EUCTR2007-002544-25-CZ进行中（未招募）不适用
A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (anti-CXCL10 Human Monoclonal Antibody) in Subjects with Active Ulcerative Colitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 106
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
- •1. Subjects must be 18 years of age or older;
- •2. Subjects with active UC on stable doses of either 5-ASA, corticosteroids, AZA, and/or 6-MP;
- •3. Mayo score of 6 to 10 points with moderate to severe disease on endoscopy (Mayo endoscopic score of at least 2) performed = 14 days of study drug administration;
- •4. Subjects on the following medications may be enrolled into the study if the medications were initiated according to the following schedules before study drug administration and if no dosing changes are anticipated during the study;
- •a. prednisolone = 20 mg daily (or equivalent) (dose must be stable for at least 2 weeks prior to study drug administration);
- •b. 5-ASA (dose must be stable for at least 4 weeks prior to study drug administration);
- •c. AZA or 6-MP (dose must be stable for at least 3 months prior to study drug administration);
- •d. Rectal steroids or 5-ASA (must have been stable for at least 4 weeks prior to study drug administration)
- •- Subjects using rectal medications must have visible disease on sigmoidoscopy at = 20 cm;
- •5. Screening laboratory values must meet the following criteria:
- •Hemoglobin = 9.5 gm/dL
- •WBC = 3000/mm3
- •Neutrophils =1.5 x109/L
- •Platelets =125 x109/L
- •Prothrombin time (PT) =1.3 X control
- •Serum creatinine <2 mg/dL
- •AST =2 X upper limit of normal
- •ALT =2 X upper limit of normal
- •6. Women must be postmenopausal (> 12 months without menses) or surgically sterile (i.e., by hysterectomy and/or bilateral oophorectomy) or must be using effective contraception (i.e., oral contraceptives, intrauterine device (IUD), double barrier method of condom and spermicide) for at least 4 weeks prior to study drug administration and agree to continue contraception for the duration of their participation in the study. Women of childbearing potential must agree to use contraception for 70 days after their last dose of study drug; and
- •7. Sexually active male subjects must use a barrier method of contraception during the study and agree to the use of male contraception for at least 180 days after the last dose of study drug.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Anti-TNF therapy within 8 weeks before study drug administration;
- •2. Any experimental therapy = 4 weeks before study drug administration;
- •3. Prior treatment with any monoclonal antibody or immunoglobulin-based fusion proteins = 8 weeks prior to study treatment;
- •4. Prior treatment with an anti-CXCL10 antibody;
- •5. Presence of Cushing’s syndrome;
- •6. Toxic megacolon or fulminant disease likely to require colectomy;
- •7. Contraindication to colonoscopy or sigmoidoscopy;
- •8. Primary or secondary immunodeficiency;
- •9. Other autoimmune disease such as systemic lupus erythematosus or rheumatoid arthritis, with the exceptions of Sjogren’s Syndrome or organ-specific autoimmune diseases such as vitiligo or well controlled hypo- or hyper-thyroidism;
- •10. Any history of malignancy, excluding adequately treated and cured basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ;
- •11. Active major psychiatric disease (subjects with stable depression receiving appropriate medical management will be permitted in the study);
- •12. Evidence of acute or chronic infection as evidenced by:
- •Stool culture positive for pathogens and/or Clostridium difficile toxin
- •Findings on Screening chest radiography such as pulmonary infiltrate(s) or adenopathy
- •Current treatment for tuberculosis infection, clinical or radiological evidence of active TB (if necessary, confirmed by expert consultation), or for subjects in North America, a positive PPD without prior prophylaxis
- •Herpes zoster =3 months prior to study drug administration
- •Active infectious disease requiring i.v. antibiotics within 4 weeks prior to study treatment or oral antibiotics at the time of enrollment
- •HIV or AIDS
- •Positive tests for HBV, or HCV indicating active or chronic infection
- •13. Clinically significant cardiac disease requiring medication, unstable angina, myocardial infarction within 6 months before study drug administration, or congestive heart failure;
- •14. Arrhythmia requiring active therapy, with the exception of clinically insignificant extrasystoles, or minor conduction abnormalities;
- •15. History of cerebrovascular disease requiring medication/treatment;
- •16. Anticoagulation therapy (low-dose aspirin prophylaxis will be permitted) or a known bleeding disorder;
- •17. Seizure disorder requiring active therapy;
- •18. Known drug or alcohol abuse;
- •19. Pregnant or nursing;
- •20. Any underlying medical condition that in the Principal Investigator’s opinion will make the administration of study drug hazardous to the subject or would obscure the interpretation of study treatment efficacy or safety; or
- •21. Inability or unwillingness to return for Follow-up visits and comply with study protocol.
研究者
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