Phase 3
N=1,372
Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease
Crohn's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02914561 ↗Enrolled (actual)
1,372
Serious AEs
9.7%
Results posted
Dec 2023
Primary outcome: Primary: Induction Study: Percentage of Participants Who Achieved Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10 — 32.9; 25.7; 19.8; 26.7 percentage of participants — p=0.0017
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Filgotinib (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lakefront Biotherapeutics NV
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Induction Study: Percentage of Participants Who Achieved Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10 |
32.9; 25.7; 19.8; 26.7; 16.7; 14.8 | 0.0017 sig |
| PRIMARY Induction Study: Percentage of Participants Who Achieved Endoscopic Response at Week 10 |
23.9; 20.8; 18.1; 11.9; 13.6; 11.4 | 0.1365 |
| PRIMARY Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by CDAI at Week 58 |
42.9; 23.5; 28.3; 22.6 | 0.0839 |
| PRIMARY Maintenance Study: Percentage of Participants Who Achieved Endoscopic Response at Week 58 |
30.4; 18.4; 9.4; 13.2 | 0.0038 sig |
| SECONDARY Induction Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 10 |
32.9; 30.6; 25.7; 29.7; 18.9; 17.9 | 0.0963 |
| SECONDARY Induction Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 10 |
52.3; 46.1; 39.7; 38.6; 35.5; 27.5 | 0.0074 sig |
| SECONDARY Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 58 |
43.8; 29.6; 26.4; 24.5 | 0.0382 sig |
| SECONDARY Maintenance Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 58 |
45.5; 33.7; 34.0; 30.2 | 0.1827 |
| SECONDARY Maintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by CDAI at Both Weeks 10 and 58 |
38.4; 19.4; 22.6; 20.8 | 0.0512 |
| SECONDARY Maintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by CDAI at Week 58 |
34.0; 4.9; 20.0; 12.0 | 0.1900 |
| SECONDARY Maintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by PRO2 at Both Weeks 10 and 58 |
41.1; 25.5; 20.8; 24.5 | 0.0122 sig |
| SECONDARY Maintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by PRO2 at Week 58 |
32.0; 7.3; 20.0; 12.0 | 0.2631 |
| SECONDARY Induction Study:Pharmacokinetic Plasma Concentrations of Filgotinib at Week 4 |
1170; 611; 1140; 604 | — |
| SECONDARY Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 10 |
46.8; 21.3; 47.9; 40.8 | — |
| SECONDARY Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 26 |
284; 58.5 | — |
| SECONDARY Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 58 |
75.8; 16.9 | — |
| SECONDARY Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 4 |
3100; 1800; 3140; 1870 | — |
| SECONDARY Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 10 |
2550; 1290; 2640; 1480 | — |
| SECONDARY Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 26 |
3090; 1460 | — |
| SECONDARY Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 58 |
2430; 1220 | — |
Summary
The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in participants who are biologic-naive and biologic-experienced.
Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Study GS-US-419-3896).
Eligibility Criteria
Key Inclusion Criteria
- Documented diagnosis of CD with a minimum disease duration of 3 months with involvement of the ileum and/or colon at a minimum, as determined by histopathology and endoscopic assessment
- Moderately to severely active CD
- Cohort A (Biologic Naïve): 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 and immunomodulators
- Cohort A (Biologic Experienced): 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) or discontinuation of use of at least one of the following agents for reasons other than inadequate clinical response, loss of response or intolerance: tumor necrosis factor alpha (TNFa) antagonists, vedolizumab, and ustekinumab
- Cohort B (Biologic Experienced): 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): TNFa antagonists, vedolizumab, and ustekinumab
Key Exclusion Criteria
- Current complications of CD such as symptomatic strictures, severe rectal/anal stenosis, fistulae other than perianal fistulae, short bowel syndrome, etc.
- Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
- Active tuberculosis (TB) or history of latent TB that has not been treated
- Use of any prohibited concomitant medications as described in the study protocol
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02914561). 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.