Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Empasiprubart IV for Chronic Inflammatory Demyelinating Polyneuropathy

The main purpose of this study is to demonstrate the how well it works and safety of empasiprubart in adults with CIDP. The study consists of a part A where participants will either receive empasiprubart or dummy treatment (placebo) for 24 weeks (6 months).

Official registry: https://clinicaltrials.gov/study/NCT07091630 · argenx · enrollment listed as 160

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Empasiprubart IV, or Placebo IV. The registry lists allocation as randomized. The main purpose of this study is to demonstrate the how well it works and safety of empasiprubart in adults with CIDP.

They plan to enroll about 160 people at 94 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

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

Interventions: Empasiprubart IV, Placebo IV

Primary outcome (registry wording): Reduction of ≥1 point compared with baseline in aINCAT score at week 24

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • 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

Public study contact (from the registry)

Sabine Coppieters, MD

857-350-4834

clinicaltrials@argenx.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

94 listed

+ 80 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07091630 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07091630?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07091630?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary