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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05327114
Other study ID # CR109195
Secondary ID 80202135CDP30012
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date September 23, 2022
Est. completion date September 30, 2028

Study information

Verified date June 2024
Source Janssen Research & Development, LLC
Contact Study Contact
Phone 844-434-4210
Email Participate-In-This-Study@its.jnj.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

CIDP is a rare, chronic autoimmune disease of the peripheral nervous system characterized by progressive weakness and impaired sensation. Nipocalimab (also referred to as JNJ-80202135 or M281) is a fully human aglycosylated immunoglobulin (Ig)G1 monoclonal antibody (mAb) designed to selectively bind, saturate, and block the IgG binding site on the endogenous neonatal Fc receptor. The study will consist of the following periods: (a) identification of participants with active CIDP (including screening [up to 4 weeks] and run-in [up to 12 weeks]); (b) open-label treatment with nipocalimab (Stage A) (12 weeks); (c) double-blind, placebo-controlled, randomized withdrawal (Stage B) (up to 52 weeks); and (d) an open-label extension (OLE) (until to 2 years after marketing authorization in the participant's local country or until nipocalimab becomes available commercially or via other continued access program, whichever comes first). Participants who discontinue treatment and intend to withdraw from the study at any point during the treatment periods (Stage A, Stage B, or the OLE) will be requested to enter an 8-weeks follow-up after the last dose of study intervention. Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarker evaluations will be assessed.


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Nipocalimab
Nipocalimab will be administered intravenously.
Placebo
Placebo will be administered intravenously.

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Sponsors (1)

Lead Sponsor Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  China,  Czechia,  France,  Greece,  Japan,  Korea, Republic of,  Poland,  Portugal,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Stage B: Time to First Occurrence of a Relapse Event Stage B time to first occurrence of a relapse event will be reported. Up to 52 weeks
Secondary Stage A: Time to Initial Confirmed Evidence of Clinical Improvement (ECI) Time to initial confirmed ECI will be reported. 12 weeks
Secondary Stage A: Percentage of Responders as Determined by ECI Stage A percentage of responders as determined by ECI will be reported. 12 weeks
Secondary Stage A: Change from Baseline Over Time in Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale Score Change from Stage A baseline over time in adjusted INCAT disability scale score will be reported. The INCAT disability scale is a clinician-rated assessment that measures activity limitation and degree of functional disability. The INCAT scale is an ordinal scale scored from 0 to 10, with higher scores indicating more disability. Baseline to 12 weeks
Secondary Stage A: Change from Stage A Baseline Over Time in Medical Research Council (MRC) Muscle Grading Scale Sum Score Change from Stage A baseline over time in MRC muscle grading scale sum score will be reported. The MRC muscle grading scale is a clinician-rated outcome that provides a strength rating (on a scale from 0 [no visible contraction] to 5 [normal]) in 6 muscles collected bilaterally: deltoid, biceps, wrist extensors, iliopsoas, quadriceps, tibialis anterior. Lower scores indicate greater impairment. Baseline to 12 weeks
Secondary Stage A: Change from Baseline Over Time in Inflammatory Rasch-Built Overall Disability Scale (I-RODS) Centile Score Change from Stage A baseline over time in I-RODS centile score will be reported. The I-RODS comprises of 24 items representing common daily activities that address upper and lower limb disability and range in difficulty from very easy to very difficult. Lower scores indicate greater activity and social participation limitations. Baseline to 12 weeks
Secondary Stage A: Change from Baseline Over Time in Mean Grip Strength (Dominant Hand) Change from Stage A baseline over time in mean grip strength (dominant hand) will be reported. Grip Strength is a quantifiable, objective performance outcome measure of hand strength, which can be measured using various devices (for example, Martin Vigorimeter and Jamar Dynamometer). Baseline to 12 weeks
Secondary Stage A: Change from Baseline Over Time in Mean Grip Strength (Non-Dominant Hand) Change from Stage A baseline over time in mean grip strength (non-dominant hand) will be reported. Grip Strength is a quantifiable, objective performance outcome measure of hand strength, which can be measured using various devices (for example, Martin Vigorimeter and Jamar Dynamometer). Baseline to 12 weeks
Secondary Stage B: Time to First Adjusted INCAT Disability Scale Score Deterioration Relative to Baseline Time to first adjusted INCAT disability scale score deterioration relative to Stage B baseline will be reported. Up to 52 weeks
Secondary 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 Time to first switch to IVIg or other SoC as a result of investigator-assessed lack of efficacy as confirmed by an independent Relapse Adjudication Committee (RAC) relative to Stage B baseline will be reported. Up to 52 weeks
Secondary Stage B: Change from Baseline Over Time in Adjusted INCAT Disability Score Change from Stage B baseline over time in adjusted INCAT disability score will be reported. Up to 52 weeks
Secondary Stage B: Change from Baseline Over Time in MRC Muscle Grading Scale Sum Score Change from Stage B baseline over time in MRC Muscle Grading Scale Sum score will be reported. Up to 52 weeks
Secondary Stage B: Change from Baseline Over Time in I-RODS Centile Score Change from Stage B baseline over time in I-RODS centile score will be reported. Up to 52 weeks
Secondary Stage B: Change from Baseline Over Time in Mean Grip Strength (Dominant Hand) Change from Stage B baseline over time in mean grip strength (dominant hand) will be reported. Grip Strength is a quantifiable, objective performance outcome measure of hand strength, which can be measured using various devices (for example, Martin Vigorimeter and Jamar Dynamometer). Up to 52 weeks
Secondary Stage B: Change from Baseline Over Time in Mean Grip Strength (Non-Dominant Hand) Change from Stage B baseline over time in mean grip strength (non-dominant hand) will be reported. Grip Strength is a quantifiable, objective performance outcome measure of hand strength, which can be measured using various devices (for example, Martin Vigorimeter and Jamar Dynamometer). Up to 52 weeks
Secondary 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 Number of participants with Binary response endpoint satisfying all 4 conditions: a) an improved adjusted INCAT Disability Score compared to Stage B baseline; b) not relapsing; c) not switching to SoC; d) not discontinuing treatment, will be reported. Up to 52 weeks
Secondary Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment Stage A: 12 weeks; Stage B: Up to 52 weeks
Secondary Percentage of Participants with Serious Adverse Events (SAEs) SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. Stage A: 12 weeks; Stage B: Up to 52 weeks
Secondary Number of Participants with Change in Electrocardiogram (ECG) Values Over Time Number of participants with change in ECG values over time will be reported. Stage A: 12 weeks; Stage B: Up to 52 weeks
Secondary Number of Participants with Change in Vital Signs Values Over Time Number of participants with change in vital signs values over time will be reported. Stage A: 12 weeks; Stage B: Up to 52 weeks
Secondary Number of Participants with Change in Clinical Laboratory Values Over Time Number of participants with change in clinical laboratory values over time will be reported. Stage A: 12 weeks; Stage B: Up to 52 weeks
Secondary Number of Participants with Clinically Significant ECG Abnormalities Number of participants in clinically significant ECG abnormalities will be reported. Stage A: 12 weeks; Stage B: Up to 52 weeks
Secondary Number of Participants with Clinically Significant Vital Signs Abnormalities Number of participants in clinically significant vital signs abnormalities will be reported. Stage A: 12 weeks; Stage B: Up to 52 weeks
Secondary Number of Participants with Clinically Significant Clinical Laboratory Abnormalities Number of participants in clinically significant clinical laboratory abnormalities will be reported. Stage A: 12 weeks; Stage B: Up to 52 weeks
Secondary Percentage of Participants with Suicidal Ideation or Suicidal Behavior based on the Columbia-Suicide Severity Rating Scale (C-SSRS) Percentage of participants with suicidal ideation or suicidal behavior based on the C-SSRS will be reported. Stage A: 12 weeks; Stage B: Up to 52 weeks
Secondary Serum Nipocalimab Concentrations Over Time in Participants Receiving Active Study Intervention Serum nipocalimab concentrations over time in participants receiving active study intervention will be reported. Stage A: 12 weeks; Stage B: Up to 52 weeks
Secondary Number of Participants with Anti-drug Antibodies (ADA) to Nipocalimab Number of participants with ADA to Nipocalimab will be reported. Stage A: 12 weeks; Stage B: Up to 52 weeks
Secondary Titers of ADA to Nipocalimab Titers of ADA to nipocalimab will be reported. Stage A: 12 weeks; Stage B: Up to 52 weeks
Secondary Number of Participants with Neutralizing Antibodies (NAb) to Nipocalimab Number of participants with NAb to Nipocalimab will be reported. Stage A: 12 weeks; Stage B: Up to 52 weeks
Secondary Change from Baseline in Total Serum Immunoglobulin (IgG) Concentrations Levels Over Time Change from baseline in total serum IgG concentrations levels over time will be reported. Stage A: Baseline to 12 weeks; Stage B: Baseline up to 52 weeks
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