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

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: f
View:

⁃ 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)

Locations
United States
Illinois
Mg0014 50168
RECRUITING
Chicago
Texas
Mg0014 50574
RECRUITING
Denton
Other Locations
Italy
Mg0014 40144
RECRUITING
Milan
Poland
Mg0014 40774
RECRUITING
Katowice
Mg0014 40218
RECRUITING
Warsaw
Republic of Korea
Mg0014 20104
RECRUITING
Seoul
Mg0014 20220
RECRUITING
Seoul
United Kingdom
Mg0014 40735
RECRUITING
Glasgow
Mg0014 40736
RECRUITING
London
Contact Information
Primary
UCB Cares
ucbcares@ucb.com
+18445992273 (USA)
Backup
UCB Cares
001 844 599 2273
Time Frame
Start Date: 2024-10-16
Estimated Completion Date: 2026-12-25
Participants
Target number of participants: 8
Treatments
Experimental: Zilucoplan Arm
Study participants will receive zilucoplan in pre-defined dose based on their weight.
Related Therapeutic Areas
Sponsors
Leads: UCB Biopharma SRL

This content was sourced from clinicaltrials.gov

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