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Looking for participantsPhase2/Phase3

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

Sponsor: Janssen Research & Development, LLC

NCT ID: NCT05327114

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Nipocalimab (drug), Placebo (drug)
How long the study runs
Study runs about 74 months (dates as stated)
About the drug or intervention
Nipocalimab — drug: Nipocalimab will be administered intravenously. · Placebo — drug: Placebo will be administered intravenously.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
201
Started
2022-09-23
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for polyradiculoneuropathy, chronic inflammatory demyelinating
  • • Phase2/Phase3 - 201 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with polyradiculoneuropathy, chronic inflammatory demyelinating

Where?

  • • Birmingham - University Hospitals Birmingham NHS Foundation Trust
  • • Devon - Royal Devon & Exeter Hospital
  • • Glasgow - NHS Greater Glasgow and Clyde
  • • London - Royal Free Hospital
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ this score exclusively from the leg disability score
  • ✓ (treatment naive)

What the study is looking for

  • ✓Adults greater than or equal to (\>=) 18 years of age at the time of consent and as applicable, must also meet the...
  • ✓Active disease as determined by CIDP Disease Activity Status (CDAS) score \>= 3
  • ✓Other protocol-defined inclusion criteria will apply

Who cannot take part

  • ✗Pure sensory CIDP or chronic immune sensory polyradiculopathy (CISP) (EAN/PNS definition)
  • ✗Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
  • ✗Other protocol-defined exclusion criteria will apply
See the full 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

Where Is This Study? (5 UK sites)

University Hospitals Birmingham NHS Foundation Trust

Birmingham B15 2TH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

Royal Devon & Exeter Hospital

Devon EX2 5DW, United Kingdom

Recruiting
Hospital R&D contact (matched)

Samantha Smart

rduh.research-eastern@nhs.net01392 406075

NHS Greater Glasgow and Clyde

Glasgow G514TF, United Kingdom

Recruiting
Hospital R&D contact (matched)

Radek Penar

radoslaw.penar@nhs.scotn/a

Royal Free Hospital

London NW3 2QG, United Kingdom

SUSPENDED
Hospital R&D contact (matched)

Natasha Ajraam

rf-tr.randd@nhs.net020 375 82150

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield S10 2 JF, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alessia Dunn

STH.ResearchAdministration@nhs.net0114 2712550

How to Get in Touch

Study Contact

Sponsor contact

CONTACT

844-434-4210 Participate-In-This-Study1@its.jnj.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09