deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT04620733

RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)

RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

Sponsor: Gilead Sciences

Conditions Primary Biliary Cholangitis
Interventions Placebo Seladelpar 10 mg Seladelpar 5 mg
Updated 26 times since 2020 Last updated: Aug 13, 2024 Started: Apr 21, 2021 Primary completion: Aug 11, 2023 Completion: Aug 11, 2023
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 Primary Biliary Cholangitis, this trial is completed. The trial is conducted by Gilead Sciences and has accumulated 26 data snapshots since 2021. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Apr 2021 · 3 months · 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 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Nov 2021 · 31 days · monthly snapshot~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshot~Dec 2021 – ~Jan 2022 · 31 days · monthly snapshot~Jan 2022 – ~Feb 2022 · 31 days · monthly snapshot~Feb 2022 – ~Mar 2022 · 28 days · monthly snapshot~Mar 2022 – ~Apr 2022 · 31 days · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Dec 2022 · 3 months · monthly snapshot~Dec 2022 – ~Feb 2023 · 2 months · monthly snapshot~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~Oct 2023 · 7 months · monthly snapshot~Oct 2023 – ~Jul 2024 · 9 months · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Oct 2024 · 30 days · monthly snapshot~Oct 2024 – ~Sep 2025 · 11 months · monthly snapshot~Sep 2025 – present · 12 months · monthly snapshot

Change History

26 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Oct 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Sep 2024 — Oct 2024 [monthly]

    Completed PHASE3

  4. Aug 2024 — Sep 2024 [monthly]

    Completed PHASE3

  5. Jul 2024 — Aug 2024 [monthly]

    Completed PHASE3

▶ Show 21 earlier versions

  1. Oct 2023 — Jul 2024 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  2. Mar 2023 — Oct 2023 [monthly]

    Active Not Recruiting PHASE3

  3. Feb 2023 — Mar 2023 [monthly]

    Active Not Recruiting PHASE3

  4. Dec 2022 — Feb 2023 [monthly]

    Active Not Recruiting PHASE3

  5. Sep 2022 — Dec 2022 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  6. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE3

  7. Jun 2022 — Jul 2022 [monthly]

    Recruiting PHASE3

  8. May 2022 — Jun 2022 [monthly]

    Recruiting PHASE3

  9. Apr 2022 — May 2022 [monthly]

    Recruiting PHASE3

  10. Mar 2022 — Apr 2022 [monthly]

    Recruiting PHASE3

  11. Feb 2022 — Mar 2022 [monthly]

    Recruiting PHASE3

  12. Jan 2022 — Feb 2022 [monthly]

    Recruiting PHASE3

  13. Dec 2021 — Jan 2022 [monthly]

    Recruiting PHASE3

  14. Nov 2021 — Dec 2021 [monthly]

    Recruiting PHASE3

  15. Oct 2021 — Nov 2021 [monthly]

    Recruiting PHASE3

  16. Sep 2021 — Oct 2021 [monthly]

    Recruiting PHASE3

  17. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE3

  18. May 2021 — Jun 2021 [monthly]

    Recruiting PHASE3

  19. Apr 2021 — May 2021 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  20. Jan 2021 — Apr 2021 [monthly]

    Not Yet Recruiting PHASE3

  21. Dec 2020 — Jan 2021 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Gilead Sciences
Data source: Gilead Sciences

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

Study Locations

Aalborg, Denmark , Ancona, Italy , Ankara, Turkey (Türkiye) , Athens, Greece , Atlanta, United States , Badalona, Spain , Baltimore, United States , Barcelona, Spain , Birmingham, United Kingdom , Bologna, Italy and 108 more locations