A clinical study to test long term safety of GLPG1690 for patients with systemic sclerosis
Phase 1
- Conditions
- Systemic sclerosisMedDRA version: 20.0Level: LLTClassification code 10042953Term: Systemic sclerosisSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2019-001279-34-ES
- Lead Sponsor
- Galapagos NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
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.
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 27
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the long-term safety and tolerability of GLPG1690 in subjects with systemic sclerosis.;Secondary Objective: Not applicable;Primary end point(s): Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), AEs over time.;Timepoint(s) of evaluation of this end point: Various timepoints during the trial as specified in the protocol
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable