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

Systemic Sclerosis Clinical Trial

Official title:

A Multicenter, Open-label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Orally Administered GLPG1690 in Subjects With Systemic Sclerosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03976648
• Other study ID #: GLPG1690-CL-206
• Secondary ID: 2019-001279-34
• Status: Terminated
• Phase: Phase 2
• Start date: July 18, 2019
• Est. completion date: April 13, 2021

Study information

• Verified date: March 2022
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: April 13, 2021
• Est. primary completion date: April 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Drug:
• GLPG1690
film-coated tablets of GLPG1690 to be administered orally

Locations

Country	Name	City	State
Belgium	UZ Gent	Gent
Belgium	UZ Leuven	Leuven
Italy	Azienda Ospedaliero Universitaria Careggi	Firenze
Italy	Ospedale San Raffaele S.r.l. - PPDS	Milano
Spain	Hospital Universitario Vall d'Hebron	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid
United Kingdom	University Hospital Aintree	Liverpool
United Kingdom	Royal Free Hospital	London
United States	University of Michigan	Ann Arbor	Michigan
United States	RASF Clinical Research Center	Boca Raton	Florida
United States	Metroplex Clinical Research Center	Dallas	Texas
United States	UT Physicians Center for Autoimmunity	Houston	Texas
United States	Pacific Arthritis Care Center	Los Angeles	California
United States	UCLA Rheumatology	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Countries where clinical trial is conducted

United States,  Belgium,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs	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.	Day 1 up to 91 weeks