ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)

  • End date
    Dec 24, 2025
  • participants needed
  • sponsor
    CymaBay Therapeutics, Inc.
Updated on 24 October 2022


An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)



To evaluate the long-term safety and tolerability of seladelpar

  • To evaluate the long-term efficacy of seladelpar
  • To evaluate the effect of seladelpar on patient-reported outcomes (pruritus)

Condition Primary Biliary Cirrhosis
Treatment Seladelpar 2 mg Capsule, Seladelpar 5 mg Capsule, Seladelpar 10 mg Capsule
Clinical Study IdentifierNCT03301506
SponsorCymaBay Therapeutics, Inc.
Last Modified on24 October 2022


Yes No Not Sure

Inclusion Criteria

Must have given written informed consent (signed and dated)
Participated in a PBC study with seladelpar
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

Exclusion criteria are only applicable for subjects with a seladelpar interruption greater
than 4 weeks prior to Day 1 of this study and for subjects who participated in CB8025-21838
irrespective of seladelpar interruption
Treatment-related adverse event (AE) leading to seladelpar discontinuation in a
previous PBC study with seladelpar (MBX-8025)
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)
AST or ALT above 3 × the upper limit of normal (ULN)
Total bilirubin above 2 × ULN
MELD score ≥ 12. For subjects on anticoagulation medication, evaluation of the
baseline INR, in concert with any current dose adjustments in anti-coagulant
Evidence of advanced PBC as defined by the Rotterdam criteria: albumin below 1× the
Auto-immune hepatitis
medications, will be taken into account when calculating this score. This will be done
lower limit of normal (LLN) AND total bilirubin above 1 × ULN)
Primary sclerosing cholangitis
in consultation with the medical monitor
Known history of alpha-1-antitrypsin deficiency
Known history of chronic viral hepatitis
For females, pregnancy or breast-feeding
eGFR ≤45 mL/min/1.73 m2 (calculated by MDRD formula)
Current use of fibrates or use of fibrates within 3 months prior to Screening
Use of colchicine, methotrexate, azathioprine, or long-term use of systemic steroids
(e.g. prednisone, prednisolone, budesonide) (>2 weeks) within 2 months prior to
Current use of obeticholic acid or use of obeticholic acid within 3 months prior to
Use of an experimental or unapproved treatment for PBC within 3 months prior to
History of malignancy diagnosed or treated, actively or within 2 years, or active
evaluation for malignancy; localized treatment of squamous or non-invasive basal cell
skin cancers and cervical carcinoma in-situ is allowed if appropriately treated prior
to Screening
Treatment with any other investigational therapy or medical device within 30 days or
within 5 half-lives, whatever is longer, prior to Screening
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
Immunosuppressant therapies (e.g., cyclosporine, tacrolimus, anti-TNF or other
immunosuppressive biologics)
Other medications that effect liver or GI functions such as absorption of medications
or the roux-en-y gastric bypass procedure may be prohibited and should be discussed
with the medical monitor on a case-by-case basis
Positive for
Hepatitis B, defined as the presence of hepatitis B surface antigen
Hepatitis C, defined as the presence of hepatitis C virus ribonucleic acid (RNA)
Human immunodeficiency virus (HIV) antibody
Active COVID-19 infection during screening
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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