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Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Primary Purpose

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Nipocalimab
Placebo
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults greater than or equal to (>=) 18 years of age at the time of consent and as applicable, must also meet the legal age of consent in the jurisdiction in which the study is taking place
  • 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)
  • Fulfilling any of the following treatment conditions: a) Currently treated with pulsed corticosteroids, oral corticosteroids and/or intravenous immunoglobulin (IVIg) or subcutaneous immunoglobulin (SCIg) and the participant is willing to discontinue or taper this treatment at the first run-in visit; or b) Without previous treatment (treatment naive); or treatment with corticosteroids and/or IVIg or SCIg discontinued at least 3 months prior to screening (untreated)
  • Active disease as determined by CIDP Disease Activity Status (CDAS) score >= 3
  • Other protocol-defined inclusion criteria will apply

Exclusion Criteria:

  • Has a history of severe and/or uncontrolled hepatic (example, viral/alcoholic/autoimmune hepatitis/cirrhosis and/or metabolic liver disease), gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension and/or any other medical or uncontrolled autoimmune disorder(s) (example, diabetes mellitus) or clinically significant abnormalities in screening laboratory that, might interfere with the participants full participation in the study, or might jeopardize the safety of the participant or the validity of the study results
  • Pure sensory CIDP or chronic immune sensory polyradiculopathy (CISP) (EAN/PNS definition)
  • Any other disease that could better explain the participant's signs and symptoms, such as significant persisting neurological deficits from stroke or central nervous system (CNS) trauma or peripheral neuropathy from another cause such as connective tissue disease or systemic lupus erythematosus
  • Polyneuropathy of other causes, including the following: Multifocal motor neuropathy (MMN); Monoclonal gammopathy of uncertain significance with antimyelin associated glycoprotein (anti-MAG) immunoglobulin M (IgM) antibodies; Hereditary motor neuropathy; Hereditary neuropathy with liability to pressure palsies (HNPP); Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes; Lumbosacral radiculoplexus neuropathy; Polyneuropathy most likely due to diabetes mellitus; Polyneuropathy most likely due to systemic illnesses; Drug- or toxin-induced polyneuropathy Note: A concomitant polyneuropathy of other causes (example, a mild, stable diabetic polyneuropathy) is not necessarily exclusionary if chronic inflammatory demyelinating polyneuropathy (CIDP) is confirmed as the main diagnosis, as determined by the investigator and confirmed by the adjudication committee
  • Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
  • Other protocol-defined exclusion criteria will apply

Sites / Locations

  • Neurology Associates PARecruiting
  • University of Kansas Medical CenterRecruiting
  • The Neurological Institute of New YorkRecruiting
  • South Shore Neurologic Associates - PatchogueRecruiting
  • The Neurological Institute, PARecruiting
  • Austin Neuromuscular CenterRecruiting
  • Xuanwu Hospital, Capital Medical UniversityRecruiting
  • The First Affiliated Hospital of NanChang UniversityRecruiting
  • Xi 'an GaoXin HospitalRecruiting
  • Fakultni nemocnice Hradec KraloveRecruiting
  • Fakultni nemocnice OstravaRecruiting
  • Pardubicka krajska nemocnice a.s.Recruiting
  • Asahikawa Medical CenterRecruiting
  • Tokyo Medical and Dental University HospitalRecruiting
  • Chiba University HospitalRecruiting
  • Seirei Hamamatsu General HospitalRecruiting
  • Kobe City Medical Center General HospitalRecruiting
  • Tokai University HospitalRecruiting
  • Saitama Medical CenterRecruiting
  • Kumamoto University HospitalRecruiting
  • Nagoya University HospitalRecruiting
  • Chubu Rosai HospitalRecruiting
  • Kindai University HospitalRecruiting
  • Dokkyo Medical University HospitalRecruiting
  • Tenri HospitalRecruiting
  • Toyama University HospitalRecruiting
  • Yamaguchi University HospitalRecruiting
  • Konkuk University Medical CenterRecruiting
  • Samsung Medical CenterRecruiting
  • Centrum MedyczneRecruiting
  • Specjalistyczne Gabinety LekarskieRecruiting
  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nipocalimab

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Stage B: Time to First Occurrence of a Relapse Event
Stage B time to first occurrence of a relapse event will be reported.

Secondary Outcome Measures

Stage A: Time to Initial Confirmed Evidence of Clinical Improvement (ECI)
Time to initial confirmed ECI will be reported.
Stage A: Percentage of Responders as Determined by ECI
Stage A percentage of responders as determined by ECI will be reported.
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.
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.
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.
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).
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).
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.
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.
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.
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.
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.
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).
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).
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.
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
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.
Number of Participants with Change in Electrocardiogram (ECG) Values Over Time
Number of participants with change in ECG values over time will be reported.
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.
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.
Number of Participants with Clinically Significant ECG Abnormalities
Number of participants in clinically significant ECG abnormalities will be reported.
Number of Participants with Clinically Significant Vital Signs Abnormalities
Number of participants in clinically significant vital signs abnormalities will be reported.
Number of Participants with Clinically Significant Clinical Laboratory Abnormalities
Number of participants in clinically significant clinical laboratory abnormalities will be reported.
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.
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.
Number of Participants with Anti-drug Antibodies (ADA) to Nipocalimab
Number of participants with ADA to Nipocalimab will be reported.
Titers of ADA to Nipocalimab
Titers of ADA to nipocalimab will be reported.
Number of Participants with Neutralizing Antibodies (NAb) to Nipocalimab
Number of participants with NAb to Nipocalimab will be reported.
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.

Full Information

First Posted
April 7, 2022
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05327114
Brief Title
Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Official Title
Phase 2/3, Multistage, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Group Withdrawal Study to Evaluate the Efficacy and Safety of Nipocalimab Administered to Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 23, 2022 (Actual)
Primary Completion Date
May 14, 2027 (Anticipated)
Study Completion Date
September 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nipocalimab
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Nipocalimab
Other Intervention Name(s)
JNJ-80202135, M281
Intervention Description
Nipocalimab will be administered intravenously.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered intravenously.
Primary Outcome Measure Information:
Title
Stage B: Time to First Occurrence of a Relapse Event
Description
Stage B time to first occurrence of a relapse event will be reported.
Time Frame
Up to 52 weeks
Secondary Outcome Measure Information:
Title
Stage A: Time to Initial Confirmed Evidence of Clinical Improvement (ECI)
Description
Time to initial confirmed ECI will be reported.
Time Frame
12 weeks
Title
Stage A: Percentage of Responders as Determined by ECI
Description
Stage A percentage of responders as determined by ECI will be reported.
Time Frame
12 weeks
Title
Stage A: Change from Baseline Over Time in Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale Score
Description
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.
Time Frame
Baseline to 12 weeks
Title
Stage A: Change from Stage A Baseline Over Time in Medical Research Council (MRC) Muscle Grading Scale Sum Score
Description
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.
Time Frame
Baseline to 12 weeks
Title
Stage A: Change from Baseline Over Time in Inflammatory Rasch-Built Overall Disability Scale (I-RODS) Centile Score
Description
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.
Time Frame
Baseline to 12 weeks
Title
Stage A: Change from Baseline Over Time in Mean Grip Strength (Dominant Hand)
Description
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).
Time Frame
Baseline to 12 weeks
Title
Stage A: Change from Baseline Over Time in Mean Grip Strength (Non-Dominant Hand)
Description
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).
Time Frame
Baseline to 12 weeks
Title
Stage B: Time to First Adjusted INCAT Disability Scale Score Deterioration Relative to Baseline
Description
Time to first adjusted INCAT disability scale score deterioration relative to Stage B baseline will be reported.
Time Frame
Up to 52 weeks
Title
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
Description
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.
Time Frame
Up to 52 weeks
Title
Stage B: Change from Baseline Over Time in Adjusted INCAT Disability Score
Description
Change from Stage B baseline over time in adjusted INCAT disability score will be reported.
Time Frame
Up to 52 weeks
Title
Stage B: Change from Baseline Over Time in MRC Muscle Grading Scale Sum Score
Description
Change from Stage B baseline over time in MRC Muscle Grading Scale Sum score will be reported.
Time Frame
Up to 52 weeks
Title
Stage B: Change from Baseline Over Time in I-RODS Centile Score
Description
Change from Stage B baseline over time in I-RODS centile score will be reported.
Time Frame
Up to 52 weeks
Title
Stage B: Change from Baseline Over Time in Mean Grip Strength (Dominant Hand)
Description
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).
Time Frame
Up to 52 weeks
Title
Stage B: Change from Baseline Over Time in Mean Grip Strength (Non-Dominant Hand)
Description
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).
Time Frame
Up to 52 weeks
Title
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
Description
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.
Time Frame
Up to 52 weeks
Title
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
Description
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
Time Frame
Stage A: 12 weeks; Stage B: Up to 52 weeks
Title
Percentage of Participants with Serious Adverse Events (SAEs)
Description
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.
Time Frame
Stage A: 12 weeks; Stage B: Up to 52 weeks
Title
Number of Participants with Change in Electrocardiogram (ECG) Values Over Time
Description
Number of participants with change in ECG values over time will be reported.
Time Frame
Stage A: 12 weeks; Stage B: Up to 52 weeks
Title
Number of Participants with Change in Vital Signs Values Over Time
Description
Number of participants with change in vital signs values over time will be reported.
Time Frame
Stage A: 12 weeks; Stage B: Up to 52 weeks
Title
Number of Participants with Change in Clinical Laboratory Values Over Time
Description
Number of participants with change in clinical laboratory values over time will be reported.
Time Frame
Stage A: 12 weeks; Stage B: Up to 52 weeks
Title
Number of Participants with Clinically Significant ECG Abnormalities
Description
Number of participants in clinically significant ECG abnormalities will be reported.
Time Frame
Stage A: 12 weeks; Stage B: Up to 52 weeks
Title
Number of Participants with Clinically Significant Vital Signs Abnormalities
Description
Number of participants in clinically significant vital signs abnormalities will be reported.
Time Frame
Stage A: 12 weeks; Stage B: Up to 52 weeks
Title
Number of Participants with Clinically Significant Clinical Laboratory Abnormalities
Description
Number of participants in clinically significant clinical laboratory abnormalities will be reported.
Time Frame
Stage A: 12 weeks; Stage B: Up to 52 weeks
Title
Percentage of Participants with Suicidal Ideation or Suicidal Behavior based on the Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
Percentage of participants with suicidal ideation or suicidal behavior based on the C-SSRS will be reported.
Time Frame
Stage A: 12 weeks; Stage B: Up to 52 weeks
Title
Serum Nipocalimab Concentrations Over Time in Participants Receiving Active Study Intervention
Description
Serum nipocalimab concentrations over time in participants receiving active study intervention will be reported.
Time Frame
Stage A: 12 weeks; Stage B: Up to 52 weeks
Title
Number of Participants with Anti-drug Antibodies (ADA) to Nipocalimab
Description
Number of participants with ADA to Nipocalimab will be reported.
Time Frame
Stage A: 12 weeks; Stage B: Up to 52 weeks
Title
Titers of ADA to Nipocalimab
Description
Titers of ADA to nipocalimab will be reported.
Time Frame
Stage A: 12 weeks; Stage B: Up to 52 weeks
Title
Number of Participants with Neutralizing Antibodies (NAb) to Nipocalimab
Description
Number of participants with NAb to Nipocalimab will be reported.
Time Frame
Stage A: 12 weeks; Stage B: Up to 52 weeks
Title
Change from Baseline in Total Serum Immunoglobulin (IgG) Concentrations Levels Over Time
Description
Change from baseline in total serum IgG concentrations levels over time will be reported.
Time Frame
Stage A: Baseline to 12 weeks; Stage B: Baseline up to 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults greater than or equal to (>=) 18 years of age at the time of consent and as applicable, must also meet the legal age of consent in the jurisdiction in which the study is taking place 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) Fulfilling any of the following treatment conditions: a) Currently treated with pulsed corticosteroids, oral corticosteroids and/or intravenous immunoglobulin (IVIg) or subcutaneous immunoglobulin (SCIg) and the participant is willing to discontinue or taper this treatment at the first run-in visit; or b) Without previous treatment (treatment naive); or treatment with corticosteroids and/or IVIg or SCIg discontinued at least 3 months prior to screening (untreated) Active disease as determined by CIDP Disease Activity Status (CDAS) score >= 3 Other protocol-defined inclusion criteria will apply Exclusion Criteria: Has a history of severe and/or uncontrolled hepatic (example, viral/alcoholic/autoimmune hepatitis/cirrhosis and/or metabolic liver disease), gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension and/or any other medical or uncontrolled autoimmune disorder(s) (example, diabetes mellitus) or clinically significant abnormalities in screening laboratory that, might interfere with the participants full participation in the study, or might jeopardize the safety of the participant or the validity of the study results Pure sensory CIDP or chronic immune sensory polyradiculopathy (CISP) (EAN/PNS definition) Any other disease that could better explain the participant's signs and symptoms, such as significant persisting neurological deficits from stroke or central nervous system (CNS) trauma or peripheral neuropathy from another cause such as connective tissue disease or systemic lupus erythematosus Polyneuropathy of other causes, including the following: Multifocal motor neuropathy (MMN); Monoclonal gammopathy of uncertain significance with antimyelin associated glycoprotein (anti-MAG) immunoglobulin M (IgM) antibodies; Hereditary motor neuropathy; Hereditary neuropathy with liability to pressure palsies (HNPP); Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes; Lumbosacral radiculoplexus neuropathy; Polyneuropathy most likely due to diabetes mellitus; Polyneuropathy most likely due to systemic illnesses; Drug- or toxin-induced polyneuropathy Note: A concomitant polyneuropathy of other causes (example, a mild, stable diabetic polyneuropathy) is not necessarily exclusionary if chronic inflammatory demyelinating polyneuropathy (CIDP) is confirmed as the main diagnosis, as determined by the investigator and confirmed by the adjudication committee Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients Other protocol-defined exclusion criteria will apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Neurology Associates PA
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Name
The Neurological Institute of New York
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
South Shore Neurologic Associates - Patchogue
City
Patchogue
State/Province
New York
ZIP/Postal Code
11772
Country
United States
Individual Site Status
Recruiting
Facility Name
The Neurological Institute, PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Name
Austin Neuromuscular Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Individual Site Status
Recruiting
Facility Name
Xuanwu Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of NanChang University
City
Nanchang
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
Xi 'an GaoXin Hospital
City
Xi'an
ZIP/Postal Code
710075
Country
China
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Králové
ZIP/Postal Code
500 05
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Pardubicka krajska nemocnice a.s.
City
Pardubice
ZIP/Postal Code
53203
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Asahikawa Medical Center
City
Asahikawa
ZIP/Postal Code
070-0901
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Medical and Dental University Hospital
City
Bunkyo-Ku
ZIP/Postal Code
113-8519
Country
Japan
Individual Site Status
Recruiting
Facility Name
Chiba University Hospital
City
Chiba-shi
ZIP/Postal Code
260-8677
Country
Japan
Individual Site Status
Recruiting
Facility Name
Seirei Hamamatsu General Hospital
City
Hamamatsu
ZIP/Postal Code
430-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kobe City Medical Center General Hospital
City
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokai University Hospital
City
Isehara
ZIP/Postal Code
259-1193
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saitama Medical Center
City
Koshigaya
ZIP/Postal Code
343-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagoya University Hospital
City
Nagoya-shi
ZIP/Postal Code
466-8560
Country
Japan
Individual Site Status
Recruiting
Facility Name
Chubu Rosai Hospital
City
Nagoya
ZIP/Postal Code
455-8530
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kindai University Hospital
City
Osaka-Sayama-shi
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Dokkyo Medical University Hospital
City
Shimotsuga-gun
ZIP/Postal Code
321-0293
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tenri Hospital
City
Tenri
ZIP/Postal Code
632-0015
Country
Japan
Individual Site Status
Recruiting
Facility Name
Toyama University Hospital
City
Toyama-shi
ZIP/Postal Code
930-0194
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yamaguchi University Hospital
City
Ube
ZIP/Postal Code
755-8505
Country
Japan
Individual Site Status
Recruiting
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne
City
Chorzów
ZIP/Postal Code
41-500
Country
Poland
Individual Site Status
Recruiting
Facility Name
Specjalistyczne Gabinety Lekarskie
City
Kraków
ZIP/Postal Code
30-539
Country
Poland
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

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