Trial · NCT05837897
A Study of Vedolizumab in Adult Participants With Moderate to Severe Crohn's Disease
NCT05837897, Phase 3, Recruiting, Takeda
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Vedolizumab in Adult Participants With Moderate to Severe Crohn's Disease. Trials, record NCT05837897. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05837897
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Vedolizumab in Adult Participants With Moderate to Severe Crohn's Disease
- NCT number
- NCT05837897
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 408 participants, estimated
- Lead sponsor
- Takeda
- Conditions
- Crohn's Disease
- Interventions
- Vedolizumab IV, Placebo
- First posted
- 2023-05-01
- Last updated
- 2026-11-02
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Clinical Response at Week 14 | Up to Week 14 | Clinical response is defined as ≥8 point decrease in 2-component patient-reported outcome (PRO2) score from baseline. The PRO2 is constituted by abdominal pain and number of liquid stools components of the Crohn's Disease Activity Index (CDAI). The PRO-2 score is the sum of the abdominal pain and stool frequency subscores of the CDAI score. The average daily number of liquid or very soft stools and abdominal pain score (with 0 indicating no pain and 3 indicating severe pain) are weighted according to the CDAI multiplication factors (2 for stool frequency and 5 for abdominal pain). |
| Secondary | Percentage of Participants Achieving Clinical Remission at Week 14 | Up to Week 14 | Clinical remission is defined as PRO2 score \<8 from baseline. The PRO2 is comprised of the stool frequency and abdominal pain components of the CDAI. The PRO-2 score is the sum of the abdominal pain and stool frequency subscores of the CDAI score. The average daily number of liquid or very soft stools and abdominal pain score (with 0 indicating no pain and 3 indicating severe pain) are weighted according to the CDAI multiplication factors (2 for stool frequency and 5 for abdominal pain). |
| Secondary | Percentage of Participants Achieving Endoscopic Response at Week 14 | Up to Week 14 | Endoscopic response is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) reduction by ≥50%. The SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of the surface area that is ulcerated, percentage of the surface area affected, and presence and type of narrowings in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 60, where higher scores indicate more severe disease. |
| Secondary | Percentage of Participants Achieving Both Clinical Response and Endoscopic Response at Week 14 | Up to Week 14 | Clinical response:≥8 point decrease in PRO2 score from baseline. Endoscopic response:SES-CD reduction by ≥50%.PRO2:number of liquid stools and abdominal pain components of the CDAI. PRO-2 score:sum of the abdominal pain and stool frequency subscores of the CDAI score.Average daily number of liquid or very soft stools and abdominal pain score (0=no pain and 3=severe pain) are weighted according to the CDAI multiplication factors (2= stool frequency;5= abdominal pain).Negative change indicates clinical response achieved.SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of the surface area that is ulcerated, percentage of the surface area affected, and presence of narrowings) in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum).Score for each endoscopic variable=sum of values obtained for each segment.SES-CD total=sum of the 4 endoscopic variable scores from 0 to 60, where higher scores=more severe disease. |
| Secondary | Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and AEs Leading to Discontinuation | From first dose up to 18 weeks after the final dose of vedolizumab (Up to approximately 78 weeks) | AE:any untoward medical occurrence in clinical investigation participants administered a drug;it does not necessarily have to have causal relationship with treatment.SAE:any untoward medical occurrence that:1)results in death,2)is life-threatening,3)requires inpatient hospitalization or prolongation of existing hospitalization,4)results in persistent or significant disability/incapacity,5)leads to a congenital anomaly/birth defect in offspring of participant or6)is medically important event that satisfies any of following:a)May require intervention to prevent items 1 through 5 above.b)May expose participant to danger,even though event is not immediately life threatening or fatal or does not result in hospitalization.AESI:serious infections,opportunistic infections such as progressive multifocal leukoencephalopathy(PML);liver injury;malignancies;infusion-related reactions,injection site reactions,systemic reactions,and hypersensitivity. |
| Secondary | Percentage of Participants With Abnormal Change from Baseline in Vital Sign Values | From first dose up to 18 weeks after the final dose of vedolizumab (Up to approximately 78 weeks) | Vital signs assessment will include body temperature, respiratory rate, blood pressure, and pulse (beats per minute). Abnormal values will be determined by the investigator. |
| Secondary | Percentage of Participants With Abnormal Change from Baseline in Laboratory Values | From first dose up to 18 weeks after the final dose of vedolizumab (Up to approximately 78 weeks) | Laboratory parameter assessment will include hematology, serum chemistry, and urinalysis. Abnormal values will be determined by the central lab. |
| Secondary | Percentage of Participants With Abnormal Change from Baseline in Electrocardiogram (ECG) Values | From first dose up to 18 weeks after the final dose of vedolizumab (Up to approximately 78 weeks) | The ECG results will be interpreted using 1 of the following categories: within normal limits, abnormal but not clinically significant, or abnormal and clinically significant. Abnormal values are determined by the investigator. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT05837897
GET https://conductscience.org/api/trials/v1/NCT05837897/registered