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A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)

StatusRecruiting
PhasePhase 3
SponsorTakeda
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites reduced: 54 → 47 locations Eligibility criteria shortened, about 25 words · Secondary endpoints: details revised at 1 of 2 entries · Study description expanded, about 2 words Show 3 more changesShow less
    • Eligibility criteria shortened, about 25 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Study description expanded, about 2 words
  2. Trial sites expanded: 1 → 54 locationsv12
  3. Primary and study completion dates: Jan 26, 2032 to Aug 12, 2030v11
  4. Re-verified, no change to tracked fieldsv10
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v9 Show 1 more changeShow less
    • Study sites: 0 to 1
Show 7 earlier versionsHide 7 earlier versions
  1. Start date: Oct 23, 2025 to Oct 27, 2025v8
  2. Start date: Oct 22, 2025 to Oct 23, 2025v7
  3. Start date: Jul 11, 2025 to Oct 22, 2025v6
  4. Start date: Dec 2, 2024 to Jul 11, 2025v5
  5. Secondary endpoints: details revised at 2 of 2 entries Study description shortened, about 12 wordsv4 Show 1 more changeShow less
    • Study description shortened, about 12 words

    See this version in full on ClinicalTrials.gov ↗

  6. Re-verified, no change to tracked fieldsv3
  7. Study Status, Referencesv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Takeda
221 trials monitored
See 15 trials at risk
Crohn's Disease
611 trials monitored
See 30 trials at risk
Ulcerative Colitis
587 trials monitored
See 34 trials at risk
The main aim of this study is to learn about medical problems (adverse events) if vedolizumab subcutaneously (SC) is given to a child or teenager with UC or CD for a long time. Other aims are to understand if the long time use of vedolizumab SC has an impact on the time period until hospital visits because of bowel swelling (inflammation) are needed and has an impact on the quality of life of children and teenagers who received vedolizumab SC. In this study, participants who responded well to the treatment with vedolizumab SC in the parent study (VedolizumabSC-3003 \[NCT06100289\]) will continue to be treated with vedolizumab SC. Participants who did not respond well to the treatment with vedolizumab SC in the parent study or who received corticosteroids in the last 4 weeks of the parent study will not receive vedolizumab SC in this study but will be followed for up to 2 years after the last treatment with vedolizumab SC in the parent study. During the study, participants will visit their study clinic several times.
Trial Details
NCT Number NCT06405087
Lead Sponsor Takeda
Conditions Ulcerative Colitis, Crohn's Disease
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov