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

STATUS

Recruiting
End date

Dec 24, 2025
participants needed

500
sponsor

CymaBay Therapeutics, Inc.

Updated on 24 October 2022

See if I qualify

cirrhosis

cholangitis

Summary

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

Description

Primary

To evaluate the long-term safety and tolerability of seladelpar

Secondary

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

Details

Condition	Primary Biliary Cirrhosis
Treatment	Seladelpar 2 mg Capsule, Seladelpar 5 mg Capsule, Seladelpar 10 mg Capsule
Clinical Study Identifier	NCT03301506
Sponsor	CymaBay Therapeutics, Inc.
Last Modified on	24 October 2022

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Eligibility		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
	Screening
	Current use of obeticholic acid or use of obeticholic acid within 3 months prior to
	Screening
	Use of an experimental or unapproved treatment for PBC within 3 months prior to
	Screening
	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

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