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NCT04779320 · ClinicalTrials.gov registry record · Phase 3
A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)
A Phase 3 study of Crohn's Disease (CD), sponsored by Takeda.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 120
- Enrollment target
- 20
- Study locations
NCT04779320: Recruiting Phase 3 study of Crohn's Disease (CD), sponsored by Takeda.
NCT04779320 is a Phase 3 study of Crohn's Disease (CD) that is actively recruiting participants, run by Takeda. The registered enrollment target is 120 participants, below the 168-participant average among 6 other Crohn's Disease (CD) trials with a reported enrollment target (29% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04779320, a Phase 3 study of Crohn's Disease (CD), is actively recruiting participants, sponsored by Takeda.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 120 participants
- Enrollment target
- 20
- Study locations
Study Summary
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe Crohn's disease will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with the vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no signs of inflammation. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive either a high dose or low dose of vedolizumab once every 8 weeks. They will receive the same dose every time.
Primary Outcome
Clinical remission is defined by PCDAI score ≤10. The PCDAI was specifically designed for use in children. The PCDAI includes a child-specific item: the height velocity variable as well as three laboratory parameters: hematocrit (HCT) (adjusted for age and sex), erythrocyte sedimentation rate (ESR), and albumin level. The PCDAI score ranges from 0 to 100, with higher scores indicating more active disease. A score of \<10 will be consistent with inactive disease, 11 to 30 will indicate mild disea
Conditions Studied
Interventions
- DRUG Vedolizumab IV
Study Locations (20)
New York
- The Steven and Alexandra Cohen Childrens Medical Center of New York - BRANY - PPDS - New Hyde Park
- University of Rochester Medical Center PPDS - Rochester
- Stony Brook University Medical Center - Stony Brook
- SUNY Upstate Medical Center - Syracuse
California
- Cedars Sinai Medical Center - Los Angeles
- Rady Childrens Hospital San Diego - PIN - San Diego
- University of California San Francisco - San Francisco
Minnesota
- MNGI Digestive Health, PA - Minneapolis
- Mayo Clinic - PIN - Rochester
Arizona
- Phoenix Childrens Hospital - Phoenix
Florida
- I.H.S Health LLC - Kissimmee
Georgia
- Childrens Center For Digestive Healthcare - Atlanta
Illinois
- Advocate Children's Hospital Park Ridge - Park Ridge
Indiana
- Riley Hospital For Children - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2022-02-10 |
| Est. Completion | 2026-05-22 |
| Phase | Phase 3 |
What NCT04779320 shows while recruiting
NCT04779320 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 168-participant average among 6 other Crohn's Disease (CD) trials with a reported enrollment target (29% lower).
The record links to 1 condition, with Crohn's Disease (CD) appearing as the primary indexed condition, and to 1 intervention - of which Vedolizumab IV is the first listed.
NCT04779320 names 20 study sites across 14 states, led by New York, California, Minnesota.
Frequently Asked Questions
What is clinical trial NCT04779320 about?
NCT04779320 is a clinical study titled "A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)". Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe Crohn's disease will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with ...
What is the current status of trial NCT04779320?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2022-02-10. Estimated completion is 2026-05-22.
What conditions does trial NCT04779320 study?
This clinical trial studies the following conditions: Crohn's Disease (CD).
What interventions are being tested in trial NCT04779320?
The interventions under investigation include: Vedolizumab IV (DRUG).
Who is sponsoring clinical trial NCT04779320?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04779320 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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