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A Phase 2, Randomized, Placebo-controlled, Parallel Group, Multicenter 12-week Study With a 52-week Extension to Evaluate the Efficacy and Safety of Two Doses of K-808 (Pemafibrate) in Subjects With Primary Biliary Cholangitis With Inadequate Response to Ursodeoxycholic Acid and/or Obeticholic Acid Treatment

Study to Evaluate the Efficacy and Safety of K-808 (pemafibrate) in Participants With Primary Biliary Cholangitis (PBC) With Inadequate Response to Ursodeoxycholic Acid (UDCA) and/or Obeticholic Acid (OCA) Treatment

Tanigawa Ryohei

Kowa Company, Ltd.

4-14, Nihonbashi-honcho 3-chome, Chuo-ku, Tokyo

ctrdinfo@kowa.co.jp

Contact for clinical trial information -

Kowa Company, Ltd.

4-14, Nihonbashi-honcho 3-chome, Chuo-ku, Tokyo

+81-3-3279-7454

ctrdinfo@kowa.co.jp

Recruiting

Jan. 15, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

Male or female participant who has a PBC diagnosis as demonstrated by the presence of >=2 of the following three diagnostic criteria:
-History of ALP above ULN for at least 6 months
-History of positive antimitochondrial antibody (AMA) titer or positive PBC-specific antinuclear antibody (ANA) titer
-Historical liver biopsy consistent with PBC
-Participant has the following qualifying biochemistry value at Screening:
-ALP>=1.5 * ULN
-Participant is >=18 years of age at consent.
-Participant meets all other eligibility criteria outlined in the Clinical Study Protocol.

-Participant meets any one of the following criteria at Screening:
-ALP>10 * ULN
-ALT or AST >5 * ULN
-Hepatitis C treatment within 5 years of Screening, or active hepatitis C as defined by positive hepatitis C antibody with the presence of hepatitis C virus ribonucleic acid; participant with active hepatitis B (HBV) infection (hepatitis B surface antigen [HbsAg] positive) will be excluded. A participant with resolved hepatitis A at least 3 months prior to the Screening Visit can be screened.
-Primary sclerosing cholangitis and secondary sclerosing cholangitis (eg, due to cholangiolithiasis, ischemia, telangiectasia, vasculitis, infectious diseases)
-Alcoholic liver disease
-History of definite autoimmune hepatitis or PBC/autoimmune hepatitis overlap, defined as both of the following: 1) IgG >2 * ULN and/or positive anti-smoothmuscle antibodies and 2) liver histology revealing moderate or severe periportal or periseptal inflammation
-Nonalcoholic steatohepatitis (NASH)
-Gilbert's Syndrome
-Alpha-1-antitrypsin deficiency, cystic fibrosis, Wilson's disease, hemochromatosis based on confirmed historically established diagnosis
-Drug-induced liver injury (DILI) as defined by typical exposure and history
-Known condition that involves bile duct obstruction or cholestasis other than PBC, eg, vascular diseases (eg, Budd-Chiari syndrome, sinusoidal obstruction syndrome, congestive hepatopathy), congenital conditions (ductal plate malformations, Caroli syndrome, congenital liver fibrosis), idiopathic ductopenia
-Hepatocellular carcinoma
-Participant meets any other exclusion criteria outlined in the Clinical Study Protocol.

Both

Primary Biliary Cholangitis

-Placebo for 12 weeks followed by K-808 (DoseA) for 52 weeks: administrated orally once daily
-Placebo for 12 weeks followed by K-808 (DoseB) for 52 weeks: administrated orally once daily
-K-808 (DoseA)12 weeks followed by K-808 (DoseA) for 52 weeks: administrated orally once daily
-K-808 (DoseB) 12 weeks followed by K-808 (DoseB) for 52 weeks: administrated orally once daily

Percent change from baseline in serum ALP after 12 weeks of treatment

+81-957-52-1058

Dec. 12, 2023

No

United States/Canada