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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02337608 | Efficacy and Safety of GLPG1205 in Subjects With Active Ulcerative Colitis | PHASE2 | COMPLETED | 64 | — | — | Dec 1, 2014 | Nov 1, 2015 | Nov 20, 2015 | 39 | Belgium, Czechia +4 |
To evaluate the efficacy of GLPG1205 in terms of changes in Mayo score comparing results at Week 8 with baseline between GLPG1205 treated subjects and placebo subjects
| Arm | Type | Description |
|---|---|---|
| GLPG1205 100mg QD | EXPERIMENTAL | GLPG1205 100mg daily dosing in the morning |
| Placebo | PLACEBO_COMPARATOR | Placebo daily dosing in the morning |
| Name | Type | Description |
|---|---|---|
| GLPG1205 | DRUG | GLPG1205 daily dosing in the morning for 12 weeks |
| Placebo | DRUG | placebo daily dosing in the morning daily for 12 weeks |
Inclusion Criteria: * Male or female subjects between 18 and 75 years * Documented history of UC * Presence of active UC for a minimum period of 14 days prior to screening and spread beyond the rectum, Mayo score ≥ 6 with rectal bleeding score ≥ 1 and endoscopy score ≥ 2 * Absence of infectious col...