MG0014 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 Brief 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). Medical Condition Generalized Myasthenia Gravis Min. Age 12 Years Max. Age 17 Years Who Can Join? All Status Recruiting 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 Study Medication Description Study Medication: ZILBRYSQ® Other Descriptive Name: zilucoplan Placebo No Comparator: No Share this study Share Facebook Share Twitter Share LinkedIn Refer to a friend Via email Study Dates October 2024 Planned Start Date of Enrollment December 2026 Planned Study Completion Date General Information Study ID: MG0014 CT.gov Number: NCT06055959 Phase: Phase 2/Phase 3 Locations Click here to find out where the clinical study is conducted Interested in our clinical studies? Just contact us Austria UCBCares.AT@ucb.com +43 (0) 1 291 80 08 0800-296176 (freephone) Belgium UCBCares.BE@ucb.com +32 2 559 92 00 0800 38 008 (freephone) www.ucbcares.be Bulgaria UCBCares.BG@ucb.com +359 2 962 9933 www.ucbcares.bg Canada +1 866 709 8444 Czech Republic UCBCares.CZ@ucb.com +420 221 773 442 800 144 395 (freephone) www.ucbcares.cz Denmark UCBCares.DK@ucb.com +45 32462480 80 253827 (freephone) www.ucbcares.dk Finland UCBCares.FI@ucb.com +358 942733300 0800 9 13353 (freephone) www.ucbcares.fi France UCBCares.FR@ucb.com +33 1 47 29 45 55 0 805 222 949 (freephone) www.ucbcares.fr Germany UCBCares.DE@ucb.com +49 2173 48 48 48 www.ucbcares.de Greece UCBCares.GR@ucb.com +30 21 0997 4200 0080 012 9910 (freephone) www.ucbcares.gr Hungary UCBCares.HU@ucb.com +36 1 472 5060 06 80 021 486 (freephone) www.ucbcares.hu Ireland UCBCares.IE@ucb.com +353 1 463 2371 1800 93 00 75 (freephone) www.ucbcares.co.uk Italy UCBCares.IT@ucb.com +39 02 3007 9300 8009-86932 (freephone) www.ucbcares.it Japan https://ucbcares.jp Luxemburg UCBCares.LU@ucb.com +32 2 559 92 12 8002 3204 (freephone) Norway UCBCares.NO@ucb.com +45 32462482 800-10101 (freephone) www.ucbcares.no Poland UCBCares.PL@ucb.com +48 22 596 97 97 00 800 121 68 25 (freephone) www.ucbcares.pl Portugal UCBCares.PT@ucb.com +351 213 025 300 800-8-56033 (freephone) Romania +4021 300 19 07 Slovakia UCBCares.SK@ucb.com +421 2 592 020 23 0800 002 566 (freephone) www.ucbcares.sk Spain UCBCares.ES@ucb.com +34 915 70 06 49 8000-99684 (freephone) www.ucbcares.es Sweden UCBCares.SE@ucb.com +45 32462481 0200 898 671 (freephone) www.ucbcares.se Switzerland +41 58 822 3180 The Netherlands UCBCares.NL@ucb.com +31 76 573 1130 0800 3434335 (freephone) www.ucbcares.nl UK UCBCares.UK@ucb.com +44 1753 777 100 0800 279 3177 (freephone) www.ucbcares.co.uk USA UCBCares@ucb.com +1-844-599-2273 www.ucb-usa.com/Patients/Patients Email Print Back to results