deltatrials
Terminated PHASE3 INTERVENTIONAL 3-arm NCT03559517

Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 305) (CARMEN CD 305)

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 305)

Sponsor: Shire

Conditions Crohn's Disease
Interventions Ontamalimab Placebo
Updated 38 times since 2018 Last updated: Apr 2, 2021 Started: Aug 29, 2018 Primary completion: Jul 7, 2020 Completion: Oct 8, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Sponsor decision to discontinue the SHP647 (ontamalimab) clinical trial development program for inflammatory bowel diseases (IBD) early.

Other terminated trials from Shire

See all terminations from Shire

Other Crohn's Disease trials with similar outcome

Browse all Crohn's Disease trials

Listed as NCT03559517, this PHASE3 trial focuses on Crohn's Disease and remains terminated or withdrawn. Sponsored by Shire, it has been updated 38 times since 2018, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jul 2018 – ~Aug 2018 · 31 days · monthly snapshot~Aug 2018 – ~Oct 2018 · 2 months · monthly snapshot~Oct 2018 – ~Nov 2018 · 31 days · monthly snapshot~Nov 2018 – ~Dec 2018 · 30 days · 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 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · 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 – ~Dec 2021 · 7 months · monthly snapshot~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

38 versions recorded

  1. Sep 2025 — Present [monthly]

    Terminated PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Terminated PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  4. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE3

  5. May 2021 — Dec 2021 [monthly]

    Terminated PHASE3

▶ Show 33 earlier versions

  1. Apr 2021 — May 2021 [monthly]

    Terminated PHASE3

  2. Mar 2021 — Apr 2021 [monthly]

    Terminated PHASE3

  3. Feb 2021 — Mar 2021 [monthly]

    Terminated PHASE3

  4. Jan 2021 — Feb 2021 [monthly]

    Terminated PHASE3

  5. Dec 2020 — Jan 2021 [monthly]

    Terminated PHASE3

  6. Nov 2020 — Dec 2020 [monthly]

    Terminated PHASE3

  7. Oct 2020 — Nov 2020 [monthly]

    Terminated PHASE3

    Status: Active Not Recruiting → Terminated

  8. Sep 2020 — Oct 2020 [monthly]

    Active Not Recruiting PHASE3

  9. Aug 2020 — Sep 2020 [monthly]

    Active Not Recruiting PHASE3

  10. Jul 2020 — Aug 2020 [monthly]

    Active Not Recruiting PHASE3

  11. Jun 2020 — Jul 2020 [monthly]

    Active Not Recruiting PHASE3

  12. May 2020 — Jun 2020 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  13. Apr 2020 — May 2020 [monthly]

    Recruiting PHASE3

  14. Mar 2020 — Apr 2020 [monthly]

    Recruiting PHASE3

  15. Feb 2020 — Mar 2020 [monthly]

    Recruiting PHASE3

  16. Jan 2020 — Feb 2020 [monthly]

    Recruiting PHASE3

  17. Dec 2019 — Jan 2020 [monthly]

    Recruiting PHASE3

  18. Nov 2019 — Dec 2019 [monthly]

    Recruiting PHASE3

  19. Oct 2019 — Nov 2019 [monthly]

    Recruiting PHASE3

  20. Sep 2019 — Oct 2019 [monthly]

    Recruiting PHASE3

  21. Aug 2019 — Sep 2019 [monthly]

    Recruiting PHASE3

  22. Jul 2019 — Aug 2019 [monthly]

    Recruiting PHASE3

  23. Jun 2019 — Jul 2019 [monthly]

    Recruiting PHASE3

  24. May 2019 — Jun 2019 [monthly]

    Recruiting PHASE3

  25. Apr 2019 — May 2019 [monthly]

    Recruiting PHASE3

  26. Mar 2019 — Apr 2019 [monthly]

    Recruiting PHASE3

  27. Feb 2019 — Mar 2019 [monthly]

    Recruiting PHASE3

  28. Jan 2019 — Feb 2019 [monthly]

    Recruiting PHASE3

  29. Dec 2018 — Jan 2019 [monthly]

    Recruiting PHASE3

  30. Nov 2018 — Dec 2018 [monthly]

    Recruiting PHASE3

  31. Oct 2018 — Nov 2018 [monthly]

    Recruiting PHASE3

  32. Aug 2018 — Oct 2018 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  33. Jul 2018 — Aug 2018 [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 , Adelaide, Australia , Amsterdam, Netherlands , Baytown, United States , Belgrade, Serbia , Berlin, Germany , Berlin-Zehlendorf, Germany , Bialystok, Poland , Biberach an der Riss, Germany and 102 more locations