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A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion moved earlier from Mar 8, 2031 to Jan 31, 2027
  2. Lead sponsor: Teva Branded Pharmaceutical Products R&D LLC to Teva Branded Pharmaceutical Products R&D LLC Primary endpoints: details revised at 1 of 2 entries · Eligibility criteria expanded, about 6 words · Secondary endpoints: details revised at 2 of 14 entries · 1 more Show 4 more changesShow less
    • Primary endpoints: details revised at 1 of 2 entries
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 2 of 14 entries
    • Publications: details revised at 1 of 1 entry
  3. 4 versions Re-verified since May 17, 2026, no change to tracked fieldsv41-v44
  4. Site details revised at 1 of 93 sitesv40
  5. 6 versions Re-verified since Feb 2, 2026, no change to tracked fieldsv34-v39
Show 32 earlier versionsHide 32 earlier versions
  1. Enrollment target: estimated 218 to confirmed 247v33
  2. Primary completion date: Dec 20, 2025 to Jan 5, 2026 Site details revised at 2 of 93 sitesv32 Show 1 more changeShow less
    • Site details revised at 2 of 93 sites
  3. Site details revised at 2 of 93 sitesv31
  4. Re-verified, no change to tracked fieldsv30
  5. Site details revised at 1 of 93 sitesv29
  6. Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc. to Teva Branded Pharmaceutical Products R&D LLC Site details revised at 1 of 93 sitesv28 Show 1 more changeShow less
    • Site details revised at 1 of 93 sites
  7. Site details revised at 2 of 93 sitesv27
  8. Site details revised at 1 of 93 sitesv26
  9. Study sites: 94 to 93v25
  10. Study sites: 95 to 94v24
  11. Trial status: Recruiting to Active, Not Recruiting Study sites: 115 to 95v23 Show 1 more changeShow less
    • Study sites: 115 to 95
  12. Site details revised at 2 of 115 sitesv22
  13. Site details revised at 1 of 115 sitesv21
  14. Study sites: 106 to 115v20
  15. Study sites: 95 to 106v19
  16. Study sites: 85 to 95v18
  17. Study sites: 79 to 85v17
  18. Study sites: 73 to 79v16
  19. Primary completion date: Jul 5, 2031 to Dec 20, 2025 Study sites: 66 to 73 · Completion date: Aug 2, 2031 to Mar 8, 2031v15 Show 2 more changesShow less
    • Study sites: 66 to 73
    • Completion date: Aug 2, 2031 to Mar 8, 2031
  20. Site details revised at 2 of 66 sitesv14
  21. Site details revised at 3 of 66 sitesv13
  22. Site details revised at 2 of 66 sitesv12
  23. Study sites: 65 to 66 Collaborators expanded, about 1 wordv11 Show 1 more changeShow less
    • Collaborators expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  24. Enrollment target: 216 to 218 Secondary endpoints: 12 to 14v10 Show 1 more changeShow less
    • Secondary endpoints: 12 to 14

    See this version in full on ClinicalTrials.gov ↗

  25. Site details revised at 1 of 65 sitesv9
  26. Primary completion date: Feb 24, 2026 to Jul 5, 2031 Study sites: 64 to 65 · Completion date: Mar 24, 2026 to Aug 2, 2031v8 Show 2 more changesShow less
    • Study sites: 64 to 65
    • Completion date: Mar 24, 2026 to Aug 2, 2031
  27. Study sites: 59 to 64v7
  28. Study sites: 51 to 59v6
  29. Enrollment target: 128 to 216 Primary completion date: Jan 13, 2025 to Feb 24, 2026 · Primary endpoints revised (2) · Study sites: 1 to 51 · 3 morev5 Show 6 more changesShow less
    • Primary completion date: Jan 13, 2025 to Feb 24, 2026
    • Primary endpoints revised (2)
    • Study sites: 1 to 51
    • Completion date: Jan 27, 2025 to Mar 24, 2026
    • Eligibility criteria shortened, about 44 words
    • Secondary endpoints: 20 to 12

    See this version in full on ClinicalTrials.gov ↗

  30. Primary completion date: Jan 12, 2025 to Jan 13, 2025 Eligibility criteria shortened, about 7 words · Secondary endpoints: details revised at 8 of 20 entriesv4 Show 2 more changesShow less
    • Eligibility criteria shortened, about 7 words
    • Secondary endpoints: details revised at 8 of 20 entries

    See this version in full on ClinicalTrials.gov ↗

  31. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Completion date: Jun 22, 2025 to Jan 27, 2025 · Start date changed from estimate of Jan 6, 2023 to Jan 11, 2023v3 Show 3 more changesShow less
    • Study sites: 0 to 1
    • Completion date: Jun 22, 2025 to Jan 27, 2025
    • Start date changed from estimate of Jan 6, 2023 to Jan 11, 2023
  32. Re-verified, no change to tracked fieldsv2
  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.
The primary objective of the study is to evaluate the efficacy of 2 different maintenance dose regimens of TEV-48574 subcutaneous (sc) administered every 4 weeks (Q4W) in adult participants with inflammatory bowel disease (IBD). Secondary objectives of the study are to: * evaluate the efficacy of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD * evaluate the safety and tolerability of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD * evaluate the immunogenicity of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult participants with IBD The total duration for a participant in the double-blind period only is 66 weeks; and for a participant in the open-label extension (OLE) period, up to an additional 268 weeks.
Trial Details
NCT Number NCT05668013
Lead Sponsor Teva Branded Pharmaceutical Products R&D LLC
Collaborators: Sanofi
Conditions Crohn Disease, Colitis, Ulcerative
Enrollment 247 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov