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Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)

Primary Purpose

Primary Biliary Cirrhosis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

MBX-8025 2 mg Capsule

MBX-8025 5 mg Capsule

MBX-8025 10 mg Capsule

About this trial

This is an interventional treatment trial for Primary Biliary Cirrhosis focused on measuring PBC, Primary Biliary Cholangitis (PBC)

Eligibility Criteria

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

Inclusion Criteria:

Must have given written informed consent (signed and dated) and any authorizations required by local law
18 to 75 years old (inclusive)
Male or female with a diagnosis of PBC, by at least two of the following criteria:
- History of AP above ULN for at least six months
- Positive AMA titers (>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies
- Documented liver biopsy result consistent with PBC
On a stable and recommended dose of UDCA for the past twelve months or intolerant to UDCA
AP ≥ 1.67 × ULN
Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose

Exclusion Criteria:

A medical condition, other than PBC, that in the investigator's opinion would preclude full participation in the study or confound its results (e.g., cancer on active treatment)
AST or ALT > 3 × ULN
Total bilirubin > 2.0 mg/dL
Total bilirubin > ULN AND albumin < LLN with the exception to subjects with Gilbert's Syndrome. Subjects with Gilbert's syndrome are excluded if Direct Bilirubin > ULN.
Auto-immune hepatitis
Primary sclerosing cholangitis
Known history of alpha-1-Antitrypsin deficiency
Known history of chronic viral hepatitis
Creatine kinase above ULN
Serum creatinine above ULN
For females, pregnancy or breast-feeding
Use of colchicine, methotrexate, azathioprine, or systemic steroids in the two months preceding screening
Current use of fibrates or simvastatin
Current use of obeticholic acid
Use of an experimental or unapproved treatment for PBC
Use of experimental or unapproved immunosuppressant
Adverse event leading to MBX-8025 discontinuation from CymaBay's phase 2 PBC study (CB8025-21528)
Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the Investigator

Sites / Locations

Institute for Liver Health
Southern California Research Center
Standford University Medicine
University of California, Davis Medical Center
Ventura Clinical Trials
Florida Research Institute
University of Miami - Center for Liver Diseases
Atlanta Gastroenterology Associates, LLC
Digestive Healthcare of Georgia
Northwestern University
Mercy Medical Center
Henry Ford Health System
University of Mississippi Medical Center
Saint Louis University, Gastroenterology & Hepatology
Northwell Health - Center for Liver Disease and Transplantation
NYU Langone Medical Center
The Mount Sinai Medical Center
Northest Clinical Research Center, LLC.
UT Southwestern Medical Center Investigation Drug Service
Baylor College of Medicine
Gastroenterology Consultants of SA
Bon Secours St. Mary's Immaculate Hospital
University of Washington
University of Calgary Liver Unit
Toronto Centre for Liver Disease
Outpatient Clinic of Internal Medicine
University Hospital Erlangen
Ifi-Studien und Projekte GmbH, An der Asklepios Klinik St. Georg
Center of Internal Medicine - Medical School of Hannover
University Medical Centre of the Johannes Guttenberg-University
Universitatsklinikum Giessen und Marburg GmbH
Medizinische Universitatsklinik Tubingen
University Hospitals Birmingham
Cambridge University Hospitals NHS Foundation Trust
Hull and East Yorkshire Hospitals NHS Trust
Royal Free London NHS Foundation Trust
Plymouth Hospitals NHS Trust
Portsmouth Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

MBX-8025 (2 mg)

MBX-8025 (5 mg)

MBX-8025 (10 mg)

Arm Description

MBX-8025 2 mg capsule once daily

MBX-8025 5 mg capsule once daily

MBX-8025 10 mg capsule once daily

Outcomes

Primary Outcome Measures

Relative Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 8

Relative change from baseline in serum ALP levels at Week 8 (endpoint). The modified Intent-to-Treat (mITT) analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment. n, denotes number of subjects evaluable for the respective timepoints

Secondary Outcome Measures

Absolute Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 12 and Week 52

Absolute change in ALP from baseline to Weeks 12 and 52 The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.

Change in Aspartate Aminotransferase (AST) From Baseline to 12 Weeks and 52 Weeks

Change from baseline in AST levels at endpoint was reported. The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.

Change in Alanine Aminotransferase (ALT) From Baseline to 12 Weeks and 52 Weeks

Change from baseline in ALT levels at endpoint was reported. The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.

Change in Gamma-glutamyl Transferase (GGT) From Baseline to 12 Weeks and 52 Weeks

Change from baseline in GGT levels at endpoint was reported. The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.

Change in Bilirubin - Total Bilirubin (TB) From Baseline to 12 Weeks and 52 Weeks

Change from baseline in TB levels at endpoint is being reported. The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.

Percentage of Participants Meet Composite Endpoint Criteria of ALP and Total Bilirubin

Participant meets composite endpoint is defined by participant meets all of the following criteria: ALP < 1.67 × upper limit of normal (ULN) Total Bilirubin within normal limit > 15% decrease in ALP Endpoint of Alkaline Phosphatase and Total Bilirubin by Visit (mITT Population)

Percentage of Participants Meet Published PBC Response Criteria - Paris I

Percentage of participants with response based on Paris I risk score was defined as ALP less than or equal to (≤) 3x ULN and aspartate aminotransferase (AST) less than or equal to (≤) 2 x ULN and Total Bilirubin ≤ 1 mg/dL. The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.

Percentage of Participants Meet Published PBC Response Criteria - Paris II

Percentage of participants with response based on Paris II risk score was defined as ALP≤1.5xULN and AST≤1.5xULN and Total Bilirubin ≤ 1 mg/dL. The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.

Percentage of Participants Meet Published PBC Response Criteria - Toronto I

Percentage of participants with response based on Toronto I risk score defined as ALP ≤ 1.67 x ULN. The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.

UK-PBC Risk Score Value

The UK-PBC Risk Score at endpoint is defined by the mean percentage risk that a PBC patient treated with ursodeoxycholic acid (UDCA) would develop liver failure requiring liver transplantation in 5, 10 and 15 years from diagnosis. The higher the score might indicate higher risk to death or live transplantation. Formula used for UK-PBC risk score = 1- 0.982 ^EXP(0.0287854*(ALP12 x ULN-1.722136304) - 0.0422873*(((TA12 xULN/10)^-1) - 8.675729006) + 1.4199 * (LN(BIL12 x ULN/10)+2.709607778)-1.960303*(Albumin x LLN-1.17673001)-0.4161954*(Platelet x LLN-1.873564875)). Where, Baseline survivor function = 0.982, 0.941, and 0.893 for 5 years, 10 years and 15 years respectively. ALP12, TA12 and BIL12 refers to the ALP, transaminases (ALT, AST), and total bilirubin assessments, respectively. The modified Intent-to-Treat (mITT) analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.

Change From Baseline in Pruritus Visual Analog Score (VAS) at Week 12 and Week 52

VAS is the commonly used graphic tool for self-reporting of pruritus intensity in patients. VAS is a simple to use, validated, reliable and widely applicable tool that does not determine the impact of pruritus to quality of life. It comprises of a 100-mm horizontal line labelled as "no symptom" on left end and "worst imaginable symptom" on right end. Based on the intensity of the itch patient is instructed to draw a vertical line on the horizontal scale having a range [VAS values (unit: mm) ranging from 0 to 100, where 0 represents "no itching" and 100 "worst possible itching"]. The modified Intent-to-Treat (mITT) analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.

Change From Baseline in PBC-40 Quality of Life (QoL) at Week 12 and Week 52

The PBC-40 QoL questionnaire is a disease-specific health-related tool developed for measuring the psychometric profile in PBC patients. It has 10 domains and 43 questions relevant to PBC, including Cognitive, Social, Emotional Function, Fatigue, Itch, and Other Symptoms. Questions in domains: 1) digestion and diet (questions 1-3); 2) experiences (questions 4-7); 3) itching (questions 8-10); 4) fatigue (questions 11-18); 5) effort and planning (questions 19-21); 6) memory and concentration (questions 22-27); 7) affects to you as person (questions 28-33); 8) affects to your social life (questions 34-37); 9) overall impact on your life (questions 38-40); 10) general health and well-being (questions A-C). Within a domain, items are scored from 1 to 5 and the individual item scores are summed to give a total domain score. High scores represent high impact and low scores low impact of PBC on QoL (mITT Population).

Percentage of Participants Meet Published PBC Response Criteria - Barcelona

Percentage of participants with response based on Barcelona risk scores was defined as Normalization of ALP or a Decrease of ALP ≥ 40%. The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.

Absolute Change in MELD Score From Baseline to 12 Weeks and 52 Weeks

Change from baseline to 12 weeks and 52 weeks in Model for End-stage Liver Disease (MELD) Score (mITT Population) The MELD score ranges from 6 to 40 and is a measure of how severe a patient's liver disease is. The higher the score, the more likely the patients will need a liver transplant. A calculated prognostic risk factor used to assess the potential need for a liver transplant. MELD(i) score = 10*[0.957*ln(creatinine mg/dL) + 0. 378*ln(total bilirubin mg/dL) + 1.120*ln (INR) + 0.643]. If MELD(i) is less than or equal to 11 then MELD = MELD(i). If MELD(i) is greater than 11 then MELD = MELD(i) + (1.32 *(137 - (Na)) - (0.033*MELD(i)*(137 - Na))

Change in GLOBE PBC Score From Baseline to 12 Weeks and 52 Weeks

Change from Baseline to 12 weeks and 52 weeks in Global PBC Study Group (GLOBE) score (mITT Population) The GLOBE score is a validated risk assessment tool providing an estimate of transplant-free survival for patients with PBC. It was developed by the Global PBC Study Group using Cox regression model on over 4,000 patients with PBC. Lower GLOBE score predicts lower risk. It is calculated from the following equation: GLOBE score = (0.044378 * age + 0.93982 * LN(total bilirubin/ULN) +(0.335648 * LN(alkaline phosphatase/ULN)) - 2.266708 * albumin /LLN -0.002581 * platelet count per 109/L) + 1.216865

Participants Meet Rotterdam Criteria

participants with Response Based on Rotterdam Criteria at Weeks 12 and 52 Rotterdam Published PBC Response Criteria by Visit (mITT Population) Rotterdam criteria: Early (normal total bilirubin and normal albumin), Moderately advanced (either abnormal albumin or abnormal total bilirubin), and Advanced (both abnormal albumin and abnormal total bilirubin). From Early stage to Moderate Stage and to Advanced Stage, it becomes worse and worse in abnormality.

Percentage of Participants Meet Composite Endpoint of AP and Total Bilirubin Criteria at Week 12 and Week 52

Percentage of participants with Response Defined by Composite Endpoint (ALP< 1.67 * Upper Limit of Normal [ULN] at Endpoint, Total Bilirubin [BIL] within Normal Limits at Endpoint, and Greater Than Equal To [≥] 15% ALP Reduction) from Baseline to Week 12 and Week 52 The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.

Percent Change in Serum Alkaline Phosphatase (ALP)

Percent change in ALP from baseline to Weeks 12 and 52 The mITT analysis set included all randomized subjects with confirmed PBC who received at least one study drug dose and had at least one post baseline ALP evaluation on treatment.

Full Information

NCT ID

NCT02955602

First Posted

November 2, 2016

Last Updated

June 21, 2022

Sponsor

CymaBay Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02955602

Brief Title

Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)

Official Title

An 8-week, Dose Ranging, Open Label, Randomized, Phase 2 Study With a 44-week Extension, to Evaluate the Safety and Efficacy of MBX-8025 in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or Intolerance to Ursodeoxycholic Acid (UDCA)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Completed

Study Start Date

November 28, 2016 (Actual)

Primary Completion Date

September 7, 2018 (Actual)

Study Completion Date

July 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CymaBay Therapeutics, Inc.

4. Oversight

5. Study Description

Brief Summary

An 8-week, dose ranging, open label, randomized, Phase 2 study with a 44-week extension, to evaluate the safety and efficacy of MBX-8025 in subjects with Primary Biliary Cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA)

Detailed Description

Primary: To evaluate the safety and efficacy of MBX-8025 2 mg, 5 mg, and 10 mg over 8 weeks of treatment Secondary: To evaluate the safety and efficacy of MBX-8025 2 mg, 5 mg, and 10 mg over 12 and 26 weeks of treatment To evaluate the safety and efficacy of MBX-8025 2 mg, 5 mg, and 10 mg over 52 weeks of treatment To evaluate the pharmacokinetics (PK) of MBX-8025 Exploratory: To evaluate the effect of MBX-8025 on bile acids, additional markers of inflammation and renal function MBX-8025 doses of 1 mg and 15 mg may be evaluated if dose adjustment occurs

6. Conditions and Keywords

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

Primary Biliary Cirrhosis

Keywords

PBC, Primary Biliary Cholangitis (PBC)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

119 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MBX-8025 (2 mg)

Arm Type

Experimental

Arm Description

MBX-8025 2 mg capsule once daily

Arm Title

MBX-8025 (5 mg)

Arm Type

Experimental

Arm Description

MBX-8025 5 mg capsule once daily

Arm Title

MBX-8025 (10 mg)

Arm Type

Experimental

Arm Description

MBX-8025 10 mg capsule once daily

Intervention Type

Drug

Intervention Name(s)

MBX-8025 2 mg Capsule

Other Intervention Name(s)

MBX-8025, seladelpar

Intervention Description

Initial 8-week treatment: • MBX-8025 2 mg Extension: The 2 mg group will be started after safety and efficacy review of the 5 mg and the 10 mg groups has been completed. Subjects will initially enter the extension on their assigned dose. The dose might be up- or down-titrated after safety and efficacy data review of the first 8 weeks of treatment. During the extension, a subject's dose might be re-adjusted for safety or efficacy reasons.

Intervention Type

Drug

Intervention Name(s)

MBX-8025 5 mg Capsule

Other Intervention Name(s)

MBX-8025, seladelpar

Intervention Description

Initial 8-week treatment: • MBX-8025 5 mg Extension: Subjects will initially enter the extension on their assigned dose. The dose might be up- or down-titrated after safety and efficacy data review of the first 8 weeks of treatment. During the extension, a subject's dose might be re-adjusted for safety or efficacy reasons.

Intervention Type

Drug

Intervention Name(s)

MBX-8025 10 mg Capsule

Other Intervention Name(s)

MBX-8025, seladelpar

Intervention Description

Initial 8-week treatment: • MBX-8025 10 mg Extension: Subjects will initially enter the extension on their assigned dose. The dose might be up- or down-titrated after safety and efficacy data review of the first 8 weeks of treatment. During the extension, a subject's dose might be re-adjusted for safety or efficacy reasons.

Primary Outcome Measure Information:

Title

Relative Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 8

Description

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Absolute Change From Baseline in Serum Alkaline Phosphatase (ALP) at Week 12 and Week 52

Description

Time Frame

12 weeks and 52 weeks

Title

Change in Aspartate Aminotransferase (AST) From Baseline to 12 Weeks and 52 Weeks

Description

Time Frame

12 weeks and 52 weeks

Title

Change in Alanine Aminotransferase (ALT) From Baseline to 12 Weeks and 52 Weeks

Description

Time Frame

12 weeks and 52 weeks

Title

Change in Gamma-glutamyl Transferase (GGT) From Baseline to 12 Weeks and 52 Weeks

Description

Time Frame

12 weeks and 52 weeks

Title

Change in Bilirubin - Total Bilirubin (TB) From Baseline to 12 Weeks and 52 Weeks

Description

Time Frame

12 weeks and 52 weeks

Title

Percentage of Participants Meet Composite Endpoint Criteria of ALP and Total Bilirubin

Description

Time Frame

12 Weeks and 52 Weeks

Title

Percentage of Participants Meet Published PBC Response Criteria - Paris I

Description

Time Frame

12 weeks and 52 weeks

Title

Percentage of Participants Meet Published PBC Response Criteria - Paris II

Description

Time Frame

12 weeks and 52 weeks

Title

Percentage of Participants Meet Published PBC Response Criteria - Toronto I

Description

Time Frame

12 weeks and 52 weeks

Title

UK-PBC Risk Score Value

Description

Time Frame

12 weeks and 52 weeks

Title

Change From Baseline in Pruritus Visual Analog Score (VAS) at Week 12 and Week 52

Description

Time Frame

12 weeks and 52 weeks

Title

Change From Baseline in PBC-40 Quality of Life (QoL) at Week 12 and Week 52

Description

Time Frame

12 weeks and 52 weeks

Title

Percentage of Participants Meet Published PBC Response Criteria - Barcelona

Description

Time Frame

12 weeks and 52 weeks

Title

Absolute Change in MELD Score From Baseline to 12 Weeks and 52 Weeks

Description

Time Frame

12 weeks and 52 weeks

Title

Change in GLOBE PBC Score From Baseline to 12 Weeks and 52 Weeks

Description

Time Frame

12 weeks and 52 weeks

Title

Participants Meet Rotterdam Criteria

Description

Time Frame

12 weeks and 52 weeks

Title

Percentage of Participants Meet Composite Endpoint of AP and Total Bilirubin Criteria at Week 12 and Week 52

Description

Time Frame

12 weeks and 52 weeks

Title

Percent Change in Serum Alkaline Phosphatase (ALP)

Description

Time Frame

12 weeks and 52 weeks

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: Must have given written informed consent (signed and dated) and any authorizations required by local law 18 to 75 years old (inclusive) Male or female with a diagnosis of PBC, by at least two of the following criteria: History of AP above ULN for at least six months Positive AMA titers (>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies Documented liver biopsy result consistent with PBC On a stable and recommended dose of UDCA for the past twelve months or intolerant to UDCA AP ≥ 1.67 × ULN Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose Exclusion Criteria: A medical condition, other than PBC, that in the investigator's opinion would preclude full participation in the study or confound its results (e.g., cancer on active treatment) AST or ALT > 3 × ULN Total bilirubin > 2.0 mg/dL Total bilirubin > ULN AND albumin < LLN with the exception to subjects with Gilbert's Syndrome. Subjects with Gilbert's syndrome are excluded if Direct Bilirubin > ULN. Auto-immune hepatitis Primary sclerosing cholangitis Known history of alpha-1-Antitrypsin deficiency Known history of chronic viral hepatitis Creatine kinase above ULN Serum creatinine above ULN For females, pregnancy or breast-feeding Use of colchicine, methotrexate, azathioprine, or systemic steroids in the two months preceding screening Current use of fibrates or simvastatin Current use of obeticholic acid Use of an experimental or unapproved treatment for PBC Use of experimental or unapproved immunosuppressant Adverse event leading to MBX-8025 discontinuation from CymaBay's phase 2 PBC study (CB8025-21528) Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the Investigator

Facility Information:

Facility Name

Institute for Liver Health

City

Chandler

State/Province

Arizona

ZIP/Postal Code

85224

Country

United States

Facility Name

Southern California Research Center

City

Coronado

State/Province

California

ZIP/Postal Code

92118

Country

United States

Facility Name

Standford University Medicine

City

Palo Alto

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

University of California, Davis Medical Center

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

Ventura Clinical Trials

City

Ventura

State/Province

California

ZIP/Postal Code

93003

Country

United States

Facility Name

Florida Research Institute

City

Lakewood Ranch

State/Province

Florida

ZIP/Postal Code

34211

Country

United States

Facility Name

University of Miami - Center for Liver Diseases

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Atlanta Gastroenterology Associates, LLC

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30308

Country

United States

Facility Name

Digestive Healthcare of Georgia

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30309

Country

United States

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Mercy Medical Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21202

Country

United States

Facility Name

Henry Ford Health System

City

Novi

State/Province

Michigan

ZIP/Postal Code

48377

Country

United States

Facility Name

University of Mississippi Medical Center

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39216

Country

United States

Facility Name

Saint Louis University, Gastroenterology & Hepatology

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63104

Country

United States

Facility Name

Northwell Health - Center for Liver Disease and Transplantation

City

Manhasset

State/Province

New York

ZIP/Postal Code

11030

Country

United States

Facility Name

NYU Langone Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

The Mount Sinai Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Northest Clinical Research Center, LLC.

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18017

Country

United States

Facility Name

UT Southwestern Medical Center Investigation Drug Service

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

Baylor College of Medicine

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Gastroenterology Consultants of SA

City

Live Oak

State/Province

Texas

ZIP/Postal Code

78233

Country

United States

Facility Name

Bon Secours St. Mary's Immaculate Hospital

City

Newport News

State/Province

Virginia

ZIP/Postal Code

23602

Country

United States

Facility Name

University of Washington

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

University of Calgary Liver Unit

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4Z6

Country

Canada

Facility Name

Toronto Centre for Liver Disease

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2C4

Country

Canada

Facility Name

Outpatient Clinic of Internal Medicine

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

University Hospital Erlangen

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Ifi-Studien und Projekte GmbH, An der Asklepios Klinik St. Georg

City

Hamburg

ZIP/Postal Code

20099

Country

Germany

Facility Name

Center of Internal Medicine - Medical School of Hannover

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

University Medical Centre of the Johannes Guttenberg-University

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Universitatsklinikum Giessen und Marburg GmbH

City

Marburg

ZIP/Postal Code

35043

Country

Germany

Facility Name

Medizinische Universitatsklinik Tubingen

City

Tubingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

University Hospitals Birmingham

City

Birmingham

ZIP/Postal Code

B15 2GW

Country

United Kingdom

Facility Name

Cambridge University Hospitals NHS Foundation Trust

City

Cambridge

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

Facility Name

Hull and East Yorkshire Hospitals NHS Trust

City

Hull

ZIP/Postal Code

HU3 2JZ

Country

United Kingdom

Facility Name

Royal Free London NHS Foundation Trust

City

London

ZIP/Postal Code

NW3 2QR

Country

United Kingdom

Facility Name

Plymouth Hospitals NHS Trust

City

Plymouth

ZIP/Postal Code

PL6 8DH

Country

United Kingdom

Facility Name

Portsmouth Hospitals NHS Trust

City

Portsmouth

ZIP/Postal Code

PO6 3LY

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35367282

Citation

Bowlus CL, Galambos MR, Aspinall RJ, Hirschfield GM, Jones DEJ, Dorffel Y, Gordon SC, Harrison SA, Kremer AE, Mayo MJ, Thuluvath PJ, Levy C, Swain MG, Neff GW, Sheridan DA, Stanca CM, Berg CP, Goel A, Shiffman ML, Vierling JM, Boudes P, Steinberg A, Choi YJ, McWherter CA. A phase II, randomized, open-label, 52-week study of seladelpar in patients with primary biliary cholangitis. J Hepatol. 2022 Aug;77(2):353-364. doi: 10.1016/j.jhep.2022.02.033. Epub 2022 Mar 30.

Results Reference

derived

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Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)

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