deltatrials
Completed PHASE3 INTERVENTIONAL 1-arm NCT00790933

An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease (GEMINI LTS)

A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab (MLN0002) in Subjects With Ulcerative Colitis and Crohn's Disease

Sponsor: Takeda

Interventions Vedolizumab
Updated 11 times since 2017 Last updated: May 2, 2022 Started: May 22, 2009 Primary completion: Oct 31, 2017 Completion: Oct 31, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Crohn's Disease and Ulcerative Colitis, this trial is completed. The trial is conducted by Takeda and has accumulated 11 data snapshots since 2009. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotUnknown Status~Feb 2017 – ~Mar 2017 · 28 days · monthly snapshotActive Not Recruiting~Mar 2017 – ~Mar 2018 · 12 months · monthly snapshotActive Not Recruiting~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshotCompleted~Jun 2018 – ~Apr 2019 · 10 months · monthly snapshotCompleted~Apr 2019 – ~Jan 2021 · 21 months · monthly snapshotCompleted~Jan 2021 – ~Jun 2022 · 17 months · monthly snapshotCompleted~Jun 2022 – ~Jul 2024 · 25 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 10 months · monthly snapshotCompleted

Change History

11 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Jun 2022 — Jul 2024 [monthly]

    Completed PHASE3

  5. Jan 2021 — Jun 2022 [monthly]

    Completed PHASE3

Show 6 earlier versions
  1. Apr 2019 — Jan 2021 [monthly]

    Completed PHASE3

  2. Jun 2018 — Apr 2019 [monthly]

    Completed PHASE3

  3. Mar 2018 — Jun 2018 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

  4. Mar 2017 — Mar 2018 [monthly]

    Active Not Recruiting PHASE3

  5. Feb 2017 — Mar 2017 [monthly]

    Active Not Recruiting PHASE3

    Status: Unknown StatusActive Not Recruiting

  6. Jan 2017 — Feb 2017 [monthly]

    Unknown Status PHASE3

    First recorded

May 2009

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Takeda
Data source: Takeda

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