Recruiting NCT05327114

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

Phase II / Phase III Interventional Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Nipocalimab, Placebo.
Who it may be relevant to: Registry conditions: Polyradiculoneuropathy, Chronic Inflammatory Demyelinating. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Canada, China +14
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

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.

Interventions

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

Primary outcome measures

Stage B: Time to First Occurrence of a Relapse Event [Time frame: Up to 52 weeks]

Secondary outcome measures (12)

Stage A: Time to Initial Confirmed Evidence of Clinical Improvement (ECI) [Time frame: 12 weeks]
Stage A: Percentage of Responders as Determined by ECI [Time frame: 12 weeks]
Stage A: Change from Baseline Over Time in Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale Score [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 [Time frame: Baseline to 12 weeks]
Stage A: Change from Baseline Over Time in Inflammatory Rasch-Built Overall Disability Scale (I-RODS) Centile Score [Time frame: Baseline to 12 weeks]
Stage A: Change from Baseline Over Time in Mean Grip Strength (Dominant Hand) [Time frame: Baseline to 12 weeks]
Stage A: Change from Baseline Over Time in Mean Grip Strength (Non-Dominant Hand) [Time frame: Baseline to 12 weeks]
Stage B: Time to First Adjusted INCAT Disability Scale Score Deterioration Relative to Baseline [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 frame: Up to 52 weeks]
Stage B: Change from Baseline Over Time in Adjusted INCAT Disability Score [Time frame: Up to 52 weeks]
Stage B: Change from Baseline Over Time in MRC Muscle Grading Scale Sum Score [Time frame: Up to 52 weeks]
Stage B: Change from Baseline Over Time in I-RODS Centile Score [Time frame: Up to 52 weeks]

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
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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Double blind
Primary purpose: Treatment

Study locations

China · 19 centers

Peking University First Hospital — Beijing
Xuanwu Hospital ,Capital Medical University — Beijing
Beijing Tiantan Hospital, Capital Medical University — Beijing
Peking University Third Hospital — Beijing
The First Hospital of Jilin University — Changchun
The Third Xiangya Hospital of Central Sourth University — Changsha
Xiangya Hospital Central South University — Changsha
Sichuan Provincial Peoples Hospital — Chengdu
… and 11 more centers

Japan · 19 centers

National Hospital Organization Asahikawa Medical Center — Asahikawa
Institute of Science Tokyo Hospital — Bunkyō City
Chiba University Hospital — Chiba
Seirei Hamamatsu General Hospital — Hamamatsu
Tokai University Hospital — Isehara
Kobe City Medical Center General Hospital — Kobe
… and 13 more centers

United States · 15 centers

IMMUNOe Health and Research Centers — Centennial
Healthcare Innovations Institute Inc — Coral Springs
Neurology Associates PA — Maitland
ALS Center at the University of Miami — Miami
University of Kansas Medical Center — Kansas City
Johns Hopkins Hospital — Baltimore
Boston Clinical Trials — Boston
Beaumont Hospital Royal Oak — Royal Oak
… and 7 more centers

France · 9 centers

CHU Bordeaux — Bordeaux
Hospices Civils de Lyon HCL — Bron
Hopital de Bicetre — Le Kremlin-Bicêtre
Hopital de la Timone — Marseille
Hopital PASTEUR — Nice
CHU Nimes Hopital Caremeau — Nîmes
Hopital de la Pitie Salpetriere — Paris
Fondation Adolphe de Rothschild Hospital — Paris
… and 1 more center

Italy · 9 centers

Azienda Ospedaliero-Universitaria Policlinico di Catania — Catania
Azienda Ospedaliera Universitaria San Martino di Genova — Genova
Casa di Cura del Policlinico — Milan
Istituto Neurologico Carlo Besta — Milan
Azienda Ospedaliera di Rilievo Nazionale A Cardarelli — Naples
Aou San Luigi Gonzaga — Orbassano
Fondazione Istituto Neurologico Casimiro Mondino — Pavia
Fondazione Policlinico Universitario A Gemelli IRCCS — Roma
… and 1 more center

Germany · 6 centers

Judisches Krankenhaus Berlin — Berlin
St. Josef-Hospital, Ruhr-Universität Bochum — Bochum
Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH — Halle
Medizinische Hochschule Hannover — Hanover
Universitaetsklinikum Leipzig — Leipzig
St Josefs Krankenhaus Potsdam Sanssouci — Potsdam

Spain · 6 centers