Safety and Tolerability of A3907 in Primary Sclerosing Cholangitis (NCT05642468) | Clinical Trial Compass
TerminatedPhase 2
Safety and Tolerability of A3907 in Primary Sclerosing Cholangitis
Stopped: Due to Sponsor decision, not due to any safety concerns
France, Italy, Poland18 participantsStarted 2023-01-09
Plain-language 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).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Adults between 18 and 75 years of age (inclusive)
✓. 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).
✓. Willing to sign informed consent.
✓. 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
✓. 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.
✓. Arms 1-3 Only: Total bilirubin \< 1.5 × ULN (unless due to Gilberts Syndrome or hemolysis) and normal direct bilirubin.
✕. 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
What they're measuring
1
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Timeframe: From first dose of study drug (Day 1) up to 14 days post last dose, approximately 112 days
✕. Arm 1-3 Only: Biliary intervention within 3 months prior to study enrollment or planned.
✕. Arm 4 Only: Planned Biliary intervention between the Screening Period and baseline.
✕. 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.
✕. 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.
✕. History of human immunodeficiency virus infection or any other known relevant infection (e.g. tuberculosis).
✕. History of ileectomy, colostomy or colectomy.
✕. 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.