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Clinical Trials/NL-OMON51913
NL-OMON51913RecruitingPhase 3

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

CymaBay Therapeutics Inc0 sites15 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Recruiting
Enrollment
15
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

Inclusion Criteria

  • •1. Must have given written informed consent (signed and dated)
  • •2. Participated in a prior PBC study with seladelpar (including CB8025-21629,
  • •CB8025-31735, or CB8025-31731), current PBC studies (CB8025-32048 or
  • •CB8025-21838), or completed a future PBC study with seladelpar that allows
  • •rollover into CB8025-31731-RE, and meet eligibility criteria for the current
  • •3. 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 study drug
  • •interruption greater than 4 weeks prior to Day 1 of this study and for subjects
  • •who participated in CB8025-21838 irrespective of seladelpar interruption.
  • •1. Treatment-related adverse event (AE) leading to study drug discontinuation
  • •in a previous PBC study with seladelpar
  • •2. 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, any active infection)
  • •3. AST or ALT above 3 × the upper limit of normal (ULN)
  • •4. Total bilirubin above 2 × ULN
  • •5. MELD score >= 12. For subjects on anticoagulation medication, evaluation of
  • •the baseline INR, in concert with any current dose adjustments in
  • •anti-coagulant medications, will be taken into account when calculating this
  • •score. This will be done in consultation with the medical monitor.
  • •6. Evidence of advanced PBC as defined by the Rotterdam criteria: albumin below
  • •1× the lower limit of normal AND total bilirubin above 1 × ULN)
  • •7. Estimated glomerular filtration rate <= 45 mL/min/1.73 m2 (calculated by
  • •Modification of Diet in Renal Disease formula)
  • •8. Auto-immune hepatitis
  • •9. Primary sclerosing cholangitis
  • •10. Known history of alpha-1-antitrypsin deficiency
  • •11. Known history of chronic viral hepatitis
  • •12. For females, pregnancy or breast-feeding
  • •13. 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. See the concomitant medication section for additional
  • •medications that may be excluded.
  • •14. Current use of fibrates or use of fibrates within 3 months prior to
  • •15. Current use of obeticholic acid or use of obeticholic acid within 3 months
  • •prior to Screening
  • •16. Use of an experimental or unapproved treatment for PBC within 3 months
  • •prior to Screening
  • •17. 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
  • •18. Treatment with any other investigational therapy or medical device within
  • •30 days or within 5 half-lives, whatever is longer, prior to Screening
  • •19. 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
  • •20. Immunosuppressant therapies (e.g., cyclosporine, tacrolimus, anti TNF or
  • •other immunosuppressive biologics)
  • •21. Other medications that effect liver or GI functions such as absorption of
  • •medications or roux-en-y gastric bypass procedure may be prohibited and should
  • •be discussed with the medical monitor on a case-by-case basis
  • •22. Positive for:
  • •a. Hepatitis B, defined as the presence of hepatitis B surface antigen
  • •b. Hepatitis C, defined as the presence of hepatitis C virus ribonucleic acid
  • •c. Human immunodeficiency virus (HIV) antibody
  • •23. Active COVID-19 infection during Screening.

Investigators

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