Open-label Extension Study of Brazikumab in Crohn’s Disease
- Conditions
- Crohns disease, unspecified,
- Registration Number
- CTRI/2022/04/041578
- Lead Sponsor
- ASTRAZENECA AB
- Brief Summary
This is a global, multicenter, open-label extension study of brazikumab limited to participants previously enrolled in Study D5271C00001. Participants in the lead-in study are eligible to enroll in Study D5271C00002 provided they continue to meet eligibility criteria and have not had adverse experiences considered to be related to study medication that resulted in discontinuation of the initial lead-in study intervention, or that in the judgement of the investigator, would disqualify them from participating. Participants will be eligible for inclusion into this study if they have completed the lead-in study, or have completed 12 weeks of treatment, but were subsequently discontinued due to lack of efficacy. Eligible participants do not need to complete the 18-week safety follow-up period of the lead-in study, if they roll-over into this study after they complete the Week 52 visit of the lead-in study. The purpose of Study D5271C00002 is to collect long-term safety data from participants in Study D5271C00001 who receive open-label brazikumab in Study D5271C00002
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 240
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 To assess the safety of long-term treatment with brazikumab in CD participants who previously completed Study D5271C00001 or discontinued from Study D5271C00001 at or after Week 12 due to lack of efficacy Week 12 onwards
- Secondary Outcome Measures
Name Time Method To assess efficacy of long-term treatment with brazikumab in participants who previously completed Study D5271C00001 or discontinued from the study at or after Week 12 due to lack of efficacy
Trial Locations
- Locations (10)
Aakash Healthcare Super Specialty Hospital
🇮🇳Delhi, DELHI, India
Acharya Vinoba Bhave Rural Hospital
🇮🇳Wardha, MAHARASHTRA, India
Asian Institute of Gastroenterology Pvt Ltd
🇮🇳Hyderabad, TELANGANA, India
Gastroplus Digestive Disease Centre Pvt Ltd
🇮🇳Ahmadabad, GUJARAT, India
M. S. Ramaiah Medical College and Hospitals
🇮🇳Bangalore, KARNATAKA, India
Max Smart Super Specialty Hospital
🇮🇳Delhi, DELHI, India
S. R Kalla Memorial Gastro and General Hospit
🇮🇳Jaipur, RAJASTHAN, India
Shree Giriraj Multispeciality Hospital
🇮🇳Rajkot, GUJARAT, India
Surat Institute of Digestive Sciences
🇮🇳Surat, GUJARAT, India
Yashoda Hospitals
🇮🇳Hyderabad, TELANGANA, India
Aakash Healthcare Super Specialty Hospital🇮🇳Delhi, DELHI, IndiaDr Sharad MalhotraPrincipal investigator01143388888drsharad.malhotra@aakashhealthcare.com