Trial · NCT06841705
Early Vedolizumab as First-Line for Immune-Related Colitis Therapy Trial
NCT06841705, Phase 2, Recruiting, Shilpa Grover, MD, MPH
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Early Vedolizumab as First-Line for Immune-Related Colitis Therapy Trial. Trials, record NCT06841705. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06841705
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Early Vedolizumab as First-Line for Immune-Related Colitis Therapy Trial
- NCT number
- NCT06841705
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 80 participants, estimated
- Lead sponsor
- Shilpa Grover, MD, MPH
- Conditions
- Immune Checkpoint Inhibitor-Related Colitis
- Interventions
Vedolizumab 300 MG Injection [Entyvio], Prednisone (and methylprednisolone), Prednisone Taper, Placebo Prednisone Capsules, Placebo Vedolizumab, Sulfamethoxazole-Trimethoprim, Placebo for Sulfamethoxazole-Trimethoprim
- First posted
- 2025-02-24
- Last updated
- 2025-11-04
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Steroid-free remission rate | 8 weeks | Defined as less than 10 mg of prednisone/day and grade 1 or lower diarrhea symptoms without the use of additional biologic rescue medication. |
| Secondary | Steroid-free remission rate | 5 weeks | Defined as less than 10 mg of prednisone/day and grade 1 or lower diarrhea symptoms without the use of additional biologic rescue medication. |
| Secondary | Change in calprotectin | 0, 2, 5 and 8 weeks | As compared to baseline |
| Secondary | Cumulative steroid exposure | 5 weeks and 8 weeks | Steroid dose x Duration of treatment |
| Secondary | Time to steroid-free colitis remission | Up to 12 months | Defined as the time from the first day of treatment to the first day with less than 10 mg of prednisone/day and grade 1 or lower symptoms. |
| Secondary | Rate of secondary immunosuppression for management of ICI colitis | 5 weeks and 8 weeks | Defined as the use of open-label prednisone or biologic rescue medication |
| Secondary | Rate of symptomatic remission | 5 weeks and 8 weeks | Defined as a reduction in stool frequency to \< 4 bowel movements/day at 1 week |
| Secondary | Hospitalization rate | 8 weeks | Due to colitis |
| Secondary | Rates of colectomy | 8 weeks | Due to colitis |
| Secondary | Endoscopic resolution of colitis | 8 weeks | Rate of endoscopic resolution of colitis will be determined, if endoscopy is performed at 8 weeks |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
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/NCT06841705
GET https://conductscience.org/api/trials/v1/NCT06841705/registered