A Trial of Inebilizumab in Participants With Autoimmune Hepatitis (MERCURY)
A Phase 2/3, Randomized, Double-blind, Multicenter, Placebo-controlled Study of Inebilizumab in Participants With Autoimmune Hepatitis
The main objectives of this trial are to evaluate the safety and tolerability of inebilizumab in participants with autoimmune hepatitis (AIH) (Part 1) and to evaluate the efficacy of inebilizumab on AIH disease activity and glucocorticoid (GC) use in the management of AIH (Part 2).
調査の概要
詳細な説明
This study will consist of a screening period (up to 56 days), a randomized controlled treatment period (78 weeks), an optional open label period (OLP) up to 78 weeks (or until potential availability of the marketed drug) for eligible participants who complete the treatment period, and a safety follow-up (SFU) period up to 78 weeks.
The randomized controlled treatment period will be divided in 2 parts, a phase 2 dose confirmation and safety part (Part 1) and an efficacy evaluating phase 3 (Part 2). Part 1 will conclude when the last Part 1 participant has had the opportunity to complete the Week 26 visit. Part 2 will begin without pausing enrollment; the same randomization ratio and study procedures are maintained.
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Amgen Call Center
- 電話番号：866-572-6436
- メール：medinfo@amgen.com
研究場所
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Arkansas
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Little Rock、Arkansas、アメリカ、72205
- 募集
- Applied Research Center of Arkansas
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California
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Rialto、California、アメリカ、92377
- 募集
- Inland Empire Liver Foundation
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Valencia、California、アメリカ、91355
- 終了しました
- Amicis Research Center
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Florida
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Jacksonville、Florida、アメリカ、32224
- 募集
- Mayo Clinic Jacksonville
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Largo、Florida、アメリカ、33771
- 募集
- Florida Research Institute
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Miami Lakes、Florida、アメリカ、33016
- 募集
- Floridian Clinical Research LLC
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Indiana
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Indianapolis、Indiana、アメリカ、46202
- 募集
- Indiana University
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Minnesota
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Rochester、Minnesota、アメリカ、55905
- 募集
- Mayo Clinic Rochester
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- 募集
- University of Pennsylvania
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South Carolina
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Charleston、South Carolina、アメリカ、29425
- 募集
- Medical University of South Carolina
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Texas
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Dallas、Texas、アメリカ、75203
- 募集
- Methodist Cardiovascular Consultants - Dallas
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San Antonio、Texas、アメリカ、78215
- 募集
- American Research Corporation
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Rozzano、イタリア、20089
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- IRCCS Istituto Clinico Humanitas
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Quebec
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Montreal、Quebec、カナダ、H2X 0A9
- 募集
- Centre de Recherche du Centre Hospitalier de l Universite de Montreal
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Montreal、Quebec、カナダ、H4A 3J1
- 募集
- McGIll University Health Centre Glen Site
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Jena、ドイツ、07747
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- Universitaetsklinikum Jena
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Zalaegerszeg、ハンガリー、8900
- 募集
- Obudai Egeszsegugyi Centrum Kft
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Paris、フランス、75012
- 募集
- Hôpital Saint Antoine
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Leuven、ベルギー、3000
- 募集
- Universitair Ziekenhuis Leuven
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Anhui
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Hefei、Anhui、中国、230601
- 募集
- The Second Hospital of Anhui Medical University
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100730
- 募集
- Peking Union Medical College Hospital
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Beijing、Beijing Municipality、中国、100034
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- Peking University First Hospital
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Beijing、Beijing Municipality、中国、100069
- 募集
- Beijing Youan Hospital, Capital Medical University
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Beijing、Beijing Municipality、中国、100050
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- Beijing Friendship Hospital, Capital Medical University
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Chongqing Municipality
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Chongqing、Chongqing Municipality、中国、400010
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- The Second Affiliated Hospital of Chongqing Medical University
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Fujian
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Fuzhou、Fujian、中国、350025
- 募集
- Mengchao Hepatobiliary Hospital of Fujian Medical University
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Henan
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Zhengzhou、Henan、中国、450052
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- The First Affiliated Hospital of Zhengzhou University
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Hubei
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Wuhan、Hubei、中国、430022
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- Union Hospital Tongji Medical College Huazhong University of Science and Technology
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Jiangsu
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Nanjing、Jiangsu、中国、210008
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- Nanjing Drum Tower Hospital
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Nanjing、Jiangsu、中国、210003
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- The Second Hospital of Nanjing
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Suzhou、Jiangsu、中国、215131
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- The Fifth Peoples Hospital of Suzhou
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Jilin
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Changchun、Jilin、中国、130021
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- The First Bethune Hospital of Jilin University
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200001
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- Renji Hospital Shanghai Jiaotong University School of Medicine
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Sichuan
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Chengdu、Sichuan、中国、610044
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- West China Hospital Sichuan University
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Tianjin Municipality
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Tianjin、Tianjin Municipality、中国、300052
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- Tianjin Medical University General Hospital
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Tianjin、Tianjin Municipality、中国、300384
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- Tianjin First Central Hospital
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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
Inclusion Criteria:
- Signed informed consent.
- Age ≥ 18 years or legal adult age within the country, whichever is older and < 75 years at the time of signing the informed consent.
- Participants must have either inadequate response to at least 9 months of SOC or are intolerant to SOC within 6 months of screening. Inadequate response to SOC treatment is defined as ALT ≥ 2 upper limit of normal (ULN) at screening after at least 9 months of SOC, including prednisone (or equivalent) > 5 mg/day and at least one conventional steroid sparing agent at guideline-concordant target or highest appropriate dose, that is azathioprine (AZA) or 6-mercaptopurine (6-MP) at appropriate weight-based dosing (typically up to 2 mg/kg/day AZA or 1 mg/kg/day 6-MP) or mycophenolate (MMF) up to 2 g/day, as judged appropriate by the investigator and documented in the medical record.
Intolerance to SOC treatment is defined as any clinically significant adverse event related to treatment that results in discontinuation of the medication or prevents dose optimization necessary to achieve or maintain biochemical response, as determined by the Principal Investigator (PI). Intolerance applies to GCs, AZA, 6-MP, or MMF. Presence of one or more clinically significant adverse effects attributed to SOC include but not limited to side effects that, in the opinion of the investigator, compromise participant's safety or quality of life, exacerbate comorbid conditions, or render continued use medically inappropriate.
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Participants with disease activity at screening as follows: ALT ≥ 2 x ULN to ≤ 7 x ULN. ALT ULN values will be gender specific.
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Participant must have a biopsy proven definitive diagnosis of AIH according to simplified diagnostic criteria (score ≥ 7). Liver biopsy should be obtained within 90 days prior to randomization. Participants must have a mHAI score ≥ 5 in the biopsy.
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Participant should be on:
- No increase in GC dose during the 28 days immediately preceding whichever biopsy is designated as the baseline sample-historical or screening-and the dose post biopsy must remain unchanged through the day of randomization AND
- Stable maximum tolerated doses of AZA or 6-MP for at least 12 weeks prior to screening (baseline) liver biopsy until randomization and during the entire treatment period unless dose reduction is deemed necessary for safety or tolerance reasons OR
- Stable maximum tolerated doses of MMF/mycophenolic acid (MPA) for at least 12 weeks prior to screening (baseline) liver biopsy until randomization and during the entire treatment period unless dose reduction is deemed necessary for safety or tolerance reasons.
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Participants must use protocol-specified contraception during treatment and for an additional 6 months after the last dose of trial intervention.
Exclusion Criteria:
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Diagnosis of definitive overlap autoimmune liver or rheumatologic syndrome with autoimmune hepatitis (eg, AIH + primary biliary cholangitis [PBC], AIH + primary sclerosing cholangitis [PSC], AIH related to Systemic Lupus Erythematosus, etc) where established overlap criteria are met.
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Acute liver failure (ALF) at screening (e.g., acute hepatic dysfunction with coagulopathy and any degree of encephalopathy) in the investigator's judgment.
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Participant has known history of:
- Allergy or reaction to any component of inebilizumab formulation or history of anaphylaxis to any human gamma globulin therapy.
- Allergy to or intolerance of protocol-required treatment, including medications for prophylaxis of infusion reactions (antipyretic such as paracetamol/acetaminophen or equivalent, diphenhydramine or equivalent, and methylprednisolone or equivalent).
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Active malignancy or history of malignancy that was active within the last 10 years, except as follows:
- In situ carcinoma of the cervix treated with apparent success with curative therapy for > 12 months prior to screening
- Curatively treated breast ductal carcinoma in situ
- Cutaneous basal cell or squamous cell carcinoma treated with apparent success with curative therapy for > 12 months prior to screening
- Prostate cancer treated with radical prostatectomy or radiation therapy with curative intent > 3 years prior to screening and without known recurrence or current treatment
- Thyroid cancer for which complete surgical resection has been performed within 5 years with well-differentiated histology (papillary thyroid carcinoma or follicular thyroid carcinoma) and there is no evidence of active disease.
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Known positive test for human immunodeficiency virus (HIV) infection. Evidence of HIV infection or positive for HIV antibodies at initial screening or current acquired, common variable or inherited, primary or secondary immunodeficiency.
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Presence or history of viral hepatitis infection:
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Positive test for, or prior treatment for, hepatitis B. A positive test for hepatitis B is detection of either:
- Positive for hepatitis B surface antigen (HBsAg) OR
- anti-HBc
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Participants with a history of or current hepatitis C virus (HCV) infection, even those considered to be cured.
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Active tuberculosis (TB) or latent TB with no documented history of adequate treatment per local SOC.
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Positive test for TB during screening is defined as positive QuantiFERON® test. At screening, all participants must be tested with an interferon-γ release assay (IGRA) (QuantiFERON®).
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History of > 1 episode of herpes zoster (any grade) and/or any other definite or probable opportunistic infection in the 12 months prior to screening.
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Estimated glomerular filtration rate < 45 mL/min/1.73 m^2 using chronic kidney disease epidemiology (CKD-EPI) 2021 formula.
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Blood tests at screening that meet any of the following criteria:
- Hemoglobin < 7.5 g/dL
- Neutrophils < 1200/mm^3
- Platelets < 150 x 10^9/L
- international normalized ratio (INR) > 1.3
- cluster of differentiation 19 (CD19)+ B cells at screen < 40 cells/µL; an exclusionary value may be repeated.
- Serum albumin level < 35 g/L
- Direct bilirubin (BIL) in serum >ULN
- Total BIL ≥ 2.0 mg/dL
- ALP > 1.5 x ULN
- AST > 7 x ULN Note: Participants with baseline cytopenia (where permitted) may be enrolled if, in the Investigator's judgment, the cytopenia derives from an alternative to AIH condition (eg, medication effect, nutritional deficiency, anemia of chronic disease etc).
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Active, clinically significant infection at the time of randomization (investigational product administration may be delayed until recovery, if within screening window, otherwise participant may be rescreened).
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History or evidence of uncontrolled alcohol use disorder (AUD), defined as participants who have a history of significant alcohol consumption, ie, consumption of >2 units/day for males and >1 unit/day for females, sustained for ≥ 3 consecutive months.
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History of recurrent significant infections (eg, requiring hospitalization or IV antibiotics) within the past 12 months.
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Major surgery within 8 weeks before screening.
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Severe cardiovascular, respiratory, endocrine, gastrointestinal, hematological, neurological, psychiatric, or systemic disorder, or any other condition that, in the opinion of the Investigator, would place the participant at unacceptable risk of complications, interfere with evaluation of the Investigational product or confound the interpretation of participant safety or trial results.
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Known immunodeficiency disorder.
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Participants with moderate-to-severe metabolic dysfunction-associated steatohepatitis (MASH) on screening/baseline liver biopsy, defined by central pathology review as steatosis grade ≥ 2 with lobular inflammation ≥ 1, and hepatocellular ballooning ≥ 1.
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Participants with decompensated cirrhosis, either historical or present at screening defined by:
- Histologic cirrhosis on screening or prior liver biopsy (fibrosis stage F4 / Ishak 5-6), and
- Prior hepatic decompensation or Child-Pugh B-C.
- Child-Pugh category A at screening, without a history of prior hepatic decompensation (ascites, encephalopathy, variceal bleeding, spontaneous bacterial peritonitis [SBP], hepatorenal syndrome [HRS], acute-on-chronic liver failure, or progression to decompensated cirrhosis), is eligible.
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Participant with a history of drug-induced liver injury (DILI), regardless of offending agent.
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Receipt of any biologic B cell-depleting therapy (eg, rituximab, ocrelizumab, obinutuzumab, ofatumumab, inebilizumab, ianalumab) in the 6 months prior to screening.
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Receipt of non-depleting B cell-directed therapy (eg, belimumab), abatacept, or other biologic immunomodulatory agent within 6 months prior screening.
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Receipt of tumor necrosis factor (TNF) inhibitors (eg, infliximab, adalimumab) within 6 months prior screening.
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Receipt of immunosuppressive agents such as calcineurin inhibitors (tacrolimus, cyclosporin except eye drops), methotrexate, mammalian target of rapamycin inhibitors (eg, everolimus) within 6 weeks prior screening.
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Receipt of any investigational agent < 12 weeks or < 5 half-lives of the drug (whichever is longer) prior to screening.
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History of inability to be tapered off of GC therapy due to adrenal insufficiency or due to recurrent or prolonged systemic glucocorticoid therapy for any medical condition other than AIH (eg, severe steroid-dependent asthma) according to PI.
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All vaccines are prohibited within 4 weeks before the first dose of trial treatment.
- Participants are recommended to be administered vaccines at least 4 weeks prior to dosing in accordance with local recommendations prior to enrollment to allow for adequate immune response.
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Required regular use of medications with known hepatotoxicity.
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Current use of:
- GCs (prednisone > 20 mg/day, or equivalent dose of other GCs)
- AZA > 2 mg/kg/day
- 6-MP > 1 mg/kg/day
- MMF > 2 g/day or MPA > 1440 mg/day.
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Any concomitant immunosuppressive treatment, alone or in combination with GCs, except for AZA, 6-MP, MMF, and MPA.
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Undetectable levels of 6-thioguanine nucleotides (6-TGN) or MPA during screening unless participants are not on AZA or MMF/MPA due to intolerance per protocol.
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No new Herbal and Dietary Supplements (HDS) products for 4 weeks prior to first dose of inebilizumab.
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Currently receiving a trial intervention, or less than 30 days or 5 half-lives if known (whichever is later) since ending a trial intervention in another investigational device or drug trial.
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Unable to safely undergo a liver biopsy.
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Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements, in the judgment of the individual and investigator.
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History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety.
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Currently pregnant (confirmed with positive pregnancy test) or breastfeeding or planning to become pregnant, donate eggs, or breastfeed while on trial until an additional 6 months after the last dose of inebilizumab (if applicable) with highest teratogenic risk.
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Participants of childbearing potential with a positive pregnancy test assessed by serum pregnancy test at screening and a urine pregnancy test at Day 1 visit.
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Participant unwilling to abstain from donating blood or plasma during the trial.
In order for participants to continue to OLP, they must:
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Have completed the randomized controlled treatment period Week 78 visit and received all doses or not discontinued investigational product for any of the following reasons:
- Anaphylaxis or a serious hypersensitivity reaction that occurred within 7 days after IV dosing and cannot be attributed to another known allergen exposure.
- Any adverse events or significant laboratory abnormality that, in the opinion of the investigator, Amgen, or Data Monitoring Committee (DMC), warrants discontinuation of dosing.
- Any life-threatening (grade 4) infection.
- Any event of sepsis or febrile neutropenia.
- Any infection listed as either a definite or probable opportunistic infection.
- Any grade 3 infusion related reactions (IRR).
- Any grade 4 serious adverse events.
- Pregnancy or a decision to become pregnant.
- Malignancy.
- Absolute neutrophil count < 800 cells/µL confirmed by repeat testing.
- Determination that the participant was ineligible for trial participation and continuation of investigational product could pose a safety risk to the participant in the judgment of the investigator or the sponsor.
- Significant noncompliance with the trial protocol, as judged by the investigator or Amgen.
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Receive dose 1 in the OLP within the window of 7 days after the randomized controlled treatment period Week 78 visit and only after the Week 78 biopsy has been completed.
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Participants who meet protocol-defined early escape criteria and discontinue the RCP may enter the OLP, provided they have not discontinued investigational product for safety-related reasons that preclude further dosing.
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 |
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実験的：Part 1: Inebilizumab
Participants will receive inebilizumab as an intravenous (IV) infusion in addition to standard of care (SOC). |
Standard of Care Inebilizumab will be administered as an IV infusion.
他の名前：
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実験的：Part 1: Placebo
Participants will receive placebo as an IV infusion in addition to SOC. |
Placebo will be administered as IV infusion. Standard of Care |
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実験的：Part 2: Inebilizumab
Participants will receive Inebilizumab as an IV infusion in addition to SOC. |
Standard of Care Inebilizumab will be administered as an IV infusion.
他の名前：
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実験的：Part 2: Placebo
Participants will receive placebo as an IV infusion in addition to SOC. |
Placebo will be administered as IV infusion. Standard of Care |
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 |
メジャーの説明 |
時間枠 |
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Part 1: Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs of Interest at Week 26
時間枠：Up to Week 26
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Up to Week 26
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Part 2: Number of Participants who Achieved Modified Histologic Activity Index (mHAI) ≤ 3 and Stable Prednisone Dose (or equivalent) ≤ 5 mg/day at Week 78
時間枠：Week 78
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Participants who met the two outcomes combined will be reported for this endpoint. |
Week 78
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Part 1: Number of Participants who Achieved Normal Alanine Aminotransferase (ALT) Levels at Week 26
時間枠：Week 26
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Week 26
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Part 1: Change from Baseline in ALT Levels at Week 26
時間枠：Baseline and Week 26
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Baseline and Week 26
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Part 1: Maximum Serum Concentration (Cmax) of Inebilizumab
時間枠：Up to Week 26
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Up to Week 26
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Part 1: Area Under the Serum Concentration-time Curve (AUC) of Inebilizumab
時間枠：Up to Week 26
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Up to Week 26
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Part 1: Change from Baseline in Peripheral B Cell Counts at Week 26
時間枠：Baseline and Week 26
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Baseline and Week 26
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Part 2: Number of Participants who Achieved Stable Prednisone Dose (or equivalent) ≤ 5 mg/day by Week 78
時間枠：Week 78
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Week 78
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Part 2: Change from Baseline in ALT Levels at Week 78
時間枠：Baseline and Week 78
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Baseline and Week 78
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Part 2: Change from Baseline in Immunoglobulin G (IgG) Levels at Week 78
時間枠：Baseline and Week 78
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Baseline and Week 78
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Part 2: Change from Baseline in Aspartate Aminotransferase (AST) Levels at Week 78
時間枠：Baseline and Week 78
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Baseline and Week 78
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Part 2: Change from Baseline in mHAI at Week 78
時間枠：Baseline and Week 78
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Baseline and Week 78
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Part 2: Number of Participants who Achieved mHAI ≤ 3 at Week 78
時間枠：Week 78
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Week 78
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Part 2: Number of Participants who Achieved Flare-free, Stable GC-free (0 mg) Normalization of ALT by Week 78
時間枠：Week 78
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Week 78
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Part 2: Cumulative GC Dose per Participant for AIH
時間枠：Up to Week 78
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Up to Week 78
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Part 2: Number of Participants with Anti-drug Antibodies (ADA)
時間枠：Up to Week 78
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Up to Week 78
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Part 2: Cmax of Inebilizumab
時間枠：Up to Week 78
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Up to Week 78
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Part 2: AUC of Inebilizumab
時間枠：Up to Week 78
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Up to Week 78
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Part 2: Number of Participants who Experienced TEAEs, Serious TEAEs, and TEAEs of Interest
時間枠：Up to Week 78
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Up to Week 78
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Part 2: Change from Baseline of GC Toxicity Index Score at Week 78
時間枠：Baseline and Week 78
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Baseline and Week 78
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Part 2: Number of Participants who Achieved Sustained Normal ALT Levels and Stable Prednisone Dose (or equivalent) ≤ 5 mg/day by Week 78
時間枠：Week 78
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Sustained normal ALT levels is defined as achieving normal ALT levels in the 3 consecutive visits. Participants who met the two outcomes combined will be reported for this endpoint. |
Week 78
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Part 2: Number of Participants who Achieved Normal ALT Levels, mHAI ≤ 3 and Stable Prednisone Dose (or equivalent) ≤ 5 mg/day at Week 78
時間枠：Week 78
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Participants who met the three outcomes combined will be reported for this endpoint. |
Week 78
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Part 2: Number of Participants who Achieved Normal ALT Levels and Stable Glucocorticoid (GC) Free (0 mg) by Week 78
時間枠：Week 78
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Participants who met the two outcomes combined will be reported for this endpoint. |
Week 78
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Part 2: Time to Persistently Achieve Normal ALT Levels and Stable Prednisone (or equivalent) ≤ 5 mg/day Through Week 78
時間枠：Up to Week 78
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Time to achieve normal ALT levels is defined as as the first occurrence of normal ALT levels in at least 2 consecutive visits through Week 78. Participants who met the two outcomes combined will be reported for this endpoint. |
Up to Week 78
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Part 2: Number of Participants who Achieved Normal ALT and IgG Levels at Week 78
時間枠：Week 78
|
Participants who met the two outcomes combined will be reported for this endpoint. |
Week 78
|
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：MD、Amgen
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 (推定)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 20240237
- 2025-522393-37-00 (Ctis)
- 2025 (米国 NIH グラント/契約)
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?
IPD プランの説明
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD 共有時間枠
Data sharing requests relating to this trial will be considered beginning 18 months after the trial has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this trial.
IPD 共有アクセス基準
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen trial/trials in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。