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Trial record 45 of 92 for:    Primary Sclerosing Cholangitis

A Study to Evaluate the Safety, and Tolerability, and Efficacy of Seladelpar in Patients With PSC

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ClinicalTrials.gov Identifier: NCT04024813
Recruitment Status : Recruiting
First Posted : July 18, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
CymaBay Therapeutics, Inc.

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).

Condition or disease Intervention/treatment Phase
Primary Sclerosing Cholangitis Drug: Seladelpar Drug: Placebo to match Seladelpar Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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 : August 15, 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021


Arm Intervention/treatment
Placebo Comparator: Placebo (N=25)
Placebo for the remainder of the study
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




Primary Outcome Measures :
  1. Relative change in Baseline serum alkaline phosphatase (AP) at Week 24 [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Incidence of treatment-emergent adverse events (TEAEs), as well as biochemistry, hematology, and urinalysis [ Time Frame: Up to 24 weeks ]
  2. Incidence and severity of PSC-related symptoms or procedures [ Time Frame: Up to 24 weeks ]
  3. Incidence of Hepatic disease progression events, defined by the occurrence of liver transplantation, MELD score, hepatic decompensation events, and/or hepatocellular carcinoma [ Time Frame: Up to 24 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Confirmed diagnosis of PSC based on any two of the following three criteria:

    • Historical evidence of an elevated AP > ULN from any prior laboratory result
    • Liver biopsy consistent with PSC
    • Abnormal cholangiography consistent with PSC as measured by MRCP, ERCP, or percutaneous transhepatic cholangiography (PTC)
  2. Subjects must have the following specific additional laboratory parameters measured by the Central Laboratory at Screening:

    • AP ≥ 1.5 × ULN and < 8 × ULN
    • Total bilirubin ≤ 2 × ULN
    • ALT and AST ≤ 5 × ULN
    • eGFR > 60 mL/min/1.73 m^2
    • Platelets ≥ 140 × 10^3/µL
    • International Normalized Ratio (INR) ≤ 1.3 (in the absence of warfarin or other anticoagulant therapy)
    • Albumin ≥ 3.5 g/dL
  3. Patients taking UDCA will be allowed to enroll if meeting the following criteria:

    • Total daily dose of ≤ 20 mg/kg/day
    • A minimum of 6 months of stable treatment
    • Minimum of 12 weeks off treatment prior to Screening if UDCA is recently discontinued

Key Exclusion Criteria:

  1. Clinically significant acute or chronic liver disease of an etiology other than PSC
  2. Patients with a diagnosis of overlapping autoimmune hepatitis (AIH) and PSC
  3. Secondary or IgG4 related sclerosing cholangitis
  4. Small duct PSC
  5. Presence of a cholangiocarcinoma on cholangiography or MRI at Screening as determined by the central radiologist and the principal investigator (PI) or medical monitor
  6. Bile duct stent or percutaneous bile duct drain placement, or balloon dilatation procedure of a stricture within 12 weeks of Screening
  7. History, evidence, or high suspicion of cholangiocarcinoma or other hepatobiliary malignancy based on imaging, screening laboratory values, and/or clinical symptoms
  8. Presumptive or diagnosed acute cholangitis within 12 weeks of Screening and through Day 1
  9. Evidence of compensated or decompensated cirrhosis based on histology, relevant medical complications, or laboratory parameters:

    • Historical liver biopsy demonstrating cirrhosis (eg, Ludwig Stage 4 or Ishak Stage 5)
    • Current or prior history of decompensated liver disease, including ascites, hepatic encephalopathy, variceal bleeding or other clinical conditions consistent with cirrhosis and/or portal hypertension,
    • Liver stiffness > 14.4 kPa by FibroScan, or
    • Combined low platelet count (< 140 × 10^3/µL ) with one of the following:

      • Serum albumin < 3.5 g/dL,
      • INR > 1.3 (not due to antithrombotic agent use), or
      • Total bilirubin > ULN
  10. Prior or actively listed for liver transplantation
  11. Prior exposure to seladelpar

Note: Other protocol defined Inclusion/Exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04024813


Contacts
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Contact: Stephen J Rossi, PharmD 510-293-8127 srossi@cymabay.com

Locations
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United States, Florida
Schiff Center for Liver Diseases/Univerity of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Katheryn Dae       kqd1@med.miami.edu   
Principal Investigator: Cynthia Levy, MD         
United States, Georgia
Piedmont Atlanta Hospital Recruiting
Atlanta, Georgia, United States, 30309
Contact: Bernard Michel    404-605-4339    Bernard.Michel@piedmont.org   
Principal Investigator: Roshan Shrestha, MD         
United States, New York
New York University Recruiting
New York, New York, United States, 10016
Contact: Kristyn Pierce       Kristyn.Pierce@nyulangone.org   
Principal Investigator: Carmen Stanca, MD         
United States, Virginia
Liver Institute of Virginia Recruiting
Newport News, Virginia, United States, 23602
Contact: Kathleen Tellish         
Principal Investigator: Mitchell Shiffman, MD         
Bon Secours Liver Institute of Richmond Recruiting
Richmond, Virginia, United States, 23226
Contact: Sarah Cornwell         
Principal Investigator: Mitchell Shiffman, MD         
Sponsors and Collaborators
CymaBay Therapeutics, Inc.

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Responsible Party: CymaBay Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04024813     History of Changes
Other Study ID Numbers: CB8025-21845
2019-001760-30 ( EudraCT Number )
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CymaBay Therapeutics, Inc.:
PSC
Cholangitis, Sclerosing
Cholangitis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Additional relevant MeSH terms:
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Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases