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

Galapagos

Status and phase: Terminated; Phase 2

Conditions: Systemic Sclerosis

Treatments: Drug: GLPG1690

Study type: Interventional

Funder types: Industry

Identifiers

NCT03976648

2019-001279-34 (EudraCT Number)

GLPG1690-CL-206

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

---

31 participants in 2 patient groups

GLPG1690 600 mg

Experimental group

Description:

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.

Treatment:

Drug: GLPG1690

Placebo

Experimental group

Description:

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.

Treatment:

Drug: GLPG1690