Trial · NCT06249555
VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study
NCT06249555, Active not recruiting, Alimentiv Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study. Trials, record NCT06249555. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06249555
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- VOICE-Early Response to Vedolizumab and IL-23 Antagonists in Participants With Crohn's Disease: A Prospective Observational Study
- NCT number
- NCT06249555
- Status
- Active not recruiting
- Enrollment
- 300 participants, estimated
- Lead sponsor
- Alimentiv Inc.
- Conditions
- Crohn's Disease
- Interventions
- Vedolizumab (VDZ), Ustekinumab (UST), Risankizumab (RISA), Guselkumab (GUS), Mirikizumab (MIR)
- First posted
- 2024-02-08
- Last updated
- 2026-11-02
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To assess time of onset of biologic therapy in pain interference | Baseline to Week 14 | Time to meaningful clinical improvement in pain interference, defined as a ≥ 2-point decrease in the PROMIS Pain Interference-SF T-score |
| Secondary | To assess time of onset of biologic therapy in multiple QOL and functioning domains | Baseline to Weeks 14, 30, and 52 | Time to meaningful clinical improvement for each individual PROMIS domain, defined as a ≥ 2-point change in the direction of improvement in the respective PROMIS domain T-score (Note: A higher PROMIS domain T-score represents more of the concept being measured. For the Ability to Participate in Social Roles and Activities domain an increase in T-score |
| Secondary | To assess the efficacy of therapy in inducing a meaningful clinical improvement in pain interference through Week 52 through a reduction in PROMIS - Pain Interference - Short Form Scores. | Baseline to Weeks 14, 30, and 52 | Meaningful clinical improvement in each individual PROMIS domain at Weeks 14, 30, and 52 |
| Secondary | To assess the efficacy of therapy in inducing a meaningful clinical improvement in fatigue through Week 52 through a reduction in PROMIS - Fatigue - Short Form Scores. | Baseline to Weeks 14, 30, and 52 | Meaningful clinical improvement in each individual PROMIS domain at Weeks 14, 30, and 52 |
| Secondary | To assess the efficacy of therapy in inducing a meaningful clinical improvement in anxiety through Week 52 through a reduction in PROMIS - Emotional Distress - Anxiety - Short Form Scores. | Baseline to Weeks 14, 30, and 52 | Meaningful clinical improvement in each individual PROMIS domain at Weeks 14, 30, and 52 |
| Secondary | To assess the efficacy of therapy in inducing a meaningful clinical improvement in depression through Week 52 through a reduction in PROMIS Emotional Distress - Depression - Short Form. | Baseline to Weeks 14, 30, and 52 | Meaningful clinical improvement in each individual PROMIS domain at Weeks 14, 30, and 52 |
| Secondary | To assess the efficacy of therapy in inducing a meaningful clinical improvement in sleep disturbance through Week 52 through a reduction in PROMIS - Sleep Disturbance - Short Form. | Baseline to Weeks 14, 30, and 52 | Meaningful clinical improvement in each individual PROMIS domain at Weeks 14, 30, and 52 |
| Secondary | To assess the efficacy of therapy in inducing a meaningful clinical improvement in physical function through Week 52 through a reduction in PROMIS - Physical Function - Short Form. | Baseline to Weeks 14, 30, and 52 | Meaningful clinical improvement in each individual PROMIS domain at Weeks 14, 30, and 52 |
| Secondary | To assess the efficacy of therapy in inducing a meaningful clinical improvement in ability to participate in social roles and activities through Week 52 through a reduction in PROMIS - Ability to Participate in Social Roles and Activities - Short Form. | Baseline to Weeks 14, 30, and 52 | Meaningful clinical improvement in each individual PROMIS domain at Weeks 14, 30, and 52 |
| Secondary | To assess early change in patient-reported symptoms within the PRO-2 through Week 14. | Baseline to Week 14 | Change in PRO-2 (liquid/very soft stool frequency + abdominal pain) from baseline to Week 14. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 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/NCT06249555
GET https://conductscience.org/api/trials/v1/NCT06249555/registered?page=2