Study of Seladelpar and Cilofexor in Participants With Primary Biliary Cholangitis
A Phase 2 Proof-of-Concept Study With a Randomized, Double-Blind, Placebo-Controlled Period, Followed by an Active Treatment Extension Period to Assess the Safety and Efficacy of Seladelpar and Cilofexor in Combination for Primary Biliary Cholangitis
The goal of this clinical study is to learn more about the combination of study drugs seladelpar and cilofexor. The study will assess, the safety, tolerability, and effectiveness of the combination drugs versus both seladelpar alone and placebo, in participants with primary biliary cholangitis (PBC).
The primary objective of this study is to determine whether the combination of seladelpar + cilofexor leads to greater alkaline phosphatase (ALP) reduction than seladelpar alone and describe the safety and tolerability of seladelpar + cilofexor.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Geschat)
Fase
- Fase 2
Contacten en locaties
Studiecontact
- Naam: Gilead Clinical Study Information Center
- Telefoonnummer: 1-833-445-3230 (GILEAD-0)
- E-mail: GileadClinicalTrials@gilead.com
Studie Locaties
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Colorado
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Colorado Springs, Colorado, Verenigde Staten, 80907
- Werving
- Peak Gastroenterology Associates
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Florida
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Lakewood Rch, Florida, Verenigde Staten, 34211
- Werving
- Florida Research Institute
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30327
- Werving
- Digestive Healthcare of Georgia
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Tennessee
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Johnson City, Tennessee, Verenigde Staten, 37604
- Werving
- GI Associates of Northeast Tennessee
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Key Inclusion Criteria:
-
Have a diagnosis of primary biliary cholangitis (PBC) as defined by a history of any 2 of the following criteria:
- ALP above 1.0 × the ULN for at least 6 months
- Positive antimitochondrial antibody titer (> 1:40 on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay) or positive PBC-specific antinuclear antibodies
- Documented liver biopsy results consistent with PBC
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Used ursodeoxycholic acid (UDCA) for the past 12 months (stable dose for > 6 months prior to screening), or intolerant to UDCA (last dose of UDCA > 90 days prior to screening)
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Have an ALP ≥ 1.67 × ULN at screening
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Have a negative serum pregnancy test at screening
Key Exclusion Criteria:
- Have other causes of liver disease including viral, alcoholic, autoimmune, and metabolic associated steatohepatitis (MASH).
- Cirrhosis with Child-Pugh Score ≥ 7, corresponding to Class B or C. Individuals with compensated cirrhosis (ie, Child-Pugh Class A) are allowed if they meet all other criteria.
- Have evidence of portal hypertension or clinically important hepatic decompensation (historic or current), including but not limited to: hepatic encephalopathy, known esophageal or gastric varices, history of liver transplantation, current placement on liver transplant list, Model for End Stage Liver Disease score ≥ 12, ascites, spontaneous bacterial peritonitis, hepatorenal syndrome.
- Have previous exposure to seladelpar or cilofexor
- Used obeticholic acid, fenofibrate, bezafibrate, elafibranor, pemafibrate, or saroglitazar within 6 weeks (42 days, inclusive) of screening date
- Require or expect to require treatment with ≥ 5 mg prednisone (or systemic equivalents) for > 2 weeks during the study
- Are on any systemic drug for antipruritic treatment that has required a dose adjustment in the 30 days before screening, or initiated a systemic antipruritic drug in the 30 days before screening
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Seladelpar (SEL) 10 mg + Placebo-to-Match (PTM) Cilofexor (CILO) Dose A + CILO Dose B
Participants will receive a dose of SEL 10 mg capsule along with PTM CILO Dose A tablets and CILO Dose B tablets, once daily up to 24 weeks. At completion of Week 24, participants will continue in an Active Treatment Extension (ATE) Period, during which they will receive SEL 10 mg along with either CILO Dose A or Dose B at the original randomized dose in a blinded fashion, up to Week 312. |
Capsule administered orally Tablet administered orally Tablet administered orally |
|
Experimenteel: SEL 10 mg + CILO Dose A + PTM CILO Dose B
Participants will receive a dose of SEL 10 mg capsule along with CILO Dose A tablets and PTM CILO Dose B tablets, once daily up to 24 weeks. At completion of Week 24, participants will continue in an ATE Period, during which they will receive SEL 10 mg along with either CILO Dose A or Dose B at the original randomized dose in a blinded fashion, up to Week 312. |
Capsule administered orally Tablet administered orally Tablet administered orally |
|
Actieve vergelijker: SEL 10 mg + PTM CILO Dose A + PTM CILO Dose B
Participants will receive a dose of SEL 10 mg capsule along with PTM CILO Dose A tablets and PTM CILO Dose B tablets, once daily up to 24 weeks. At completion of Week 24, participants will continue in an ATE Period, during which they will initiate open-label SEL 10 mg and be re-randomized in a 1:1 ratio to receive CILO Dose A or Dose B in a blinded fashion, up to Week 312. |
Capsule administered orally Tablet administered orally Tablet administered orally |
|
Placebo-vergelijker: PTM SEL 10 mg + PTM CILO Dose A + PTM CILO Dose B
Participants will receive a dose of PTM SEL 10 mg capsule along with PTM CILO Dose A tablets and PTM CILO Dose B tablets once daily up to 24 weeks. At completion of Week 24, participants will continue in an ATE Period, during which they will initiate open-label SEL 10 mg and be re-randomized in a 1:1 ratio to receive CILO Dose A or Dose B in a blinded fashion, up to Week 312. |
Tablet administered orally Tablet administered orally Capsule administered orally |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Change From Baseline in Serum Concentration of Alkaline Phosphate (ALP) at Week 24
Tijdsspanne: Baseline, Week 24
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Baseline, Week 24
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Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Tijdsspanne: First dose up to 30 days post last dose (up to 318 weeks)
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First dose up to 30 days post last dose (up to 318 weeks)
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Percentage of Participants Experiencing Serious Adverse Events (SAEs)
Tijdsspanne: First dose up to 30 days post last dose (up to 318 weeks)
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First dose up to 30 days post last dose (up to 318 weeks)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Proportion of Participants Achieving the Biochemistry Composite Endpoint at Week 24
Tijdsspanne: Week 24
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Defined as the percentage of participants with ALP < 1.67 × upper limit of normal (ULN), ALP decrease of ≥ 15%, and total bilirubin ≤ 1 × ULN. |
Week 24
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Proportion of Participants Achieving ALP Normalization at Week 24
Tijdsspanne: Week 24
|
ALP Normalization is defined as ALP ≤ 1.0 × ULN. |
Week 24
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Change From Baseline to Week 24 in Weekly Average Pruritus Numerical Rating Scale (NRS)
Tijdsspanne: Baseline, Week 24
|
Baseline, Week 24
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Gilead Study Director, Gilead Sciences
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- GS-US-763-7930
- 2026-525722-37 (Andere identificatie: EU Trial (CTIS) number)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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