Back to search
Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Clinicaltrials.gov:
EU CTIS:
#2023-508425-28-00
EudraCT:
J&J ID:
#CR109195
Other:
#80202135CDP3001
Other:
#2023
Trials at a glance
Status
Enrolling
Condition
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Trial type
Interventional
Trial phase
Phase 2
Investigational
product
product
Nipocalimab
Placebo
Age
18+ years old
Biological sex
All
Placebo?
Yes
Trial start date
September 23, 2022
Trial end date
November 27, 2028
CT.gov ID
#NCT05327114
Share the trial ID with your doctor to see if trial participation is right for you. Participation depends on an independent medical assessment.
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.
Primary outcome measures
- Stage B: Time to First Occurrence of a Relapse Event
Secondary outcome measures
- Stage A: Time to Initial Confirmed Evidence of Clinical Improvement (ECI)
- Stage A: Percentage of Responders as Determined by ECI
- Stage A: Change from Baseline Over Time in Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale Score
- Stage A: Change from Stage A Baseline Over Time in Medical Research Council (MRC) Muscle Grading Scale Sum Score
- Stage A: Change from Baseline Over Time in Inflammatory Rasch-Built Overall Disability Scale (I-RODS) Centile Score
- Stage A: Change from Baseline Over Time in Mean Grip Strength (Dominant Hand)
- Stage A: Change from Baseline Over Time in Mean Grip Strength (Non-Dominant Hand)
- Stage B: Time to First Adjusted INCAT Disability Scale Score Deterioration Relative to Baseline
- Stage B: Time to First Switch to Intravenous Immunoglobulin (IVIg) or Other Standard of Care (SoC) as a Result of Investigator-assessed Lack of Efficacy as Confirmed by an Independent RAC Relative to Baseline
- Stage B: Change from Baseline Over Time in Adjusted INCAT Disability Score
- Stage B: Change from Baseline Over Time in MRC Muscle Grading Scale Sum Score
- Stage B: Change from Baseline Over Time in I-RODS Centile Score
- Stage B: Change from Baseline Over Time in Mean Grip Strength (Dominant Hand)
- Stage B: Change from Baseline Over Time in Mean Grip Strength (Non-Dominant Hand)
- Stage B: Number of Participants with Binary Response Endpoint Satisfying all 4 Conditions: a) An Improved Adjusted INCAT Disability Score Compared to Baseline; b) Not Relapsing; c) Not Switching to SoC; d) Not Discontinuing Treatment
- Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
- Percentage of Participants with Serious Adverse Events (SAEs)
- Number of Participants with Change in Electrocardiogram (ECG) Values Over Time
- Number of Participants with Change in Vital Signs Values Over Time
- Number of Participants with Change in Clinical Laboratory Values Over Time
- Number of Participants with Clinically Significant ECG Abnormalities
- Number of Participants with Clinically Significant Vital Signs Abnormalities
- Number of Participants with Clinically Significant Clinical Laboratory Abnormalities
- Percentage of Participants with Suicidal Ideation or Suicidal Behavior based on the Columbia-Suicide Severity Rating Scale (C-SSRS)
- Serum Nipocalimab Concentrations Over Time in Participants Receiving Active Study Intervention
- Number of Participants with Anti-drug Antibodies (ADA) to Nipocalimab
- Titers of ADA to Nipocalimab
- Number of Participants with Neutralizing Antibodies (NAb) to Nipocalimab
- Change from Baseline in Total Serum Immunoglobulin (IgG) Concentrations Levels Over Time
Access detailed information on the trial:
Clinical trials information
Key links
© Johnson & Johnson and its affiliates 2026
