deltatrials
Completed PHASE3 INTERVENTIONAL 10-arm NCT02407236

A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UNIFI)

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

Sponsor: Janssen Research & Development, LLC

Conditions Colitis, Ulcerative Inflammatory Bowel Diseases
Interventions Placebo IV Placebo SC Ustekinumab IV Ustekinumab SC
Updated 46 times since 2017 Last updated: Apr 25, 2025 Started: Jul 10, 2015 Primary completion: Aug 10, 2018 Completion: Nov 30, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Colitis, Ulcerative and Inflammatory Bowel Diseases and is currently completed. Janssen Research & Development, LLC leads this study, which shows 46 recorded versions since 2015 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Apr 2017 · 59 days · monthly snapshot~Apr 2017 – ~May 2017 · 30 days · monthly snapshot~May 2017 – ~Oct 2017 · 5 months · monthly snapshot~Oct 2017 – ~Dec 2017 · 2 months · monthly snapshot~Dec 2017 – ~Mar 2018 · 3 months · monthly snapshot~Mar 2018 – ~Apr 2018 · 31 days · monthly snapshot~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshot~Jun 2018 – ~Sep 2018 · 3 months · monthly snapshot~Sep 2018 – ~Nov 2018 · 2 months · monthly snapshot~Nov 2018 – ~Dec 2018 · 30 days · monthly snapshot~Dec 2018 – ~Apr 2019 · 4 months · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Sep 2019 · 2 months · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Dec 2019 · 2 months · monthly snapshot~Dec 2019 – ~Jan 2020 · 31 days · monthly snapshot~Jan 2020 – ~Feb 2020 · 31 days · monthly snapshot~Feb 2020 – ~Mar 2020 · 29 days · monthly snapshot~Mar 2020 – ~Apr 2020 · 31 days · monthly snapshot~Apr 2020 – ~May 2020 · 30 days · monthly snapshot~May 2020 – ~Jun 2020 · 31 days · monthly snapshot~Jun 2020 – ~Aug 2020 · 2 months · monthly snapshot~Aug 2020 – ~Oct 2020 · 2 months · monthly snapshot~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshot~Nov 2020 – ~Dec 2020 · 30 days · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Apr 2021 · 59 days · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Jun 2021 · 31 days · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Nov 2021 · 31 days · monthly snapshot~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshot~Dec 2021 – ~Mar 2022 · 3 months · monthly snapshot~Mar 2022 – ~Sep 2022 · 6 months · monthly snapshot~Sep 2022 – ~Feb 2023 · 5 months · monthly snapshot~Feb 2023 – ~Jul 2024 · 17 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Mar 2025 · 6 months · monthly snapshot~Mar 2025 – ~May 2025 · 2 months · monthly snapshot~May 2025 – ~Sep 2025 · 4 months · monthly snapshot~Sep 2025 – present · 12 months · monthly snapshot

Change History

46 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. May 2025 — Sep 2025 [monthly]

    Completed PHASE3

  3. Mar 2025 — May 2025 [monthly]

    Completed PHASE3

  4. Sep 2024 — Mar 2025 [monthly]

    Completed PHASE3

  5. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

▶ Show 41 earlier versions

  1. Feb 2023 — Jul 2024 [monthly]

    Completed PHASE3

  2. Sep 2022 — Feb 2023 [monthly]

    Completed PHASE3

  3. Mar 2022 — Sep 2022 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  4. Dec 2021 — Mar 2022 [monthly]

    Active Not Recruiting PHASE3

  5. Nov 2021 — Dec 2021 [monthly]

    Active Not Recruiting PHASE3

  6. Oct 2021 — Nov 2021 [monthly]

    Active Not Recruiting PHASE3

  7. Sep 2021 — Oct 2021 [monthly]

    Active Not Recruiting PHASE3

  8. Jun 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE3

  9. May 2021 — Jun 2021 [monthly]

    Active Not Recruiting PHASE3

  10. Apr 2021 — May 2021 [monthly]

    Active Not Recruiting PHASE3

  11. Feb 2021 — Apr 2021 [monthly]

    Active Not Recruiting PHASE3

  12. Jan 2021 — Feb 2021 [monthly]

    Active Not Recruiting PHASE3

  13. Dec 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE3

  14. Nov 2020 — Dec 2020 [monthly]

    Active Not Recruiting PHASE3

  15. Oct 2020 — Nov 2020 [monthly]

    Active Not Recruiting PHASE3

  16. Aug 2020 — Oct 2020 [monthly]

    Active Not Recruiting PHASE3

  17. Jun 2020 — Aug 2020 [monthly]

    Active Not Recruiting PHASE3

  18. May 2020 — Jun 2020 [monthly]

    Active Not Recruiting PHASE3

  19. Apr 2020 — May 2020 [monthly]

    Active Not Recruiting PHASE3

  20. Mar 2020 — Apr 2020 [monthly]

    Active Not Recruiting PHASE3

  21. Feb 2020 — Mar 2020 [monthly]

    Active Not Recruiting PHASE3

  22. Jan 2020 — Feb 2020 [monthly]

    Active Not Recruiting PHASE3

  23. Dec 2019 — Jan 2020 [monthly]

    Active Not Recruiting PHASE3

  24. Oct 2019 — Dec 2019 [monthly]

    Active Not Recruiting PHASE3

  25. Sep 2019 — Oct 2019 [monthly]

    Active Not Recruiting PHASE3

  26. Jul 2019 — Sep 2019 [monthly]

    Active Not Recruiting PHASE3

  27. Jun 2019 — Jul 2019 [monthly]

    Active Not Recruiting PHASE3

  28. May 2019 — Jun 2019 [monthly]

    Active Not Recruiting PHASE3

  29. Apr 2019 — May 2019 [monthly]

    Active Not Recruiting PHASE3

  30. Dec 2018 — Apr 2019 [monthly]

    Active Not Recruiting PHASE3

  31. Nov 2018 — Dec 2018 [monthly]

    Active Not Recruiting PHASE3

  32. Sep 2018 — Nov 2018 [monthly]

    Active Not Recruiting PHASE3

  33. Jun 2018 — Sep 2018 [monthly]

    Active Not Recruiting PHASE3

  34. Apr 2018 — Jun 2018 [monthly]

    Active Not Recruiting PHASE3

  35. Mar 2018 — Apr 2018 [monthly]

    Active Not Recruiting PHASE3

  36. Dec 2017 — Mar 2018 [monthly]

    Active Not Recruiting PHASE3

  37. Oct 2017 — Dec 2017 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  38. May 2017 — Oct 2017 [monthly]

    Recruiting PHASE3

  39. Apr 2017 — May 2017 [monthly]

    Recruiting PHASE3

  40. Feb 2017 — Apr 2017 [monthly]

    Recruiting PHASE3

  41. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE3

    First recorded

Jul 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Janssen Research & Development, LLC
Data source: Janssen Research & Development, LLC

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aarhus, Denmark , Ageo-shi, Japan , Amiens, France , Amsterdam, Netherlands , Ann Arbor, United States , Antwerp, Belgium , Asahikawa, Japan , Atlanta, United States , Auckland, New Zealand , Balatonfüred, Hungary and 236 more locations