Phase 3
Completed N=1,351
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
Source: ClinicalTrials.gov NCT02914522 ↗Enrolled (actual)
1,351
Serious AEs
4.5%
Results posted
Apr 2021
Primary outcomePrimary: Induction Study: Percentage of Participants Who Achieved Endoscopy/Bleeding/Stool Frequency (EBS) Remission at Week 10 — 26.1; 19.1; 15.3; 11.5 percentage of participants — p=0.0157
◆ Published Evidence
Emerging
6citations · ~3 / year
Distinct trajectories of symptomatic response in ulcerative colitis during filgotinib therapy: A post hoc analysis from the SELECTION study.
Summary
The primary objectives of this study are to evaluate the efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis (UC) in participants who are biologic-naive and biologic-experienced.
Participants who complete the study, or met protocol specified efficacy discontinuation criteria will have the option to enter a separate, long-term extension (LTE) study (Gilead Study GS-US-418-3899: NCT02914535).
Linked Publications (5)
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Distinct trajectories of symptomatic response in ulcerative colitis during filgotinib therapy: A post hoc analysis from the SELECTION study.
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Mediators of Filgotinib Treatment Effects in Ulcerative Colitis: Exploring Circulating Biomarkers in the Phase 2b/3 SELECTION Study.
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Impact of Concomitant Thiopurine on the Efficacy and Safety of Filgotinib in Patients with Ulcerative Colitis: Post Hoc Analysis of the Phase 2b/3 SELECTION Study.
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Association between endo-histological outcomes and colonic mucosal transcriptomic profiles in patients with ulcerative colitis receiving filgotinib.
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Factors associated with response to filgotinib and the prognostic power of faecal calprotectin for ulcerative colitis in the phase 2b/3 SELECTION trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Induction Study: Percentage of Participants Who Achieved Endoscopy/Bleeding/Stool Frequency (EBS) Remission at Week 10 |
26.1; 19.1; 15.3; 11.5; 9.5; 4.2 | 0.0157 sig |
| PRIMARY Maintenance Study: Percentage of Participants Who Achieved EBS Remission at Week 58 |
37.2; 11.2; 23.8; 13.5 | < 0.0001 sig |
| SECONDARY Induction Study: Percentage of Participants Who Achieved MCS Remission at Week 10 |
24.5; 17.0; 12.4; 9.5; 6.0; 4.2 | 0.0053 sig |
| SECONDARY Induction Study: Percentage of Participants Who Achieved an Endoscopic Subscore of 0 at Week 10 |
12.2; 5.8; 3.6; 3.4; 2.1; 2.1 | 0.0047 sig |
| SECONDARY Induction Study: Percentage of Participants Who Achieved Geboes Histologic Remission at Week 10 |
35.1; 23.8; 16.1; 19.8; 13.7; 8.5 | <0.0001 sig |
| SECONDARY Induction Study: Percentage of Participants Who Achieved MCS Remission (Alternative Definition) at Week 10 |
12.2; 8.7; 4.4; 3.8; 2.1; 2.1 | 0.0105 sig |
| SECONDARY Induction Study: Pharmacokinetic (PK) Parameter: Cmax of Filgotinib and Its Metabolite GS-829845 |
1746.3; 725.1; 2283.3; 977.9; 3227.5; 1812.2 | — |
| SECONDARY Induction Study: PK Parameter: Tmax of Filgotinib and Its Metabolite GS-829845 |
1.50; 0.75; 1.00; 0.57; 3.76; 3.00 | — |
| SECONDARY Induction Study: PK Parameter: AUCtau of Filgotinib and Its Metabolite GS-82984 |
5501.3; 1909.3; 6475.6; 2492.3; 57982.0; 31187.9 | — |
| SECONDARY Induction Study: PK Parameter: AUClast of Filgotinib and Its Metabolite GS-82984 |
5537.3; 1881.9; 6743.1; 2420.3; 60938.4; 30643.2 | — |
| SECONDARY Induction Study: PK Parameter: Ctau of Filgotinib and Its Metabolite GS-82984 |
12.0; 4.5; 36.6; 4.1; 2050.0; 934.8 | — |
| SECONDARY Maintenance Study: Percentage of Participants Who Achieved MCS Remission at Week 58 |
34.7; 9.2; 22.7; 13.5 | <0.0001 sig |
| SECONDARY Maintenance Study: Percentage of Participants Who Achieved Sustained EBS Remission at Week 58 |
18.1; 5.1; 8.7; 7.9 | 0.0024 sig |
| SECONDARY Maintenance Study: Percentage of Participants Who Achieved 6-Month Corticosteroid-Free EBS Remission at Week 58 |
27.2; 6.4; 13.6; 5.4 | 0.0055 sig |
| SECONDARY Maintenance Study: Percentage of Participants Who Achieved Endoscopic Subscore of 0 at Weeks 58 |
15.6; 6.1; 13.4; 7.9 | 0.0157 sig |
| SECONDARY Maintenance Study: Percentage of Participants Who Achieved Geboes Histologic Remission at Week 58 |
38.2; 13.3; 27.9; 18.0 | <0.0001 sig |
| SECONDARY Maintenance Study: Percentage of Participants Who Achieved MCS Remission (Alternative Definition) at Week 58 |
22.1; 6.1; 12.2; 7.9 | 0.0005 sig |
| SECONDARY Maintenance Study: Plasma Concentration of Filgotinib and Its Metabolite GS-829845 |
8.5; 4.4; 3.9; 4.1; 2495.0; 1180.0 | — |
Eligibility Criteria
Key Inclusion Criteria
- Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of the screening visit
- Documented diagnosis of UC of at least 6 months AND with a minimum disease extent of 15 cm from the anal verge. Documentation should include endoscopic and histopathologic evidence of UC.
- A surveillance colonoscopy is required at screening in individuals with a history of UC for 8 or more years, if one was not performed in the prior 24 months
- Moderately to severely active UC
- Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines): corticosteroids, immunomodulators, tumor necrosis factor alpha (TNFa) antagonists, or vedolizumab
Key Exclusion Criteria
- Presence of Crohn's disease, indeterminate colitis, ischemic colitis, fulminant colitis, ulcerative proctitis, or toxic mega-colon
- Active tuberculosis (TB) or history of latent TB that has not been treated
- Use of any concomitant prohibited medications as described in the protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02914522) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.