Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)

Gilead Sciences

Status and phase: Enrolling; Phase 3

Conditions: Primary Biliary Cirrhosis

Treatments: Drug: Seladelpar 10 mg Capsule; Drug: Seladelpar 5 mg Capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT03301506

2020-005198-29 (EudraCT Number)

2024-511753-22-00 (EU Trial (CTIS) Number)

CB8025-31731-RE

Details and patient eligibility

About

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

Full 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)

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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 (LLN) AND total bilirubin above 1 × ULN)

7. eGFR ≤45 mL/min/1.73 m2 (calculated by MDRD 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

14. Current use of fibrates or use of fibrates within 3 months prior to Screening

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 the 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:

    1. Hepatitis B, defined as the presence of hepatitis B surface antigen
    2. Hepatitis C, defined as the presence of hepatitis C virus ribonucleic acid (RNA)
    3. Human immunodeficiency virus (HIV) antibody

23. Active COVID-19 infection during screening

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Seladelpar 5 mg Capsules

Experimental group

Treatment:

Drug: Seladelpar 5 mg Capsule

Seladelpar 10 mg Capsule

Experimental group

Treatment:

Drug: Seladelpar 10 mg Capsule