NL-OMON45834已完成2 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 - AMG 714 in adult patients with Type II Refractory Celiac Disease
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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, etc.).;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) less than 3x the upper limits of normal (ULN)
- •c) Total bilirubin of less than 2.5 x ULN
- •d) Total white blood cell count (WBC) > 300/mm3
- •e) Platelet count > 85,000/mm3
- •f) INR less than 1.5
- •g) Albumin of more than 10 g/L (i.e., 1 g/dL or 1.45 mol/L)
- •10. Subjects receiving systemic steroids must be on a stable dose for at least 4 weeks prior to randomization, the dose should not exceed 20 mg of prednisone, prednisolone or equivalent per day. Oral budesonide will be accepted at a maximum dose of 9 mg per day.
- •11. Willingness and ability to comply with study procedures and protocol stipulated concomitant medication guidelines
排除标准
- •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 cancer
- •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.
- •6. History of alcohol or drug abuse that would interfere with the ability to comply with the study protocol.
- •7. History of clinically significant hypersensitivity to the study drug or any related drugs or to any of the excipients.
- •8. Positive hepatitis B (Hep B), hepatitis C (Hep C), or Human immunodeficiency virus (HIV) infection test results at the time of screening.
- •9. Females who are pregnant or are planning to become pregnant during the study participation period or 6 months after last dose, or are currently breastfeeding.
- •10. Participation in another investigational drug or device study or treatment with an investigational drug within 30 days or 5 half-lives, whichever is longer, prior to randomization
- •11. Any additional reason, which in the opinion of the Investigator, would prevent the subject from safe
研究者
相似试验
进行中（未招募）
1 期
Randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of ANB019 in the treatment of Aniceiform Rash in patients with Cancer receiving EGFRi or MEKi therapyAcneiform RashMedDRA version: 21.0Level: LLTClassification code 10037847Term: Rash acneiformSystem Organ Class: 100000004858EUCTR2020-003494-22-CZAnaptysBio Inc.45
进行中（未招募）
不适用
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of BG00012 when given with Methotrexate to Subjects with Active Rheumatoid Arthritis who have had an Inadequate Response to Coventional Disease-Modifying Anti-rheumatic Drug TherapyMedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritisRheumatoid ArthritisEUCTR2008-004754-33-CZBiogen Idec Limited150
已完成
2 期
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Antiviral Activity of SPC3649 (miravirsen) Administered to Treatment-Naïve Subjects with Chronic Hepatitis C (CHC) Infectioliver inflammation10047438Hepatitis CNL-OMON34513Santaris Pharma A/S16
进行中（未招募）
1 期
A study to examine the effectiveness and safety of a experimental new treatment (AMG 714) for adult patients with Type II Refractory Celiac Disease.Type II Refractory Celiac Disease (RCD-II)EUCTR2015-004063-36-ESCelimmune LLC28
进行中（未招募）
不适用
Efficacy and Safety Study in Mild Asthmatic Subjects Undergoing Allergen ChallengeMild asthma with allergen challengeMedDRA version: 16.1Level: LLTClassification code 10003561Term: Asthma, unspecifiedSystem Organ Class: 100000004855EUCTR2012-001729-28-DEInfinity Pharmaceuticals, Inc.54