Open-label Extension Study of Brazikumab in Crohn’s Disease
- Conditions
- Health Condition 1: K509- Crohns disease, unspecified
- Registration Number
- CTRI/2022/04/041578
- Lead Sponsor
- ASTRAZENECA AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 0
1)Male or female participants with successful completion or early termination due to lack of efficacy from Study D5271C00001
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 D5271C00001 in the opinion of the investigator and/or sponsor
6)Willingness and ability to attend all study visits, comply with the study procedures, read and write in order to complete questionnaires, and be able to complete the study
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 ischemic colitis, colonic mucosal dysplasia, or primary sclerosing
cholangitis. Bile acid malabsorption and other conditions that may potentially confound assessments must be treated prior to baseline (Week 0)
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 (excluding lack of efficacy)
5)Chronic hepatitis B or C infection
6)Known history of primary immunodeficiency, splenectomy, or any underlying condition that predisposes the subject to infection, including HIV infection. Participants with positive results of HIV testing by the central laboratory will be excluded
Prolonged QTcF interval, or conditions leading to additional risk for QT prolongation
8)Participants with electrolyte abnormalities such as hypokalemia and hypomagnesemia that would increase the risk of QT prolongation are to be corrected prior to enrollment
9)Clinically significant kidney disease including but not limited to:(a) Chronic kidney disease with an estimated glomerular filtration rate of less than 30 ml/min calculated by MDRD equation, as applicable, by the central laboratory at screening are excluded
10)Females who are pregnant, nursing, or planning a pregnancy during the study OR females who are of childbearing potential and do not agree to use a highly effective method of contraception consistently and correctly
11)Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
12)Previous participation in the present study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method