safely and effectively delay the return of symptoms by blocking harmful immune actions.

Will I have to stop taking my current medications?

If you are currently treated with certain medications like intravenous or subcutaneous immunoglobulin, you will need to stop them by the run-in baseline visit. If you are on oral corticosteroids over 20 mg/day, you must reduce the dose to 20 mg/day or less during the run-in period.

What makes the drug Nipocalimab unique for treating CIDP?

Nipocalimab is unique because it targets the neonatal Fc receptor (FcRn), which is involved in recycling antibodies and prolonging their lifespan in the body. This mechanism is different from other treatments for CIDP, which typically focus on suppressing the immune system or reducing inflammation.12345

What data supports the effectiveness of the drug Nipocalimab for treating CIDP?

While there is no direct data on Nipocalimab for CIDP, similar treatments like Rituximab, which also target immune system components, have shown improvement in patients with CIDP, especially those with specific antibodies. This suggests that targeting immune pathways can be effective in managing CIDP symptoms.678910

Who Is on the Research Team?

JR

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Other protocol-defined inclusion criteria will apply
I am on low-dose steroids, willing to adjust my treatment, or have not started treatment.
I have been diagnosed with CIDP that is getting worse or coming back.
See 2 more

Exclusion Criteria

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.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 4 weeks

Run-in

Participants with active CIDP undergo a run-in period to assess initial response

up to 12 weeks

Open-label Treatment (Stage A)

Participants receive open-label nipocalimab to assess clinical improvement

12 weeks
IV infusion every 2 weeks

Double-blind, Placebo-controlled Withdrawal (Stage B)

Participants are randomized to receive either nipocalimab or placebo to evaluate relapse prevention

up to 52 weeks
IV infusion every 2 weeks

Open-label Extension (OLE)

Participants may continue receiving nipocalimab until 2 years after marketing authorization or commercial availability

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Nipocalimab
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: NipocalimabExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials
1,022
Recruited
6,408,000+
Joaquin Duato profile image

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD profile image

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Published Research Related to This Trial

Rituximab, a B cell-depleting monoclonal antibody, showed a 75% responsiveness rate in treating chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) based on a systematic review of 15 studies involving 96 patients.
The treatment resulted in significant improvements in disability scores and muscle power, particularly in patients who tested positive for anti-IgG4 antibodies, indicating its potential effectiveness in this specific subgroup.
Efficacy of rituximab treatment in chronic inflammatory demyelinating polyradiculoneuropathy: a systematic review and meta-analysis.Hu, J., Sun, C., Lu, J., et al.[2022]
Low dose rituximab (100 mg weekly for 4 weeks, then monthly) significantly improved clinical function scores in patients with treatment-resistant chronic inflammatory demyelinating polyneuropathy (CIDP) with anti-NF-155 antibodies over a 6-month follow-up period.
The treatment mechanism involves effective B cell depletion, leading to a decrease in certain B cell subsets associated with disease severity, while promoting the reestablishment of regulatory B cells, which may help in managing the condition.
Efficacy of low dose rituximab in treatment-resistant CIDP with antibodies against NF-155.Jiao, L., Xiang, Y., Li, S., et al.[2020]
The open-label phase 2 study (NCT04658472) will assess the efficacy and safety of SAR445088, a monoclonal antibody targeting complement C1s, in 90 patients with chronic inflammatory demyelinating polyneuropathy (CIDP), focusing on different patient groups including those currently treated, refractory to treatment, and treatment-naïve.
The trial's innovative design utilizes Bayesian statistics to evaluate treatment responses and safety, aiming to provide a more efficient way to develop new therapies for CIDP, which currently has significant unmet treatment needs.
An innovative phase 2 proof-of-concept trial design to evaluate SAR445088, a monoclonal antibody targeting complement C1s in chronic inflammatory demyelinating polyneuropathy.Querol, L., Lewis, RA., Hartung, HP., et al.[2023]

Citations

Efficacy of rituximab treatment in chronic inflammatory demyelinating polyradiculoneuropathy: a systematic review and meta-analysis. [2022]
Efficacy of low dose rituximab in treatment-resistant CIDP with antibodies against NF-155. [2020]
An innovative phase 2 proof-of-concept trial design to evaluate SAR445088, a monoclonal antibody targeting complement C1s in chronic inflammatory demyelinating polyneuropathy. [2023]
Deregulated Fcγ receptor expression in patients with CIDP. [2018]
Autoantibodies to a Nodal Isoform of Neurofascin in Pediatric Chronic Inflammatory Demyelinating Polyneuropathy. [2023]
MHC class I-related neonatal Fc receptor for IgG is functionally expressed in monocytes, intestinal macrophages, and dendritic cells. [2022]
Reproducible quantification of IgG uptake at endogenous and overexpressed FcRn levels at pH 7.4: Comparison of a wild type IgG and a stronger FcRn binding variant. [2020]
Variants of the human high-affinity receptor (Fc gamma RI) for immunoglobulin G. [2019]
Epitope mapping of new monoclonal antibodies recognizing distinct human FcRII (CD32) isoforms. [2006]
FcγRIIB as a key determinant of agonistic antibody efficacy. [2016]
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