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

Phase 3RecruitingNCT05327114

Janssen Research & Development, LLC201 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

201

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Interventions

NipocalimabDRUG

Nipocalimab will be administered intravenously.

PlaceboDRUG

Placebo will be administered intravenously.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 * Inflammatory Neuropathy Cause and Treatment (INCAT) disability score between 2 and 9 at the Run-In Baseline visit for participants entering Run-In, or Stage A Baseline visit for participants directly entering Stage A. Participants with an INCAT score of 2 at trial entry must have this score exclusively from the leg disability score * Fulfilling any of the following treatment conditions: a) Currently treated with oral corticosteroids (CS) less than or equal to (\<=) 20 milligrams (mg)/day; or b) Currently treated with pulsed CS, and/or intravenous immunoglobulin (IVIg) or subcutaneous immunoglobulin (SCIg) and the participant is willing to discontinue no later than the run-in baseline visit; or c) Currently treated with oral CS greater than (\>) 20 mg/day and the participant is willing to taper to \<=20 mg/day during the run-in period; or d) Without previous treatment (treatment naive); or treatment with CS 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

Locations (108)

Outcomes

Primary Outcomes

Stage B: Time to First Occurrence of a Relapse Event

Stage B time to first occurrence of a relapse event will be reported.

Time frame: Up to 52 weeks

Secondary Outcomes

Stage A: Time to Initial Confirmed Evidence of Clinical Improvement (ECI)

Time to initial confirmed ECI will be reported.

Time frame: 12 weeks

Stage A: Percentage of Responders as Determined by ECI

Stage A percentage of responders as determined by ECI will be reported.

Time frame: 12 weeks

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.

Time frame: Baseline to 12 weeks

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.

Time frame: Baseline to 12 weeks

Stage A: Change from Baseline Over Time in Inflammatory Rasch-Built Overall Disability Scale (I-RODS) Centile Score

Central Contacts

Study Contact

CONTACT

844-434-4210 Participate-In-This-Study1@its.jnj.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

IMMUNOe Health and Research Centers

Centennial, Colorado, United States

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Healthcare Innovations Institute Inc

Coral Springs, Florida, United States

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Neurology Associates PA

Maitland, Florida, United States

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University of Kansas Medical Center

Kansas City, Kansas, United States

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Johns Hopkins Hospital

Baltimore, Maryland, United States

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Boston Clinical Trials

Boston, Massachusetts, United States

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Beaumont Hospital Royal Oak

Royal Oak, Michigan, United States

COMPLETED

Kansas City Veterans Affairs Medical Center

Kansas City, Missouri, United States

RECRUITING

The Neurological Institute of New York

New York, New York, United States

COMPLETED

South Shore Neurologic Associates - Patchogue

Patchogue, New York, United States

RECRUITING

...and 98 more locations

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

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).

Time frame: Baseline to 12 weeks

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).

Time frame: Baseline to 12 weeks

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.

Time frame: Up to 52 weeks

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.

Time frame: Up to 52 weeks

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.

Time frame: Up to 52 weeks

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.

Time frame: Up to 52 weeks

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.

Time frame: Up to 52 weeks

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).

Time frame: Up to 52 weeks

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).

Time frame: Up to 52 weeks

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.

Time frame: Up to 52 weeks

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