Trial · NCT02914561
Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease
NCT02914561, Phase 3, Completed, Lakefront Biotherapeutics NV; results first posted 2023-12-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease. Trials, record NCT02914561. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02914561
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease
- NCT number
- NCT02914561
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,372 participants, actual
- Lead sponsor
- Lakefront Biotherapeutics NV
- Conditions
- Crohn's Disease
- Interventions
- Filgotinib, Placebo
- First posted
- 2016-09-26
- Last updated
- 2023-12-18
- Other registries' IDs
- eudract:2016-001367-36
- Results first posted
- 2023-12-18
Source ClinicalTrials.gov
Registered outcomes20
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 Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10 | Week 10 | The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Clinical remission was defined as a CDAI of \< 150 points. |
| Primary | Induction Study: Percentage of Participants Who Achieved Endoscopic Response at Week 10 | Week 10 | The Simple Endoscopic Score for Crohn's Disease (SES-CD) assessed the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater severity of disease. Endoscopic response was defined as ≥ 50% reduction from baseline in total SES-CD score. |
| Primary | Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by CDAI at Week 58 | Week 58 | The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Clinical remission was defined as a CDAI of \< 150 points. |
| Primary | Maintenance Study: Percentage of Participants Who Achieved Endoscopic Response at Week 58 | Week 58 | The SES-CD assessed the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater severity of disease. Endoscopic response was defined as ≥ 50% reduction from baseline in total SES-CD score. |
| Secondary | Induction Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 10 | Week 10 | The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days. Clinical Remission was defined as the average daily stool score ≤3 points AND average daily abdominal pain score ≤1 point. |
| Secondary | Induction Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 10 | Week 10 | The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Clinical response was defined as reduction in CDAI score from Induction baseline by at least 100 points or CDAI score \< 150 points. |
| Secondary | Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 58 | Week 58 | The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days. Clinical Remission was defined as the average daily stool score ≤3 points AND average daily abdominal pain score ≤1 point. |
| Secondary | Maintenance Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 58 | Week 58 | The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Clinical response was defined as reduction in CDAI score from Induction baseline by at least 100 points or CDAI score \< 150 points. |
| Secondary | Maintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by CDAI at Both Weeks 10 and 58 | Weeks 10 and 58 | The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Sustained Clinical Remission by CDAI: CDAI \<150 combined at both Week 10 and Week 58. |
| Secondary | Maintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by CDAI at Week 58 | Week 58 | The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. 6-Month Corticosteroid-Free Clinical remission by CDAI: CDAI \<150 with no corticosteroid use for indication of Crohn's disease for at least 6 months prior to Week 58. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
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 Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10 | Week 10 | The Full Analysis Set (FAS) for each 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 | Induction Study: Percentage of Participants Who Achieved Endoscopic Response at Week 10 | Week 10 | FAS for induction study was analyzed. | percentage of participants | NUMBER |
| PRIMARY | Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by CDAI at Week 58 | Week 58 | The FAS for the Maintenance Study included all participants randomized to either the filgotinib 200 mg or filgotinib 100 mg treatment groups in the Induction Studies who were re-randomized in the Maintenance Study and took at least 1 dose of study drug in the Maintenance Study and achieved clinical remission by PRO2 or endoscopic response at Week 10. | percentage of participants | NUMBER |
| PRIMARY | Maintenance Study: Percentage of Participants Who Achieved Endoscopic Response at Week 58 | Week 58 | The FAS for the Maintenance Study was analyzed. | percentage of participants | NUMBER |
| SECONDARY | Induction Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 10 | Week 10 | FAS for induction study was analyzed. | percentage of participants | NUMBER |
| SECONDARY | Induction Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 10 | Week 10 | FAS for induction study was analyzed. | percentage of participants | NUMBER |
| SECONDARY | Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 58 | Week 58 | The FAS for the Maintenance Study was analyzed. | percentage of participants | NUMBER |
| SECONDARY | Maintenance Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 58 | Week 58 | The FAS for the Maintenance Study was analyzed. | percentage of participants | NUMBER |
| SECONDARY | Maintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by CDAI at Both Weeks 10 and 58 | Weeks 10 and 58 | The FAS for the Maintenance Study was analyzed. | percentage of participants | NUMBER |
| SECONDARY | Maintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by CDAI at Week 58 | Week 58 | The FAS for the Maintenance Study with available data was analyzed. | percentage of participants | NUMBER |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group80
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 Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10 | Cohort A: Filgotinib 200 mg (Induction Study) | 32.9 | 95% Confidence Interval 26.5 to 39.3 | percentage of participants | |
| Induction Study: Percentage of Participants Who Achieved Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10 | Cohort A: Filgotinib 100 mg (Induction Study) | 25.7 | 95% Confidence Interval 20.0 to 31.4 | percentage of participants | |
| Induction Study: Percentage of Participants Who Achieved Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10 | Cohort A: Placebo (Induction Study) | 19.8 | 95% Confidence Interval 14.5 to 25.1 | percentage of participants | |
| Induction Study: Percentage of Participants Who Achieved Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10 | Cohort B: Filgotinib 200 mg (Induction Study) | 26.7 | 95% Confidence Interval 20.4 to 33.1 | percentage of participants | |
| Induction Study: Percentage of Participants Who Achieved Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10 | Cohort B: Filgotinib 100 mg (Induction Study) | 16.7 | 95% Confidence Interval 11.6 to 21.7 | percentage of participants | |
| Induction Study: Percentage of Participants Who Achieved Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10 | Cohort B: Placebo (Induction Study) | 14.8 | 95% Confidence Interval 10.0 to 19.7 | percentage of participants | |
| Induction Study: Percentage of Participants Who Achieved Endoscopic Response at Week 10 | Cohort A: Filgotinib 200 mg (Induction Study) | 23.9 | 95% Confidence Interval 18.0 to 29.7 | percentage of participants | |
| Induction Study: Percentage of Participants Who Achieved Endoscopic Response at Week 10 | Cohort A: Filgotinib 100 mg (Induction Study) | 20.8 | 95% Confidence Interval 15.5 to 26.1 | percentage of participants | |
| Induction Study: Percentage of Participants Who Achieved Endoscopic Response at Week 10 | Cohort A: Placebo (Induction Study) | 18.1 | 95% Confidence Interval 13.0 to 23.3 | percentage of participants | |
| Induction Study: Percentage of Participants Who Achieved Endoscopic Response at Week 10 | Cohort B: Filgotinib 200 mg (Induction Study) | 11.9 | 95% Confidence Interval 7.2 to 16.6 | percentage of participants |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 results by groupParticipant flow88
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction Study (Day 1 to Week 10) | STARTED | Cohort A: Filgotinib 200 mg (Induction Study) | 223 | |
| Induction Study (Day 1 to Week 10) | STARTED | Cohort A: Filgotinib 100 mg (Induction Study) | 245 | |
| Induction Study (Day 1 to Week 10) | STARTED | Cohort A: Placebo (Induction Study) | 239 | |
| Induction Study (Day 1 to Week 10) | STARTED | Cohort B: Filgotinib 200 mg (Induction Study) | 204 | |
| Induction Study (Day 1 to Week 10) | STARTED | Cohort B: Filgotinib 100 mg (Induction Study) | 230 | |
| Induction Study (Day 1 to Week 10) | STARTED | Cohort B: Placebo (Induction Study) | 231 | |
| Induction Study (Day 1 to Week 10) | STARTED | Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study) | 0 | |
| Induction Study (Day 1 to Week 10) | STARTED | Filgotinib 200 mg to Placebo (Maintenance Study) | 0 | |
| Induction Study (Day 1 to Week 10) | STARTED | Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study) | 0 | |
| Induction Study (Day 1 to Week 10) | STARTED | Filgotinib 100 mg to Placebo (Maintenance Study) | 0 |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 participant flowAdverse events1,584
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 | Cohort A: Filgotinib 200 mg (Induction Study) | 3 | 222 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort A: Filgotinib 100 mg (Induction Study) | 8 | 245 | 8 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort A: Placebo (Induction Study) | 7 | 237 | 7 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort B: Filgotinib 200 mg (Induction Study) | 6 | 202 | 7 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort B: Filgotinib 100 mg (Induction Study) | 8 | 228 | 8 |
| other | Anaemia | Blood and lymphatic system disorders | Cohort B: Placebo (Induction Study) | 2 | 229 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study) | 3 | 118 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Filgotinib 200 mg to Placebo (Maintenance Study) | 3 | 56 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study) | 3 | 104 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Filgotinib 100 mg to Placebo (Maintenance Study) | 1 | 55 | 1 |
1 to 10 of 1,584Source ClinicalTrials.gov
See all 1,584 adverse eventsAdverse event totals33
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A: Filgotinib 200 mg (Induction Study) | 0 | 222 |
| Total, all-cause mortality | Cohort A: Filgotinib 100 mg (Induction Study) | 0 | 245 |
| Total, all-cause mortality | Cohort A: Placebo (Induction Study) | 0 | 237 |
| Total, all-cause mortality | Cohort B: Filgotinib 200 mg (Induction Study) | 0 | 202 |
| Total, all-cause mortality | Cohort B: Filgotinib 100 mg (Induction Study) | 0 | 228 |
| Total, all-cause mortality | Cohort B: Placebo (Induction Study) | 0 | 229 |
| Total, all-cause mortality | Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study) | 0 | 118 |
| Total, all-cause mortality | Filgotinib 200 mg to Placebo (Maintenance Study) | 0 | 56 |
| Total, all-cause mortality | Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study) | 0 | 104 |
| Total, all-cause mortality | Filgotinib 100 mg to Placebo (Maintenance Study) | 0 | 55 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39637881 | DERIVED |
Source PubMed
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.
None in this release.
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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