An extension study to learn if Zilucoplan is safe and works over a long period in adult participants with generalized myasthenia gravis.

Phase 3

Active, not recruiting

Conditions: Generalized Myasthenia Gravis

Registration Number: 2024-512399-37-00

Lead Sponsor: UCB Biopharma

Brief Summary: To evaluate the long-term safety and tolerability of zilucoplan in subjects with gMG who have completed a qualifying zilucoplan clinical study

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing, recruitment ended

Sex: Not specified

Target Recruitment: 37

Inclusion Criteria

Completion of a qualifying zilucoplan study

Able to provide informed consent, including signing and dating the informed consent form (ICF)

Vaccination with a quadrivalent meningococcal vaccine and, where available, meningococcal serotype B vaccine. A booster vaccination should also be administered as clinically indicated, according to the local SOC, for subjects who have been previously vaccinated against Neisseria meningitidis

Female subjects of childbearing potential must have a negative urine pregnancy test within 24 hours prior to the first dose of study drug

Sexually active female subjects of childbearing potential (i.e., women who are not postmenopausal or who have not had a hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) and all male subjects (who have not been surgically sterilized by vasectomy) must agree to use effective contraception during the study and during the safety follow-up period of 40 days after the last dose of study drug. Postmenopausal women are, for the purposes of this protocol, defined as women who have not had menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.

Exclusion Criteria

Pregnant, planning to become pregnant, or nursing female subjects

With the exception of a prior zilucoplan trial, participation in another concurrent clinical trial involving an experimental therapeutic intervention (participation in observational studies and/or registry studies is permitted)

Unable or unwilling to comply with the requirements of the study

Commenced any disallowed medication per the exclusion criteria from the qualifying zilucoplan study or alter the dose of any other concomitant medication, unless medically indicated

Any new or worsening medical condition (since entry into the qualifying zilucoplan study) including active malignancy (except curatively resected squamous or basal cell carcinoma of the skin); significant medical disorder; psychiatric disorder; laboratory abnormality or any other reason that, in the opinion of the investigator or Sponsor, would disqualify the subject from participation in this study

Hypersensitivity to zilucoplan, placebo or any of its excipients

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• Incidence of TEAEs		• Incidence of TEAEs

Secondary Outcome Measures

Name	Time	Method
• CFB to Week E12 in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score		• CFB to Week E12 in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score
• CFB to Week E12 in the Quantitative Myasthenia Gravis (QMG) Score		• CFB to Week E12 in the Quantitative Myasthenia Gravis (QMG) Score
• CFB to Week E12 in the Myasthenia Gravis Composite (MGC) Score		• CFB to Week E12 in the Myasthenia Gravis Composite (MGC) Score
• CFB to Week E12 in the Myasthenia Gravis – Quality of Life revised (MG-QOL15r) Score		• CFB to Week E12 in the Myasthenia Gravis – Quality of Life revised (MG-QOL15r) Score

Trial Locations

Locations (16): Hospital Universitari Vall D Hebron
🇪🇸
Barcelona, Spain
Hospital De La Santa Creu I Sant Pau
🇪🇸
Barcelona, Spain
Hospital Universitario Basurto
🇪🇸
Bilbao, Spain
IRCCS Foundation Istituto Neurologico Carlo Besta
🇮🇹
Milan, Italy
Oslo University Hospital HF
🇳🇴
Oslo, Norway
Krakowska Akademia Neurologii Sp. z o.o.
🇵🇱
Cracow, Poland
Michalski I Partnerzy Lekarze sp.p.
🇵🇱
Cracow, Poland
Neurologia Śląska Centrum Medyczne
🇵🇱
Katowice, Poland
Mtz Clinical Research Powered By Pratia
🇵🇱
Warsaw, Poland
Specjalistyczne Gabinety Sp. z o.o.
🇵🇱
Cracow, Poland
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Hospital Universitari Vall D Hebron
🇪🇸Barcelona, Spain
Raul Juntas Morales
Site contact
+34932746000
raul.juntas@vallhebron.cat