Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03798366 | A Clinical Study to Test How Effective and Safe GLPG1690 is for Participants With Systemic Sclerosis | PHASE2 | COMPLETED | 33 | — | — | Jan 14, 2019 | Jun 22, 2020 | May 4, 2021 | 18 | United States, Belgium +4 |
The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening.
The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening.
The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening.
The mRSS is a validated physical examination method for estimating skin thickness. The 17 body site mRSS was used, with each body site assessed on a scale of 0 (uninvolved) to 3 (severe thickening) with a total score range from 0 (best) to 51 (worst), with higher scores indicating greater severity of skin thickening.
| Arm | Type | Description |
|---|---|---|
| GLPG1690 600 mg | EXPERIMENTAL | Participants received GLPG1690 600 milligrams (mg), orally once daily for 24 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants received GLPG1690 matching placebo, orally once daily for 24 weeks. |
| Name | Type | Description |
|---|---|---|
| GLPG1690 | DRUG | Film-coated tablets of GLPG1690 for oral use. |
| Placebo | DRUG | Film-coated tablets of GLPG1690 matching placebo for oral use. |
Inclusion Criteria: * Able and willing to comply with the protocol requirements and to sign the informed consent form (ICF) as approved by the Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to any screening evaluations. * Male and female participants ≥18 years at the tim...