NCT07638566Not yet recruitingPhase 2/3
A Study to Assess the Correct Dose, Safety and Efficacy of Empasiprubart in Adolescent Participants Aged 12 to Less Than 18 Years With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
An Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Empasiprubart in Adolescent Participants Aged 12 to Less Than 18 Years With Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Source: ClinicalTrials.gov · Last updated 10 Jun 2026
Brief summary (registry, in English)
The main purpose of the study is to determine the correct dose of empasiprubart in adolescent participants. It also aims to evaluate if empasiprubart may work and how safe it is for the use in children living with CIDP. The study consists of an open label treatment phase where participants will receive empasiprubart for up to 27 months approximately. After the final dose of empasiprubart, participants will enter a safety follow-up period for up to 14 months approximately. The overall study duration for each participant is up to 43 months. More information can be found here: clinicaltrials.argenx.com/emlight
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 6 (estimated)
- First submitted
- 5 Jun 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- argenx
- NCT number
- NCT07638566
- EU CT number
- 2025-524153-14-00
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 6
- From 1 Sept 2026 to the primary completion date, 30 Apr 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior use of other long-acting immunomodulatory treatment.
Other illness
- 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 that puts the participant at undue risk.
Other
- Possible CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021).
- Sensory CIDP (including sensory-predominant CIDP).
Who the study is looking for
- Is aged 12 to \<18 years.
- Meets criteria for CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021).
- Has a diagnosis of 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.
Age in the registry: 12 years to 17 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.