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Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangitis

Primary Purpose

Primary Biliary Cholangitis

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

ASC42 5 mg

ASC42 10 mg

ASC42 15 mg

Placebo

About this trial

This is an interventional treatment trial for Primary Biliary Cholangitis focused on measuring ASC42, primary biliary cholangitis, PBC

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 and ≤75 years old at screening.
Definite or probable PBC diagnosis, as demonstrated by the presence of ≥ 2 of the following 3 diagnostic factors:
1. Biochemical evidence of cholestasis based on ALP elevation.
2. Presence of AMA, or other PBC-specific autoantibodies, including sp100 or gp210, if AMA is negative.
3. Liver biopsy consistent with PBC.
Screening ALP ≥ 1.67× ULN
Taking UDCA for at least 6 months (stable dose for ≥ 3 months) prior to Day 0, or unable to tolerate UDCA (no UDCA for ≥ 3 months) prior to Day 0.

Exclusion Criteria:

ALT or AST > 5× ULN; ALP >10× ULN
History or presence of other concomitant liver diseases
Child-Pugh grade B or C

Sites / Locations

Beijing Friendship Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

ASC42 tablets of 5mg

ASC42 tablets of 10mg

ASC42 tablets of 15mg

Placebo

Arm Description

ASC42 tablets 5mg for 12 weeks

ASC42 tablets 10mg for 12 weeks

ASC42 tablets 15mg for 12 weeks

Placebo for 12 weeks

Outcomes

Primary Outcome Measures

Percentage changes of alkaline phosphatase (ALP) compared with baseline.

Secondary Outcome Measures

Percentage changes and absolute changes of alkaline phosphatase (ALP) compared with baseline.

Percentage changes and absolute changes of serum γ-glutamyltransferase (GGT), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) compared with baseline.

Incidence of treatment-emergent adverse events, serious adverse events and adverse events of special interests.

Full Information

NCT ID

NCT05190523

First Posted

December 13, 2021

Last Updated

February 21, 2023

Sponsor

Gannex Pharma Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05190523

Brief Title

Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangitis

Official Title

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangitis

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 6, 2022 (Actual)

Primary Completion Date

November 6, 2023 (Anticipated)

Study Completion Date

November 6, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gannex Pharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This study is a phase II, multicenter, randomized, double-blind, placebo-controlled, seamless adaptive design clinical study, aiming to evaluate the safety and effectiveness of three doses of ASC42 matched placebo in subjects with primary biliary cholangitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Biliary Cholangitis

Keywords

ASC42, primary biliary cholangitis, PBC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ASC42 tablets of 5mg

Arm Type

Experimental

Arm Description

ASC42 tablets 5mg for 12 weeks

Arm Title

ASC42 tablets of 10mg

Arm Type

Experimental

Arm Description

ASC42 tablets 10mg for 12 weeks

Arm Title

ASC42 tablets of 15mg

Arm Type

Experimental

Arm Description

ASC42 tablets 15mg for 12 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo for 12 weeks

Intervention Type

Drug

Intervention Name(s)

ASC42 5 mg

Intervention Description

5 mg of ASC42 tablets orally once daily for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

ASC42 10 mg

Intervention Description

2 x 5 mg of ASC42 tablets orally once daily for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

ASC42 15 mg

Intervention Description

15 mg of ASC42 tablets orally once daily for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo tablets orally once daily for 12 weeks.

Primary Outcome Measure Information:

Title

Percentage changes of alkaline phosphatase (ALP) compared with baseline.

Time Frame

Day85

Secondary Outcome Measure Information:

Title

Percentage changes and absolute changes of alkaline phosphatase (ALP) compared with baseline.

Time Frame

Day15\29\57\85

Title

Percentage changes and absolute changes of serum γ-glutamyltransferase (GGT), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) compared with baseline.

Time Frame

Day15\29\57\85

Title

Incidence of treatment-emergent adverse events, serious adverse events and adverse events of special interests.

Time Frame

Day15\29\57\85

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 and ≤75 years old at screening. Definite or probable PBC diagnosis, as demonstrated by the presence of ≥ 2 of the following 3 diagnostic factors: Biochemical evidence of cholestasis based on ALP elevation. Presence of AMA, or other PBC-specific autoantibodies, including sp100 or gp210, if AMA is negative. Liver biopsy consistent with PBC. Screening ALP ≥ 1.67× ULN Taking UDCA for at least 6 months (stable dose for ≥ 3 months) prior to Day 0, or unable to tolerate UDCA (no UDCA for ≥ 3 months) prior to Day 0. Exclusion Criteria: ALT or AST > 5× ULN; ALP >10× ULN History or presence of other concomitant liver diseases Child-Pugh grade B or C

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jidong Jia, Medical Doctor

Phone

+8613501378269

jiamd@263.net

First Name & Middle Initial & Last Name or Official Title & Degree

Hong You, Doctor

Phone

+8613521130181

youhong30@sina.com

Facility Information:

Facility Name

Beijing Friendship Hospital, Capital Medical University

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100071

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jidong Jia

Phone

+8613501378269

jiamd@263.net

First Name & Middle Initial & Last Name & Degree

Jidong Jia, Doctor

12. IPD Sharing Statement

Learn more about this trial

Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangitis

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