NCT06920004 A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP
| NCT ID | NCT06920004 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | argenx |
| Condition | Chronic Inflammatory Demyelinating Polyneuropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 218 participants |
| Start Date | 2025-08-22 |
| Primary Completion | 2027-09 |
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 218 participants in total. It began in 2025-08-22 with a primary completion date of 2027-09.
⚠ 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 compare empasiprubart and IVIg for treating people with CIDP. This study consists of a Part A where participants will either receive empasiprubart and a placebo resembling IVIg, or IVIg and a placebo resembling empasiprubart 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/emvigorate
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, multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP * Has responded to IVIg in the past 5 years * Receiving treatment with IVIg within a standard optimal maintenance dosing regimen, with a minimum weekly IVIg dose of at least 0.125 g/kg * Has residual disability and active disease Exclusion Criteria: * Besides the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of CIDP or puts the participant at undue risk, including polyneuropathy of other causes * Meets the criteria for possible or sensory CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021) * Use of other long-acting immunomodulatory treatment
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06920004 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 NCT06920004 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 218 participants.
Is NCT06920004 currently recruiting?
Yes, NCT06920004 is actively recruiting participants. Contact the research team at clinicaltrials@argenx.com for enrollment information.
Where is the NCT06920004 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 NCT06920004 clinical trial?
NCT06920004 is sponsored by argenx. The trial plans to enroll 218 participants.