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NCT Number: NCT05327114

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.

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Key information

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Diseases Disease Attributes Immune System Diseases Nervous System Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Polyradiculoneuropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospital Gral Agudos Ignacio Pirovano, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nipocalimab

Drug

Nipocalimab will be administered intravenously.

Other names: JNJ-80202135, M281

Placebo

Drug

Placebo will be administered intravenously.

Primary outcomes

  1. Stage B: Time to First Occurrence of a Relapse Event

    Time frame: Up to 52 weeks

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

Secondary outcomes

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

    Time frame: 12 weeks

    Time to initial confirmed ECI will be reported.

  2. Stage A: Percentage of Responders as Determined by ECI

    Time frame: 12 weeks

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

  3. Stage A: Change from Baseline Over Time in Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale Score

    Time frame: Baseline to 12 weeks

    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.

  4. Stage A: Change from Stage A Baseline Over Time in Medical Research Council (MRC) Muscle Grading Scale Sum Score

    Time frame: Baseline to 12 weeks

    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.

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

    Time frame: Baseline to 12 weeks

    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.

  6. Stage A: Change from Baseline Over Time in Mean Grip Strength (Dominant Hand)

    Time frame: Baseline to 12 weeks

    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).

  7. Stage A: Change from Baseline Over Time in Mean Grip Strength (Non-Dominant Hand)

    Time frame: Baseline to 12 weeks

    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).

  8. Stage B: Time to First Adjusted INCAT Disability Scale Score Deterioration Relative to Baseline

    Time frame: Up to 52 weeks

    Time to first adjusted INCAT disability scale score deterioration relative to Stage B baseline will be reported.

  9. 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 frame: Up to 52 weeks

    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.

  10. Stage B: Change from Baseline Over Time in Adjusted INCAT Disability Score

    Time frame: Up to 52 weeks

    Change from Stage B baseline over time in adjusted INCAT disability score will be reported.

  11. Stage B: Change from Baseline Over Time in MRC Muscle Grading Scale Sum Score

    Time frame: Up to 52 weeks

    Change from Stage B baseline over time in MRC Muscle Grading Scale Sum score will be reported.

  12. Stage B: Change from Baseline Over Time in I-RODS Centile Score

    Time frame: Up to 52 weeks

    Change from Stage B baseline over time in I-RODS centile score will be reported.

  13. Stage B: Change from Baseline Over Time in Mean Grip Strength (Dominant Hand)

    Time frame: Up to 52 weeks

    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).

  14. Stage B: Change from Baseline Over Time in Mean Grip Strength (Non-Dominant Hand)

    Time frame: Up to 52 weeks

    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).

  15. 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

    Time frame: Up to 52 weeks

    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.

  16. Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)

    Time frame: Stage A: 12 weeks; Stage B: Up to 52 weeks

    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

  17. Percentage of Participants with Serious Adverse Events (SAEs)

    Time frame: Stage A: 12 weeks; Stage B: Up to 52 weeks

    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.

  18. Number of Participants with Change in Electrocardiogram (ECG) Values Over Time

    Time frame: Stage A: 12 weeks; Stage B: Up to 52 weeks

    Number of participants with change in ECG values over time will be reported.

  19. Number of Participants with Change in Vital Signs Values Over Time

    Time frame: Stage A: 12 weeks; Stage B: Up to 52 weeks

    Number of participants with change in vital signs values over time will be reported.

  20. Number of Participants with Change in Clinical Laboratory Values Over Time

    Time frame: Stage A: 12 weeks; Stage B: Up to 52 weeks

    Number of participants with change in clinical laboratory values over time will be reported.

  21. Number of Participants with Clinically Significant ECG Abnormalities

    Time frame: Stage A: 12 weeks; Stage B: Up to 52 weeks

    Number of participants with clinically significant ECG abnormalities will be reported.

  22. Number of Participants with Clinically Significant Vital Signs Abnormalities

    Time frame: Stage A: 12 weeks; Stage B: Up to 52 weeks

    Number of participants with clinically significant vital signs abnormalities will be reported.

  23. Number of Participants with Clinically Significant Clinical Laboratory Abnormalities

    Time frame: Stage A: 12 weeks; Stage B: Up to 52 weeks

    Number of participants with clinically significant clinical laboratory abnormalities will be reported.

  24. Percentage of Participants with Suicidal Ideation or Suicidal Behavior based on the Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: Stage A: 12 weeks; Stage B: Up to 52 weeks

    Percentage of participants with suicidal ideation or suicidal behavior based on the C-SSRS will be reported.

  25. Serum Nipocalimab Concentrations Over Time in Participants Receiving Active Study Intervention

    Time frame: Stage A: 12 weeks; Stage B: Up to 52 weeks

    Serum nipocalimab concentrations over time in participants receiving active study intervention will be reported.

  26. Number of Participants with Anti-drug Antibodies (ADA) to Nipocalimab

    Time frame: Stage A: 12 weeks; Stage B: Up to 52 weeks

    Number of participants with ADA to Nipocalimab will be reported.

  27. Titers of ADA to Nipocalimab

    Time frame: Stage A: 12 weeks; Stage B: Up to 52 weeks

    Titers of ADA to nipocalimab will be reported.

  28. Number of Participants with Neutralizing Antibodies (NAb) to Nipocalimab

    Time frame: Stage A: 12 weeks; Stage B: Up to 52 weeks

    Number of participants with NAb to Nipocalimab will be reported.

  29. Change from Baseline in Total Serum Immunoglobulin (IgG) Concentrations Levels Over Time

    Time frame: Stage A: Baseline to 12 weeks; Stage B: Baseline up to 52 weeks

    Change from baseline in total serum IgG concentrations levels over time will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2027
Study completion
2029
First posted
Apr 14, 2022
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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