Nipocalimab for CIDP
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Run-in
Participants with active CIDP undergo a run-in period to assess initial response
Open-label Treatment (Stage A)
Participants receive open-label nipocalimab to assess clinical improvement
Double-blind, Placebo-controlled Withdrawal (Stage B)
Participants are randomized to receive either nipocalimab or placebo to evaluate relapse prevention
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
What Are the Treatments Tested in This Trial?
Interventions
- Nipocalimab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
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
Janssen Research & Development, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University