An Open-label Extension Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis

Sponsor
UCB Biopharma SRL
Study ID
NCT06435312
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

  • Generalized Myasthenia Gravis

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zilucoplan — DRUG
    Zilucoplan will be administered subcutaneously to pediatric study participants

Study Details

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

Key Dates

First listed
May 30, 2024
Start date
Nov 19, 2024
Status verified
Jul 2026
Primary completion
Oct 26, 2027
Completion
Nov 19, 2027

Study Design

Enrollment
8 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Zilucoplan Arm
    Study participants will receive Zilucoplan at a pre-defined dose based on their weight.

Primary Outcome Measure

Occurence of treatment emergent adverse events during the course of the study [ Time Frame: Baseline (Day 1) to Safety Follow-up (up to Week 60) ]

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