NL-OMON47395已完成2 期
An Open Label, Single Group, Long Term Safety Extension Trial of BI655066/ABBV-066 (Risankizumab), in Patients with Moderately to Severely Active Crohn's Disease. - Extension study of Risankizumab in Crohn's disease
AbbVie0 个研究点目标入组 6 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
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. Patients with Crohn`s disease, who have successfully completed the preceding trial 1311.6. Successful treatment is defined as:
- •- Completion of period 2 in 1311.6 with a clinical response (drop in CDAI from baseline by but no remission (CDAI < 150) at Visit E1; or
- •- Completion of period 3 in 1311.6 with a clinical response (drop in CDAI from baseline by >=100) or remission (CDAI < 150) at Visit E5;2. Female patients:
- •a. Women of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopause), that, if sexually active agree to use one of the appropriate medically accepted methods of birth control in addition to the consistent and correct use of a condom from date of screening until 20 weeks after last administration of study medication. Medically accepted methods of contraception are: ethinyl estradiol containing contraceptives, diaphragm with spermicide
- •substance, and intra-uterine-device, or
- •b. Surgically sterilized female patients with documentation of prior hysterectomy, tubal ligation or complete bilateral oophorectomy, or
- •c. Postmenopausal women with postmenopausal is defined as permanent
- •cessation = 1 year of previously occurring menses, and
- •d. Negative serum ß-Human Chorionic Gonadotrophin test at screening.
- •Serum ß-Human Chorionic Gonadotrophin ( ß-HCG) pregancy test will be done at screening only in case when urine pregnancy test is positive.;Male patients:
- •a. Who are documented to be sterile, or
- •b. Who consistently and correctly use effective method of contraception (i.e. condoms) during the study and 20 weeks after last administration of study medication;3. Be able to adhere to the study visit schedule and other protocol requirements.
排除标准
- •1. Patients who were not compliant with key study procedures (colonoscopy, treatment compliance, endpoint assessment, contraception measures) in preceding trial 1311.6
- •2. Patients who could not tolerate BI 655066 treatment for tolerability or safety reasons in the preceding trial
- •3. Are pregnant, nursing, or planning pregnancy while enrolled in the study, or within 20 weeks after receiving the last dose of study medication.
- •4. Patients must agree not to receive a live virus or bacterial or BCG vaccination during the study or up to 12 months after the last administration of study drug.
- •5. Patients who have developed malignancy, or suspicion of active malignant disease during the preceding trial
- •6. Are intending to participate in any other study using an investigational agent or procedure during participation in this study.
- •7. Cannot adhere to the concomitant medication requirements
研究者
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