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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 May 2021 |
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Main ID: |
NCT03976648 |
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Date of registration:
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04/06/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Clinical Study to Test Long Term Safety of GLPG1690 for Patients With Systemic Sclerosis
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Scientific title:
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A Multicenter, Open-label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Orally Administered GLPG1690 in Subjects With Systemic Sclerosis |
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Date of first enrolment:
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July 18, 2019 |
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Target sample size:
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31 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT03976648 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Belgium
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Italy
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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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Dick de Vries, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Galapagos NV |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female subjects who completed the 24-week treatment period of Study
GLPG1690-CL-204 and who according to the investigator's judgment may benefit from
long-term treatment with GLPG1690.
Exclusion Criteria:
- Any condition or circumstances that, in the opinion of the investigator, may make a
subject unlikely or unable to complete the study or comply with study procedures and
requirements.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Systemic Sclerosis
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Intervention(s)
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Drug: GLPG1690
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Primary Outcome(s)
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Number of adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
[Time Frame: From start of study medication in study GLPG1690-CL-204 through day 30 after last dose in study GLPG1690-CL-206]
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Secondary ID(s)
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2019-001279-34
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GLPG1690-CL-206
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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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