Primary Biliary CholangitisPhase 2NCT05190523
Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangitis
A Phase 2 study testing ASC42 5 mg, ASC42 10 mg and ASC42 15 mg in people with Primary Biliary Cholangitis, run by Gannex Pharma Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Biliary Cholangitis
- What is being tested?
- ASC42 5 mg, ASC42 10 mg and ASC42 15 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 6 Apr 2022to 13 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- ALT or AST > 5× ULN; ALP >10× ULN
- History or presence of other concomitant liver diseases
- Child-Pugh grade B or C
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100071
About this study
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
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.
- Conditions
- Primary Biliary Cholangitis
- Being tested
- ASC42 5 mg, ASC42 10 mg, ASC42 15 mg, Placebo
- Keywords
- ASC42, primary biliary cholangitis, PBC
- Medical subject headings
- Liver Cirrhosis, Biliary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASC42 5 mgDrug
5 mg of ASC42 tablets orally once daily for 12 weeks.
ASC42 10 mgDrug
2 x 5 mg of ASC42 tablets orally once daily for 12 weeks.
ASC42 15 mgDrug
15 mg of ASC42 tablets orally once daily for 12 weeks.
PlaceboDrug
Placebo tablets orally once daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| ASC42 tablets of 5mg | Experimental | ASC42 tablets 5mg for 12 weeks Receives: Drug: ASC42 5 mg |
| ASC42 tablets of 10mg | Experimental | ASC42 tablets 10mg for 12 weeks Receives: Drug: ASC42 10 mg |
| ASC42 tablets of 15mg | Experimental | ASC42 tablets 15mg for 12 weeks Receives: Drug: ASC42 15 mg |
| Placebo | Placebo comparator | Placebo for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage changes of alkaline phosphatase (ALP) compared with baseline.
Measured: Day85
Secondary outcomes (3)
Percentage changes and absolute changes of alkaline phosphatase (ALP) compared with baseline.
Measured: Day15\29\57\85
Percentage changes and absolute changes of serum γ-glutamyltransferase (GGT), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) compared with baseline.
Measured: Day15\29\57\85
Incidence of treatment-emergent adverse events, serious adverse events and adverse events of special interests.
Measured: Day15\29\57\85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start6 Apr 2022
- Primary completion13 Mar 2024
- Study completion13 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Biliary CholangitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gannex Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190523
- Sponsor's protocol ID
- ASC42-202
- Status last verified
- Sep 2024
- First submitted
- 13 Dec 2021
- Last updated
- 27 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05190523
- Acronym / sponsor ID
- ASC42-202
- Conditions
- Primary Biliary Cholangitis
- Keywords
- ASC42, primary biliary cholangitis, PBC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Gannex Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 13 Mar 2024 (actual)
- First posted
- 13 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ASC42 tablets of 5mg | Experimental | Drug: ASC42 5 mgASC42 tablets 5mg for 12 weeks |
| ASC42 tablets of 10mg | Experimental | Drug: ASC42 10 mgASC42 tablets 10mg for 12 weeks |
| ASC42 tablets of 15mg | Experimental | Drug: ASC42 15 mgASC42 tablets 15mg for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo for 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- 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.
Key exclusion criteria (3 listed)
- ALT or AST > 5× ULN; ALP >10× ULN
- History or presence of other concomitant liver diseases
- Child-Pugh grade B or C
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASC42 5 mg5 mg of ASC42 tablets orally once daily for 12 weeks. | Drug | ASC42 tablets of 5mg |
| ASC42 10 mg2 x 5 mg of ASC42 tablets orally once daily for 12 weeks. | Drug | ASC42 tablets of 10mg |
| ASC42 15 mg15 mg of ASC42 tablets orally once daily for 12 weeks. | Drug | ASC42 tablets of 15mg |
| PlaceboPlacebo tablets orally once daily for 12 weeks. | Drug | Placebo |
Primary outcome
Percentage changes of alkaline phosphatase (ALP) compared with baseline.
Time frame: Day85
3 secondary outcomes
Percentage changes and absolute changes of alkaline phosphatase (ALP) compared with baseline.
Time frame: Day15\29\57\85
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
Incidence of treatment-emergent adverse events, serious adverse events and adverse events of special interests.
Time frame: Day15\29\57\85
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ASC42 5 mg, ASC42 10 mg and ASC42 15 mg in people with Primary Biliary Cholangitis, run by Gannex Pharma Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage changes of alkaline phosphatase (ALP) compared with baseline. (time frame: Day85). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.