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.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Gilead Clinical Study Information Center
- 電話番号：1-833-445-3230 (GILEAD-0)
- メール：GileadClinicalTrials@gilead.com
研究場所
-
-
Colorado
-
Colorado Springs、Colorado、アメリカ、80907
- 募集
- Peak Gastroenterology Associates
-
-
Florida
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Lakewood Rch、Florida、アメリカ、34211
- 募集
- Florida Research Institute
-
-
Georgia
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Atlanta、Georgia、アメリカ、30327
- 募集
- Digestive Healthcare of Georgia
-
-
Tennessee
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Johnson City、Tennessee、アメリカ、37604
- 募集
- GI Associates of Northeast Tennessee
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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 |
|
実験的：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 |
|
アクティブコンパレータ：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 |
|
プラセボコンパレーター：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 |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change From Baseline in Serum Concentration of Alkaline Phosphate (ALP) at Week 24
時間枠：Baseline, Week 24
|
Baseline, Week 24
|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
時間枠：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)
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of Participants Achieving the Biochemistry Composite Endpoint at Week 24
時間枠：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
時間枠：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)
時間枠：Baseline, Week 24
|
Baseline, Week 24
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Gilead Study Director、Gilead Sciences
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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