UCB's Global Corporate Website

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

Not yet recruiting
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

Study Dates

October 2024

Planned Start Date of Enrollment

December 2027

Planned Study Completion Date

General Information

Study ID:
MG0015
CT.gov Number:
NCT06435312
Phase:
Phase 3

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

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

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

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