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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02914535 | Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis | PHASE3 | ACTIVE NOT_RECRUITING | 1,173 | — | — | Feb 23, 2017 | Sep 1, 2026 | May 22, 2026 | 323 | United States, Argentina +37 |
| NCT02914522 | Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis | PHASE3 | COMPLETED | 1,351 | — | — | Nov 14, 2016 | Mar 31, 2020 | Apr 21, 2021 | 343 | United States, Argentina +38 |
EBS remission was defined as an endoscopic subscore of 0 or 1; rectal bleeding subscore of 0; and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration); rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes; stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal. Total score for EBS ranged from 0 to 9 (sum of all subscores), with higher scores indicating more severe disease.
EBS remission was defined as an endoscopic subscore of 0 or 1; rectal bleeding subscore of 0; and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration); rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes; stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal. Total score for EBS ranged from 0 to 9 (sum of all subscores), with higher scores indicating more severe disease.
| Arm | Type | Description |
|---|---|---|
| Filgotinib 200 mg (blinded dosing) | EXPERIMENTAL | Filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks |
| Filgotinib 100 mg (blinded dosing) | EXPERIMENTAL | Filgotinib 100 mg + placebo to match filgotinib 200 mg for up to 336 weeks |
| Placebo (blinded dosing) | PLACEBO_COMPARATOR | Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks |
| Filgotinib 200 mg (open-label) | EXPERIMENTAL | Filgotinib 200 mg for up to 336 weeks |
| Filgotinib 100 mg (open-label) | EXPERIMENTAL | Filgotinib 100 mg for up to 336 weeks |
| Induction Study (Cohort A): Filgotinib 200 mg | EXPERIMENTAL | Participants in Cohort A (biologic-naive) received filgotinib 200 milligrams (mg) and placebo-to-match (PTM) filgotinib 100 mg orally once daily for 10 weeks. |
| Induction Study (Cohort A): Filgotinib 100 mg | EXPERIMENTAL | Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. |
| Induction Study (Cohort A): Placebo | PLACEBO_COMPARATOR | Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. |
| Induction Study (Cohort B): Filgotinib 200 mg | EXPERIMENTAL | Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. |
| Induction Study (Cohort B): Filgotinib 100 mg | EXPERIMENTAL | Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks. |
| Induction Study (Cohort B): Placebo | PLACEBO_COMPARATOR | Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks. |
| Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg | EXPERIMENTAL | Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either Endoscopy/Bleeding/Stool Frequency (EBS) remission or Mayo Clinic Score (MCS) response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg for an additional 47 weeks (up to Week 58). |
| Maintenance Study: Placebo From Induction Filgotinib 200 mg | PLACEBO_COMPARATOR | Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58). |
| Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg | EXPERIMENTAL | Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg for an additional 47 weeks (up to Week 58). |
| Maintenance Study: Placebo From Induction Filgotinib 100 mg | PLACEBO_COMPARATOR | Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58). |
| Maintenance Study: Placebo From Induction Placebo | PLACEBO_COMPARATOR | Participants in the Placebo arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib for an additional 47 weeks (up to Week 58). |
| Name | Type | Description |
|---|---|---|
| Filgotinib | DRUG | Tablet(s) administered orally once daily |
| Placebo | DRUG | Tablet(s) administered orally once daily |
| PTM filgotinib | DRUG | Tablet(s) administered orally once daily |
Key Inclusion Criteria: * Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial * Must have enrolled in Gilead-sponsored UC parent protocol GS US 418-3898 or any other Gilead/Gala...