RECRUITING

A Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-10-16
Study Completion:2026-12-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06055959

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Participant has known positive serology for muscle-specific kinase
  2. * 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
  3. * Participant has had a thymectomy within 6 months prior to Baseline
  4. * Participant has minimal Manifestation Status of MG based on the clinical judgement of the Investigator
  5. * Current or recent systemic infection within 2 weeks prior to Baseline or infection requiring intravenous antibiotics within 4 weeks prior to Baseline

Contacts and Locations

Study Contact

UCB Cares
CONTACT
+18445992273 (USA)
ucbcares@ucb.com
UCB Cares
CONTACT
001 844 599 2273

Principal Investigator

UCB Cares
STUDY_DIRECTOR
001 844 599 2273

Study Locations (Sites)

Mg0014 50168
Chicago, Illinois, 60611
United States
Mg0014 50574
Denton, Texas, 76208
United States

Collaborators and Investigators

Sponsor: UCB Biopharma SRL

  • UCB Cares, STUDY_DIRECTOR, 001 844 599 2273

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-16
Study Completion Date2026-12-25

Study Record Updates

Study Start Date2024-10-16
Study Completion Date2026-12-25

Terms related to this study

Keywords Provided by Researchers

  • RA101495
  • gMG
  • generalized myasthenia gravis
  • zilucoplan
  • pediatric
  • MG0014

Additional Relevant MeSH Terms

  • Generalized Myasthenia Gravis