MG0015 An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Zilucoplan in Pediatric Study Participants With Acetylcholine Receptor Antibody Positive Generalized Myasthenia Gravis Brief summary 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 Medical Condition Generalized Myasthenia Gravis Min. Age 12 Years Max. Age - Who Can Join? All Status Enrolling by invitation Inclusion criteria United States of America (USA) specific inclusion criterion: - Participant must be ≥ 12 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 years of age at the time of signing the Informed Consent/Assent according to local regulation. Global specific inclusion criteria: - Participant has completed the MG0014 according to the protocol, and further treatment with zilucoplan is in the interest of the participant in the investigator?s opinion - Participant agrees to receive booster vaccinations against meningococcal infections during the study, if clinically indicated according to the local standard of care Exclusion criteria - Study participant met any mandatory investigational medicinal product (IMP) withdrawal or mandatory permanent discontinuation criteria in MG0014 or permanently discontinued IMP - Participant has known positive serology for muscle-specific kinase - Participant has known hypersensitivity to any components of the IMP - Participant has a prior history of meningococcal disease Study Medication Description Study Medication: ZILBRYSQ? Other Descriptive Name: zilucoplan Placebo No Comparator: No Share this study Refer to a friend Via email Study Dates November 2024 Actual Start Date of Enrollment December 2027 Planned Study Completion Date General Information Study ID: MG0015 CT.gov Number: Phase: Phase 3 Locations Interested in our clinical studies? Just contact us Austria 金禾娱乐城Cares.AT@ucb.com +43 (0) 1 291 80 08 0800-296176 (freephone) Belgium 金禾娱乐城Cares.BE@ucb.com +32 2 559 92 00 0800 38 008 (freephone) Bulgaria 金禾娱乐城Cares.BG@ucb.com +359 2 962 9933 Canada +1 866 709 8444 Czech Republic 金禾娱乐城Cares.CZ@ucb.com +420 221 773 442 800 144 395 (freephone) Denmark 金禾娱乐城Cares.DK@ucb.com +45 32462480 80 253827 (freephone) Finland 金禾娱乐城Cares.FI@ucb.com +358 942733300 0800 9 13353 (freephone) France 金禾娱乐城Cares.FR@ucb.com +33 1 47 29 45 55 0 805 222 949 (freephone) Germany 金禾娱乐城Cares.DE@ucb.com +49 2173 48 48 48 Greece 金禾娱乐城Cares.GR@ucb.com +30 21 0997 4200 0080 012 9910 (freephone) Hungary 金禾娱乐城Cares.HU@ucb.com +36 1 472 5060 06 80 021 486 (freephone) Ireland 金禾娱乐城Cares.IE@ucb.com +353 1 463 2371 1800 93 00 75 (freephone) Italy 金禾娱乐城Cares.IT@ucb.com +39 02 3007 9300 8009-86932 (freephone) Japan Luxemburg 金禾娱乐城Cares.LU@ucb.com +32 2 559 92 12 8002 3204 (freephone) Norway 金禾娱乐城Cares.NO@ucb.com +45 32462482 800-10101 (freephone) Poland 金禾娱乐城Cares.PL@ucb.com +48 22 596 97 97 00 800 121 68 25 (freephone) Portugal 金禾娱乐城Cares.PT@ucb.com +351 213 025 300 800-8-56033 (freephone) Romania +4021 300 19 07 Slovakia 金禾娱乐城Cares.SK@ucb.com +421 2 592 020 23 0800 002 566 (freephone) Spain 金禾娱乐城Cares.ES@ucb.com +34 915 70 06 49 8000-99684 (freephone) Sweden 金禾娱乐城Cares.SE@ucb.com +45 32462481 0200 898 671 (freephone) Switzerland +41 58 822 3180 The Netherlands 金禾娱乐城Cares.NL@ucb.com +31 76 573 1130 0800 3434335 (freephone) UK 金禾娱乐城Cares.UK@ucb.com +44 1753 777 100 0800 279 3177 (freephone) USA 金禾娱乐城Cares@ucb.com +1-844-599-2273 Email Print Back to results
