Study Stopped
Strategic decision to discontinue the development of brazikumab in inflammatory bowel disease.
An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease
INTREPID
A 52-Week, Multicenter, Randomized, Double-blind, Placebo and Active-Controlled, Operationally Seamless Phase 2b/3, Parallel-group Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID Lead-In)
3 other identifiers
interventional
89
17 countries
102
Brief Summary
This study seeks to evaluate the safety and efficacy of brazikumab versus placebo (Stage I) and versus an active comparator (Stage 2) in participants with moderately to severely active CD and will include assessments of clinical response as demonstrated by improvement of symptoms and colonic mucosal appearance as observed on endoscopy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2018
Longer than P75 for phase_2
102 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2018
CompletedFirst Posted
Study publicly available on registry
November 29, 2018
CompletedStudy Start
First participant enrolled
December 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 18, 2023
CompletedResults Posted
Study results publicly available
June 23, 2026
CompletedJune 23, 2026
May 1, 2026
4.9 years
November 20, 2018
October 11, 2024
May 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CDAI Remission
CDAI remission is defined as \- CDAI score \< 150 Further, if the patient * discontinue treatment prematurely for any reason * takes rescue treatment or meet the rescue criteria * uses prohibited medication the patient is considered as unsuccessfully treated and imputed as non-responder
at Week 12
Secondary Outcomes (22)
Endoscopic Response
at Week 12
Clinical Remission
at Week 12
CDAI Response
at Week 12
CDAI Remission
at Week 12 and 52
CDAI Response
at Week 12 and 52
- +17 more secondary outcomes
Other Outcomes (1)
Physical Examination
through Week 68
Study Arms (6)
(Stage 1) Brazikumab high dose
EXPERIMENTALIntravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48
(Stage 1) Brazikumab low dose
EXPERIMENTALIntravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48
(Stage 1) Placebo
PLACEBO COMPARATORIntravenous placebo on Days 1, 29, and 57, followed by subcutaneous placebo on Day 85 and every 4 weeks through Week 48
(Stage 2) Brazikumab high dose
EXPERIMENTALIntravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48
(Stage 2) Brazikumab low dose
EXPERIMENTALIntravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous on Day 85 and every 4 weeks through Week 48
(Stage 2) Humira®
ACTIVE COMPARATORAdministered subcutaneously on Day 1, Day 15, and Day 29 and every 2 weeks through Week 50
Interventions
Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48
Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48
Administered subcutaneously on Day 1, Day 15, and Day 29 and every 2 weeks through Week 50.
Intravenous placebo on Days 1, 29, 57 followed by subcutaneous placebo on Day 85 and every 4 weeks through Week 48
Eligibility Criteria
You may not qualify if:
- At the time of signing the informed consent, the participant must be 18 to 80 years of age, inclusive.
- Moderately to severely active CD defined by a CDAI score of 220 to 450 AND; CDAI LSF score ≥ 5 OR CDAI AP score ≥ 2; AND SES-CD of at least 6
- Participant had an inadequate response or intolerance to intervention with conventional treatment \[oral aminosalicylates, oral CS, azathioprine, methotrexate, or 6-mercaptopurine\], or prior biological treatment, or demonstrated CS dependence for the treatment of CD. For participants who have previously used biological treatment, a participant may have failed up to 3 biologics that include up to 2 different mechanisms of action.
- Participants taking 5-aminosalicylates, Oral prednisone (or equivalent), Budesonide, Immunomodulators, Oral antibiotics, Immunomodulators, Probiotics must be at a stable dose.
- Participant must have the QFT-TB test performed and meet the following TB criteria.
- A TB worksheet must also be completed:
- Participant has no known history of active TB.
- Participant has no known history of latent TB without completion of an appropriate course of intervention.
- Meets 1 of the following acceptable TB test results:
- i. Negative QFT-TB obtained from central laboratory during Screening, OR ii. For a positive QFT-TB test obtained during Screening from the central laboratory, active TB must be ruled out or treated and negative QFT-TB confirmed by central laboratory OR iii. Indeterminate QFT-TB test obtained during the Screening Period from the central laboratory with ongoing QFT-TB testing as outlined in Appendix G. Participants with an indeterminate QFT-TB test can continue with Screening if they have all of the following:
- no symptoms/risk factors per TB worksheet provided by the sponsor
- no known recent exposure to a case of active TB
- no evidence of active TB on chest x-ray within 8 weeks prior to Screening or during Screening
- confirmed QFT-TB negative by central laboratory
- Female participants of childbearing potential must have a negative urine pregnancy test prior to administration of study intervention and must agree to use a highly effective method of birth control (confirmed by the investigator) from randomization throughout the study duration and for at least 18 weeks after last dose of study intervention.
- +36 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (102)
Research Site
Phoenix, Arizona, 85037, United States
Research Site
Little Rock, Arkansas, 72212, United States
Research Site
Lancaster, California, 93534, United States
Research Site
Lincoln, California, 95648, United States
Research Site
Poway, California, 92064, United States
Research Site
San Diego, California, 92103, United States
Research Site
Colorado Springs, Colorado, 80907, United States
Research Site
Boca Raton, Florida, 33487, United States
Research Site
Clearwater, Florida, 33756, United States
Research Site
Kissimmee, Florida, 34741, United States
Research Site
Lakeland, Florida, 33813, United States
Research Site
Miami, Florida, 33157, United States
Research Site
Miami, Florida, 33165, United States
Research Site
Miami, Florida, 33189, United States
Research Site
Miami Lakes, Florida, 33016, United States
Research Site
Naples, Florida, 34102, United States
Research Site
St. Petersburg, Florida, 33710, United States
Research Site
Tampa, Florida, 33626, United States
Research Site
Atlanta, Georgia, 30328, United States
Research Site
Atlanta, Georgia, 30342, United States
Research Site
Decatur, Georgia, 30033, United States
Research Site
Oak Lawn, Illinois, 60453, United States
Research Site
Brownsburg, Indiana, 46112, United States
Research Site
Chesterfield, Michigan, 48047, United States
Research Site
Las Vegas, Nevada, 89123, United States
Research Site
Albuquerque, New Mexico, 87108, United States
Research Site
Morehead City, North Carolina, 28557, United States
Research Site
Beachwood, Ohio, 44122, United States
Research Site
Oklahoma City, Oklahoma, 73102, United States
Research Site
Uniontown, Pennsylvania, 15401, United States
Research Site
Carrollton, Texas, 75007, United States
Research Site
Houston, Texas, 77017, United States
Research Site
Houston, Texas, 77058, United States
Research Site
McAllen, Texas, 78503, United States
Research Site
Pflugerville, Texas, 78660, United States
Research Site
Stafford, Texas, 77477, United States
Research Site
North Chesterfield, Virginia, 23236, United States
Research Site
Spokane, Washington, 99204, United States
Research Site
New Westminster, British Columbia, V3L 3W4, Canada
Research Site
Chicoutimi, Quebec, G7H 5H6, Canada
Research Site
České Budějovice, 370 01, Czechia
Research Site
Hořovice, 268 31, Czechia
Research Site
Hradec Králové, 500 12, Czechia
Research Site
Olomouc, 772 00, Czechia
Research Site
Augsburg, 86156, Germany
Research Site
Berlin, 10825, Germany
Research Site
Hamburg, 20251, Germany
Research Site
Kiel, 24105, Germany
Research Site
Minden, 32423, Germany
Research Site
Remscheid, 42859, Germany
Research Site
Ulm, 89081, Germany
Research Site
Budapest, 1082, Hungary
Research Site
Bangalore, 560054, India
Research Site
Hyderabad, 500032, India
Research Site
Jaipur, 302001, India
Research Site
Surat, 395002, India
Research Site
Haifa, 3109601, Israel
Research Site
Jerusalem, 9103102, Israel
Research Site
Petah Tikva, 4941492, Israel
Research Site
Milan, 20132, Italy
Research Site
Milan, 20154, Italy
Research Site
Padova, 35128, Italy
Research Site
Rozzano, 20089, Italy
Research Site
Bydgoszcz, 85 168, Poland
Research Site
Chojnice, 89-600, Poland
Research Site
Krakow, 31-513, Poland
Research Site
Poznan, 61-731, Poland
Research Site
Rzeszów, 35-302, Poland
Research Site
Sopot, 81-756, Poland
Research Site
Torun, 87-100, Poland
Research Site
Warsaw, 00-189, Poland
Research Site
Warsaw, 00-728, Poland
Research Site
Warsaw, 03-580, Poland
Research Site
Wroclaw, 52-210, Poland
Research Site
Zamość, 22-400, Poland
Research Site
Aramil, 624002, Russia
Research Site
Moscow, 115419, Russia
Research Site
Perm, 614000, Russia
Research Site
Banská Bystrica, 97401, Slovakia
Research Site
Košice, 04013, Slovakia
Research Site
Nitra, 94901, Slovakia
Research Site
Cape Town, 7500, South Africa
Research Site
Cape Town, 7708, South Africa
Research Site
Johannesburg, 1827, South Africa
Research Site
Plumstead, 7800, South Africa
Research Site
Busan, 48108, South Korea
Research Site
Daegu, 42415, South Korea
Research Site
Seoul, 06351, South Korea
Research Site
Seoul, 156-755, South Korea
Research Site
Madrid, 28046, Spain
Research Site
Pontevedra, 36071, Spain
Research Site
Valencia, 46010, Spain
Research Site
Kaohsiung City, 80756, Taiwan
Research Site
Taichung, 40447, Taiwan
Research Site
Taipei, 100, Taiwan
Research Site
Taipei, 114, Taiwan
Research Site
Kharkiv, 61037, Ukraine
Research Site
Kyiv, 03680, Ukraine
Research Site
Kyiv, 04050, Ukraine
Research Site
Kyiv, 04078, Ukraine
Research Site
Coventry, CV2 2DX, United Kingdom
Research Site
West Bromwich, B71 4HJ, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was early terminated and development of brazikumab stopped. Following cessation of development all study related dosing was immediately stopped. Site data cleaning engagement proved challenging. A patient centric approach was taken to focus data cleaning on key safety variables (adverse events). However, the database was locked with unclean data for the outcome measures. Please be aware that the data submitted needs to be considered with the data quality in mind.
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Kathy Bohannon
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2018
First Posted
November 29, 2018
Study Start
December 7, 2018
Primary Completion
October 18, 2023
Study Completion
October 18, 2023
Last Updated
June 23, 2026
Results First Posted
June 23, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.