A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP
Recruiting
Phase 3
Interventional Study
Chronic Inflammatory Demyelinating Polyneuropathy
CIDP
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 160 (estimated)
- Sponsor
- argenx · Industry
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About This Trial
The main purpose of this study is to demonstrate the efficacy and safety of empasiprubart in adults with CIDP. The study consists of a part A where participants will either receive empasiprubart or placebo for 24 weeks (6 months). Following part A, participants will enter part B in which all participants will receive empasiprubart for 96 weeks (24 months).
More information can be found here: http…
Trial Locations
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Eligibility 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 dista…
Contacts