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FXR Agonist

Setanaxib for Primary Biliary Cholangitis (TRANSFORM Trial)

Manhasset, NY
Phase 2
Waitlist Available
Research Sponsored by Genkyotex Suisse SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening (day -28) and week 24

Summary

This trial is testing setanaxib, a drug that may help lower liver enzyme levels, in people with a liver condition called PBC who don't respond well to the usual treatment. The goal is to see if setanaxib can improve their liver function by reducing enzyme levels. Setanaxib is being tested for its potential to improve liver function in PBC patients who do not respond well to standard treatments.

Who is the study for?
Adults diagnosed with primary biliary cholangitis (PBC) who have an inadequate response or intolerance to ursodeoxycholic acid, and a liver stiffness of ≥8.8 kPa. Participants must not be pregnant, should use effective contraception, and cannot have certain conditions like high bilirubin levels, significant kidney dysfunction, other liver diseases, recent infections requiring antibiotics, or any history of hypersensitivity to setanaxib.
What is being tested?
The trial is testing the effectiveness of setanaxib on patients with PBC compared to a placebo. The main goal is to see if there's an improvement in liver function after 52 weeks for those taking setanaxib who previously didn't respond well or couldn't tolerate standard treatment.
What are the potential side effects?
While specific side effects for setanaxib are not listed here, common side effects may include gastrointestinal symptoms such as diarrhea and abdominal pain (as noted in UDCA intolerance), potential allergic reactions due to drug sensitivity, and general medication-related risks like fatigue or headaches.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening (day -28) and week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening (day -28) and week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change from Baseline in Fatigue
Change from Baseline in PGIC Pruritus
Change from Baseline in PGIS Pruritus
+7 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Setanaxib 1600 mg/dayExperimental Treatment1 Intervention
Participants will be administered setanaxib at a dose of 1600 mg/day for the 24-week double-blind treatment period.
Group II: Setanaxib 1200 mg/dayExperimental Treatment1 Intervention
Participants will be administered setanaxib at a dose of 1200 mg/day for the 24-week double-blind treatment period.
Group III: PlaceboPlacebo Group1 Intervention
Participants will be administered a placebo for the 24-week double-blind treatment period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Setanaxib
2022
Completed Phase 2
~140

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Primary Biliary Cirrhosis (PBC) include ursodeoxycholic acid (UDCA) and obeticholic acid (OCA). UDCA works by reducing the concentration of toxic bile acids, thereby decreasing liver inflammation and damage. OCA, a farnesoid X receptor agonist, helps to reduce bile acid synthesis and increase bile flow. These mechanisms are crucial for PBC patients as they help to slow disease progression and alleviate symptoms. Setanaxib, a selective NADPH oxidase inhibitor, is being studied for its potential to reduce oxidative stress and inflammation in PBC, offering a novel approach to managing the disease.

Find a Location

Closest Location:Northwell Health· Manhasset, NY

Who is running the clinical trial?

Genkyotex Suisse SALead Sponsor
1 Previous Clinical Trials
55 Total Patients Enrolled
Calliditas Therapeutics Suisse SALead Sponsor
1 Previous Clinical Trials
55 Total Patients Enrolled

Media Library

Setanaxib (FXR Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05014672 — Phase 2
Primary Biliary Cholangitis Research Study Groups: Setanaxib 1200 mg/day, Setanaxib 1600 mg/day, Placebo
Primary Biliary Cholangitis Clinical Trial 2023: Setanaxib Highlights & Side Effects. Trial Name: NCT05014672 — Phase 2
Setanaxib (FXR Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05014672 — Phase 2
~20 spots leftby Dec 2025