CTRI/2022/03/040837暂停2 期
A Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis (EXPEDITION OLE)
试验速览
- 阶段
- 2 期
- 状态
- 暂停
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
入选标准
- •1)Successfully completed or discontinued participation due to lack of efficacy after Week 10 in the lead-in Study D5272C00001
- •2)Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
- •3)Capable of giving signed informed consent
- •4)Written informed consent from the participant has been obtained prior to any study related procedures
- •5)Demonstration of adequate compliance with the study procedures in Study D5272C00001 in the opinion of the investigator and/or sponsor
- •6)Willingness and ability to attend all study visits, comply with the study procedures, and be able to complete the study period
- •7)Participant must be 18 to 80 years of age inclusive, at the time of signing the ICF
排除标准
- •1)Any participant with an unresolved AE from the lead-in study that, in the investigator’s opinion, would limit the participant’s ability to participate in or complete this study
- •2)Current diagnosis of fulminant colitis, CD or indeterminate colitis, presence of a fistula consistent with CD, primary sclerosing cholangitis, celiac disease, or toxic megacolon. Bile acid malabsorption and other conditions that may potentially confound assessments must be treated prior to baseline
- •3)Organ or cell-based transplantation (eg, islet cell transplantation or autologous stem cell transplantation) with the exception of corneal transplant
- •4)Participant meets criteria for discontinuation of study intervention during prior lead-in study
- •5)Chronic hepatitis B or C infection
- •6)Known history of primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, including HIV infection. Participants with positive results of HIV testing by the central laboratory will be excluded
- •7)Prolonged QTcF interval (QTc > 450 msec or QTc > 480 for participants with bundle branch block; determined on central ECG), or conditions leading to additional risk for QT prolongation (eg, congenital long-QT syndrome
- •8)Females who are pregnant, breast feeding, or planning a pregnancy during the study OR females who are of childbearing potential and do not agree to use contraception consistently and correctly as required by the study protocol
- •9)Judgment by the investigator or sponsor that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirement
- •10)Previous enrollment in the present study
研究者
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