Open-Label Extension Study of Zilucoplan in Subjects with Generalized Myasthenia Gravis

Phase 1

• Conditions: Generalized Myasthenia Gravis; MedDRA version: 20.0Level: LLTClassification code 10028415Term: MyastheniaSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-001565-33-PL
• Lead Sponsor: Ra Pharmaceuticals, Inc. (now part of UCB)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-19
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

To be eligible for this study, subjects must meet ALL of the following inclusion criteria:

1. Completion of a qualifying Ra Pharmaceuticals sponsored zilucoplan study
2. Able to provide informed consent, including signing and dating the informed consent form (ICF)
3. 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
4. Female subjects of childbearing potential must have a negative urine pregnancy test within 24 hours prior to the first dose of study drug
5. 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Subjects who meet ANY of the following exclusion criteria must be excluded from the study:

1. Pregnant, planning to become pregnant, or nursing female subjects
2. 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)
3. Unable or unwilling to comply with the requirements of the study
4. 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
5. 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
6. Hypersensitivity to zilucoplan, placebo or any of its excipients

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified