Condition or disease | Intervention/treatment | Phase |
---|---|---|
Primary Sclerosing Cholangitis | Drug: Seladelpar Drug: Placebo to match Seladelpar | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Dose masking |
Primary Purpose: | Treatment |
Official Title: | A Phase 2, Randomized, Double Blind, Placebo Controlled, Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of Seladelpar Administered for 24 Weeks in Adult Patients With Primary Sclerosing Cholangitis (PSC) |
Actual Study Start Date : | November 12, 2019 |
Actual Primary Completion Date : | January 9, 2020 |
Actual Study Completion Date : | January 9, 2020 |
Arm | Intervention/treatment |
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Placebo Comparator: Placebo (N=25)
Placebo for the remainder of the study
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Drug: Placebo to match Seladelpar
Capsule(s) administered orally once daily
|
Experimental: Seladelpar 5 mg (N=25)
5 mg seladelpar daily for the remainder of the study
|
Drug: Seladelpar
Capsule(s) administered orally once daily
Other Name: MBX-8025
|
Experimental: Seladelpar 10 mg (N=25)
10 mg seladelpar for the remainder of the study
|
Drug: Seladelpar
Capsule(s) administered orally once daily
Other Name: MBX-8025
|
Experimental: Seladepar 25 mg (N=25)
25 mg seladelpar for the remainder of the study
|
Drug: Seladelpar
Capsule(s) administered orally once daily
Other Name: MBX-8025
|
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Confirmed diagnosis of PSC based on any two of the following three criteria:
Subjects must have the following specific additional laboratory parameters measured by the Central Laboratory at Screening:
Patients taking UDCA will be allowed to enroll if meeting the following criteria:
Key Exclusion Criteria:
Evidence of compensated or decompensated cirrhosis based on histology, relevant medical complications, or laboratory parameters:
Combined low platelet count (< 140 × 10^3/µL ) with one of the following:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
United States, California | |
Sutter Pacific Medical Foundation - California Pacific Medical Center | |
San Francisco, California, United States, 94109 | |
United States, Colorado | |
University of Colorado Denver and Hospital | |
Aurora, Colorado, United States, 80045 | |
United States, Florida | |
Schiff Center for Liver Diseases/University of Miami | |
Miami, Florida, United States, 33136 | |
United States, Georgia | |
Piedmont Atlanta Hospital | |
Atlanta, Georgia, United States, 30309 | |
United States, Michigan | |
Henry Ford Health System | |
Novi, Michigan, United States, 48377 | |
United States, New York | |
New York University | |
New York, New York, United States, 10016 | |
United States, Virginia | |
Liver Institute of Virginia | |
Newport News, Virginia, United States, 23602 | |
Bon Secours Liver Institute of Richmond | |
Richmond, Virginia, United States, 23226 | |
Canada, Ontario | |
Toronto Centre for Liver Disease-Toronto General Hospital | |
Toronto, Ontario, Canada, M5G 2C4 | |
Poland | |
ID Clinic | |
Mysłowice, Poland, 41-400 |
Tracking Information | |||||
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First Submitted Date ICMJE | June 20, 2019 | ||||
First Posted Date ICMJE | July 18, 2019 | ||||
Last Update Posted Date | June 3, 2021 | ||||
Actual Study Start Date ICMJE | November 12, 2019 | ||||
Actual Primary Completion Date | January 9, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Relative change in Baseline serum alkaline phosphatase (AP) at Week 24 [ Time Frame: 24 weeks ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study to Evaluate the Safety, and Tolerability, and Efficacy of Seladelpar in Patients With PSC | ||||
Official Title ICMJE | A Phase 2, Randomized, Double Blind, Placebo Controlled, Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of Seladelpar Administered for 24 Weeks in Adult Patients With Primary Sclerosing Cholangitis (PSC) | ||||
Brief Summary | The objectives of this study are to evaluate the effect of seladelpar treatment compared to placebo on efficacy, safety, and tolerability in patients with primary sclerosing cholangitis (PSC). | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Masking Description: Dose masking Primary Purpose: Treatment
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Condition ICMJE | Primary Sclerosing Cholangitis | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
1 | ||||
Original Estimated Enrollment ICMJE |
100 | ||||
Actual Study Completion Date ICMJE | January 9, 2020 | ||||
Actual Primary Completion Date | January 9, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Canada, Poland, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04024813 | ||||
Other Study ID Numbers ICMJE | CB8025-21845 2019-001760-30 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | CymaBay Therapeutics, Inc. | ||||
Study Sponsor ICMJE | CymaBay Therapeutics, Inc. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | CymaBay Therapeutics, Inc. | ||||
Verification Date | June 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |