A Clinical Study to Test Long Term Safety of GLPG1690 for Patients With Systemic Sclerosis

Phase 2

Terminated

• Conditions: Systemic Sclerosis
• Interventions: Drug: GLPG1690

• Registration Number: NCT03976648
• Lead Sponsor: Galapagos NV

Brief Summary

This study was the extension of the double-blind study GLPG1690-CL-204 (NCT03798366). The main purpose of the study was to see how GLPG1690 was tolerated in participants with systemic sclerosis and whether there were any side effects in a long-term treatment period.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-04
• Study First Submitted QC: 2019-06-04
• Study First Posted: 2019-06-06
• Study Start: 2019-07-18
• Primary Completion: 2021-04-13
• Study Completion: 2021-04-13
• Results First Submitted: 2022-02-16
• Results First Submitted QC: 2022-02-16
• Status Verified: 2022-03
• Results First Posted: 2022-03-15
• Last Update Submitted: 2022-03-16
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Male or female participants 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 participant unlikely or unable to complete the study or comply with study procedures and requirements.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GLPG1690 600 mg	GLPG1690	Participants who received GLPG1690 600 milligrams (mg) in the GLPG1690-CL-204 (NCT03798366) study received GLPG1690 600 mg orally once daily up to 91 weeks.
Placebo	GLPG1690	Participants who received placebo matched to GLPG1690 in the GLPG1690-CL-204 (NCT03798366) study received GLPG1690 600 mg orally once daily up to 91 weeks.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs	Day 1 up to 91 weeks	An adverse event (AE) was any untoward medical occurrence in a participant administered study drug and which did not necessarily have a causal relationship with study drug. A treatment-emergent adverse event (TEAE) is any AE with an onset date on or after the start of stud drug intake and no later than 30 days after last dose of study drug, or any worsening of any AE on or after the start of stud drug intake. A serious AE was defined as an AE that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was medically significant. Safety analysis set consisted of all randomized participants who received at least 1 dose of investigational product.

Trial Locations

Locations (14)

UZ Gent; 🇧🇪 Gent, Belgium

Hospital Universitario Vall d'Hebron; 🇪🇸 Barcelona, Spain

Royal Free Hospital; 🇬🇧 London, United Kingdom

Ospedale San Raffaele S.r.l. - PPDS; 🇮🇹 Milano, Italy

UCLA Rheumatology; 🇺🇸 Los Angeles, California, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

UT Physicians Center for Autoimmunity; 🇺🇸 Houston, Texas, United States

UZ Leuven; 🇧🇪 Leuven, Belgium

Pacific Arthritis Care Center; 🇺🇸 Los Angeles, California, United States

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Azienda Ospedaliero Universitaria Careggi; 🇮🇹 Firenze, Italy

University Hospital Aintree; 🇬🇧 Liverpool, United Kingdom

RASF Clinical Research Center; 🇺🇸 Boca Raton, Florida, United States

Metroplex Clinical Research Center; 🇺🇸 Dallas, Texas, United States