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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01829321 | Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Study of GLPG0974 in Subjects With Ulcerative Colitis | PHASE2 | COMPLETED | 45 | — | — | Apr 1, 2013 | Apr 1, 2014 | Apr 25, 2014 | 16 | Belgium, Czechia +2 |
To evaluate the safety and tolerability of GLPG0974 in terms of the number of adverse events reported
To evaluate the safety and tolerability of GLPG0974 in terms of the changes in physical exam measures reported
To evaluate the safety and tolerability of GLPG0974 in terms of the changes in vital signs as measured by heart rate, blood pressure and oral temperature reported
To evaluate the safety and tolerability of GLPG0974 in terms of the changes in 12-lead ECG measures reported
To evaluate the safety and tolerability of GLPG0974 in terms of changes in blood safety lab parameters reported
To evaluate the safety and tolerability of GLPG0974 in terms of changes in urine safety lab parameters reported
| Arm | Type | Description |
|---|---|---|
| GLPG0974 | EXPERIMENTAL | 1 capsule of 200 mg GLPG0974 twice daily |
| Placebo | PLACEBO_COMPARATOR | 1 capsule placebo twice daily |
| Name | Type | Description |
|---|---|---|
| GLPG0974 | DRUG | 1 capsule in the morning and 1 capsule in the evening with food during 28 days |
| Placebo | DRUG | 1 capsule in the morning and 1 capsule in the evening with food during 28 days |
Key Inclusion Criteria: * Men or women between 18 to 75 years of age inclusive, on the day of signing the informed consent with a documented history of UC. * Presence of mild-to-moderately active ulcerative colitis as evidenced by clinical signs and endoscopy. * Medication: 5-ASA. * Absence of infe...