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NCT07091630
A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP
Conditions: Chronic Inflammatory Demyelinating Polyneuropathy, CIDP, Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 160
Sponsor: argenx
Location: University of Alabama at Birmingham - 1720 University Blvd Birmingham Alabama
Summary
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: https://clinicaltrials.argenx.com/emnergize
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 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
Source: ClinicalTrials.gov (NCT07091630). StuddyBuddy aggregates publicly available trial information.