Trial · NCT04130919
Study to Evaluate the Efficacy and Safety of Tilpisertib in Adults With Moderately to Severely Active Ulcerative Colitis
NCT04130919, Phase 2, Terminated, Gilead Sciences; results first posted 2022-08-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Efficacy and Safety of Tilpisertib in Adults With Moderately to Severely Active Ulcerative Colitis. Trials, record NCT04130919. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04130919
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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 Tilpisertib in Adults With Moderately to Severely Active Ulcerative Colitis
- NCT number
- NCT04130919
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Ulcerative Colitis
- Interventions
- Tilpisertib, Placebo
- First posted
- 2019-10-18
- Last updated
- 2022-08-24
- Other registries' IDs
- eudract:2019-001430-33
- Results first posted
- 2022-08-24
- Limitations and caveats
Gilead made the decision to discontinue the development of tilpisertib since a new molecular entity was able to achieve greater target coverage. The decision was not due to any safety concerns. Since only 19 participants were enrolled, none of the planned statistical analyses were performed. During the coronavirus disease 2019 (COVID-19) pandemic, there were changes to protocol visits and procedures where necessary to mitigate the impact of the pandemic to the study.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved Clinical Remission Per Modified Mayo Clinic Score (MCS) at Week 10 | Week 10 | The modified MCS is a scoring system for assessment of ulcerative colitis (UC) activity and is 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 or more stools more than normal), and physician's global assessment (PGA) (range: 0 to 3, where 0 = normal and 3 = severe disease). Total score for MCS ranges from 0 to 12 (sum of all subscores), with higher scores indicating higher disease activity. Clinical remission per modified MCS is defined as stool frequency subscore ≤ 1 and not greater than baseline, rectal bleeding subscore of 0, and endoscopic subscore ≤ 1 at Week 10. |
| Secondary | Percentage of Participants Who Achieved Endoscopic Response at Week 10 | Week 10 | Endoscopic response was defined as an endoscopic subscore of ≤ 1 at Week 10. Endoscopic subscore is a part of the modified MCS which is a scoring system for assessment of UC activity. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease, 1 = mild disease (erythema, decreased vascular pattern), 2 = moderate disease (marked erythema, lack of vascular pattern, friability, erosions), and 3 = severe disease (spontaneous bleeding, ulceration). |
| Secondary | Percentage of Participants Who Achieved MCS Response at Week 10 | Week 10 | The modified MCS is a scoring system for assessment of UC activity and is 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 or more stools more than normal), and PGA (range: 0 to 3, where 0 = normal and 3 = severe disease). Total score for MCS ranges from 0 to 12 (sum of all subscores), with higher scores indicating higher disease activity. MCS response is defined as a decrease from baseline of ≥ 3 points and at least 30% in MCS, in addition to a ≥ 1 point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore ≤ 1 at Week 10. |
| Secondary | Percentage of Participants Who Achieved MCS Remission at Week 10 | Week 10 | The modified MCS is a scoring system for assessment of UC activity and is 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 or more stools more than normal), and PGA (range: 0 to 3, where 0 = normal and 3 = severe disease). Total score for MCS ranges from 0 to 12 (sum of all subscores), with higher scores indicating higher disease activity. MCS remission is defined as a MCS score of ≤ 2 and no individual subscore \> 1 at Week 10. |
| Secondary | Percentage of Participants Who Achieved Histologic Remission Based Upon the Geboes Scale at Week 10 | Week 10 | Geboes histologic remission was assessed using the Geboes histologic scores to identify histologic changes in ulcerative colitis. 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). Histologic remission 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. Geboes score ranges from 0 to 5.4. Lower values indicate better outcome. |
| Secondary | Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label phase: First dose date up to 50.7 weeks plus 30 days | Treatment-emergent adverse events (TEAEs) for the Blinded Treatment phase are either defined as AEs with an onset date on or after the Blinded Treatment phase study drug start date and no later than 30 days after permanent discontinuation of the Blinded Treatment phase study drug if no Open-label Treatment phase study drug was taken, or any AEs with an onset date on or after the Blinded Treatment phase study drug start date and before the Open-label Treatment phase study drug start date if Open-label Treatment phase study drug was taken and/or any AEs leading to premature discontinuation of Blinded Treatment phase study drug. TEAEs for the Open-label Treatment phase are either defined as AEs with an onset date on or after the Open-label Treatment phase study drug start date and no later than 30 days after permanent discontinuation of the Open-lab Treatment phase study drug and/or any AEs leading to premature discontinuation of Open-label Treatment phase study drug. |
| Secondary | Percentage of Participants Who Experienced Laboratory Abnormalities | Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label phase: First dose date up to 50.7 weeks plus 30 days | Treatment-emergent laboratory abnormalities for Blinded Treatment phase are defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of Blinded Treatment phase study drug plus 30 days for participants who permanently discontinued Blinded Treatment phase study drug or before the first dose of Open-label Treatment phase study drug. For the Open-label Treatment phase, treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from Open-label baseline at any postbaseline time point, up to and including the date of last dose of Open-label Treatment phase study drug plus 30 days for participants who permanently discontinued Open-label phase study drug. For maximum postbaseline toxicity grade, the most severe graded abnormality from all tests was counted for each patient. Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieved Clinical Remission Per Modified Mayo Clinic Score (MCS) at Week 10 | Week 10 | Full analysis set included all randomized participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Endoscopic Response at Week 10 | Week 10 | Participants in the Full Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved MCS Response at Week 10 | Week 10 | Participants in the Full Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved MCS Remission at Week 10 | Week 10 | Participants in the Full Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Histologic Remission Based Upon the Geboes Scale at Week 10 | Week 10 | Participants in the Full Analysis Set with at least 1 histological assessment were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label phase: First dose date up to 50.7 weeks plus 30 days | Safety Analysis Set included all participants who received at least one dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Experienced Laboratory Abnormalities | Blinded Treatment phase: First dose date up to 50.6 weeks plus 30 days; Open-label phase: First dose date up to 50.7 weeks plus 30 days | Participants in the Safety Analysis Set were analyzed. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieved Clinical Remission Per Modified Mayo Clinic Score (MCS) at Week 10 | Tilpisertib 300 mg (Blinded Treatment Phase) | 0 | percentage of participants | ||
| Percentage of Participants Who Achieved Clinical Remission Per Modified Mayo Clinic Score (MCS) at Week 10 | Tilpisertib 100 mg (Blinded Treatment Phase) | 0 | percentage of participants | ||
| Percentage of Participants Who Achieved Clinical Remission Per Modified Mayo Clinic Score (MCS) at Week 10 | Placebo (Blinded Treatment Phase) | 0 | percentage of participants | ||
| Percentage of Participants Who Achieved Endoscopic Response at Week 10 | Tilpisertib 300 mg (Blinded Treatment Phase) | 14.3 | percentage of participants | ||
| Percentage of Participants Who Achieved Endoscopic Response at Week 10 | Tilpisertib 100 mg (Blinded Treatment Phase) | 16.7 | percentage of participants | ||
| Percentage of Participants Who Achieved Endoscopic Response at Week 10 | Placebo (Blinded Treatment Phase) | 0 | percentage of participants | ||
| Percentage of Participants Who Achieved MCS Response at Week 10 | Tilpisertib 300 mg (Blinded Treatment Phase) | 28.6 | percentage of participants | ||
| Percentage of Participants Who Achieved MCS Response at Week 10 | Tilpisertib 100 mg (Blinded Treatment Phase) | 16.7 | percentage of participants | ||
| Percentage of Participants Who Achieved MCS Response at Week 10 | Placebo (Blinded Treatment Phase) | 16.7 | percentage of participants | ||
| Percentage of Participants Who Achieved MCS Remission at Week 10 | Tilpisertib 300 mg (Blinded Treatment Phase) | 0 | percentage of participants |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Blinded Treatment Phase | STARTED | Tilpisertib 300 mg (Blinded Treatment Phase) | 7 | |
| Blinded Treatment Phase | STARTED | Tilpisertib 100 mg (Blinded Treatment Phase) | 6 | |
| Blinded Treatment Phase | STARTED | Placebo (Blinded Treatment Phase) | 6 | |
| Blinded Treatment Phase | STARTED | Tilpisertib 300 mg From Tilpisertib 300 mg (Open-label Treatment Phase) | 0 | |
| Blinded Treatment Phase | STARTED | Tilpisertib 300 mg From Tilpisertib 100 mg (Open-label Treatment Phase) | 0 | |
| Blinded Treatment Phase | STARTED | Tilpisertib 300 mg From Placebo (Open-label Treatment Phase) | 0 | |
| Blinded Treatment Phase | COMPLETED | Tilpisertib 300 mg (Blinded Treatment Phase) | 5 | |
| Blinded Treatment Phase | COMPLETED | Tilpisertib 100 mg (Blinded Treatment Phase) | 4 | |
| Blinded Treatment Phase | COMPLETED | Placebo (Blinded Treatment Phase) | 3 | |
| Blinded Treatment Phase | COMPLETED | Tilpisertib 300 mg From Tilpisertib 300 mg (Open-label Treatment Phase) | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events192
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 | Tilpisertib 300 mg (Blinded Treatment Phase) | 1 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | Tilpisertib 100 mg (Blinded Treatment Phase) | 0 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo (Blinded Treatment Phase) | 0 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Tilpisertib 300 mg From Tilpisertib 300 mg (Open-label Treatment Phase) | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Tilpisertib 300 mg From Tilpisertib 100 mg (Open-label Treatment Phase) | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Tilpisertib 300 mg From Placebo (Open-label Treatment Phase) | 0 | 3 | |
| other | External ear inflammation | Ear and labyrinth disorders | Tilpisertib 300 mg (Blinded Treatment Phase) | 1 | 7 | |
| other | External ear inflammation | Ear and labyrinth disorders | Tilpisertib 100 mg (Blinded Treatment Phase) | 0 | 6 | |
| other | External ear inflammation | Ear and labyrinth disorders | Placebo (Blinded Treatment Phase) | 0 | 6 | |
| other | External ear inflammation | Ear and labyrinth disorders | Tilpisertib 300 mg From Tilpisertib 300 mg (Open-label Treatment Phase) | 0 | 4 |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tilpisertib 300 mg (Blinded Treatment Phase) | 0 | 7 |
| Total, all-cause mortality | Tilpisertib 100 mg (Blinded Treatment Phase) | 0 | 6 |
| Total, all-cause mortality | Placebo (Blinded Treatment Phase) | 0 | 6 |
| Total, all-cause mortality | Tilpisertib 300 mg From Tilpisertib 300 mg (Open-label Treatment Phase) | 0 | 4 |
| Total, all-cause mortality | Tilpisertib 300 mg From Tilpisertib 100 mg (Open-label Treatment Phase) | 0 | 3 |
| Total, all-cause mortality | Tilpisertib 300 mg From Placebo (Open-label Treatment Phase) | 0 | 3 |
| Total, other adverse events | Tilpisertib 300 mg (Blinded Treatment Phase) | 4 | 7 |
| Total, other adverse events | Tilpisertib 100 mg (Blinded Treatment Phase) | 3 | 6 |
| Total, other adverse events | Placebo (Blinded Treatment Phase) | 2 | 6 |
| Total, other adverse events | Tilpisertib 300 mg From Tilpisertib 300 mg (Open-label Treatment Phase) | 2 | 4 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
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/NCT04130919
GET https://conductscience.org/api/trials/v1/NCT04130919/results?page=2