Clinical trial · Interventional
An Open-label Extension Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis
An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Zilucoplan in Pediatric Study Participants With Acetylcholine Receptor Antibody Positive Generalized Myasthenia Gravis
NCT06435312CI-TRIAL-00120037ziMyG+enrolling by invitationPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess the long-term safety and tolerability of an additional 52 weeks of Zilucoplan treatment administered by subcutaneous injection once daily in pediatric study participants
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Generalized Myasthenia Gravis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zilucoplan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Zilucoplan Arm
- description
- Study participants will receive Zilucoplan at a pre-defined dose based on their weight.
- interventionNames
- Drug: Zilucoplan
Primary outcomes (4)
- measure
- Occurence of treatment emergent adverse events during the course of the study
- timeFrame
- Baseline (Day 1) to Safety Follow-up (up to Week 60)
- description
- An adverse event (AE) is any untoward medical occurence in a patient or clinical investigation where the study participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
- measure
- Occurence of treatment-emergent serious adverse events (TESAEs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: United States of America (USA) specific inclusion criterion: \- Participant must be ≥ 12 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 years of age at the time of signing the Informed Consent/Assent according to local regulation. Global specific inclusion criteria: * Participant has completed the MG0014 according to the protocol, and further treatment with zilucoplan is in the interest of the participant in the investigator´s opinion * Participant agrees to receive booster vaccinations against meningococcal infections during the study, if clinically indicated according to the local standard of care Exclusion Criteria: * Study participant met any mandatory investigational medicinal product (IMP) withdrawal or mandatory permanent discontinuation criteria in MG0014 or permanently discontinued IMP * Participant has known positive serology for muscle-specific kinase * Participant has known hypersensitivity to any components of the IMP * Participant has a prior history of meningococcal disease
References
Publications (0)
Data not yet available
No reference posted for this study.