Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

Summary

To evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on ALP and total bilirubin and to evaluate the safety of seladelpar over 12 months of treatment compared to placebo

Official Title

RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

Keywords

Primary Biliary Cholangitis Primary Biliary Cholangitis (PBC) PBC Cholangitis Liver Cirrhosis, Biliary Seladelpar Seladelpar 10 mg Seladelpar 5 mg

Eligibility

You can join if…

Open to people ages 18-75

  1. Must have given written informed consent (signed and dated) and any authorizations required by local law
  2. 18 to 75 years old (inclusive)
  3. Male or female with a definitive diagnosis of PBC
  4. UDCA for the past 12 months (stable dose for >3 months prior to screening) OR intolerant to UDCA (last dose of UDCA >3 months prior to screening)
  5. Laboratory parameters measured by the Central Laboratory at screening:
  6. ALP ≥1.67× ULN
  7. Aspartate aminotransferase (AST) ≤3× ULN
  8. ALT ≤3× ULN
  9. Total bilirubin ≤2× ULN
  10. Estimated glomerular filtration rate (eGFR) >60 mL/min/1.73 m2 (calculated by the Modification of Diet in Renal Disease study equation)
  11. International normalized ratio (INR) below 1.1× ULN For subjects on anticoagulation therapy, INR must be maintained in the range required for prophylaxis for their specific disease.
  12. Platelet count ≥100×103/µL
  13. Females of reproductive potential must use at least 1 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

You CAN'T join if...

  1. Advanced PBC as defined by the Rotterdam criteria (albumin below the lower limit of normal AND total bilirubin above 1.0× ULN)
  2. Clinically important hepatic decompensation, including the history of liver transplantation, current placement on liver transplantation list, or current Model for End-Stage Liver Disease (MELD) score ≥12, complications of portal hypertension and / or cirrhosis with complications, including history or presence of spontaneous bacterial peritonitis, hepatocellular carcinoma, or hepatorenal syndrome
  3. History or presence of other concomitant chronic liver diseases (for example, AIH, PSC, NASH, alcoholic liver disease, hepatitis B, hepatitis C, etc.)
  4. Known history of human immunodeficiency virus (HIV) or positive antibody test at screening
  5. Clinically important alcohol consumption
  6. History of malignancy diagnosed or treated, actively or within 2 years, or ongoing evaluation for malignancy; localized treatment of squamous or noninvasive basal cell skin cancers and cervical carcinoma in situ is allowed if appropriately treated prior to screening.
  7. Treatment with obeticholic acid (OCA) or fibrates (eg, bezafibrate, fenofibrate, elafibranor, lanifibranor, pemafibrate, saroglitizar) 3 months prior to screening
  8. Treatment with colchicine, methotrexate, azathioprine, or long-term systemic corticosteroids (>2 weeks) during 2 months prior to screening
  9. Treatment with anti-pruritic drugs (eg, cholestyramine, naltrexone, rifampicin, sertraline, or any experimental approach) must be on a stable dose within 1 month prior to screening
  10. . Treatment with any other investigational therapy or device within 30 days or within 5 half-lives, whichever is longer, prior to screening
  11. . For females, pregnancy or breastfeeding
  12. . 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
  13. . Immunosuppressant therapies
  14. . Other medications that effect liver or GI functions

Locations

  • University of California, Davis Medical Center accepting new patients
    Sacramento California 95817 United States
  • California Pacific Medical Center - Sutter Pacific Medical Foundation accepting new patients
    San Francisco California 94109 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CymaBay Therapeutics, Inc.
Links
Sign up for this study
ID
NCT04620733
Phase
Phase 3
Study Type
Interventional
Last Updated