Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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16 December 2019 |
Main ID: |
EUCTR2019-001565-33-GB |
Date of registration:
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01/11/2019 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Open-Label Extension Study of Zilucoplan in Subjects with Generalized Myasthenia Gravis
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Scientific title:
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A Phase 3, Multicenter, Open-Label Extension Study of Zilucoplan in Subjects with Generalized Myasthenia Gravis - RAISE-XT |
Date of first enrolment:
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30/10/2019 |
Target sample size:
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200 |
Recruitment status: |
Authorised-recruitment may be ongoing or finished |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-001565-33 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
Number of treatment arms in the trial: 1
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Canada
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France
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Germany
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Italy
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Japan
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Norway
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Spain
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Trial Information
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Address:
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87 Cambridge Park Drive
MA, 02140
Cambridge
United States |
Telephone:
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+1 617 4014060 |
Email:
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trials@rapharma.com |
Affiliation:
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Ra Pharmaceuticals, Inc |
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Name:
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Clinical Trial Information
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Address:
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87 Cambridge Park Drive
MA, 02140
Cambridge
United States |
Telephone:
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+1 617 4014060 |
Email:
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trials@rapharma.com |
Affiliation:
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Ra Pharmaceuticals, Inc |
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Key inclusion & exclusion criteria
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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. Postmenopausal women are, for the purposes of this protocol, defined as women who have gone 12 consecutive months without menstruation
Are the trial subjects under 18? no Number of subjects for this age range: 0 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.Did not start 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) or any other reason that, in the opinion of the investigator or Sponsor, would disqualify the subject from participation in this study
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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Generalized Myasthenia Gravis MedDRA version: 20.0
Level: LLT
Classification code 10028415
Term: Myasthenia
System Organ Class: 100000004859
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Intervention(s)
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Product Name: Zilucoplan Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Zilucoplan CAS Number: 1841136-73-9 Current Sponsor code: RA101495 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 40-
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Primary Outcome(s)
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Secondary Objective: Not applicable
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Primary end point(s): Efficacy endpoints: •MG-ADL Score •QMG Score •MG-QOL15r •MGC Score Safety endpoints
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Main Objective: •To provide access to zilucoplan for subjects with gMG who have completed a qualifying Ra Pharmaceuticals sponsored zilucoplan study and who wish to continue receiving zilucoplan •To evaluate the long-term efficacy of zilucoplan in subjects with gMG who have completed a qualifying Ra Pharmaceuticals sponsored zilucoplan clinical study •To evaluate the long-term safety and tolerability of zilucoplan in subjects with gMG who have completed a qualifying Ra Pharmaceuticals sponsored zilucoplan clinical study
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Timepoint(s) of evaluation of this end point: during each visit
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Secondary Outcome(s)
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Secondary end point(s): Not applicable
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Timepoint(s) of evaluation of this end point: Not applicable
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Secondary ID(s)
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RA101495-02.302
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Source(s) of Monetary Support
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Ra Pharmaceuticals, Inc.
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Ethics review
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Status: Approved
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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