Crohn's DiseasePhase 2/3INTREPIDNCT03759288
An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease
A Phase 2/3 study testing Brazikumab low dose, Brazikumab high dose and Humira® in people with Crohn's Disease and IBD, run by AstraZeneca at 102 sites in 17 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn's Disease, IBD
- What is being tested?
- Brazikumab low dose, Brazikumab high dose and Humira®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 102 sitesin 17 countries
- Study dates
- 7 Dec 2018to 18 Oct 2023
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At the time of signing the informed consent, the participant must be 18 to 80 years of age, inclusive.
- A diagnosis of ileal, ileocolonic, or colonic CD with an onset of symptoms for a minimum of 3 months prior to Screening as determined by the investigator based on clinical history, exclusion of other etiologies including infectious causes, and characteristic endoscopic and/or histologic findings.
- 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.
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- 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:
- 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
- 7 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.
- 8 Women not of childbearing potential are defined as women who are either permanently sterilized or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrhoeic for 12 months prior to the planned date of randomization without an alternative medical cause.
- 9 Nonsterilized males who are sexually active with a female partner of childbearing potential must comply with the methods of contraception during treatment and until the end of relevant systemic exposure in the male participant, plus a further 18 weeks.
- 10 Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
- 11 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 period.
- 12 Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples for optional genetic research that supports Genomic Initiative.
- Complete inclusion criteria are in the study protocol
Who cannot join
- Participant is unable or unwilling to have endoscopic procedures performed during the study.
- History or current diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, colonic mucosal dysplasia, primary sclerosing cholangitis, or untreated bile acid malabsorption.
- History of toxic megacolon within 3 months prior to Randomization.
- Any intra-abdominal surgery, bowel resection, diversion, placement of ostomy or stoma within 3 months prior to Screening. Participants with a draining stoma, ostomy, or extensive colonic resection are excluded irrespective of the time from surgery.
- Participant has an enterocutaneous or enterovesicular fistula. Participants with other active fistulas, including perianal fistulas, may be considered for enrollment if there is no anticipation for surgery and there is no evidence of active infection (eg, abscess).
- Bowel perforation during the 6 months prior to Screening or evidence of obstruction within 3 months of Screening.
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- Complications of CD including short bowel syndrome, strictures/stenoses with obstruction or pre-stenotic dilation, or conditions where surgery may be anticipated within 6 months, or other conditions that may confound efficacy evaluations for the study.
- Participant has any non-passable colonic stenosis/narrowing identified during the qualifying ileocolonoscopy (successful endoscope passage to the caecum with inability to enter the endoscope into the ileum is not covered under this exclusion criterion, and does not require exclusion).
- Ongoing nutritional dependency for total parenteral nutrition or an elemental diet at Screening.
- Participant has any of the following related to infections: • Evidence of a recent (within 6 months of Randomization) systemic fungal infection, requiring inpatient hospitalization, and/or antifungal treatment. • Any infection requiring hospitalization or treatment with IV anti-infectives (including antiviral treatment) within 4 weeks of Screening. • Cytomegalovirus or Epstein-Barr virus infection that has not resolved within 8 weeks prior to Screening • Clinically significant chronic infection (eg, osteomyelitis) that has not resolved within 8 weeks of Screening • Nonserious infection requiring oral anti-infectives within 2 weeks prior to randomization must be further discussed with the Study Physician/designee. • Participant has clinical evidence of or suspected to have an abscess during Screening. • Diagnosis of peritonitis or receiving treatment for peritonitis within 8 weeks prior to Screening • Participant has any underlying condition that predisposes participant to infections • Clinically significant active infection or signs/symptoms of infection that has the potential to worsen with immunosuppressive therapy • Signs or symptoms of ongoing infection due to intestinal pathogens
- Previous allogenic bone marrow transplant or history of organ or cell-based transplantation (eg, islet cell transplantation or autologous stem cell transplantation) with the exception of corneal transplant.
- Chronic hepatitis B or C infection.
- Known history of primary immunodeficiency, splenectomy, or any underlying condition that predisposes the subject to infection, includingHIV infection.
- Prior history of or current diagnosis of a demyelinating disorder.
- Participant has received the following treatment: • Adalimumab, certolizumab pegol, infliximab, or golimumab: within 8 weeks prior to Randomization • Vedolizumab or ustekinumab within 12 weeks prior to Randomization • Other prohibited medication, biologic or small molecule treatment within 5 half-lives prior to Randomization • Fecal microbiota transplantation: within 8 weeks prior to Screening ileocolonoscopy
- Except for ustekinumab, prior exposure to any biologic agent targeting IL-12 or IL-23.
- Participants who received cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, tacrolimus (FK-506), or tofacitinib within 2 weeks prior to Screening Visit 1.
- Known history of allergy to the study intervention formulation or any of its excipients or components of the delivery device, or to any other biologic therapy.
- Participants received more than 1 dose of IV or intramuscular steroids within 2 weeks prior to Screening Visit 1.
- Participant received topical (rectal) aminosalicylic acid (eg, mesalamine) or topical (rectal) steroids within 2 weeks prior to Randomization.
- Participant received a Bacille Calmette-Guérin vaccination within 12 months of Randomization or any other live vaccine less than 4 weeks prior to Randomization or is planning to receive any such vaccine over the course of the study.
- Participant has known or suspected history of chronic use of NSAIDs (defined as at least 3 times per week for more than 3 months; not applicable to daily aspirin use up to 325mg per day) and/or opiates, drug, or alcohol abuse.
- History of cancer with the following exceptions: (a) A history of basal cell carcinoma and/or squamous cell carcinoma of the skin, with apparent successful curative therapy greater than 12 months prior to Screening (b) Carcinoma in situ of the cervix, with apparent successful curative therapy, greater than 12 months prior to Screening.
- Clinically significant cardiovascular conditions including recent myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III/IV heart failure within 6 months of Screening.
- 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).
- Clinically significant kidney disease
- Abnormal laboratory results at Screening
- Other concurrent medical conditions: Participant has known, preexisting, clinically significant endocrine, autoimmune, metabolic, neurologic, renal, gastrointestinal, hepatic, hematological, respiratory or any other system abnormalities that are not associated with CD and are uncontrolled with standard treatment.
- Participant is currently enrolled in another investigational device or drug study, or is within 35 days or 5 half-lives, whichever is longer, since ending another investigational device or drug study, or receiving other investigational agent(s)
- Transfusion of blood, plasma, or platelets within the 30 days prior to Screening.
- 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.
- Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
- Previous randomization in the present study. . Complete exclusion criteria are in the study protocol
Trial locations and contacts
102 sites in 17 countries.
102 sites in 17 countries
United States38 sites
Research Site
Albuquerque, New Mexico, 87108
Research Site
Atlanta, Georgia, 30328
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Atlanta, Georgia, 30342
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Beachwood, Ohio, 44122
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Boca Raton, Florida, 33487
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Brownsburg, Indiana, 46112
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Carrollton, Texas, 75007
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Chesterfield, Michigan, 48047
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Clearwater, Florida, 33756
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Colorado Springs, Colorado, 80907
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Decatur, Georgia, 30033
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Houston, Texas, 77017
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Houston, Texas, 77058
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Kissimmee, Florida, 34741
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Lakeland, Florida, 33813
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Lancaster, California, 93534
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Las Vegas, Nevada, 89123
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Lincoln, California, 95648
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Little Rock, Arkansas, 72212
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McAllen, Texas, 78503
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Miami, Florida, 33157
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Miami, Florida, 33165
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Miami, Florida, 33189
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Miami Lakes, Florida, 33016
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Morehead City, North Carolina, 28557
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Naples, Florida, 34102
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North Chesterfield, Virginia, 23236
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Oak Lawn, Illinois, 60453
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Oklahoma City, Oklahoma, 73102
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Pflugerville, Texas, 78660
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Phoenix, Arizona, 85037
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Poway, California, 92064
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San Diego, California, 92103
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Spokane, Washington, 99204
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St. Petersburg, Florida, 33710
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Stafford, Texas, 77477
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Tampa, Florida, 33626
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Uniontown, Pennsylvania, 15401
Poland12 sites
Research Site
Bydgoszcz, 85 168
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Chojnice, 89-600
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Krakow, 31-513
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Poznan, 61-731
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Rzeszów, 35-302
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Sopot, 81-756
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Torun, 87-100
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Warsaw, 00-189
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Warsaw, 00-728
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Warsaw, 03-580
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Wroclaw, 52-210
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Zamość, 22-400
Germany7 sites
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Augsburg, 86156
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Berlin, 10825
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Hamburg, 20251
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Kiel, 24105
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Minden, 32423
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Remscheid, 42859
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Ulm, 89081
Czechia4 sites
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České Budějovice, 370 01
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Hořovice, 268 31
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Hradec Králové, 500 12
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Olomouc, 772 00
India4 sites
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Bangalore, 560054
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Hyderabad, 500032
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Jaipur, 302001
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Surat, 395002
Italy4 sites
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Milan, 20132
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Milan, 20154
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Padova, 35128
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Rozzano, 20089
South Africa4 sites
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Cape Town, 7500
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Cape Town, 7708
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Johannesburg, 1827
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Plumstead, 7800
South Korea4 sites
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Busan, 48108
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Daegu, 42415
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Seoul, 06351
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Seoul, 156-755
Taiwan4 sites
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Kaohsiung City, 80756
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Taichung, 40447
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Taipei, 100
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Taipei, 114
Ukraine4 sites
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Kharkiv, 61037
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Kyiv, 03680
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Kyiv, 04050
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Kyiv, 04078
Israel3 sites
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Haifa, 3109601
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Jerusalem, 9103102
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Petah Tikva, 4941492
Russia3 sites
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Aramil, 624002
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Moscow, 115419
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Perm, 614000
Slovakia3 sites
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Banská Bystrica, 97401
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Košice, 04013
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Nitra, 94901
Spain3 sites
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Madrid, 28046
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Pontevedra, 36071
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Valencia, 46010
Canada2 sites
Research Site
Chicoutimi, Quebec, G7H 5H6
Research Site
New Westminster, British Columbia, V3L 3W4
United Kingdom2 sites
Research Site
Coventry, CV2 2DX
Research Site
West Bromwich, B71 4HJ
About this study
Official title: 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)
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
- Conditions
- Crohn's Disease, IBD
- Being tested
- Brazikumab low dose, Brazikumab high dose, Humira®, Placebo
- Keywords
- Crohn's Disease, Inflammatory bowel disease, Brazikumab, IL23 receptor, IBD, CD
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brazikumab low doseDrug
Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48
Brazikumab high doseDrug
Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48
Humira®Drug
Administered subcutaneously on Day 1, Day 15, and Day 29 and every 2 weeks through Week 50.
PlaceboDrug
Intravenous placebo on Days 1, 29, 57 followed by subcutaneous placebo on Day 85 and every 4 weeks through Week 48
| Study group | Role | What they receive |
|---|---|---|
| (Stage 1) Brazikumab high dose | Experimental | Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48 Receives: Drug: Brazikumab high dose |
| (Stage 1) Brazikumab low dose | Experimental | Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48 Receives: Drug: Brazikumab low dose |
| (Stage 1) Placebo | Placebo comparator | Intravenous placebo on Days 1, 29, and 57, followed by subcutaneous placebo on Day 85 and every 4 weeks through Week 48 Receives: Drug: Placebo |
| (Stage 2) Brazikumab high dose | Experimental | Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48 Receives: Drug: Brazikumab high dose |
| (Stage 2) Brazikumab low dose | Experimental | Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous on Day 85 and every 4 weeks through Week 48 Receives: Drug: Brazikumab low dose |
| (Stage 2) Humira® | Active comparator | Administered subcutaneously on Day 1, Day 15, and Day 29 and every 2 weeks through Week 50 Receives: Drug: Humira® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at Week 12
Secondary outcomes (22)
Endoscopic Response
Endoscopic response is defined as
- Minimum of 50% decrease from Baseline in SES-CD total score
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
Measured: at Week 12
Clinical Remission
Clinical Remission is defined as
- Average daily LSF subscore of ≤ 3 as assessed on the CDAI LSF item AND average daily AP subscore of ≤ 1 as assessed on the CDAI AP item
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
Measured: at Week 12
CDAI Response
CDAI response is defined as
- CDAI score of < 150 points or CDAI reduction from Baseline of ≥ 100 points
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
Measured: at Week 12
CDAI Remission
CDAI remission at both Week 12 and Week 52 is defined as
- CDAI score < 150 at both Week 12 and 52
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
Measured: at Week 12 and 52
CDAI Response
CDAI response at both Week 12 and Week 52 is defined as
- CDAI score of < 150 points or CDAI reduction from Baseline of ≥ 100 points at both Week 12 and 52
Measured: at Week 12 and 52
Endoscopic Response
Endoscopic response at both Week 12 and Week 52 is defined as
- Minimum of 50% decrease from Baseline in SES-CD total score at both Week 12 and 52
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
Measured: at Week 12 and 52
Clinical Remission
Clinical remission at both Week 12 and Week 52 is defined as
- Average daily LSF subscore of ≤ 3 as assessed on the CDAI LSF item AND average daily AP subscore of ≤ 1 as assessed on the CDAI AP item at both Week 12 and 52
Measured: at Week 12 and 52
Endoscopic Remission
Endoscopic remission is defined as
- SES-CD total score of 0-2, OR SES-CD total score of ≤ 4 and at least 2 point reduction from Baseline with no subscore > 1
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
Measured: at Week 52
Clinical Remission
Clinical remission is defined as
- Average daily LSF subscore of ≤ 3 as assessed on the CDAI LSF item AND average daily AP subscore of ≤ 1 as assessed on the CDAI AP item
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
Measured: at Week 52
CDAI Response
CDAI response is defined as
- CDAI score of < 150 points or CDAI reduction from Baseline of ≥ 100 points
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
Measured: at Week 52
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
Measured: at Week 52
Endoscopic Response
Endoscopic response is defined as
- Minimum of 50% decrease from Baseline in SES-CD total score
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
Measured: at Week 52
SES-CD Total Score of 0-2
SES-CD total score of 0 - 2 is defined as
- SES-CD total score of 0 - 2
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
Measured: at Week 52
Endoscopic Response and Endoscopic Remission
Endoscopic response and endoscopic remission is defined as
- Endoscopic response at Week 12 and
- endoscopic remission at Week 52
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
Measured: at Week 12 (response) and at Week 52 (remission)
Serum Brazikumab Concentration
serum concentration of brazikumab
Measured: 68 Weeks
Incidence of Anti-drug Antibodies
Immunogenicity: incidence of brazikumab anti-drug antibodies in serum
Measured: through Week 68
Exposure-response
Derive exposure-response model linking primary endpoint to metrics of model predicted individual brazikumab exposures.
Measured: through Week 68
Serum IL-22 Concentration Clinical Cut-off
Derive the relationship between baseline serum IL-22 concentration and efficacy of brazikumab through CDAI remission and endoscopic response.
Measured: at Week 12
Adverse Events
Number and percentage of patients with reported Adverse Events
Measured: through Week 68
Laboratory Values
Number and percentage of participants with Potentially Clinically Significant Postbaseline results in hematology, clinical chemistry, and urinalysis.
Measured: through Week 68
Vital Signs
Number and percentage of participants with Potentially Clinically Significant Postbaseline results in systolic, diastolic pulse rate.
Measured: through Week 68
ECGs
Number and percentage of participants with Potentially Clinically Significant Postbaseline results in 12-lead ECG recordings.
Measured: through Week 68
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start7 Dec 2018
- Primary completion18 Oct 2023
- Study completion18 Oct 2023
Why it stopped: Strategic decision to discontinue the development of brazikumab in inflammatory bowel disease.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathy Bohannon, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03759288
- Sponsor's protocol ID
- D5271C00001
- Other IDs
- #3150-301-008, 2018-004346-42, 2018
- Acronym
- INTREPID
- Status last verified
- May 2026
- First submitted
- 20 Nov 2018
- Last updated
- 23 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03759288
- Acronym / sponsor ID
- INTREPID / D5271C00001
- Conditions
- Crohn's Disease, IBD
- Keywords
- Crohn's Disease, Inflammatory bowel disease, Brazikumab, IL23 receptor, IBD, CD
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic decision to discontinue the development of brazikumab in inflammatory bowel disease.
- Enrolment
- 89 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- 18 Oct 2023 (actual)
- Study completion
- 18 Oct 2023 (actual)
- First posted
- 29 Nov 2018 (actual)
- Results
- Posted 23 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| (Stage 1) Brazikumab high dose | Experimental | Drug: Brazikumab high doseIntravenous 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 | Experimental | Drug: Brazikumab low doseIntravenous 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 comparator | Drug: PlaceboIntravenous 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 | Experimental | Drug: Brazikumab high doseIntravenous 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 | Experimental | Drug: Brazikumab low doseIntravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous on Day 85 and every 4 weeks through Week 48 |
| (Stage 2) Humira® | Active comparator | Drug: Humira®Administered subcutaneously on Day 1, Day 15, and Day 29 and every 2 weeks through Week 50 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- At the time of signing the informed consent, the participant must be 18 to 80 years of age, inclusive.
- A diagnosis of ileal, ileocolonic, or colonic CD with an onset of symptoms for a minimum of 3 months prior to Screening as determined by the investigator based on clinical history, exclusion of other etiologies including infectious causes, and characteristic endoscopic and/or histologic findings.
- 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.
Key exclusion criteria (33 listed)
- Participant is unable or unwilling to have endoscopic procedures performed during the study.
- History or current diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, colonic mucosal dysplasia, primary sclerosing cholangitis, or untreated bile acid malabsorption.
- History of toxic megacolon within 3 months prior to Randomization.
- Any intra-abdominal surgery, bowel resection, diversion, placement of ostomy or stoma within 3 months prior to Screening. Participants with a draining stoma, ostomy, or extensive colonic resection are excluded irrespective of the time from surgery.
- Participant has an enterocutaneous or enterovesicular fistula. Participants with other active fistulas, including perianal fistulas, may be considered for enrollment if there is no anticipation for surgery and there is no evidence of active infection (eg, abscess).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brazikumab low doseIntravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48 | Drug | (Stage 1) Brazikumab low dose, (Stage 2) Brazikumab low dose |
| Brazikumab high doseIntravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48 | Drug | (Stage 1) Brazikumab high dose, (Stage 2) Brazikumab high dose |
| Humira®Administered subcutaneously on Day 1, Day 15, and Day 29 and every 2 weeks through Week 50. | Drug | (Stage 2) Humira® |
| PlaceboIntravenous placebo on Days 1, 29, 57 followed by subcutaneous placebo on Day 85 and every 4 weeks through Week 48 | Drug | (Stage 1) Placebo |
Primary outcome
CDAI Remission
Time frame: at Week 12
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
22 secondary outcomes
Endoscopic Response
Time frame: at Week 12
Clinical Remission
Time frame: at Week 12
CDAI Response
Time frame: at Week 12
CDAI Remission
Time frame: at Week 12 and 52
CDAI Response
Time frame: at Week 12 and 52
Endoscopic Response
Time frame: at Week 12 and 52
Clinical Remission
Time frame: at Week 12 and 52
Endoscopic Remission
Time frame: at Week 52
Clinical Remission
Time frame: at Week 52
CDAI Response
Time frame: at Week 52
CDAI Remission
Time frame: at Week 52
Endoscopic Response
Time frame: at Week 52
SES-CD Total Score of 0-2
Time frame: at Week 52
Endoscopic Response and Endoscopic Remission
Time frame: at Week 12 (response) and at Week 52 (remission)
Serum Brazikumab Concentration
Time frame: 68 Weeks
Incidence of Anti-drug Antibodies
Time frame: through Week 68
Exposure-response
Time frame: through Week 68
Serum IL-22 Concentration Clinical Cut-off
Time frame: at Week 12
Adverse Events
Time frame: through Week 68
Laboratory Values
Time frame: through Week 68
Vital Signs
Time frame: through Week 68
ECGs
Time frame: through Week 68
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Redacted CSR synopsisLink provided by the sponsor.
- Redacted SAPLink provided by the sponsor.
- Redacted CSPLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathy Bohannon study director
AstraZeneca
102 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Brazikumab low dose, Brazikumab high dose and Humira® in people with Crohn's Disease and IBD, run by AstraZeneca at 102 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 102 sites in United States, Poland, Germany, Czechia, India and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CDAI Remission (time frame: at Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.