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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Gilead Clinical Study Information Center
- Número de teléfono: 1-833-445-3230 (GILEAD-0)
- Correo electrónico: GileadClinicalTrials@gilead.com
Ubicaciones de estudio
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Colorado
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Colorado Springs, Colorado, Estados Unidos, 80907
- Reclutamiento
- Peak Gastroenterology Associates
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Florida
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Lakewood Rch, Florida, Estados Unidos, 34211
- Reclutamiento
- Florida Research Institute
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Georgia
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Atlanta, Georgia, Estados Unidos, 30327
- Reclutamiento
- Digestive Healthcare of Georgia
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Tennessee
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Johnson City, Tennessee, Estados Unidos, 37604
- Reclutamiento
- GI Associates of Northeast Tennessee
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Key Inclusion Criteria:
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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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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 |
|
Experimental: 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 |
|
Comparador activo: 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 |
|
Comparador de placebos: 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 |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Change From Baseline in Serum Concentration of Alkaline Phosphate (ALP) at Week 24
Periodo de tiempo: Baseline, Week 24
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Baseline, Week 24
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Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Periodo de tiempo: 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)
Periodo de tiempo: First dose up to 30 days post last dose (up to 318 weeks)
|
First dose up to 30 days post last dose (up to 318 weeks)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of Participants Achieving the Biochemistry Composite Endpoint at Week 24
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: Baseline, Week 24
|
Baseline, Week 24
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Gilead Study Director, Gilead Sciences
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GS-US-763-7930
- 2026-525722-37 (Otro identificador: EU Trial (CTIS) number)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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