A Phase 2 interventional study of Filgotinib and Placebo to match filgotinib in Fistulizing Crohn's Disease, sponsored by Gilead Sciences. Completed at 27 sites in 9 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-04-08.
Sponsored by Gilead Sciences · Phase 2, Interventional, and Treatment
The primary objective of this study is to evaluate the efficacy of filgotinib as compared to placebo in establishing combined fistula response at Week 24. Participants will have the option to enter a separate Long-Term Extension (LTE) study (GS-US-419-3896; NCT02914600) if they meet eligibility requirements.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 57 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Previously demonstrated an inadequate clinical response, loss of response to, or intolerance of at least 1 of the following agents (depending on current country treatment recommendations/guidelines):
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Filgotinib 200 mg + placebo to match filgotinib 100 mg for 24 weeks
Drug: Filgotinib · Drug: Placebo to match filgotinib
Filgotinib 100 mg + placebo to match filgotinib 200 mg for 24 weeks
Drug: Filgotinib · Drug: Placebo to match filgotinib
Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for 24 weeks
Drug: Placebo to match filgotinib
Tablet(s) administered orally once daily
Also known as: GS-6034, GLPG0634
Tablet(s) administered orally once daily
Percentage of Participants Who Achieved Combined Fistula Response at Week 24
Combined fistula response at Week 24 was defined as reduction of greater than or equal to (≥) 1 from baseline in the number of draining external perianal fistula openings that were present at baseline, and absence of fluid collections \> 1 centimeter (cm) on magnetic resonance imaging (MRI) pelvis at Week 24, among participants with at least 1 draining external perianal fistula opening at baseline.
Time frame: Week 24
Percentage of Participants Who Achieved Combined Fistula Remission at Week 24
Combined fistula remission at Week 24 was defined as perianal fistula closure of all external openings that were draining at baseline, and absence of fluid collections \> 1 cm on MRI of pelvis at Week 24, among participants with at least 1 draining external perianal fistula opening at baseline.
Time frame: Week 24
Time to Clinical Fistula Response up to Week 24
Time to clinical fistula response was defined as the time interval in days from date of first dosing of study drug to the first observation (during scheduled or unscheduled clinical visits) when ≥ 1 of the draining external perianal fistula openings that were present at baseline achieves perianal fistula closure, among participants with at least 1 draining external perianal fistula opening at baseline. Participants not known to had a clinical fistula response were to have their clinical fistula response time censored at the last time that lack of clinical fistula response was documented.
Time frame: Time from treatment start to first visit when ≥ 1 of the draining external perianal fistula openings that were present at baseline achieved perianal fistula closure up to Week 24
Time to Clinical Fistula Remission up to Week 24
Time to clinical fistula remission was defined as the time interval in days from date of first dosing of study drug to the first observation (during schedule or unscheduled clinical visits) of perianal fistula closure of all external openings that were draining at baseline, among participants with at least 1 draining external perianal fistula opening at baseline. Participants not known to had a clinical fistula remission were have their clinical fistula remission time censored at the last time that lack of clinical fistula remission was documented.
Time frame: Time from treatment start to first visit when perianal fistula closure takes place of all external openings that were draining at baseline up to Week 24
Percentage of Participants Who Achieved Proctitis Remission at Week 24
The simple endoscopic score for Crohn's disease (SES-CD) score evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and presence of narrowings). The total SES-CD is calculated as the sum of the 4 variables for the required bowel segment. Values are given to each variable and for every examined bowel segment. The SES-CD size of ulcer subscore ranges from 0 (none) to 3 (very large) and for ulcerated surface subscore ranges from 0 (none) to 3 (\>30 % of affected area). Higher value of the subscore indicates disease worsening. Proctitis remission at Week 24 was defined as a proctitis SES-CD score (sum of ulcer size and ulcerated surface SES-CD endoscopy subscores for the rectum and anal canal) of 0 assessed by centrally read flexible sigmoidoscopy at Week 24, in participants that had moderately to severely active proctitis at baseline. Moderately to Severely Active Proctitis defined as proctitis SES-CD Score \> 2.
Time frame: Week 24
Participants were enrolled at study sites in Europe and the United States. The first participant was screened on 06 April 2017. The last study visit occurred on 17 February 2021.
| Milestone | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Started | 17 | 25 | 15 |
| Completed | 14 | 12 | 6 |
| Not completed | 3 | 13 | 9 |
| Withdrew: Non-responder [crohn's disease activity index (cdai) and perianal cdai non-response] at week 10 | 1 | 5 | 3 |
| Withdrew: Protocol-specified disease worsening | 1 | 3 | 3 |
| Withdrew: Adverse event | 1 | 2 | 2 |
| Withdrew: Investigator's discretion | 0 | 1 | 1 |
| Withdrew: Withdrew consent | 0 | 2 | 0 |
Combined fistula response at Week 24 was defined as reduction of greater than or equal to (≥) 1 from baseline in the number of draining external perianal fistula openings that were present at baseline, and absence of fluid collections \> 1 centimeter (cm) on magnetic resonance imaging (MRI) pelvis at Week 24, among participants with at least 1 draining external perianal fistula opening at baseline.
| percentage of participants | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Percentage of Participants Who Achieved Combined Fistula Response at Week 24 | 47.1 (26.0 to 68.9) | 29.2 (14.6 to 47.9) | 25.0 (7.2 to 52.7) |
Combined fistula remission at Week 24 was defined as perianal fistula closure of all external openings that were draining at baseline, and absence of fluid collections \> 1 cm on MRI of pelvis at Week 24, among participants with at least 1 draining external perianal fistula opening at baseline.
| percentage of participants | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Percentage of Participants Who Achieved Combined Fistula Remission at Week 24 | 47.1 (26.0 to 68.9) | 25.0 (11.5 to 43.5) | 16.7 (3.0 to 43.8) |
Time to clinical fistula response was defined as the time interval in days from date of first dosing of study drug to the first observation (during scheduled or unscheduled clinical visits) when ≥ 1 of the draining external perianal fistula openings that were present at baseline achieves perianal fistula closure, among participants with at least 1 draining external perianal fistula opening at baseline. Participants not known to had a clinical fistula response were to have their clinical fistula response time censored at the last time that lack of clinical fistula response was documented.
| days | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Time to Clinical Fistula Response up to Week 24 | 15 (15 to 28) | 16 (15 to 71) | 35.5 (15 to 71) |
Time to clinical fistula remission was defined as the time interval in days from date of first dosing of study drug to the first observation (during schedule or unscheduled clinical visits) of perianal fistula closure of all external openings that were draining at baseline, among participants with at least 1 draining external perianal fistula opening at baseline. Participants not known to had a clinical fistula remission were have their clinical fistula remission time censored at the last time that lack of clinical fistula remission was documented.
| days | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Time to Clinical Fistula Remission up to Week 24 | 15 (15 to 70) | 29 (16 to 74) | 71 (26 to NA) |
The simple endoscopic score for Crohn's disease (SES-CD) score evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and presence of narrowings). The total SES-CD is calculated as the sum of the 4 variables for the required bowel segment. Values are given to each variable and for every examined bowel segment. The SES-CD size of ulcer subscore ranges from 0 (none) to 3 (very large) and for ulcerated surface subscore ranges from 0 (none) to 3 (\>30 % of affected area). Higher value of the subscore indicates disease worsening. Proctitis remission at Week 24 was defined as a proctitis SES-CD score (sum of ulcer size and ulcerated surface SES-CD endoscopy subscores for the rectum and anal canal) of 0 assessed by centrally read flexible sigmoidoscopy at Week 24, in participants that had moderately to severely active proctitis at baseline. Moderately to Severely Active Proctitis defined as proctitis SES-CD Score \> 2.
| percentage of participants | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Percentage of Participants Who Achieved Proctitis Remission at Week 24 | 10.0 (0.5 to 39.4) | 15.4 (2.8 to 41.0) | 28.6 (5.3 to 65.9) |
Collected over All-Cause Mortality: First dose date up to 24 weeks plus 30 days; Adverse Events: First dose date up to 24 weeks plus 30 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Filgotinib 200 mg | 0/17 (0%) | 5/17 (29.4%) | 13/17 (76.5%) |
| Filgotinib 100 mg | 0/25 (0%) | 2/25 (8%) | 14/25 (56%) |
| Placebo | 0/15 (0%) | 1/15 (6.7%) | 11/15 (73.3%) |
| Event | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| Crohn's diseaseGastrointestinal disorders | 1/17 | 2/25 | 0/15 |
| Vulval abscessInfections and infestations | 0/17 | 0/25 | 1/15 |
| Intestinal obstructionGastrointestinal disorders | 1/17 | 0/25 | 0/15 |
| Large intestinal stenosisGastrointestinal disorders | 1/17 | 0/25 | 0/15 |
| BronchitisInfections and infestations | 1/17 | 0/25 | 0/15 |
| Suspected COVID-19Infections and infestations | 1/17 | 0/25 | 0/15 |
| Event | Filgotinib 200 mg | Filgotinib 100 mg | Placebo |
|---|---|---|---|
| FatigueGeneral disorders | 3/17 | 3/25 | 0/15 |
| Anal abscessInfections and infestations | 3/17 | 0/25 | 1/15 |
| InfluenzaInfections and infestations | 3/17 | 1/25 | 2/15 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 3/17 | 2/25 | 0/15 |
| Anal fistulaGastrointestinal disorders | 2/17 | 2/25 | 2/15 |
| NasopharyngitisInfections and infestations | 2/17 | 2/25 | 2/15 |
| RashSkin and subcutaneous tissue disorders | 1/17 | 1/25 | 2/15 |
| Crohn's diseaseGastrointestinal disorders | 2/17 | 2/25 | 1/15 |
| NauseaGastrointestinal disorders | 2/17 | 2/25 | 1/15 |
| Oral herpesInfections and infestations | 2/17 | 0/25 | 1/15 |
| Age, Continuous(years) | Filgotinib 200 mg | Filgotinib 100 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 39 ± 11.2 | 41 ± 14.0 | 39 ± 11.8 | 40 ± 12.5 |
| Sex: Female, Male(Participants) | Filgotinib 200 mg | Filgotinib 100 mg | Placebo | Total |
|---|---|---|---|---|
| Female | 9 | 10 | 4 | 23 |
| Male | 8 | 15 | 11 | 34 |
| Race/Ethnicity, Customized(Participants) | Filgotinib 200 mg | Filgotinib 100 mg | Placebo | Total |
|---|---|---|---|---|
| Race — American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Race — Asian | 0 | 2 | 0 | 2 |
| Race — Black or African American | 1 | 2 | 1 | 4 |
| Race — Native Hawaiian or Pacific Islander | 0 | 0 | 0 | 0 |
| Race — White | 15 | 19 | 14 | 48 |
| Race — Other | 0 | 0 | 0 | 0 |
| Race — Not Permitted | 1 | 2 | 0 | 3 |
| Race/Ethnicity, Customized(Participants) | Filgotinib 200 mg | Filgotinib 100 mg | Placebo | Total |
|---|---|---|---|---|
| Ethnicity — Not Hispanic or Latino | 17 | 23 | 15 | 55 |
| Ethnicity — Hispanic or Latino | 0 | 1 | 0 | 1 |
| Ethnicity — Not Permitted | 0 | 1 | 0 | 1 |
| Region of Enrollment(participants) | Filgotinib 200 mg | Filgotinib 100 mg | Placebo | Total |
|---|---|---|---|---|
| Canada | 1 | 3 | 1 | 5 |
| Austria | 4 | 2 | 2 | 8 |
| Belgium | 1 | 1 | 1 | 3 |
| Hungary | 1 | 1 | 1 | 3 |
| United States | 4 | 15 | 8 | 27 |
| United Kingdom | 1 | 0 | 0 | 1 |
| Italy | 0 | 0 | 1 | 1 |
| France | 2 | 3 | 0 | 5 |
| Germany | 3 | 0 | 1 | 4 |
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Gilead Sciences