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Safety and Tolerability of A3907 in Primary Sclerosing Cholangitis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Safety and Tolerability of A3907 in Primary Sclerosing Cholangitis

An Open Label, Phase 2 Study to Evaluate the Effect of A3907 on Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Adults With Primary Sclerosing Cholangitis (PSC)

NCT05642468•Albireo, an Ipsen Company

View on ClinicalTrials.gov

Summary

This study will test a drug called A3907 to see how safe and tolerated it is for treating people with Primary Sclerosing Cholangitis (PSC).

Detailed Description

This study will test a drug called A3907 to see how safe and tolerated it is for treating people with Primary Sclerosing Cholangitis (PSC). Detailed Description: The primary goal of this study in participants with PSC with and without a Clinically Relevant Stricture (CRS) who are treated with A3907 is to assess the safety and tolerability of A3907 following repeat doses. Secondary goals include evaluation of the pharmacokinetic properties of A3907 (the study of how the body interacts with A3907 for the entire duration of exposure) and changes in safety parameters via laboratory testing such as liver enzymes, bile acid levels and markers of bile acid synthesis

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Adults between 18 and 75 years of age (inclusive)
•2. Clinical diagnosis of large-duct PSC as evidenced by chronic cholestasis with evidence of more than 6 months duration with either a consistent magnetic resonance cholangiopancreatography (MRCP) or endoscopic retrograde cholangiopancreatography (ERCP) showing sclerosing cholangitis. and historical evidence of elevated alkaline phosphatase (ALP).
•3. Willing to sign informed consent.
•4. Women of childbearing potential (WOCBP) and males with female partners of childbearing potential must agree to use contraception. Women of nonchildbearing potential (WONCBP) have a confirmatory follicle-stimulating hormone \[FSH\] level ≥ 40 mIU/mL
•5. Alkaline phosphatase Phosphatase (ALP) value \> 1.5 × upper limit of normal (ULN) but ≤ 10 × ULNULN at Visit 1 (Screening Period). Before starting 12 weeks treatment variability of \< 30% between ALP values at Visit 1 and Visit 2 must be confirmed. If variability is \> 30 % a third ALP value may be obtained. If the third ALP value meets \>1.5 × ULN but ≤ 10 × ULN the patient can start the 12-week treatment period.
•6. Arms 1-3 Only: Total bilirubin \< 1.5 × ULN (unless due to Gilberts Syndrome or hemolysis) and normal direct bilirubin.
•7. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 × ULN
•8. Serum bile acid level \> ULN
•9. Arms 1 - 3 Only: An MRCP or equivalent imaging modality performed within 6 months before the Screening Period that is consistent with PSC without a clinically relevant stricture.
•10. Arm 4 Only: An MRCP or equivalent imaging modality performed within 6 months before the Screening. Period that is consistent with PSC with a clinically relevant stricture, or clinically relevant bile duct obstruction (see Inclusion # 12 for additional information).
+5 more criteria

Exclusion Criteria

•1. Presence of documented secondary sclerosing cholangitis, small duct PSC, known or suspected overlapping clinical and histologic diagnosis of autoimmune hepatitis or other causes of chronic liver disease
•2. Arm 1-3 Only: Biliary intervention within 3 months prior to study enrollment or planned.
•3. Arm 4 Only: Planned Biliary intervention between the Screening Period and baseline.
•4. Presence of alternative causes of chronic liver disease, including alcohol-associated liver disease, nonalcoholic steatohepatitis, primary biliary cholangitis, autoimmune hepatitis, or active hepatitis B or C.
•5. IBD with uncontrolled moderate to severe activity and/or on treatment with any immunosuppressive, immunomodulator, or biologic agent for treatment of IBD (i.e. azathioprine, 6 mercaptopurine, tacrolimus, methotrexate, infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib, ozanimod). Treatment with corticosteroids (including budesonide, budesonide MMX and beclomethasone) in the previous 4 weeks.
•6. History of human immunodeficiency virus infection or any other known relevant infection (e.g. tuberculosis).
•7. History of ileectomy, colostomy or colectomy.
•8. History of malignancy, including hepatocellular carcinoma and cholangiocarcinoma within the past 10 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated.
•9. Alpha-fetoprotein (AFP) \> 20 ng/mL (at the Screening Visit) with 4-phase liver CT or MRI suggesting presence of liver cancer.
•10. History of transplants, including liver transplantation, or currently on active transplantation list (Arms 1 3). Arm 4 may be on an active liver transplantation list.
+24 more criteria

Locations (8)

Hopital Saint Antoine

Paris, France

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

ASST di Monza - Azienda Ospedaliera San Gerardo

Monza, Italy

Azienda Ospedale Università Padova

Padua, Italy

Centrum Medyczne INTER-MED

Częstochowa, Poland

Uniwersyteckie Centrum Kliniczne im. Prof. Kornela Gibinskiego

Katowice, Poland

ID Clinic Arkadiusz Pisula

Mysłowice, Poland

Hospital Clinic de Barcelona

Barcelona, Spain

Key Dates

Start Date

January 9, 2023

Primary Completion Date

July 10, 2025

Completion Date

July 10, 2025

Last Updated

July 30, 2025

Enrollment

ACTUAL participants

Conditions

Primary Sclerosing Cholangitis

Interventions

Ritivixibat

DRUG

Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients

NCT04753996

Primary Sclerosing CholangitisPSC+1 more

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RECRUITING

A-LiNK: Improving Outcomes in Autoimmune Liver Disease

NCT05750498

Autoimmune HepatitisPrimary Sclerosing Cholangitis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Tolerability of A3907 in Primary Sclerosing Cholangitis

Inclusion Criteria

Exclusion Criteria

Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients

A-LiNK: Improving Outcomes in Autoimmune Liver Disease

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