Home › Trials › NCT07091630

Empasiprubart for adults with CIDP

A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Empasiprubart IV in Adults With Chronic Inflammatory Demyelinating Polyneuropathy

PHASE3 · argenx · NCT07091630

This study will test whether IV empasiprubart helps improve symptoms and is safe for adults with CIDP, with an initial 24-week randomized comparison to placebo followed by two years of empasiprubart for all participants.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment160 (estimated)
Ages18 Years and up
SexAll
Sponsorargenx (industry)
Locations43 sites (Rancho Mirage, California and 42 other locations)
Trial IDNCT07091630 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults diagnosed with CIDP per the 2021 EAN/PNS guidelines who have active disease and residual disability and who can discontinue or switch prior CIDP treatments are ideal candidates.

Not a fit: People with sensory-predominant CIDP, possible (not definite) CIDP diagnoses, polyneuropathy from other causes, or a clinical diagnosis of systemic lupus erythematosus would not be expected to benefit or are excluded from participation.

Why it matters

Potential benefit: If successful, empasiprubart could offer a new treatment option that reduces disability and prevents relapses in adults with CIDP.

How similar studies have performed: Other therapies that reduce pathogenic antibodies have shown benefit in antibody-mediated neuromuscular conditions and some promise in CIDP, but empasiprubart itself is undergoing confirmatory Phase 3 testing.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Rancho Mirage, California and 42 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Chronic Inflammatory Demyelinating Polyneuropathy, CIDP, Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.