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)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Chronic Inflammatory Demyelinating Polyneuropathy
  • Age: Between 18 Year(s) - 89 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), progressing or relapsing forms.
    2. Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score between 2 and 9 (a score of 2 has to be exclusively from leg disability).
    3. Fulfilling any of the following treatment conditions:
      1. Currently treated with pulsed corticosteroids, oral corticosteroids and/or IVIg or SCIg and the patient is willing to discontinue or taper this treatment at the first run-in visit;
      2. or
      3. Without previous treatment (treatment naïve); or Treatment with corticosteroids and/or IVIg or SCIg discontinued at least 3 months prior to screening (untreated)
    4. Active disease as determined by CIDP Disease Activity Status (CDAS) score =3.
    5. Has sufficient venous access to allow drug administration by infusion and blood sampling as per the protocol.

You may not be eligible for this study if the following are true:

    1. Has a history of severe and/or uncontrolled hepatic (e.g., 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) (e.g., diabetes mellitus)
    2. Pure sensory CIDP or chronic immune sensory polyradiculopathy (CISP).
    3. 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.
    4. Any other disease that could better explain the patient'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.
    5. Any history of myelopathy or evidence of central demyelination.
    6. Currently has a malignancy or has a history of malignancy within 3 years before screening (with the exception of localized basal cell carcinoma and/or squamous cell carcinoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months [defined as a minimum of 12 weeks] before the first study intervention administration or cervical carcinoma in situ that has been treated with no



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