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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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT03239860 |
Date of registration:
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12/07/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Assessing the HERV-W Env ANtagonist GNbAC1 for Evaluation in an Open Label Long-term Safety Study in Patients With Multiple Sclerosis
ANGEL-MS |
Scientific title:
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A Long-Term International, Extension of Study GNC-003 With GNbAC1 in Patients With Relapsing Remitting Multiple Sclerosis |
Date of first enrolment:
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June 6, 2017 |
Target sample size:
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220 |
Recruitment status: |
Terminated |
URL:
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https://clinicaltrials.gov/show/NCT03239860 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Bulgaria
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Croatia
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Czechia
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Estonia
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Germany
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Hungary
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Italy
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Poland
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Russian Federation
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Serbia
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Spain
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Ukraine
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Key inclusion & exclusion criteria
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Main Inclusion Criteria:
- Patients must have completed Period 2 of study GNC-003 and must meet all eligibility
criteria for the GNC-004 study
- Patients (male or female with reproductive potential) must agree to use highly
effective methods of birth control
- Provision of written informed consent to participate prior to any trial procedure as
shown by signature on the subject consent form.
Main Exclusion Criteria:
- Patients not having completed the study GNC-003
- Pregnancy
- The emergence of any disease diagnosis during the course of study GNC-003 that is not
MS and could better explain the patient's neurological signs and symptoms
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis, Relapsing-Remitting
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Intervention(s)
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Drug: GNbAC1 Monoclonal Antibody
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Primary Outcome(s)
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Long term safety of GNbAC1
[Time Frame: 96 Weeks]
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Secondary Outcome(s)
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Long term efficacy of GNbAC1 in terms of disability
[Time Frame: 96 Weeks]
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Long term efficacy of GNbAC1 in terms of MRI outcomes
[Time Frame: 96 Weeks]
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Long term efficacy of GNbAC1 in terms of disease progression
[Time Frame: 96 Weeks]
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Long term efficacy of GNbAC1 in terms of relapse rate
[Time Frame: 96 Weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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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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