A Study of LY3981314 in Participants With Autoimmune Hepatitis
An Open Label, Single-Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effect of LY3981314 in Patients With Autoimmune Hepatitis
The purpose of the study is to assess if a single dose of LY3981314 is safe in participants with autoimmune hepatitis. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body
The study will last about 30 weeks.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- フェーズ 1
連絡先と場所
研究連絡先
研究連絡先
- 名前:Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- 電話番号:1-317-615-4559
- メール:LillyTrials@Lilly.com
研究連絡先のバックアップ
- 名前:Physicians interested in becoming principal investigators please contact
- メール:clinical_inquiry_hub@lilly.com
研究場所
-
-
Indiana
-
Indianapolis、Indiana、アメリカ、46202
- Indiana University Health
-
主任研究者:
- Craig Lammert
-
コンタクト:
- 電話番号:317-278-9292
-
-
Texas
-
Dallas、Texas、アメリカ、75203
- Methodist Dallas Medical Center
-
主任研究者:
- Parvez Mantry
-
コンタクト:
- 電話番号:214-947-4450
-
-
参加基準
適格基準
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
Inclusion Criteria:
-
Have a confirmed diagnosis of autoimmune hepatitis (AIH) for greater than or equal to (≥) 6 months according to American Association for the Study of Liver Diseases diagnostic criteria (Appendix 8, Section 10.8)
-
Have alanine aminotransferase (ALT) greater than (>) 1.5x upper limit of normal (ULN) to less than (<) 5x ULN
-
Have elevated soluble FAS (sFAS) based on Sponsor predetermined threshold
-
Be on a stable immunosuppressive medication regimen for AIH with no dose changes or weaning of treatment for ≥8 weeks prior to screening, and no anticipated medication adjustments until after the post-treatment liver biopsy at Day 29. The following medications are permitted for the management of AIH:
- Azathioprine
- 6-Mercaptopurine
- Inhibitors of inosine monophosphate dehydrogenase (mycophenolate mofetil, mycophenolate sodium, mycophenolic acid)
- Tacrolimus
- Cyclosporine
- Corticosteroids at a dose equivalent to less than or equal to (≤) 10 mg of prednisone per day
Exclusion Criteria:
-
Have clinical, laboratory, histological, or imaging evidence of cirrhosis
-
Have a controlled attenuation parameter (CAP) score >300 decibel-milliwatt (dB/m) as measured by transient elastography
-
Have clinical evidence of hepatic decompensation as defined by the presence of any of the following abnormalities
- international normalized ratio >1.3
- history of esophageal varices, ascites or hepatic encephalopathy
-
Have or had other forms of chronic liver disease per Medical History:
- alcoholic liver disease
- hepatitis B
- hepatitis C
- history of primary biliary cholangitis or primary sclerosing cholangitis
- history of celiac disease, or other autoimmune disorders including immune-checkpoint related hepatitis associated with elevated aminotransferases
- uncontrolled thyroid disease
- current drug-induced liver disease based on typical exposure and history
- metabolic dysfunction associated steatohepatitis, Wilson's disease, hemochromatosis, alpha-1-antitrypsin deficiency, or cystic fibrosis-related liver disease
- suspected or proven liver cancer
- any other physician confirmed liver disease other than AIH
-
Have any medical condition that, in the opinion of the investigator, may increase the risk of complications related to liver biopsy (for example, a known coagulopathy, inherited disorders of hemostasis, sickle cell disease, amyloidosis)
-
Have any of the following laboratory abnormalities at screening:
-
Platelet count <150,000/cubic millimeter (mm³)
-
Hemoglobin
- <10 grams per deciliter (g/dL) for individuals assigned female at birth (AFAB)
- <11 g/dL for individuals assigned male at birth (AMAB)
-
Absolute neutrophil count <1000/mm³
-
Transferrin saturation >50 percentage (%) (except when it has been demonstrated that a diagnosis of hemochromatosis has been excluded by genetic testing or when a previous liver biopsy has demonstrated no evidence of iron overload.)
-
Total bilirubin > ULN unless known Gilbert's syndrome per Medical History.
- Gilbert's syndrome participant must have normal direct bilirubin; if diagnosis of Gilbert's cannot be confirmed by medical records, participant may not participate in the study
-
Have renal impairment measured as estimated glomerular filtration rate<60 milliliters per minute (mL/min)/1.73 square meter (m²), calculated using the Chronic Kidney Disease Epidemiology Collaboration Creatinine Equation (2021 version), as determined by the local laboratory during screening
-
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:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的:LY3981314
LY3981314 administered subcutaneously (SC) |
Administered SC |
この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
時間枠:Baseline up to Approximately Week 25
|
Baseline up to Approximately Week 25
|
二次結果の測定
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Pharmacokinetics (PK): Plasma Concentrations of LY3981314
時間枠:Baseline Up to Approximately Week 25
|
Baseline Up to Approximately Week 25
|
協力者と研究者
捜査官
捜査官
- スタディディレクター:Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)、Eli Lilly and Company
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- 27811
- J6H-MC-KXAB (その他の識別子:Eli Lilly and Company)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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