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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
Contacts et emplacements
Coordonnées de l'étude
- Nom: Gilead Clinical Study Information Center
- Numéro de téléphone: 1-833-445-3230 (GILEAD-0)
- E-mail: GileadClinicalTrials@gilead.com
Lieux d'étude
-
-
Colorado
-
Colorado Springs, Colorado, États-Unis, 80907
- Recrutement
- Peak Gastroenterology Associates
-
-
Florida
-
Lakewood Rch, Florida, États-Unis, 34211
- Recrutement
- Florida Research Institute
-
-
Georgia
-
Atlanta, Georgia, États-Unis, 30327
- Recrutement
- Digestive Healthcare of Georgia
-
-
Tennessee
-
Johnson City, Tennessee, États-Unis, 37604
- Recrutement
- GI Associates of Northeast Tennessee
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
-
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)
-
Have an ALP ≥ 1.67 × ULN at screening
-
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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 |
|
Expérimental: 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 |
|
Comparateur actif: 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 |
|
Comparateur placebo: 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 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Change From Baseline in Serum Concentration of Alkaline Phosphate (ALP) at Week 24
Délai: Baseline, Week 24
|
Baseline, Week 24
|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Délai: 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)
|
|
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Proportion of Participants Achieving the Biochemistry Composite Endpoint at Week 24
Délai: Week 24
|
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
|
|
Proportion of Participants Achieving ALP Normalization at Week 24
Délai: Week 24
|
ALP Normalization is defined as ALP ≤ 1.0 × ULN. |
Week 24
|
|
Change From Baseline to Week 24 in Weekly Average Pruritus Numerical Rating Scale (NRS)
Délai: Baseline, Week 24
|
Baseline, Week 24
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Gilead Study Director, Gilead Sciences
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- GS-US-763-7930
- 2026-525722-37 (Autre identifiant: EU Trial (CTIS) number)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .