A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease

StatusRecruiting
PhasePhase 2
SponsorTakeda
Started

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Trial flagged as At Risk
Primary completion moved at least 4 months later Sep 18, 2026 → Feb 17, 2027
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Record History

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  1. Primary endpoints: details revised at 1 of 1 entry Show 4 more changesShow less
    • Trial sites expanded: 190 → 201 locations
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 9 of 9 entries
    • Study description expanded, about 4 words
  2. Primary completion pushed from Sep 18, 2026 to Feb 17, 2027v23
  3. Trial sites reduced: 193 → 190 locationsv22
  4. Study sites: 194 to 193v21
  5. Trial sites expanded: 176 → 194 locationsv20
Show 18 earlier versionsHide 18 earlier versions
  1. Study sites: 177 to 176v19
  2. Study sites: 178 to 177v18
  3. Study sites: 179 to 178v17
  4. Study sites: 185 to 179v16
  5. Study sites: 197 to 185v15
  6. Study sites: 196 to 197v14
  7. Study sites: 167 to 196v13
  8. Site details revised at 20 of 167 sitesv12
  9. Site details revised at 36 of 167 sitesv11
  10. Study sites: 146 to 167v10
  11. Study sites: 180 to 146
    • Eligibility criteria shortened, about 68 words
    • Secondary endpoints revised (9)
    v9
  12. Study sites: 209 to 180v8
  13. 2 versions Re-verified since Jul 17, 2024, no change to tracked fieldsv6-v7
  14. Study sites: 215 to 209
    • Eligibility criteria expanded, about 79 words
    • Study description revised
    v5
  15. Study sites: 10 to 215v4
  16. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 10
    • Start date changed from estimate of Mar 6, 2024 to Mar 5, 2024
    v3
  17. Study Status, Referencesv2
  1. Study First Submitted
  • 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
222 trials monitored
See 14 trials at risk
Crohn's Disease
643 trials monitored
See 36 trials at risk
Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. The purpose of this study is to evaluate the efficacy and safety of TAK-279 versus placebo in participants with moderately to severely active Crohn's disease (CD). The main aim of this study is to learn if the 3 different doses of TAK-279 reduce bowel inflammation and ulcers in the bowel compared to the placebo after 12 weeks of treatment. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate medical problems. An endoscopy will be used to check the bowel for inflammation. The participants will be treated with TAK-279 for 52 weeks (1 year). During the study, participants will visit their study clinic 15 times.
Trial Details
NCT Number NCT06233461
Lead Sponsor Takeda
Conditions
(from sponsor)		 Crohn's Disease
Related terms Crohn Disease
Enrollment 268 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov