Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03759288




Registration number
NCT03759288
Ethics application status
Date submitted
20/11/2018
Date registered
29/11/2018
Date last updated
12/10/2023

Titles & IDs
Public title
An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease
Scientific 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)
Secondary ID [1] 0 0
#3150-301-008
Secondary ID [2] 0 0
D5271C00001
Universal Trial Number (UTN)
Trial acronym
INTREPID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
IBD 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Brazikumab low dose
Treatment: Drugs - Brazikumab high dose
Treatment: Drugs - Humira®
Treatment: Drugs - Placebo

Experimental: (Stage 1) Brazikumab high dose - Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48

Experimental: (Stage 1) Brazikumab low dose - Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48

Placebo Comparator: (Stage 1) Placebo - Intravenous placebo on Days 1, 29, and 57, followed by subcutaneous placebo on Day 85 and every 4 weeks through Week 48

Experimental: (Stage 2) Brazikumab high dose - Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48

Experimental: (Stage 2) Brazikumab low dose - Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous on Day 85 and every 4 weeks through Week 48

Active Comparator: (Stage 2) Humira® - Administered subcutaneously on Day 1, Day 15, and Day 29 and every 2 weeks through Week 50


Treatment: Drugs: Brazikumab low dose
Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48

Treatment: Drugs: Brazikumab high dose
Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48

Treatment: Drugs: Humira®
Administered subcutaneously on Day 1, Day 15, and Day 29 and every 2 weeks through Week 50.

Treatment: Drugs: Placebo
Intravenous placebo on Days 1, 29, 57 followed by subcutaneous placebo on Day 85 and every 4 weeks through Week 48
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Stage 1. Percentage of patients with CDAI remission
Timepoint [1] 0 0
at Week 12
Primary outcome [2] 0 0
Stage 2. Percentage of patients with endoscopic response
Timepoint [2] 0 0
at Week 52
Primary outcome [3] 0 0
Stage 2. Percentage of patients with clinical remission
Timepoint [3] 0 0
at Week 52
Secondary outcome [1] 0 0
Stage 1. Percentage of patients with endoscopic response
Timepoint [1] 0 0
at Week 12
Secondary outcome [2] 0 0
Stage 1. Percentage of patients with clinical remission
Timepoint [2] 0 0
at Week 12
Secondary outcome [3] 0 0
Stage 1. Percentage of patients with CDAI response
Timepoint [3] 0 0
at Week 12
Secondary outcome [4] 0 0
Stage 1. Percentage of patients with CDAI remission
Timepoint [4] 0 0
at both Week 12 and Week 52
Secondary outcome [5] 0 0
Stage 1. Percentage of patients with CDAI response
Timepoint [5] 0 0
at both Week 12 and Week 52
Secondary outcome [6] 0 0
Stage 1. Percentage of patients with endoscopic response
Timepoint [6] 0 0
at both Week 12 and Week 52
Secondary outcome [7] 0 0
Stage 1. Percentage of patients with clinical remission
Timepoint [7] 0 0
at both Week 12 and Week 52
Secondary outcome [8] 0 0
Stage 1. Percentage of patients with endoscopic remission
Timepoint [8] 0 0
at Week 52
Secondary outcome [9] 0 0
Stage 1. Percentage of patients with clinical remission
Timepoint [9] 0 0
at Week 52
Secondary outcome [10] 0 0
Stage 1. Percentage of patients with CDAI response
Timepoint [10] 0 0
at Week 52
Secondary outcome [11] 0 0
Stage 1. Percentage of patients with CDAI remission
Timepoint [11] 0 0
at Week 52
Secondary outcome [12] 0 0
Stage 1. Percentage of patients with endoscopic response
Timepoint [12] 0 0
at Week 52
Secondary outcome [13] 0 0
Stage 1. Percentage of patients with SES-CD total score of 0-2
Timepoint [13] 0 0
at Week 52
Secondary outcome [14] 0 0
Stage 1. Percentage of patients with endoscopic response and endoscopic remission
Timepoint [14] 0 0
Endoscopic response at Week 12, endoscopic remission at Week 52
Secondary outcome [15] 0 0
Stage 1. Serum concentration of brazikumab
Timepoint [15] 0 0
Through Week 68
Secondary outcome [16] 0 0
Stage 1. Incidence of anti-drug antibodies
Timepoint [16] 0 0
Through Week 68
Secondary outcome [17] 0 0
Stage 1. Exposure-response
Timepoint [17] 0 0
Through Week 68
Secondary outcome [18] 0 0
Stage 1. Serum IL-22 concentration clinical cutoff for Stage 2
Timepoint [18] 0 0
at Week 12
Secondary outcome [19] 0 0
Stage 1. Number and percentage of patients with adverse events
Timepoint [19] 0 0
Through Week 68
Secondary outcome [20] 0 0
Stage 1. Percentage of patients with potentially clinically significant changes in laboratory values
Timepoint [20] 0 0
Through Week 68
Secondary outcome [21] 0 0
Stage 1. Percentage of patients with potentially clinically significant changes in vital signs
Timepoint [21] 0 0
Through Week 68
Secondary outcome [22] 0 0
Stage 1. Percentage of patients with potentially clinically significant changes in physical exams
Timepoint [22] 0 0
Through Week 68
Secondary outcome [23] 0 0
Stage 1. Percentage of patients with potentially clinically significant changes in ECGs
Timepoint [23] 0 0
Through Week 68
Secondary outcome [24] 0 0
Stage 2. Percentage of patients with endoscopic response
Timepoint [24] 0 0
at both Week 12 and Week 52
Secondary outcome [25] 0 0
Stage 2. Percentage of patients with clinical remission
Timepoint [25] 0 0
at both Week 12 and Week 52
Secondary outcome [26] 0 0
Stage 2: Percentage of patients with endoscopic remission
Timepoint [26] 0 0
at Week 52
Secondary outcome [27] 0 0
Stage 2. Percentage of patients with clinical remission
Timepoint [27] 0 0
at Week 52
Secondary outcome [28] 0 0
Stage 2: Percentage of patients with CS-free endoscopic remission
Timepoint [28] 0 0
at Week 52
Secondary outcome [29] 0 0
Stage 2. Percentage of patients with CS-free clinical remission
Timepoint [29] 0 0
at Week 52
Secondary outcome [30] 0 0
Stage 2: Percentage of patients with CS-free endoscopic remission
Timepoint [30] 0 0
at Week 52
Secondary outcome [31] 0 0
Stage 2: Percentage of patients with CS-free clinical remission
Timepoint [31] 0 0
at Week 52
Secondary outcome [32] 0 0
Stage 2. Percentage of patients with endoscopic response
Timepoint [32] 0 0
at Week 12
Secondary outcome [33] 0 0
Stage 2. Percentage of patients with clinical remission
Timepoint [33] 0 0
at Week 12
Secondary outcome [34] 0 0
Stage 2. Percentage of patients with endoscopic response and endoscopic remission
Timepoint [34] 0 0
Endoscopic response at Week 12, endoscopic remission at Week 52
Secondary outcome [35] 0 0
Stage 2. Percentage of patients with clinical remission
Timepoint [35] 0 0
at both Week 12 and Week 52
Secondary outcome [36] 0 0
Stage 2. Percentage of patients achieving CS-free endoscopic response
Timepoint [36] 0 0
at Week 52
Secondary outcome [37] 0 0
Stage 2. Percentage of patients with clinical remission
Timepoint [37] 0 0
at Week 52
Secondary outcome [38] 0 0
Stage 2. Serum concentration of brazikumab
Timepoint [38] 0 0
Through Week 68
Secondary outcome [39] 0 0
Stage 2. Incidence of anti-drug antibodies
Timepoint [39] 0 0
Through Week 68
Secondary outcome [40] 0 0
Stage 2. Exposure-response
Timepoint [40] 0 0
Through Week 68
Secondary outcome [41] 0 0
Stage 2. Number and percentage of patients with adverse events
Timepoint [41] 0 0
Through Week 68
Secondary outcome [42] 0 0
Stage 2. Percentage of patients with potentially clinically significant changes in laboratory values
Timepoint [42] 0 0
Through Week 68
Secondary outcome [43] 0 0
Stage 2. Percentage of patients with potentially clinically significant changes in vital signs
Timepoint [43] 0 0
Through Week 68
Secondary outcome [44] 0 0
Stage 2. Percentage of patients with potentially clinically significant changes in physical exams
Timepoint [44] 0 0
Through Week 68
Secondary outcome [45] 0 0
Stage 2. Percentage of patients with potentially clinically significant changes in ECGs
Timepoint [45] 0 0
Through Week 68

Eligibility
Key inclusion criteria
Inclusion and
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria are the same for both Stage 1 and Stage 2; however,
participants enrolled in Stage 1 will not be permitted to enroll in Stage 2.

Inclusion Criteria:

1. At the time of signing the informed consent, the participant must be 18 to 80 years of
age, inclusive.

2. 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.

3. 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

4. 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.

5. Participants taking 5-aminosalicylates, Oral prednisone (or equivalent), Budesonide,
Immunomodulators, Oral antibiotics, Immunomodulators, Probiotics must be at a stable
dose.

6. Participant must have the QFT-TB test performed and meet the following TB criteria.

A TB worksheet must also be completed:

1. Participant has no known history of active TB.

2. Participant has no known history of latent TB without completion of an appropriate
course of intervention.

3. 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:

1. no symptoms/risk factors per TB worksheet provided by the sponsor

2. no known recent exposure to a case of active TB

3. no evidence of active TB on chest x-ray within 8 weeks prior to Screening or during
Screening

4. 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



1. Participant is unable or unwilling to have endoscopic procedures performed during the
study.

2. History or current diagnosis of ulcerative colitis, indeterminate colitis, microscopic
colitis, ischemic colitis, colonic mucosal dysplasia, primary sclerosing cholangitis,
or untreated bile acid malabsorption.

3. History of toxic megacolon within 3 months prior to Randomization.

4. 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.

5. 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).

6. Bowel perforation during the 6 months prior to Screening or evidence of obstruction
within 3 months of Screening.

7. 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.

8. 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).

9. Ongoing nutritional dependency for total parenteral nutrition or an elemental diet at
Screening.

10. 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

11. 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.

12. Chronic hepatitis B or C infection.

13. Known history of primary immunodeficiency, splenectomy, or any underlying condition
that predisposes the subject to infection, includingHIV infection.

14. Prior history of or current diagnosis of a demyelinating disorder.

15. 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

16. Except for ustekinumab, prior exposure to any biologic agent targeting IL-12 or IL-23.

17. Participants who received cyclosporine, mycophenolate mofetil, sirolimus (rapamycin),
thalidomide, tacrolimus (FK-506), or tofacitinib within 2 weeks prior to Screening
Visit 1.

18. 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.

19. Participants received more than 1 dose of IV or intramuscular steroids within 2 weeks
prior to Screening Visit 1.

20. Participant received topical (rectal) aminosalicylic acid (eg, mesalamine) or topical
(rectal) steroids within 2 weeks prior to Randomization.

21. 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.

22. 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.

23. 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.

24. 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.

25. 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).

26. Clinically significant kidney disease

27. Abnormal laboratory results at Screening

28. 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.

29. 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)

30. Transfusion of blood, plasma, or platelets within the 30 days prior to Screening.

31. 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.

32. Employees of the clinical study site or any other individuals involved with the
conduct of the study, or immediate family members of such individuals.

33. Previous randomization in the present study. . Complete exclusion criteria are in the
study protocol

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
13/10/2023
Actual
Sample size
Target
Accrual to date
Final
89
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Nevada
Country [11] 0 0
United States of America
State/province [11] 0 0
New Mexico
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Canada
State/province [19] 0 0
British Columbia
Country [20] 0 0
Canada
State/province [20] 0 0
Quebec
Country [21] 0 0
Czechia
State/province [21] 0 0
Ceske Budejovice
Country [22] 0 0
Czechia
State/province [22] 0 0
Horovice
Country [23] 0 0
Czechia
State/province [23] 0 0
Hradec Kralove
Country [24] 0 0
Czechia
State/province [24] 0 0
Olomouc
Country [25] 0 0
Germany
State/province [25] 0 0
Augsburg
Country [26] 0 0
Germany
State/province [26] 0 0
Berlin
Country [27] 0 0
Germany
State/province [27] 0 0
Hamburg
Country [28] 0 0
Germany
State/province [28] 0 0
Kiel
Country [29] 0 0
Germany
State/province [29] 0 0
Minden
Country [30] 0 0
Germany
State/province [30] 0 0
Remscheid
Country [31] 0 0
Germany
State/province [31] 0 0
Ulm
Country [32] 0 0
Hungary
State/province [32] 0 0
Budapest
Country [33] 0 0
India
State/province [33] 0 0
Bangalore
Country [34] 0 0
India
State/province [34] 0 0
Hyderabad
Country [35] 0 0
India
State/province [35] 0 0
Jaipur
Country [36] 0 0
India
State/province [36] 0 0
Surat
Country [37] 0 0
Israel
State/province [37] 0 0
HaIFA
Country [38] 0 0
Israel
State/province [38] 0 0
Jerusalem
Country [39] 0 0
Israel
State/province [39] 0 0
Petah Tikva
Country [40] 0 0
Italy
State/province [40] 0 0
Milano
Country [41] 0 0
Italy
State/province [41] 0 0
Padova
Country [42] 0 0
Italy
State/province [42] 0 0
Rozzano
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Busan
Country [44] 0 0
Korea, Republic of
State/province [44] 0 0
Daegu
Country [45] 0 0
Korea, Republic of
State/province [45] 0 0
Seoul
Country [46] 0 0
Poland
State/province [46] 0 0
Bydgoszcz
Country [47] 0 0
Poland
State/province [47] 0 0
Chojnice
Country [48] 0 0
Poland
State/province [48] 0 0
Kraków
Country [49] 0 0
Poland
State/province [49] 0 0
Poznan
Country [50] 0 0
Poland
State/province [50] 0 0
Rzeszow
Country [51] 0 0
Poland
State/province [51] 0 0
Sopot
Country [52] 0 0
Poland
State/province [52] 0 0
Torun
Country [53] 0 0
Poland
State/province [53] 0 0
Warszawa
Country [54] 0 0
Poland
State/province [54] 0 0
Wroclaw
Country [55] 0 0
Poland
State/province [55] 0 0
Zamosc
Country [56] 0 0
Russian Federation
State/province [56] 0 0
Aramil
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Moscow
Country [58] 0 0
Russian Federation
State/province [58] 0 0
Perm
Country [59] 0 0
Slovakia
State/province [59] 0 0
Banska Bystrica
Country [60] 0 0
Slovakia
State/province [60] 0 0
Kosice
Country [61] 0 0
Slovakia
State/province [61] 0 0
Nitra
Country [62] 0 0
South Africa
State/province [62] 0 0
Cape Town
Country [63] 0 0
South Africa
State/province [63] 0 0
Johannesburg
Country [64] 0 0
South Africa
State/province [64] 0 0
Plumstead
Country [65] 0 0
Spain
State/province [65] 0 0
Madrid
Country [66] 0 0
Spain
State/province [66] 0 0
Pontevedra
Country [67] 0 0
Spain
State/province [67] 0 0
Valencia
Country [68] 0 0
Taiwan
State/province [68] 0 0
Kaohsiung
Country [69] 0 0
Taiwan
State/province [69] 0 0
Taichung
Country [70] 0 0
Taiwan
State/province [70] 0 0
Taipei City
Country [71] 0 0
Taiwan
State/province [71] 0 0
Taipei
Country [72] 0 0
Ukraine
State/province [72] 0 0
Kharkiv
Country [73] 0 0
Ukraine
State/province [73] 0 0
Kyiv
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Coventry
Country [75] 0 0
United Kingdom
State/province [75] 0 0
West Bromwich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT03759288
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Kathy Bohannon
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03759288