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Clinical Trials in the UK / NCT05327114
Recruiting Phase 2/3

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

NCT05327114 · tracked via the Priya Life Science UK tracker
Sponsor
Janssen Research & Development, LLC
Phase
Phase 2/3
Started
2022-09-23
Last updated
2026-08-28

Condition(s) studied

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Investigational drug(s) / intervention(s)

NipocalimabPlacebo

Nipocalimab: Nipocalimab will be administered intravenously.

Placebo: Placebo will be administered intravenously.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (120)

FacilityCityRegionStatus
IMMUNOe Health and Research Centers Centennial Colorado Recruiting
Healthcare Innovations Institute Inc Coral Springs Florida Recruiting
Neurology Associates PA Maitland Florida Completed
ALS Center at the University of Miami Miami Florida Recruiting
Augusta University Augusta Georgia Recruiting
University of Kansas Medical Center Kansas City Kansas Recruiting
Johns Hopkins Hospital Baltimore Maryland Recruiting
Boston Clinical Trials Boston Massachusetts Completed
Beaumont Hospital Royal Oak Royal Oak Michigan Completed
Kansas City Veterans Affairs Medical Center Kansas City Missouri Recruiting
The Neurological Institute of New York New York New York Completed
South Shore Neurologic Associates - Patchogue Patchogue New York Recruiting
The Neurological Institute, PA Charlotte North Carolina Recruiting
Cleveland Clinic Main Campus Cleveland Ohio Recruiting
Austin Neuromuscular Center Austin Texas Recruiting
Advocate Health - Aurora St. Luke's Medical Center Milwaukee Wisconsin Recruiting
Hospital Italiano de Buenos Aires Buenos Aires Argentina Recruiting
Instituto Fleni Buenos Aires Argentina Recruiting
Hospital Gral Agudos Ignacio Pirovano Buenos Aires Argentina Recruiting
INECO Neurociencias Orono Rosario Argentina Recruiting
The Alfred Hospital Melbourne Australia Completed
Gold Coast University Hospital Parkwood Australia Completed
The Ottawa Hospital Ottawa NeuroMuscular Centre Ottawa Canada Recruiting
Peking University First Hospital Beijing China Recruiting
Xuanwu Hospital ,Capital Medical University Beijing China Recruiting
Beijing Tiantan Hospital, Capital Medical University Beijing China Recruiting
Peking University Third Hospital Beijing China Recruiting
The First Hospital of Jilin University Changchun China Recruiting
The Third Xiangya Hospital of Central Sourth University Changsha China Recruiting
Xiangya Hospital Central South University Changsha China Recruiting
Sichuan Provincial Peoples Hospital Chengdu China Recruiting
Chifeng Municipal Hospital Chifeng China Recruiting
Fujian Medical University Union Hospital Fuzhou China Recruiting
The First Affiliated Hospital Sun Yat sen University Guangzhou China Recruiting
Qilu Hospital of Shandong University Jinan China Recruiting
Qianfoshan hospital of Shandong Province Jinan China Completed
The First Affiliated Hospital of NanChang University Nanchang China Recruiting
Huashan Hospital Fudan University Shanghai China Recruiting
Tong Ren Hospital Shanghai Jiao Tong University school of medicine Shanghai China Completed
Renmin Hospital of Wuhan University Wuhan China Recruiting

+ 80 more sites — see the full list on the official registry below.

More Janssen Research & Development, LLC trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05327114 on ClinicalTrials.gov ↗ ← All trials in the UK