Empasiprubart for adults with CIDP

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults who meet the EAN/PNS diagnostic criteria for CIDP and who have active disease and residual disability are randomized in Part A to receive intravenous empasiprubart or placebo for 24 weeks. After completing Part A, all participants enter Part B and receive open-label empasiprubart for 96 weeks. Participants already on CIDP treatments must be willing to stop or switch to the study drug before the first dose. The trial tracks clinical measures of disability and safety during the blinded period and long-term outcomes during the open-label extension.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Meets criteria for CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
* Has either typical CIDP or 1 of the following CIDP variants: motor CIDP (including motor-predominant CIDP), multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP
* Has residual disability and active disease
* Has not received previous treatment for CIDP; or has stopped receiving CIDP treatment; or is receiving CIDP treatment (pulsed or oral corticosteroids, immunoglobulins, PLEX, or FcRn inhibitors)
* Participants already receiving CIDP treatment will have to discontinue their CIDP treatment before first IMP administration and must be willing to switch to the study IMP

Exclusion Criteria:

* Meets the criteria for possible CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)
* Sensory CIDP (including sensory-predominant CIDP)
* Polyneuropathy of other causes
* Clinical diagnosis of systemic lupus erythematosus (SLE)
* Use of other long-acting immunomodulatory treatment or prior treatment (at any time) with total lymphoid irradiation or bone marrow transplantation

Where it's running

• University of Alabama at Birmingham - 1720 University Blvd
  Birmingham, Alabama, United States Recruiting
• Banner University of Arizona Medical Center
  Tucson, Arizona, United States Recruiting
• Samir Macwan, M.D., Inc. (S corporation)
  Rancho Mirage, California, United States Recruiting
• Colorado Springs Neurological Associates
  Colorado Springs, Colorado, United States Recruiting
• Medstar Health Research Institute
  Washington D.C., District of Columbia, United States Recruiting
• Gables Neurology
  Miami, Florida, United States Recruiting

+44 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Sabine Coppieters, MD
• Email: clinicaltrials@argenx.com
• Phone: 857-350-4834

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Real-world efgartigimod use in adults with CIDP

  This study will see if efgartigimod helps adults with CIDP when given as part of routine clinical care.

  Recruiting at 22 sites argenx · Wilmington, North Carolina and 22 other locations · NCT07264426

• Empasiprubart versus IVIg for treating CIDP in adults

  This trial tests whether empasiprubart works as well as IVIg and is safe for adults with CIDP who currently benefit from IVIg.

  Recruiting at 107 sites Phase 3 argenx · Birmingham, Alabama and 106 other locations · NCT06920004

• Comparing IVIG and SCIG dosing for CIDP

  This trial will test whether body composition changes how IVIG and SCIG deliver protective antibodies in adults with CIDP.

  Recruiting Phase 1 Rutgers, The State University of New Jersey · New Brunswick, New Jersey · NCT05584631

• KITE-363 treatment for relapsed or refractory autoimmune neurologic diseases

  This study will test whether KITE-363 is safe and can help people with relapsed or treatment-resistant autoimmune neurologic diseases such as MS, CIDP, and myasthenia gravis.

  Recruiting at 10 sites Phase 1 Gilead Sciences · Newport Beach, California and 9 other locations · NCT07304154

• Immunoadsorption treatment for chronic inflammatory demyelinating polyneuropathy

  This observational study will try immunoadsorption as a next-step treatment for adults with CIDP who do not respond well to IVIg or methylprednisolone.

  Recruiting University of Ulm · Ulm, Baden-Wurttemberg · NCT07154524

• Imeroprubart for adults with CIDP

  This study will test whether the monoclonal antibody Imeroprubart helps adults with active CIDP who are already on stable immunoglobulin or corticosteroid treatment.

  Recruiting at 117 sites Phase 2 Immunovant Sciences GmbH · Tucson, Arizona and 141 other locations · NCT07032662

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.