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Clinical Trial: ARISE Study for CIDP

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

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ARISE study logoHave you been diagnosed with CIDP? A clinical research study (ARISE) is now enrolling to evaluate an investigational medication.

Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare disease where the body’s natural defenses, like antibodies, attack the covering of the nerves, called myelin, and damage nerve function. While symptoms aren’t the same for everyone, CIDP can make your arms and legs feel weak and slow your movements. The purpose of the ARISE Study is to evaluate the safety and efficacy of an investigational medication in adults with active CIDP.

You may be eligible to participate if you:

  • Are an adult aged 18 years or older
  • Have been diagnosed with active CIDP
  • Fulfill any of the following treatment conditions:
    • Currently treated with oral corticosteroids (CS) ≤20 mg/day; or
    • Currently treated with pulsed corticosteroids (CS), and/or Intravenous immunoglobulin (IVIg) or Subcutaneous immunoglobulin (SCIg) and willing to discontinue; or
    • Currently treated with oral CS >20 mg/day and willing to taper to ≤20 mg/day; or
    • Without previous treatment; or
    • Treatment with CS and/or IVIg or SCIg was discontinued at least 3 months
      prior to screening

What can I expect if I join the study?

  • You will receive a thorough medical exam and your CIDP diagnosis will be confirmed.
  • If you qualify and are currently receiving treatment for CIDP, you may be asked to discontinue or taper off this treatment.
  • You will receive study-required medical care throughout the study by a neuromuscular neurologist.
  • All who qualify will receive the investigational medication for a portion of the study. The investigational medication will be an IV infusion.
  • If you qualify for another portion of the study, you will be randomly assigned to receive either the investigational medication or a placebo that has no active drug. You will not know which treatment you will receive.
  • If you qualify for all portions of the study and wish to continue, you can expect to spend up to 2–5 years in the study.

Participants will receive study-required medical care at no cost. Participants who qualify to receive the investigational medication will receive it at no cost. The study will not pay for other medical care or current medication(s) needed to support your daily health care routine.

Visit https://globaltrialfinder.janssen.com/trial/CR109195 and https://clinicaltrials.gov/ct2/show/NCT05327114 to learn more about this clinical study.

Sponsored by

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