Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects With Primary… (NCT05104853) | Clinical Trial Compass
CompletedPhase 1/2
Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects With Primary Biliary Cholangitis
United States42 participantsStarted 2022-01-25
Plain-language summary
This study is a Phase 2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-104. The study consists of a 120 day primary study followed by a 20 month long-term safety and durability of response follow-up period.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Subjects who are willing and able to provide Institutional Review Board (IRB) approved written informed consent and privacy language as per national regulations.
✓. Men and non-pregnant women, ages 18-75 years inclusive.
✓. Subjects with a PBC diagnosis as demonstrated by the presence of 2 or more of the following 3 diagnostic factors:
✓. Alkaline phosphatase \> 1.5× ULN for at least 6 months
✓. Positive AMA titer or, if AMA negative or in low titer (\<1:40), positive PBC-specific antibodies (anti-GP210 and/or anti-SP100 and/or antibodies against the major M2 components \[PDC-E2, 2-oxo-glutaric acid dehydrogenase complex\])
✓. Liver biopsy findings consistent with PBC
✓. Subjects who are unresponsive to UDCA and/or OCA after 6 months of treatment at a stable dose as measured by ALP \> 1.5× ULN.
✓. For subjects on any medication used to treat the symptoms of PBC (ex. UDCA, OCA, seladelpar), subjects must be on a stable dose for a minimum of 3 months prior to enrollment and must agree not to change their dose through study Day 60 unless reviewed by the medical monitor and approved by the site investigator.
Exclusion criteria
✕. Subjects with a Class B or Class C Child-Pugh score.
✕. Subjects with concomitant liver diseases including chronic viral hepatitis B or C, autoimmune hepatitis, PSC, alcoholic liver disease, Wilson's disease, hemochromatosis, or Gilbert's syndrome.
What they're measuring
1
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: through Study Completion, an average of 720 Days
✕. Subjects who have previously undergone liver transplantation.
✕. Subjects with decompensated liver disease as defined by the presence or history of any of the following:
✕. Subjects with a history of cerebrovascular accident in the past 12 months.
✕. Subjects with history of myocardial infarction, as defined by any of the following criteria:
✕. Subjects with chronic kidney disease, as defined by estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2 for at least 3 months (per CKD EPI Equation - 2021).
✕. Subjects with uncontrolled diabetes, as defined by HbA1c \> 7%.