Trial · NCT02914600
Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease
NCT02914600, Phase 3, Terminated, Lakefront Biotherapeutics NV; results first posted 2024-07-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease. Trials, record NCT02914600. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02914600
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease
- NCT number
- NCT02914600
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,188 participants, actual
- Lead sponsor
- Lakefront Biotherapeutics NV
- Conditions
- Crohn's Disease
- Interventions
- Filgotinib, Placebo
- First posted
- 2016-09-26
- Last updated
- 2024-07-10
- Other registries' IDs
- eudract:2016-002763-34
- Results first posted
- 2024-07-10
- Limitations and caveats
The results of DIVERSITY 1 study with filgotinib in participants with moderate to severely active CD failed to meet the co-primary endpoints of clinical remission and endoscopic response for filgotinib 100 mg q.d. and 200 mg q.d. in the study. After analyzing all available data from the DIVERSITY 1 and DIVERSITY long term extension (LTE) studies, the sponsor decided not to pursue extension of the filgotinib indication for CD and decided to terminate the DIVERSITY LTE study.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From the First Dose to Week 312 | An AE was defined as any untoward medical occurrence in a participant administered a study drug, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug whether or not considered related to the study drug. Treatment-emergent adverse events (TEAEs) were defined as 1 or both of the following: * Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug * Any AEs leading to premature discontinuation of study drug. |
| Secondary | Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300 | The PRO2 was a composite score based on 2 components of CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3, higher values mean greater abdominal pain) assessed for 7 days. 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 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, higher values mean worse well-being), and number of liquid or very soft stools were summed over the 7 days prior to each visit. The remaining predictors were also weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Change from baseline for number of liquid or very soft stool per day was reported. |
| Secondary | Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain | Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300 | The PRO2 was a composite score based on 2 components of CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3, higher values mean greater abdominal pain) assessed for 7 days. 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, higher values mean worse well-being), 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. Change from baseline in abdominal pain was reported. |
| Secondary | Change From Baseline in CDAI Scores | Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300 | 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 (rated on a scale of 0-3, higher values mean greater abdominal pain), general well-being (0-4, higher values mean worse well-being), 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | From the First Dose to Week 312 | Safety Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300 | Participants from safety analysis set with available data were analyzed. | Number of liquid/very soft stools/day | MEAN |
| SECONDARY | Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain | Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300 | Participants from safety analysis set with available data were analyzed. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in CDAI Scores | Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300 | Participants from safety analysis set with available data were analyzed. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group75
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Filgotinib 200 mg | 820 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Filgotinib 100 mg | 103 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Placebo | 96 | Participants | ||
| Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Filgotinib 200 mg | Baseline | 5.6 | Standard Deviation 3.26 | Number of liquid/very soft stools/day |
| Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Filgotinib 100 mg | Baseline | 4.0 | Standard Deviation 3.12 | Number of liquid/very soft stools/day |
| Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Placebo | Baseline | 2.2 | Standard Deviation 1.92 | Number of liquid/very soft stools/day |
| Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Filgotinib 200 mg | Change at Week 12 | -1.6 | Standard Deviation 2.71 | Number of liquid/very soft stools/day |
| Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Filgotinib 100 mg | Change at Week 12 | -0.7 | Standard Deviation 2.01 | Number of liquid/very soft stools/day |
| Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Placebo | Change at Week 12 | 0.2 | Standard Deviation 1.44 | Number of liquid/very soft stools/day |
| Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools | Filgotinib 200 mg | Change at Week 24 | -1.8 | Standard Deviation 2.89 | Number of liquid/very soft stools/day |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Filgotinib 200 mg | 945 | |
| Overall Study | STARTED | Filgotinib 100 mg | 119 | |
| Overall Study | STARTED | Placebo | 124 | |
| Overall Study | Treated | Filgotinib 200 mg | 944 | |
| Overall Study | Treated | Filgotinib 100 mg | 119 | |
| Overall Study | Treated | Placebo | 124 | |
| Overall Study | COMPLETED | Filgotinib 200 mg | 0 | |
| Overall Study | COMPLETED | Filgotinib 100 mg | 0 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Filgotinib 200 mg | 945 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events798
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 | Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Filgotinib 200 mg | 14 | 944 | 16 |
| other | Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Filgotinib 100 mg | 3 | 119 | 3 |
| other | Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Placebo | 0 | 124 | 0 |
| other | Hypertension | Vascular disorders | Filgotinib 200 mg | 40 | 944 | 41 |
| other | Hypertension | Vascular disorders | Filgotinib 100 mg | 8 | 119 | 8 |
| other | Hypertension | Vascular disorders | Placebo | 3 | 124 | 3 |
| other | Pyrexia | General disorders | Filgotinib 200 mg | 65 | 944 | 94 |
| other | Pyrexia | General disorders | Filgotinib 100 mg | 3 | 119 | 4 |
| other | Pyrexia | General disorders | Placebo | 0 | 124 | 0 |
| other | Fatigue | General disorders | Filgotinib 200 mg | 35 | 944 | 40 |
1 to 10 of 798Source ClinicalTrials.gov
See all 798 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Filgotinib 200 mg | 6 | 944 |
| Total, all-cause mortality | Filgotinib 100 mg | 2 | 119 |
| Total, all-cause mortality | Placebo | 1 | 124 |
| Total, other adverse events | Filgotinib 200 mg | 697 | 944 |
| Total, other adverse events | Filgotinib 100 mg | 89 | 119 |
| Total, other adverse events | Placebo | 78 | 124 |
| Total, serious adverse events | Filgotinib 200 mg | 284 | 944 |
| Total, serious adverse events | Filgotinib 100 mg | 34 | 119 |
| Total, serious adverse events | Placebo | 20 | 124 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02914600
GET https://conductscience.org/api/trials/v1/NCT02914600/results?page=2