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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
Kontakter och platser
Studiekontakt
- Namn: Gilead Clinical Study Information Center
- Telefonnummer: 1-833-445-3230 (GILEAD-0)
- E-post: GileadClinicalTrials@gilead.com
Studieorter
-
-
Colorado
-
Colorado Springs, Colorado, Förenta staterna, 80907
- Rekrytering
- Peak Gastroenterology Associates
-
-
Florida
-
Lakewood Rch, Florida, Förenta staterna, 34211
- Rekrytering
- Florida Research Institute
-
-
Georgia
-
Atlanta, Georgia, Förenta staterna, 30327
- Rekrytering
- Digestive Healthcare of Georgia
-
-
Tennessee
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Johnson City, Tennessee, Förenta staterna, 37604
- Rekrytering
- GI Associates of Northeast Tennessee
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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 |
|
Experimentell: 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 |
|
Aktiv komparator: 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-jämförare: 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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Change From Baseline in Serum Concentration of Alkaline Phosphate (ALP) at Week 24
Tidsram: Baseline, Week 24
|
Baseline, Week 24
|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Tidsram: 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)
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Proportion of Participants Achieving the Biochemistry Composite Endpoint at Week 24
Tidsram: 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
Tidsram: 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)
Tidsram: Baseline, Week 24
|
Baseline, Week 24
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Gilead Study Director, Gilead Sciences
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- GS-US-763-7930
- 2026-525722-37 (Annan identifierare: EU Trial (CTIS) number)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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