Completed PHASE2 INTERVENTIONAL 3-arm NCT05014672

A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness (TRANSFORM)

TRANSFORM: A 24-week, Randomized, Placebo-controlled, Double-blind, Phase 2b Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness

Sponsor: Calliditas Therapeutics Suisse SA

Conditions Liver Stiffness Primary Biliary Cholangitis

Interventions Placebo Setanaxib

Updated 24 times since 2021 Last updated: Apr 7, 2025 Started: Feb 14, 2022 Primary completion: May 31, 2024 Completion: Jul 2, 2024

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Liver Stiffness and Primary Biliary Cholangitis, this trial is completed. The trial is conducted by Calliditas Therapeutics Suisse SA and has accumulated 24 data snapshots since 2022. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

24 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE2
May 2025 — Sep 2025 [monthly]

Completed PHASE2
Sep 2024 — May 2025 [monthly]

Completed PHASE2
Aug 2024 — Sep 2024 [monthly]

Completed PHASE2

Status: Active Not Recruiting → Completed
Jul 2024 — Aug 2024 [monthly]

Active Not Recruiting PHASE2

▶ Show 19 earlier versions

Jun 2024 — Jul 2024 [monthly]

Active Not Recruiting PHASE2
May 2024 — Jun 2024 [monthly]

Active Not Recruiting PHASE2
Apr 2024 — May 2024 [monthly]

Active Not Recruiting PHASE2

Status: Recruiting → Active Not Recruiting · Phase: PHASE2_PHASE3 → PHASE2
Nov 2023 — Apr 2024 [monthly]

Recruiting PHASE2_PHASE3
Sep 2023 — Nov 2023 [monthly]

Recruiting PHASE2_PHASE3
Jul 2023 — Sep 2023 [monthly]

Recruiting PHASE2_PHASE3
Jun 2023 — Jul 2023 [monthly]

Recruiting PHASE2_PHASE3
Apr 2023 — Jun 2023 [monthly]

Recruiting PHASE2_PHASE3
Mar 2023 — Apr 2023 [monthly]

Recruiting PHASE2_PHASE3
Feb 2023 — Mar 2023 [monthly]

Recruiting PHASE2_PHASE3
Jan 2023 — Feb 2023 [monthly]

Recruiting PHASE2_PHASE3
Nov 2022 — Jan 2023 [monthly]

Recruiting PHASE2_PHASE3
Sep 2022 — Nov 2022 [monthly]

Recruiting PHASE2_PHASE3
Jul 2022 — Sep 2022 [monthly]

Recruiting PHASE2_PHASE3
May 2022 — Jul 2022 [monthly]

Recruiting PHASE2_PHASE3
Dec 2021 — May 2022 [monthly]

Recruiting PHASE2_PHASE3

Status: Not Yet Recruiting → Recruiting
Nov 2021 — Dec 2021 [monthly]

Not Yet Recruiting PHASE2_PHASE3
Oct 2021 — Nov 2021 [monthly]

Not Yet Recruiting PHASE2_PHASE3
Sep 2021 — Oct 2021 [monthly]

Not Yet Recruiting PHASE2_PHASE3

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Calliditas Therapeutics Suisse SA

Data source: Calliditas Therapeutics AB

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

Study Locations

Alicante, Spain , Almería, Spain , Amiens, France , Ancona, Italy , Angers, France , Ann Arbor, United States , Badalona, Spain , Barcelona, Spain , Bedford Park, Australia , Beersheba, Israel and 108 more locations