NCT06055959RecruitingPhase 2/3
A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis
A Multicenter Open-Label, Uncontrolled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Activity of Zilucoplan in Pediatric Study Participants From 2 to Less Than 18 Years of Age With Acetylcholine Receptor Antibody Positive Generalized Myasthenia Gravis
Source: ClinicalTrials.gov · Last updated 5 Nov 2026
Brief summary (registry, in English)
The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, safety, tolerability, immunogenicity and activity of zilucoplan (ZLP) in pediatric study participants with generalized myasthenia gravis (gMG).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 8 (estimated)
- First submitted
- 20 Sept 2023
- Start date
- 16 Oct 2024
- Primary completion date
- 12 May 2027
- Lead sponsor
- UCB Biopharma SRL
- Diseases
- Myasthenia gravis
- NCT number
- NCT06055959
- EU CT number
- 2022-502072-23-00
- EudraCT number
- 2022-502072-23
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 8
- From 16 Oct 2024 to the primary completion date, 12 May 2027
- 9 sites in 5 countries
- 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
- Participant has had a thymectomy within 6 months prior to Baseline
- Current or recent systemic infection within 2 weeks prior to Baseline or infection requiring intravenous antibiotics within 4 weeks prior to Baseline
Other illness
- Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's ability to participate in this study
Other
- Participant has known positive serology for muscle-specific kinase
- Participant has minimal Manifestation Status of MG based on the clinical judgement of the Investigator
Who the study is looking for
- United States of America (USA) specific inclusion criterion:
- \- Participant must be 12 to \<18 years of age at the time of signing the Informed consent/assent according to local regulation
- Rest of world (ROW) specific inclusion criterion:
- \- Participant must be 2 to \<18 years of age at the time of signing the Informed consent/assent according to local regulation
- Global inclusion criteria:
- Participant has a diagnosis of generalized myasthenia gravis (gMG) confirmed by a prior positive serologic test result to acetylcholine receptor (AChR) prior to Screening
- Participant meets the criteria as defined by the Myasthenia Gravis Foundation of America (MGFA) Clinical Classification II to IV at Screening
- Participants with gMG, including:
- An MG-activities of daily living (MG-ADL) total score of 6 or more in adolescents from 12 years to \<18 years of age at Screening
- Documented weakness in at least 1 limb, neck, or bulbar muscle in children from 2 years to \<12 years of age at Screening (does not apply to US)
- Documented vaccination against meningococcal infections within 3 years prior to study start. If not fully vaccinated, participants must receive appropriate prophylactic antibiotic treatment until at least 2 weeks after the initial dose of vaccine(s)
Age in the registry: 12 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mg0014 40735 Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Recruiting |
| Mg0014 40736 Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| IRCCS Foundation Istituto Neurologico Carlo Besta Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Mg0014 20104 Coordinator of this site? Confirm its status | Seoul | South Korea | Withdrawn |
| Mg0014 20220 Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Neurologia Śląska Centrum Medyczne Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Mg0014 50168 Coordinator of this site? Confirm its status | Chicago | United States | Withdrawn |
| Mg0014 50574 Coordinator of this site? Confirm its status | Denton | United States | Withdrawn |
This page is information, not medical advice. Discuss any trial with your doctor.