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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03595618 | A Study to Assess Efficacy and Safety of GLPG1972/S201086 in Participants With Knee Osteoarthritis | PHASE2 | COMPLETED | 932 | — | — | Aug 14, 2018 | Jul 14, 2020 | Jul 28, 2021 | 44 | United States |
Reduction in cartilage loss was assessed by cartilage thickness as measured in the medial cMTFC of the target knee using qMRI.
| Arm | Type | Description |
|---|---|---|
| GLPG1972 75 mg | EXPERIMENTAL | Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks. |
| GLPG1972 150 mg | EXPERIMENTAL | Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks. |
| GLPG1972 300 mg | EXPERIMENTAL | Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks. |
| Name | Type | Description |
|---|---|---|
| GLPG1972 | DRUG | Film-coated tablets of GLPG1972 for oral use. |
| Placebo | DRUG | Film-coated tablets of matching placebo for oral use. |
Inclusion Criteria: * Male participants or female participants of non-childbearing potential and not breastfeeding. * Body weight \> 40 kg, body mass index (BMI) \< 40 kg/m\^2. * Diagnosed for knee osteoarthritis based on clinical and radiological criteria of the American College of Rheumatology. *...