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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04024813
Recruitment Status : Suspended (unexpected histological findings in a phase 2 study in NASH patients CB8025-21730)
First Posted : July 18, 2019
Last Update Posted : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
CymaBay Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE June 20, 2019
First Posted Date  ICMJE July 18, 2019
Last Update Posted Date December 11, 2019
Actual Study Start Date  ICMJE August 15, 2019
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2019)
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
 (submitted: July 16, 2019)
  • Incidence of treatment-emergent adverse events (TEAEs), as well as biochemistry, hematology, and urinalysis [ Time Frame: Up to 24 weeks ]
  • Incidence and severity of PSC-related symptoms or procedures [ Time Frame: Up to 24 weeks ]
  • 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 ]
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
Condition  ICMJE Primary Sclerosing Cholangitis
Intervention  ICMJE
  • Drug: Seladelpar
    Capsule(s) administered orally once daily
    Other Name: MBX-8025
  • Drug: Placebo to match Seladelpar
    Capsule(s) administered orally once daily
Study Arms  ICMJE
  • Placebo Comparator: Placebo (N=25)
    Placebo for the remainder of the study
    Intervention: Drug: Placebo to match Seladelpar
  • Experimental: Seladelpar 5 mg (N=25)
    5 mg seladelpar daily for the remainder of the study
    Intervention: Drug: Seladelpar
  • Experimental: Seladelpar 10 mg (N=25)
    10 mg seladelpar for the remainder of the study
    Intervention: Drug: Seladelpar
  • Experimental: Seladepar 25 mg (N=25)
    25 mg seladelpar for the remainder of the study
    Intervention: Drug: Seladelpar
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Actual Enrollment  ICMJE
 (submitted: December 9, 2019)
1
Original Estimated Enrollment  ICMJE
 (submitted: July 16, 2019)
100
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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 December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP