NCT07091630 A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP
| NCT ID | NCT07091630 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | argenx |
| Condition | Chronic Inflammatory Demyelinating Polyneuropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-09-16 |
| Primary Completion | 2027-10-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 160 participants in total. It began in 2025-09-16 with a primary completion date of 2027-10-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07091630 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Inflammatory Demyelinating Polyneuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07091630 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 160 participants.
Is NCT07091630 currently recruiting?
Yes, NCT07091630 is actively recruiting participants. Contact the research team at clinicaltrials@argenx.com for enrollment information.
Where is the NCT07091630 trial being conducted?
This trial is being conducted at Birmingham, United States, Rancho Mirage, United States, Colorado Springs, United States, Washington D.C., United States and 11 additional locations.
Who is sponsoring the NCT07091630 clinical trial?
NCT07091630 is sponsored by argenx. The trial plans to enroll 160 participants.