Evaluating Zilucoplan for Pediatric Myasthenia Gravis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the pharmacokinetics, pharmacodynamics, safety, tolerability, immunogenicity, and activity of zilucoplan in pediatric participants diagnosed with generalized myasthenia gravis (gMG). It includes participants aged 2 to 18 years, with specific inclusion criteria based on age and severity of their condition. The study aims to gather comprehensive data on how zilucoplan affects children with gMG, potentially leading to improved treatment options.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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)

Exclusion Criteria:

* Participant has known positive serology for muscle-specific kinase
* 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
* Participant has had a thymectomy within 6 months prior to Baseline
* Participant has minimal Manifestation Status of MG based on the clinical judgement of the Investigator
* Current or recent systemic infection within 2 weeks prior to Baseline or infection requiring intravenous antibiotics within 4 weeks prior to Baseline

Where it's running

• Mg0014 40144
  Milan, Italy Recruiting
• Mg0014 40774
  Katowice, Poland Recruiting
• Mg0014 20220
  Seoul, South Korea Recruiting
• Mg0014 40735
  Glasgow, United Kingdom Recruiting
• Mg0014 40736
  London, United Kingdom Recruiting
• Mg0014 50168
  Chicago, Illinois, United States Withdrawn

Study contacts

• Study coordinator: UCB Cares
• Email: ucbcares@ucb.com
• Phone: +18445992273 (USA)

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• SHR-2173 injection added to standard care for generalized myasthenia gravis

  This Phase 2 trial tests whether SHR-2173 added to usual treatment helps adults with generalized myasthenia gravis more than a placebo add-on.

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• Ravulizumab for Generalized Myasthenia Gravis in Chinese Adults

  This trial tests ravulizumab in Chinese adults with generalized myasthenia gravis to see if it helps symptoms while checking safety and how the drug behaves in the body.

  Recruiting at 8 sites Phase 3 Alexion Pharmaceuticals, Inc. · Beijing and 9 other locations · NCT07596784

• Tracking Real-Life Myasthenia Gravis Symptoms in Patients on Rozanolixizumab

  This observational study follows adults with generalized myasthenia gravis who are treated with Rozanolixizumab to see how their symptoms and fatigue change in real life.

  Recruiting Centre Hospitalier Universitaire de Nice · Nice, Alpes-maritimes and 10 other locations · NCT07570589

• ADAPT Forward master protocol testing multiple regimens for generalized myasthenia gravis

  This platform tests several drug regimens, including efgartigimod IV and empasiprubart IV, in adults with generalized myasthenia gravis to find safer and more effective treatment combinations.

  Recruiting at 37 sites argenx · Carlsbad, California and 36 other locations · NCT07294170

• Adding empasiprubart to efgartigimod for AChR-antibody positive generalized myasthenia gravis

  This trial will test whether adding empasiprubart to efgartigimod infusions helps people with AChR-antibody positive generalized myasthenia gravis who have only had a partial response to efgartigimod.

  Recruiting at 33 sites Phase 2 argenx · Carlsbad, California and 32 other locations · NCT07284420

• Oral steroid tapering for adults with generalized myasthenia gravis on ravulizumab.

  This study will try a predefined prednisone taper to see if adults with generalized myasthenia gravis on ravulizumab can safely reduce their daily steroid dose.

  Recruiting Phase 4 Alexion Pharmaceuticals, Inc. · Chicago, Illinois and 11 other locations · NCT07221838

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.