A Clinical Study to Test How Effective and Safe GLPG1690 is for Patients With Systemic Sclerosis (NOVESA)
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|ClinicalTrials.gov Identifier: NCT03798366|
Recruitment Status : Completed
First Posted : January 9, 2019
Last Update Posted : January 27, 2021
The main purpose of the study is to see if GLPG1690 helps (together with the standard of care treatment) in the treatment of the skin and other areas affected by systemic sclerosis.
Another aim is to find out how safe/well tolerated GLPG1690 will be and whether there are any side effects. The study will also look at other things, including whether the study drug affects disease progression and also if it changes any aspect of the quality of life.
|Condition or disease||Intervention/treatment||Phase|
|Systemic Sclerosis||Drug: GLPG1690 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2a Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy, Safety, and Tolerability of Orally Administered GLPG1690 for 24 Weeks in Subjects With Systemic Sclerosis|
|Actual Study Start Date :||January 14, 2019|
|Actual Primary Completion Date :||May 21, 2020|
|Actual Study Completion Date :||June 22, 2020|
film-coated tablets of GLPG1690 for oral use
|Placebo Comparator: Placebo||
film-coated tablets of matching placebo for oral use
- Change from baseline in modified Rodnan skin score (mRSS) over 24 weeks [ Time Frame: At screening and Week 24 ]To evaluate the efficacy of GLPG1690 as evaluated by mRSS compared to placebo over 24 weeks for the treatment of subjects with systemic sclerosis. The 17-site mRSS will be used, with each body site assessed for skin thickness on a scale of 0 (uninvolved) to 3 (severe thickening) with a maximum score of 51.
- Number of participants with adverse events (AEs) over 24 weeks as assessed by CTCAE version 5.0. [ Time Frame: From screening until Week 24 ]To evaluate the safety and tolerability of GLPG1690 compared to placebo over 24 weeks in the treatment of subjects with systemic sclerosis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03798366
|Study Director:||Dick de Vries, MD||Galapagos NV|