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Trial record 5 of 6 for:    CymaBay | PBC

RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)

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ClinicalTrials.gov Identifier: NCT04620733
Recruitment Status : Recruiting
First Posted : November 9, 2020
Last Update Posted : September 13, 2021
Sponsor:
Information provided by (Responsible Party):
CymaBay Therapeutics, Inc.

Brief 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

Condition or disease Intervention/treatment Phase
Primary Biliary Cholangitis Drug: Seladelpar 10 mg Drug: Placebo Drug: Seladelpar 5 mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : April 21, 2021
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : March 2023


Arm Intervention/treatment
Experimental: Seladelpar 10 mg Drug: Seladelpar 10 mg
Seladelpar 10 mg one capsule daily for double-blind period, for a duration of up to 12 months

Placebo Comparator: Placebo Drug: Placebo
One capsule daily for double-blind period, for a duration of up to 12 months

Experimental: Seladelpar 5 mg Drug: Seladelpar 5 mg
If down-titration needed, one capsule daily for double-blind period, for a duration of up to 12 months




Primary Outcome Measures :
  1. Composite endpoint of ALP and total bilirubin [ Time Frame: 12 months ]
    • ALP < 1.67× ULN,
    • ≥ 15% decrease in ALP, and
    • Total bilirubin ≤1.0× ULN


Secondary Outcome Measures :
  1. Normalization of ALP [ Time Frame: 12 months ]
    Proportion of subjects with ALP ≤1.0× ULN

  2. Change in baseline numerical rating scale (NRS) [ Time Frame: 6 months ]
    Weekly averaged pruritus NRS in subjects with baseline NRS ≥4. The NRS is a scale of 0 (no itching) to 10 (worst imaginable itching)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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:

    1. ALP ≥1.67× ULN
    2. Aspartate aminotransferase (AST) ≤3× ULN
    3. ALT ≤3× ULN
    4. Total bilirubin ≤2× ULN
    5. Estimated glomerular filtration rate (eGFR) >60 mL/min/1.73 m2 (calculated by the Modification of Diet in Renal Disease study equation)
    6. 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.
    7. Platelet count ≥100×103/µL
  6. 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

Exclusion Criteria:

  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

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): NCT04620733


Contacts
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Contact: Elaine Watkins, DO, MSPH 510-293-8800 ewatkins@cymabay.com

Locations
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Sponsors and Collaborators
CymaBay Therapeutics, Inc.
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Responsible Party: CymaBay Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04620733    
Other Study ID Numbers: CB8025-32048
First Posted: November 9, 2020    Key Record Dates
Last Update Posted: September 13, 2021
Last Verified: July 2021

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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.:
Primary Biliary Cholangitis (PBC)
PBC
Additional relevant MeSH terms:
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Cholangitis
Liver Cirrhosis, Biliary
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholestasis, Intrahepatic
Cholestasis
Liver Diseases
Liver Cirrhosis