deltatrials
Completed PHASE3 INTERVENTIONAL 4-arm NCT02736409

An Extension Study to Evaluate Maintenance of Efficacy and Long-term Treatment Effect of Oral Budesonide Suspension (OBS) in Adults and Adolescents With Eosinophilic Esophagitis (EoE) (ORBIT2)

A Phase 3, Multicenter, Double-blind Extension Study to Evaluate Maintenance of Efficacy of Oral Budesonide Suspension (OBS) and Long-term Treatment Effect of OBS in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) With Eosinophilic Esophagitis (EoE)

Sponsor: Shire

Conditions Eosinophilic Esophagitis (EoE)
Interventions Oral Budesonide Suspension (OBS) Placebo
Updated 19 times since 2017 Last updated: Jan 30, 2025 Started: Apr 1, 2016 Primary completion: Nov 12, 2019 Completion: Nov 12, 2019
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 Eosinophilic Esophagitis (EoE), this trial is completed. The trial is conducted by Shire and has accumulated 19 data snapshots since 2016. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Apr 2017 · 59 days · monthly snapshot~Apr 2017 – ~Jun 2017 · 2 months · monthly snapshot~Jun 2017 – ~Jul 2017 · 30 days · monthly snapshot~Jul 2017 – ~Dec 2017 · 5 months · monthly snapshot~Dec 2017 – ~Feb 2018 · 2 months · monthly snapshot~Feb 2018 – ~Jun 2018 · 4 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Dec 2018 · 5 months · monthly snapshot~Dec 2018 – ~Mar 2019 · 3 months · monthly snapshot~Mar 2019 – ~May 2019 · 2 months · monthly snapshot~May 2019 – ~Feb 2020 · 9 months · monthly snapshot~Feb 2020 – ~Jan 2021 · 11 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Jul 2024 · 41 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Mar 2025 · 6 months · monthly snapshot~Mar 2025 – ~Sep 2025 · 6 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

19 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Mar 2025 — Sep 2025 [monthly]

    Completed PHASE3

  3. Sep 2024 — Mar 2025 [monthly]

    Completed PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  5. Feb 2021 — Jul 2024 [monthly]

    Completed PHASE3

▶ Show 14 earlier versions

  1. Jan 2021 — Feb 2021 [monthly]

    Completed PHASE3

  2. Feb 2020 — Jan 2021 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  3. May 2019 — Feb 2020 [monthly]

    Active Not Recruiting PHASE3

  4. Mar 2019 — May 2019 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  5. Dec 2018 — Mar 2019 [monthly]

    Recruiting PHASE3

  6. Jul 2018 — Dec 2018 [monthly]

    Recruiting PHASE3

  7. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE3

  8. Feb 2018 — Jun 2018 [monthly]

    Recruiting PHASE3

  9. Dec 2017 — Feb 2018 [monthly]

    Recruiting PHASE3

  10. Jul 2017 — Dec 2017 [monthly]

    Recruiting PHASE3

  11. Jun 2017 — Jul 2017 [monthly]

    Recruiting PHASE3

  12. Apr 2017 — Jun 2017 [monthly]

    Recruiting PHASE3

  13. Feb 2017 — Apr 2017 [monthly]

    Recruiting PHASE3

  14. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE3

    First recorded

Apr 2016

Trial started

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

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

Ann Arbor, United States , Asheville, United States , Atlanta, United States , Aurora, United States , Baton Rouge, United States , Birmingham, United States , Boston, United States , Bozeman, United States , Bristol, United States , Chapel Hill, United States and 46 more locations