deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT01969838

Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis (Simplify 1)

A Phase 3, Randomized, Double-blind Active-controlled Study Evaluating Momelotinib vs. Ruxolitinib in Subjects With Primary Myelofibrosis (PMF) or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)

Sponsor: Sierra Oncology LLC - a GSK company

Conditions Post-Essential Thrombocythemia Myelofibrosis Post-Polycythemia Vera Myelofibrosis Primary Myelofibrosis
Interventions Momelotinib Placebo to match momelotinib Placebo to match ruxolitinib Ruxolitinib
Updated 15 times since 2017 Last updated: May 10, 2023 Started: Dec 6, 2013 Primary completion: Sep 12, 2016 Completion: May 2, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01969838, this PHASE3 trial focuses on Post-Essential Thrombocythemia Myelofibrosis and Post-Polycythemia Vera Myelofibrosis and remains completed. Sponsored by Sierra Oncology LLC - a GSK company, it has been updated 15 times since 2013, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Apr 2017 · 59 days · monthly snapshot~Apr 2017 – ~Jul 2017 · 3 months · monthly snapshot~Jul 2017 – ~Jun 2018 · 11 months · monthly snapshot~Jun 2018 – ~Sep 2018 · 3 months · monthly snapshot~Sep 2018 – ~Mar 2019 · 6 months · monthly snapshot~Mar 2019 – ~May 2020 · 14 months · monthly snapshot~May 2020 – ~Jan 2021 · 8 months · monthly snapshot~Jan 2021 – ~Apr 2022 · 15 months · monthly snapshot~Apr 2022 – ~Jun 2023 · 14 months · monthly snapshot~Jun 2023 – ~Jul 2023 · 30 days · monthly snapshot~Jul 2023 – ~Jul 2024 · 12 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

15 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. Jul 2023 — Jul 2024 [monthly]

    Completed PHASE3

  5. Jun 2023 — Jul 2023 [monthly]

    Completed PHASE3

▶ Show 10 earlier versions

  1. Apr 2022 — Jun 2023 [monthly]

    Completed PHASE3

  2. Jan 2021 — Apr 2022 [monthly]

    Completed PHASE3

  3. May 2020 — Jan 2021 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  4. Mar 2019 — May 2020 [monthly]

    Active Not Recruiting PHASE3

  5. Sep 2018 — Mar 2019 [monthly]

    Active Not Recruiting PHASE3

  6. Jun 2018 — Sep 2018 [monthly]

    Active Not Recruiting PHASE3

  7. Jul 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE3

  8. Apr 2017 — Jul 2017 [monthly]

    Active Not Recruiting PHASE3

  9. Feb 2017 — Apr 2017 [monthly]

    Active Not Recruiting PHASE3

  10. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE3

    First recorded

Dec 2013

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Sierra Oncology LLC - a GSK company
Data source: Sierra Oncology LLC - a GSK company

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

Study Locations

Aalborg, Denmark , Adelaide, Australia , Afula, Israel , Antwerp, Belgium , Arad, Romania , Ashkelon, Israel , Atlanta, United States , Badalona, Spain , Baltimore, United States , Barcelona, Spain and 104 more locations