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FXR Agonist
Setanaxib for Primary Biliary Cholangitis (TRANSFORM Trial)
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
Awards & highlights
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening (day -28) and week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening (day -28) and week 24
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 moreTrial 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
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My bilirubin levels are high, but my albumin levels are normal.I have had a liver transplant, am waiting for one, or have severe liver disease.I use birth control that contains only progestogen.I have never used setanaxib or been in a setanaxib study before.I have had serious liver problems, including bleeding, confusion due to liver disease, severe infection in my abdomen, fluid buildup needing treatment, or have been listed for a liver transplant.I have cirrhosis with complications, such as liver cancer.I have been on OCA, fenofibrate, or bezafibrate for 6+ months with a stable dose for over 3 months.I haven't needed antibiotics for an infection in the last 2 weeks.I do not have conditions like Paget's disease that affect my ALP levels.I haven't taken any prohibited medications in the last 3 months.My kidney function is reduced, with an eGFR below 60.I have had cancer within the last 5 years, but it may still be okay depending on the type.I am 18 years old or older.I stopped taking bezafibrate or fenofibrate more than 3 months ago.I have antibodies indicating primary biliary cholangitis (PBC).My fallopian tubes are surgically blocked.I agree to use a condom and ensure my partner uses birth control during and for 90 days after the trial.I am abstaining from sexual activity for the study's duration.I agree not to donate sperm/eggs for 90 days after my last treatment dose.My INR is above 1.2, but I am on blood thinners.I do not have other liver diseases like hepatitis C, unless cured for 6 months, active hepatitis B, NASH, alcoholic liver disease, autoimmune hepatitis, or others.I have had treatment for a non-spreading skin cancer.I am using a combined hormonal birth control method.I have been on a stable dose of UDCA for over 3 months or am intolerant to UDCA.I am a woman who can have children and have tested negative for pregnancy.I am using or will use effective birth control before and after the trial.My drug test was positive, but it's due to my prescribed medication.My cervical cancer in situ has been properly treated.I have a history of bone marrow disorders or severe anemia.My heart condition is not stable.I stopped taking OCA over 3 months ago due to intolerance.I have had surgery or a condition that could affect how my body absorbs medication.
Research Study Groups:
This trial has the following groups:- Group 1: Setanaxib 1200 mg/day
- Group 2: Setanaxib 1600 mg/day
- Group 3: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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