| CTRI Number |
CTRI/2022/04/041578 [Registered on: 01/04/2022] Trial Registered Prospectively |
| Last Modified On: |
17/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Open-label Extension Study of Brazikumab in Crohn’s Disease |
|
Scientific Title of Study
|
An Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn’s Disease (INTREPID OLE) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2019-001866-14 |
EudraCT |
| D5271C00002 (Amendment 3, V 4.0) dated 02 MAR 2021 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
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| Affiliation |
|
| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh Kadam |
| Designation |
Director – Site Management and Monitoring |
| Affiliation |
AstraZeneca Pharma India Ltd. |
| Address |
AstraZeneca Pharma India Ltd.,
Block N1, 12th Floor, Manyata Embassy Business Park, Rachenahalli, Outer Ring Road
Bangalore
KARNATAKA
560045
India |
| Phone |
919535999494 |
| Fax |
|
| Email |
Santosh.Kadam@astrazeneca.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Santosh Kadam |
| Designation |
Director – Site Management and Monitoring |
| Affiliation |
AstraZeneca Pharma India Ltd. |
| Address |
AstraZeneca Pharma India Ltd.,
Block N1, 12th Floor, Manyata Embassy Business Park, Rachenahalli, Outer Ring Road
Bangalore
KARNATAKA
560045
India |
| Phone |
919535999494 |
| Fax |
|
| Email |
Santosh.Kadam@astrazeneca.com |
|
|
Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
ASTRAZENECA AB |
| Address |
151 85, SÖDERTÄLJE, SWEDEN |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| AstraZeneca Pharma India Limited |
Block N1, 12th Floor, Manyata Embassy Business Park,
Rachenahalli, Outer Ring Road, Bangalore, 560045, Karnataka
|
|
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Countries of Recruitment
|
Canada
Czech Republic
France
Germany
Hungary
India
Ireland
Italy
Poland
Republic of Korea
Russian Federation
Slovakia
South Africa
Spain
Taiwan
Ukraine
United Kingdom
United States of America |
|
Sites of Study
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sharad Malhotra |
Aakash Healthcare Super Specialty Hospital |
Dept. of Gastroenterology
Hospital Plot, Rd Number 201, Dwarka Sector-3, PIN-110075
New Delhi
DELHI |
01143388888
drsharad.malhotra@aakashhealthcare.com |
| Dr Vijendra Kirnake |
Acharya Vinoba Bhave Rural Hospital |
Dept. of Gastroenterology
Jawaharlal Nehru Medical College, Datta Meghe Institute of Medical Sciences, Sawangi Meghe, Wardha-442004
Wardha
MAHARASHTRA |
7152287702
drvijendrakirnake@gmail.com |
| Dr Rupa Banerjee |
Asian Institute of Gastroenterology Pvt Ltd |
Dept. of Gastroenterology
Gachibowli, Mindspace Road, PIN-500032
Hyderabad
TELANGANA |
04042444222
rupabanerjee.aig@gmail.com |
| Dr Ravindra Laxmanbhai Gaadhe |
Gastroplus Digestive Disease Centre Pvt Ltd |
Dept. of Gastroenterology
D Block, 3rd Floor Galaxy Bazar, Sunrise Park Road, Vastrapur, PIN 380054
Ahmadabad
GUJARAT |
07948944777
ravindragaadhe@gmail.com |
| Dr Avinash Balekuduru |
M. S. Ramaiah Medical College and Hospitals |
Dept. of Gastroenterology
MSR Nagar, MSRIT post, New BEL Road, PIN-560054
Bangalore
KARNATAKA |
08023609999
avinashbalekuduru@gmail.com |
| Dr Kaushal Madan |
Max Smart Super Specialty Hospital |
Dept. of Gastroenterology
A Unit of Gujarmal Modi Hospital and Research centre for Medical Sciences, Mandir Marg, Press Enclave Road, Saket, PIN, 110017
New Delhi
DELHI |
01171212121
k_madan_2000@yahoo.com |
| Dr Mukesh Kalla |
S. R Kalla Memorial Gastro and General Hospit |
Dept. of Gastroenterology
78 79, Dhuleshwar Garden, Sardar Patel Marg, Behind HSBC Bank, C Scheme, PIN-302001
Jaipur
RAJASTHAN |
01412379779
drmkalla@rediffmail.com |
| Dr Chetan Mehta |
Shree Giriraj Multispeciality Hospital |
Dept. of Gastroenterology
27, Navjyot Park, 150 Feet Ring Road, PIN-360004
Rajkot
GUJARAT |
2812587087
mehtacn@hotmail.com |
| Dr Subhashchandra Nandwani |
Surat Institute of Digestive Sciences |
Dept. of Gastroenterology
A unit of SIDS Healthcare Pvt. Ltd., Vijay Nagar Gate 3, Ring Rd, opp. Gandhi College, Majura Gate, PIN-395002
Surat
GUJARAT |
02612800000
subhashnandwani@yahoo.com |
| Dr B Ravi Shankar |
Yashoda Hospitals |
Dept. of Gastroenterology
Behind Hari Hara Kala Bhavan, SP Road, PIN-500003
Hyderabad
TELANGANA |
04067778999
b_ravishankar@yahoo.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Aakash Healthcare Super Speciality Hospital Institutional Ethics Committee |
Submittted/Under Review |
| Ethics Committee, MS Ramaiah Medical College and Hospital |
Submittted/Under Review |
| Gastroplus Ethics Committee, Gastroplus Hospital |
Submittted/Under Review |
| Institutional Ethics Committee of Datta Meghe Institute of Medical Sciences |
Submittted/Under Review |
| Institutional Ethics Committee, Academy of Medical Education & Research, Yashoda Hospital |
Submittted/Under Review |
| Institutional Ethics Committee, Asian Institute of Gastroenterology |
Submittted/Under Review |
| Max Healthcare Ethics Committee |
Submittted/Under Review |
| S R Kalla Memorial Ethical Committee For Human Research |
Submittted/Under Review |
| Shree Giriraj Hospital Research Ethics Committee |
Approved |
| Surat Institute of Digestive Sciences Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K509||Crohns disease, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brazikumab |
Eligible non-responders will receive IV induction dosing with of brazikumab at Week 0, Week 4, and Week 8 followed by maintenance dosing of brazikumab SC every 4 weeks thereafter up to Week 52 |
| Intervention |
Brazikumab |
Responders and completers in the lead-in study will receive maintenance dose of Brazikumab administered SC every 4 weeks in the open label study up to week 52 |
| Comparator Agent |
NA |
NA |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
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
|
Week 12 onwards |
|
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Target Sample Size
|
Total Sample Size="240"
Sample Size from India="65"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
02/06/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
06/01/2020 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Suspended |
| Recruitment Status of Trial (India) |
Suspended |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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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 |