Trial · 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
NCT02914522, Phase 3, Completed, Gilead Sciences; results first posted 2021-04-21
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ConductScience Library. 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. Trials, record NCT02914522. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02914522
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT02914522
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,351 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Ulcerative Colitis
- Interventions
- Filgotinib, PTM filgotinib
- First posted
- 2016-09-26
- Last updated
- 2021-04-21
- Other registries' IDs
- eudract:2016-001392-78
- Results first posted
- 2021-04-21
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Induction Study: Percentage of Participants Who Achieved Endoscopy/Bleeding/Stool Frequency (EBS) Remission at Week 10 | Week 10 | 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. |
| Primary | Maintenance Study: Percentage of Participants Who Achieved EBS Remission at Week 58 | Week 58 | 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. |
| Secondary | Induction Study: Percentage of Participants Who Achieved MCS Remission at Week 10 | Week 10 | MCS remission was defined as having a MCS of 2 or less and no single subscore higher than 1. The MCS was composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease \[spontaneous bleeding, ulceration\]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and physician's global assessment (PGA). The PGA acknowledged the participant's daily recollection of abdominal discomfort and general sense of wellbeing, and other observations, such as physical findings and the participant's performance status. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease. |
| Secondary | Induction Study: Percentage of Participants Who Achieved an Endoscopic Subscore of 0 at Week 10 | Week 10 | Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration). |
| Secondary | Induction Study: Percentage of Participants Who Achieved Geboes Histologic Remission at Week 10 | Week 10 | Geboes histologic remission was assessed using the Geboes histologic scores for evaluation of disease severity in ulcerative colitis and classifies histologic changes. Remission was defined as having Grade 0 of \<= 0.3, Grade 1 of \<= 1.1, Grade 2A of \<= 2A.3, Grade 2B of 2B.0, Grade 3 of 3.0, Grade 4 of 4.0, and Grade 5 of 5.0. Possible scores are Grade 0: Architectural changes (0.0=No abnormality to 0.3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (1.0=No increase to 1.3=Marked increase); Grade 2A: Eosinophils in lamina propria (2A.0=No increase to 2A.3-=Marked increase; Grade 2B: Neutrophils in lamina propria (2B.0= No increase to 2B.3=Marked increase); Grade 3: Neutrophils in epithelium (3.0=None to 3.3=\>50% crypts involved); Grade 4: Crypt destruction (4.0=none to 4.3=Unequivocal crypt destruction), and Grade 5: Erosions and ulcerations: (5.0=No erosion, ulceration or granulation to 5.4=Ulcer or granulation tissue). |
| Secondary | Induction Study: Percentage of Participants Who Achieved MCS Remission (Alternative Definition) at Week 10 | Week 10 | MCS remission (alternative definition) was defined as having rectal bleeding, stool frequency, and PGA subscores of 0 and an endoscopic subscore of 0 or 1; overall MCS of ≤ 1. MCS possible subscores: rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), PGA subscore (range: 0 to 3 with higher score indicating the severe disease), and an endoscopic subscore (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease \[spontaneous bleeding, ulceration\]. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease. |
| Secondary | Induction Study: Pharmacokinetic (PK) Parameter: Cmax of Filgotinib and Its Metabolite GS-829845 | Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10 | Cmax is defined as the maximum observed concentration of drug. |
| Secondary | Induction Study: PK Parameter: Tmax of Filgotinib and Its Metabolite GS-829845 | Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10 | Tmax is defined as the time to reach maximum observed concentration of drug. |
| Secondary | Induction Study: PK Parameter: AUCtau of Filgotinib and Its Metabolite GS-82984 | Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10 | AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). |
| Secondary | Induction Study: PK Parameter: AUClast of Filgotinib and Its Metabolite GS-82984 | Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10 | AUClast is defined as the concentration of drug from time zero to the last observable concentration. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Induction Study: Percentage of Participants Who Achieved Endoscopy/Bleeding/Stool Frequency (EBS) Remission at Week 10 | Week 10 | Full Analysis Set for the Induction study (Cohorts A and B) included all randomized participants who took at least 1 dose of study drug in the corresponding Induction study. | percentage of participants | NUMBER |
| PRIMARY | Maintenance Study: Percentage of Participants Who Achieved EBS Remission at Week 58 | Week 58 | Full Analysis Set for the Maintenance Study included all participants randomized to either the filgotinib 200 mg or filgotinib 100 mg treatment groups in the Induction Study (Cohorts A and B) who achieved EBS remission or MCS response at Week 10, were rerandomized, and took at least 1 dose of study drug in the Maintenance Study. | percentage of participants | NUMBER |
| SECONDARY | Induction Study: Percentage of Participants Who Achieved MCS Remission at Week 10 | Week 10 | Participants in the Full Analysis Set for the Induction Study (Cohorts A and B) were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Induction Study: Percentage of Participants Who Achieved an Endoscopic Subscore of 0 at Week 10 | Week 10 | Participants in the Full Analysis Set for the Induction Study (Cohorts A and B) were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Induction Study: Percentage of Participants Who Achieved Geboes Histologic Remission at Week 10 | Week 10 | Participants in the Full Analysis Set for the Induction study (Cohorts A and B) were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Induction Study: Percentage of Participants Who Achieved MCS Remission (Alternative Definition) at Week 10 | Week 10 | Participants in the Full Analysis Set for the Induction Study (Cohorts A and B) were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Induction Study: Pharmacokinetic (PK) Parameter: Cmax of Filgotinib and Its Metabolite GS-829845 | Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10 | PK Substudy Analysis Set included all randomized participants who took at least 1 dose of filgotinib, participated in the PK substudy, and had at least 1 nonmissing intensive concentration value for filgotinib and/or GS-829845 with available data were analyzed. | nanograms per milliliter (ng/mL) | MEAN |
| SECONDARY | Induction Study: PK Parameter: Tmax of Filgotinib and Its Metabolite GS-829845 | Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10 | Participants in the PK Substudy Analysis Set with available data were analyzed. | hour (h) | MEDIAN |
| SECONDARY | Induction Study: PK Parameter: AUCtau of Filgotinib and Its Metabolite GS-82984 | Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10 | Participants in the PK Substudy Analysis Set with available data were analyzed. | hour*nanograms per milliliter (h*ng/mL) | MEAN |
| SECONDARY | Induction Study: PK Parameter: AUClast of Filgotinib and Its Metabolite GS-82984 | Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10 | Participants in the PK Substudy Analysis Set with available data were analyzed. | h*ng/mL | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group106
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Induction Study: Percentage of Participants Who Achieved Endoscopy/Bleeding/Stool Frequency (EBS) Remission at Week 10 | Induction Study (Cohort A): Filgotinib 200 mg | 26.1 | 95% Confidence Interval 20.4 to 31.8 | percentage of participants | |
| Induction Study: Percentage of Participants Who Achieved Endoscopy/Bleeding/Stool Frequency (EBS) Remission at Week 10 | Induction Study (Cohort A): Filgotinib 100 mg | 19.1 | 95% Confidence Interval 14.3 to 23.9 | percentage of participants | |
| Induction Study: Percentage of Participants Who Achieved Endoscopy/Bleeding/Stool Frequency (EBS) Remission at Week 10 | Induction Study (Cohort A): Placebo | 15.3 | 95% Confidence Interval 8.9 to 21.7 | percentage of participants | |
| Induction Study: Percentage of Participants Who Achieved Endoscopy/Bleeding/Stool Frequency (EBS) Remission at Week 10 | Induction Study (Cohort B): Filgotinib 200 mg | 11.5 | 95% Confidence Interval 7.4 to 15.5 | percentage of participants | |
| Induction Study: Percentage of Participants Who Achieved Endoscopy/Bleeding/Stool Frequency (EBS) Remission at Week 10 | Induction Study (Cohort B): Filgotinib 100 mg | 9.5 | 95% Confidence Interval 5.9 to 13.0 | percentage of participants | |
| Induction Study: Percentage of Participants Who Achieved Endoscopy/Bleeding/Stool Frequency (EBS) Remission at Week 10 | Induction Study (Cohort B): Placebo | 4.2 | 95% Confidence Interval 0.6 to 7.9 | percentage of participants | |
| Maintenance Study: Percentage of Participants Who Achieved EBS Remission at Week 58 | Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg | 37.2 | 95% Confidence Interval 30.2 to 44.2 | percentage of participants | |
| Maintenance Study: Percentage of Participants Who Achieved EBS Remission at Week 58 | Maintenance Study: Placebo From Induction Filgotinib 200 mg | 11.2 | 95% Confidence Interval 4.5 to 18.0 | percentage of participants | |
| Maintenance Study: Percentage of Participants Who Achieved EBS Remission at Week 58 | Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg | 23.8 | 95% Confidence Interval 17.2 to 30.5 | percentage of participants | |
| Maintenance Study: Percentage of Participants Who Achieved EBS Remission at Week 58 | Maintenance Study: Placebo From Induction Filgotinib 100 mg | 13.5 | 95% Confidence Interval 5.8 to 21.1 | percentage of participants |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 results by groupParticipant flow66
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction Study: Up to Week 11 | STARTED | Induction Study (Cohort A): Filgotinib 200 mg | 245 | |
| Induction Study: Up to Week 11 | STARTED | Induction Study (Cohort A): Filgotinib 100 mg | 278 | |
| Induction Study: Up to Week 11 | STARTED | Induction Study (Cohort A): Placebo | 137 | |
| Induction Study: Up to Week 11 | STARTED | Induction Study (Cohort B): Filgotinib 200 mg | 262 | |
| Induction Study: Up to Week 11 | STARTED | Induction Study (Cohort B): Filgotinib 100 mg | 286 | |
| Induction Study: Up to Week 11 | STARTED | Induction Study (Cohort B): Placebo | 143 | |
| Induction Study: Up to Week 11 | STARTED | Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg | 0 | |
| Induction Study: Up to Week 11 | STARTED | Maintenance Study: Placebo From Induction Filgotinib 200 mg | 0 | |
| Induction Study: Up to Week 11 | STARTED | Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg | 0 | |
| Induction Study: Up to Week 11 | STARTED | Maintenance Study: Placebo From Induction Filgotinib 100 mg | 0 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 participant flowAdverse events847
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Induction Study (Cohort A): Filgotinib 200 mg | 6 | 245 | |
| other | Anaemia | Blood and lymphatic system disorders | Induction Study (Cohort A): Filgotinib 100 mg | 10 | 277 | |
| other | Anaemia | Blood and lymphatic system disorders | Induction Study (Cohort A): Placebo | 4 | 137 | |
| other | Anaemia | Blood and lymphatic system disorders | Induction Study (Cohort B): Filgotinib 200 mg | 12 | 262 | |
| other | Anaemia | Blood and lymphatic system disorders | Induction Study (Cohort B): Filgotinib 100 mg | 11 | 285 | |
| other | Anaemia | Blood and lymphatic system disorders | Induction Study (Cohort B): Placebo | 10 | 142 | |
| other | Anaemia | Blood and lymphatic system disorders | Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg | 4 | 202 | |
| other | Anaemia | Blood and lymphatic system disorders | Maintenance Study: Placebo From Induction Filgotinib 200 mg | 0 | 99 | |
| other | Anaemia | Blood and lymphatic system disorders | Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg | 4 | 179 | |
| other | Anaemia | Blood and lymphatic system disorders | Maintenance Study: Placebo From Induction Filgotinib 100 mg | 1 | 91 |
1 to 10 of 847Source ClinicalTrials.gov
See all 847 adverse eventsAdverse event totals33
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Induction Study (Cohort A): Filgotinib 200 mg | 0 | 245 |
| Total, all-cause mortality | Induction Study (Cohort A): Filgotinib 100 mg | 0 | 278 |
| Total, all-cause mortality | Induction Study (Cohort A): Placebo | 0 | 137 |
| Total, all-cause mortality | Induction Study (Cohort B): Filgotinib 200 mg | 0 | 262 |
| Total, all-cause mortality | Induction Study (Cohort B): Filgotinib 100 mg | 0 | 286 |
| Total, all-cause mortality | Induction Study (Cohort B): Placebo | 0 | 143 |
| Total, all-cause mortality | Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg | 2 | 202 |
| Total, all-cause mortality | Maintenance Study: Placebo From Induction Filgotinib 200 mg | 0 | 99 |
| Total, all-cause mortality | Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg | 0 | 179 |
| Total, all-cause mortality | Maintenance Study: Placebo From Induction Filgotinib 100 mg | 0 | 91 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse event totalsPapers12
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
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Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT02914522/results?page=2