deltatrials
Completed PHASE3 INTERVENTIONAL 3-arm NCT03290781

An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis (FIGARO UC 303)

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303)

Sponsor: Shire

Conditions Ulcerative Colitis
Interventions Ontamalimab Placebo
Updated 43 times since 2017 Last updated: Dec 16, 2021 Started: Apr 4, 2018 Primary completion: Jul 1, 2021 Completion: Jul 1, 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 Ulcerative Colitis and is currently completed. Shire leads this study, which shows 43 recorded versions since 2018 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Oct 2017 – ~Dec 2017 · 2 months · monthly snapshot~Dec 2017 – ~Mar 2018 · 3 months · monthly snapshot~Mar 2018 – ~May 2018 · 2 months · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Aug 2018 · 2 months · monthly snapshot~Aug 2018 – ~Oct 2018 · 2 months · monthly snapshot~Oct 2018 – ~Dec 2018 · 2 months · monthly snapshot~Dec 2018 – ~Jan 2019 · 31 days · monthly snapshot~Jan 2019 – ~Feb 2019 · 31 days · monthly snapshot~Feb 2019 – ~Mar 2019 · 28 days · monthly snapshot~Mar 2019 – ~Apr 2019 · 31 days · monthly snapshot~Apr 2019 – ~Jun 2019 · 2 months · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Sep 2019 · 31 days · monthly snapshot~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Nov 2019 · 31 days · monthly snapshot~Nov 2019 – ~Dec 2019 · 30 days · 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 – ~Jul 2020 · 30 days · monthly snapshot~Jul 2020 – ~Aug 2020 · 31 days · monthly snapshot~Aug 2020 – ~Sep 2020 · 31 days · monthly snapshot~Sep 2020 – ~Oct 2020 · 30 days · 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 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 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 – ~Feb 2022 · 5 months · monthly snapshot~Feb 2022 – ~Jul 2024 · 29 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – ~Nov 2025 · 2 months · monthly snapshot~Nov 2025 – present · 8 months · monthly snapshot

Change History

43 versions recorded

  1. Nov 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2025 — Nov 2025 [monthly]

    Completed PHASE3

  3. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  5. Feb 2022 — Jul 2024 [monthly]

    Completed PHASE3

▶ Show 38 earlier versions

  1. Sep 2021 — Feb 2022 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  2. Jun 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE3

  3. May 2021 — Jun 2021 [monthly]

    Active Not Recruiting PHASE3

  4. Apr 2021 — May 2021 [monthly]

    Active Not Recruiting PHASE3

  5. Mar 2021 — Apr 2021 [monthly]

    Active Not Recruiting PHASE3

  6. Feb 2021 — Mar 2021 [monthly]

    Active Not Recruiting PHASE3

  7. Jan 2021 — Feb 2021 [monthly]

    Active Not Recruiting PHASE3

  8. Dec 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE3

  9. Nov 2020 — Dec 2020 [monthly]

    Active Not Recruiting PHASE3

  10. Oct 2020 — Nov 2020 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  11. Sep 2020 — Oct 2020 [monthly]

    Recruiting PHASE3

  12. Aug 2020 — Sep 2020 [monthly]

    Recruiting PHASE3

  13. Jul 2020 — Aug 2020 [monthly]

    Recruiting PHASE3

  14. Jun 2020 — Jul 2020 [monthly]

    Recruiting PHASE3

  15. May 2020 — Jun 2020 [monthly]

    Recruiting PHASE3

  16. Apr 2020 — May 2020 [monthly]

    Recruiting PHASE3

  17. Mar 2020 — Apr 2020 [monthly]

    Recruiting PHASE3

  18. Feb 2020 — Mar 2020 [monthly]

    Recruiting PHASE3

  19. Jan 2020 — Feb 2020 [monthly]

    Recruiting PHASE3

  20. Dec 2019 — Jan 2020 [monthly]

    Recruiting PHASE3

  21. Nov 2019 — Dec 2019 [monthly]

    Recruiting PHASE3

  22. Oct 2019 — Nov 2019 [monthly]

    Recruiting PHASE3

  23. Sep 2019 — Oct 2019 [monthly]

    Recruiting PHASE3

  24. Aug 2019 — Sep 2019 [monthly]

    Recruiting PHASE3

  25. Jul 2019 — Aug 2019 [monthly]

    Recruiting PHASE3

  26. Jun 2019 — Jul 2019 [monthly]

    Recruiting PHASE3

  27. Apr 2019 — Jun 2019 [monthly]

    Recruiting PHASE3

  28. Mar 2019 — Apr 2019 [monthly]

    Recruiting PHASE3

  29. Feb 2019 — Mar 2019 [monthly]

    Recruiting PHASE3

  30. Jan 2019 — Feb 2019 [monthly]

    Recruiting PHASE3

  31. Dec 2018 — Jan 2019 [monthly]

    Recruiting PHASE3

  32. Oct 2018 — Dec 2018 [monthly]

    Recruiting PHASE3

  33. Aug 2018 — Oct 2018 [monthly]

    Recruiting PHASE3

  34. Jun 2018 — Aug 2018 [monthly]

    Recruiting PHASE3

  35. May 2018 — Jun 2018 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  36. Mar 2018 — May 2018 [monthly]

    Not Yet Recruiting PHASE3

  37. Dec 2017 — Mar 2018 [monthly]

    Not Yet Recruiting PHASE3

  38. Oct 2017 — Dec 2017 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Shire
Data source: Takeda

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

Study Locations

Aachen, Germany , Aberdeen, United Kingdom , Abiko, Japan , Adelaide, Australia , Aguascalientes, Mexico , Alkmaar, Netherlands , Amsterdam, Netherlands , Anaheim, United States , Ann Arbor, United States , Asahikawa, Japan and 307 more locations