EUCTR2015-004063-36-FI进行中（未招募）1 期
A Phase 2a, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients with Type II Refractory Celiac Disease, an In Situ Small Bowel T Cell Lymphoma.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must fulfill all of the following inclusion criteria to be eligible for participation at screening and at Visit 1 (Week 0/Day 0):
- •1. Adult males or females 18 years of age or older.
- •2. Demonstrated willingness to participate in the study as
- •documented by signed informed consent.
- •3. Females of non-childbearing potential defined as
- •postmenopausal (>45 years of age with amenorrhea for at least
- •12 months or any age with amenorrhea for at least 6 months and
- •a serum follicle stimulating hormone [FSH] level >40 IU/L at
- •Screening); or permanently sterilized (e.g., bilateral tubal
- •occlusion, hysterectomy, bilateral salpingectomy,
- •oophorectomy); or otherwise incapable of pregnancy
- •Females of child bearing potential (FOCBP) or males who agree
- •to practice two highly effective methods of birth control (as
- •determined by the Investigator; one of the methods must be a
- •barrier technique) from Screening through the end of study
- •participation (Visit 9, Week 16/Day 112).
- •4. Prior confirmed diagnosis of RCD-II defined by the following
- •criteria: celiac disease confirmed by histology, endoscopy or
- •serology; with persistent and recurrent symptoms (e.g., diarrhea,
- •weight loss, abdominal pain); with abnormal small bowel
- •histology; with aberrant intraepithelial lymphocytosis of > 20
- •aberrant intraepithelial lymphocytes (IEL) per 100 CD45+ cells
- •as determined by flow cytometry (or >50% if determined by
- •immunohistochemistry); despite adherence to a strict GFD for at
- •least 6 months; and after exclusion of other potential causes of
- •symptomatic non-response (e.g., microscopic colitis, bacterial
- •overgrowth, lactose intolerance, exocrine pancreatic
- •insufficiency, hyperthyroidism, etc.) and intestinal histological
- •abnormality (autoimmune enteropathy, giardiasis,
- •immunodeficiency, collagenous sprue, Whipple’s disease,
- •NOTE: Subjects who have been treated for RCD-II must continue to
- •have increased aberrant IELs (>20% by flow cytometry or 50%
- •by IHC) and abnormal small bowel histology (Marsh =1) and
- •must have had prior history of symptoms, however symptoms are
- •not required of previously treated subjects, or subjects being
- •treated with steroids, at the time of study entry.
- •5. Total attempted adherence to a GFD for at least 6 consecutive
- •months prior to screening. Subjects must also agree to make no
- •changes to their current GFD for the duration of study
- •participation.
- •6. Anti-tissue transglutaminase (IgA and IgG) at screening <2 x the
- •diagnostic level for celiac disease (weak positive or negative).
- •7. Human leukocyte antigen DQ (HLA-DQ) typing compatible
- •with celiac disease provided or obtained prior to baseline biopsy.
- •8. Life expectancy > 4 months.
- •9. Laboratory values:
- •a) Estimated creatinine clearance (CCr) > 30
- •mL/min/1.73m2 using the Cockcroft-Gault equation
- •b) Serum alkaline phosphatase (AP), alanine transaminase
- •(ALT/SGPT), and aspartate aminotransferase (AST/SGOT)
- 另有 12 项未显示
排除标准
- •Subjects will be excluded from participation in the study if there is
- •evidence of any of the following, at screening or Visit 1:
- •1. Diagnosis of Type I Refractory Celiac Disease (RCD-I) or
- •enteropathy-associated T cell lymphoma (EATL, excluded by the
- •site’s standard imaging techniques for this purpose).
- •2. Presence of any of the following related to infection:
- •a) Active acute infection requiring systemic antibiotic,
- •parenteral antifungal, or systemic antiviral treatments
- •b) Severe infection within the 3 months prior to screening
- •c) History of tuberculosis (TB)
- •d) Positive Interferon Gamma Release Assay (IGRA) test at
- •screening OR known recent exposure (within 6 months prior
- •to screening) to a patient with active TB; the subject can be
- •enrolled if he or she has been successfully treated with
- •appropriate chemoprophylaxis.
- •e) History within the 3 years prior to screening of an
- •opportunistic infection typical of those seen in
- •immunocompromised subjects (e.g., systemic candida
- •infection, or systemic fungal infection).
- •3. Current diagnosis or history of cancer within the past 5 years,
- •except RCD-II, successfully-treated basal cell or squamous cell
- •carcinoma, cervical carcinoma-in-situ, or early stage prostate
- •4. History or presence of clinically significant disease that in the
- •opinion of the Investigator would confound the subject’s
- •participation and follow-up in the clinical trial or put the subject
- •at unnecessary risk including but not limited to:
- •a) Cardiovascular disease [e.g., uncontrolled hypertension
- •(defined as office systolic blood pressure [BP] equal to or
- •greater than 180 mmHg or office diastolic BP equal or
- •greater than 110 mm/Hg), unstable angina, congestive heart
- •failure worse than the New York Heart Association Class II,
- •coronary angioplasty or myocardial infarction within the last
- •6 months, uncontrolled atrial or ventricular cardiac
- •arrhythmias clinically significant pleural or pericardial
- •effusion or ascites)
- •b) pulmonary disease (e.g., severe chronic pulmonary disease)
- •c) renal, hematological, gastrointestinal, endocrine (e.g.,
- •poorly controlled diabetes), immunologic, dermatologic,
- •neurological, or psychiatric disease
- •5. History of significant immune suppression:
- •- Bone marrow transplant (BMT) or cladribine therapy less
- •than 6 months prior to baseline. In other words, cladribine
- •and bone marrow transplant naïve, primary non-responders
- •(treatment resistant), secondary non-responders (relapse
- •after response/remission) and incomplete responders may
- •be enrolled in the study if cladribine therapy and/or BMT
- •were not provided within the 6 months prior to
- •randomization.
- •- Potent systemic immune suppressants (e.g., azathioprine)
- •in the 3 months prior to baseline.
- 另有 13 项未显示
研究者
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