An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID)

November 20, 2023 updated by: AstraZeneca

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
89

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W4
        • Research Site
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Research Site
  • Czechia
      • Ceske Budejovice, Czechia, 370 01
        • Research Site
      • Horovice, Czechia, 268 31
        • Research Site
      • Hradec Kralove, Czechia, 500 12
        • Research Site
      • Olomouc, Czechia, 772 00
        • Research Site
  • Germany
      • Augsburg, Germany, 86156
        • Research Site
      • Berlin, Germany, 10825
        • Research Site
      • Hamburg, Germany, 20251
        • Research Site
      • Kiel, Germany, 24105
        • Research Site
      • Minden, Germany, 32423
        • Research Site
      • Remscheid, Germany, 42859
        • Research Site
      • Ulm, Germany, 89081
        • Research Site
  • Hungary
      • Budapest, Hungary, 1082
        • Research Site
  • India
      • Bangalore, India, 560054
        • Research Site
      • Hyderabad, India, 500032
        • Research Site
      • Jaipur, India, 302001
        • Research Site
      • Surat, India, 395002
        • Research Site
  • Israel
      • HaIFA, Israel, 3109601
        • Research Site
      • Jerusalem, Israel, 9103102
        • Research Site
      • Petah Tikva, Israel, 4941492
        • Research Site
  • Italy
      • Milano, Italy, 20132
        • Research Site
      • Milano, Italy, 20154
        • Research Site
      • Padova, Italy, 35128
        • Research Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 48108
        • Research Site
      • Daegu, Korea, Republic of, 42415
        • Research Site
      • Seoul, Korea, Republic of, 06351
        • Research Site
      • Seoul, Korea, Republic of, 156-755
        • Research Site
  • Poland
      • Bydgoszcz, Poland, 85 168
        • Research Site
      • Chojnice, Poland, 89-600
        • Research Site
      • Kraków, Poland, 31-513
        • Research Site
      • Poznań, Poland, 61-731
        • Research Site
      • Rzeszow, Poland, 35-302
        • Research Site
      • Sopot, Poland, 81-756
        • Research Site
      • Toruń, Poland, 87-100
        • Research Site
      • Warszawa, Poland, 00-635
        • Research Site
      • Warszawa, Poland, 03-580
        • Research Site
      • Warszawa, Poland, 00-728
        • Research Site
      • Wrocław, Poland, 52-210
        • Research Site
      • Zamość, Poland, 22-400
        • Research Site
  • Russian Federation
      • Aramil, Russian Federation, 624002
        • Research Site
      • Moscow, Russian Federation, 115419
        • Research Site
      • Perm, Russian Federation, 614000
        • Research Site
  • Slovakia
      • Banska Bystrica, Slovakia, 97401
        • Research Site
      • Kosice, Slovakia, 04013
        • Research Site
      • Nitra, Slovakia, 94901
        • Research Site
  • South Africa
      • Cape Town, South Africa, 7500
        • Research Site
      • Cape Town, South Africa, 7708
        • Research Site
      • Johannesburg, South Africa, 1827
        • Research Site
      • Plumstead, South Africa, 7800
        • Research Site
  • Spain
      • Madrid, Spain, 28046
        • Research Site
      • Pontevedra, Spain, 36071
        • Research Site
      • Valencia, Spain, 46010
        • Research Site
  • Taiwan
      • Kaohsiung, Taiwan, 80756
        • Research Site
      • Taichung, Taiwan, 40447
        • Research Site
      • Taipei, Taiwan, 100
        • Research Site
      • Taipei City, Taiwan, 114
        • Research Site
  • Ukraine
      • Kharkiv, Ukraine, 61037
        • Research Site
      • Kyiv, Ukraine, 04050
        • Research Site
      • Kyiv, Ukraine, 03680
        • Research Site
      • Kyiv, Ukraine, 04078
        • Research Site
  • United Kingdom
      • Coventry, United Kingdom, CV2 2DX
        • Research Site
      • West Bromwich, United Kingdom, B71 4HJ
        • Research Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85037
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72212
        • Research Site
    • California
      • Lancaster, California, United States, 93534
        • Research Site
      • Lincoln, California, United States, 95648
        • Research Site
      • Poway, California, United States, 92064
        • Research Site
      • San Diego, California, United States, 92103
        • Research Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Research Site
    • Florida
      • Boca Raton, Florida, United States, 33487
        • Research Site
      • Clearwater, Florida, United States, 33756
        • Research Site
      • Kissimmee, Florida, United States, 34741
        • Research Site
      • Lakeland, Florida, United States, 33813
        • Research Site
      • Miami, Florida, United States, 33165
        • Research Site
      • Miami, Florida, United States, 33157
        • Research Site
      • Miami, Florida, United States, 33189
        • Research Site
      • Miami Lakes, Florida, United States, 33016
        • Research Site
      • Naples, Florida, United States, 34102
        • Research Site
      • Saint Petersburg, Florida, United States, 33710
        • Research Site
      • Tampa, Florida, United States, 33626
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Research Site
      • Atlanta, Georgia, United States, 30342
        • Research Site
      • Decatur, Georgia, United States, 30033
        • Research Site
    • Illinois
      • Oak Lawn, Illinois, United States, 60453
        • Research Site
    • Indiana
      • Brownsburg, Indiana, United States, 46112
        • Research Site
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89123
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Research Site
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • Research Site
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • Research Site
    • Pennsylvania
      • Uniontown, Pennsylvania, United States, 15401
        • Research Site
    • Texas
      • Carrollton, Texas, United States, 75007
        • Research Site
      • Houston, Texas, United States, 77058
        • Research Site
      • Houston, Texas, United States, 77017
        • Research Site
      • McAllen, Texas, United States, 78503
        • Research Site
      • Pflugerville, Texas, United States, 78660
        • Research Site
      • Stafford, Texas, United States, 77477
        • Research Site
    • Virginia
      • North Chesterfield, Virginia, United States, 23236
        • Research Site
    • Washington
      • Spokane, Washington, United States, 99204
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion and 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

Exclusion Criteria:

  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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Drug: 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
Drug: 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
Drug: Placebo
Intravenous placebo on Days 1, 29, 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
Drug: 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
Drug: 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
Active Comparator: (Stage 2) Humira®
Administered subcutaneously on Day 1, Day 15, and Day 29 and every 2 weeks through Week 50
Drug: Humira®
Administered subcutaneously on Day 1, Day 15, and Day 29 and every 2 weeks through Week 50.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Stage 1. Percentage of patients with CDAI remission
Time Frame: at Week 12
CDAI remission is defined as achieving the CDAI score below 150 (measured by PRO questionnaire and objective items (i.e. weight, hematocrit)).
at Week 12
Stage 2. Percentage of patients with endoscopic response
Time Frame: at Week 52
Endoscopic response is described as minimum of 50% decrease from Baseline in SES-CD total score.
at Week 52
Stage 2. Percentage of patients with clinical remission
Time Frame: at Week 52
Clinical remission is defined for a participant to satisfy the following two response thresholds simultaneously: 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 (measured by PRO questionnaire).
at Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Stage 1. Percentage of patients with endoscopic response
Time Frame: at Week 12
Endoscopic response is described as minimum of 50% decrease from Baseline in SES-CD total score.
at Week 12
Stage 1. Percentage of patients with clinical remission
Time Frame: at Week 12
Clinical remission is defined for a participant to satisfy the following two response thresholds simultaneously: 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 (measured by PRO questionnaire).
at Week 12
Stage 1. Percentage of patients with CDAI response
Time Frame: at Week 12
CDAI response is defined as achieving the CDAI score of < 150 points or CDAI reduction from Baseline of ≥ 100 points (measured by PRO questionnaire and objective items (i.e. weight, hematocrit)).
at Week 12
Stage 1. Percentage of patients with CDAI remission
Time Frame: at both Week 12 and Week 52
CDAI remission is defined as achieving the CDAI score below 150 (measured by PRO questionnaire and objective items (i.e. weight, hematocrit)).
at both Week 12 and Week 52
Stage 1. Percentage of patients with CDAI response
Time Frame: at both Week 12 and Week 52
CDAI response is defined as achieving the CDAI score of < 150 points or CDAI reduction from Baseline of ≥ 100 points (measured by PRO questionnaire and objective items (i.e. weight, hematocrit)).
at both Week 12 and Week 52
Stage 1. Percentage of patients with endoscopic response
Time Frame: at both Week 12 and Week 52
Endoscopic response is described as minimum of 50% decrease from Baseline in SES-CD total score.
at both Week 12 and Week 52
Stage 1. Percentage of patients with clinical remission
Time Frame: at both Week 12 and Week 52
Clinical remission is defined for a participant to satisfy the following two response thresholds simultaneously: 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 (measured by PRO questionnaire).
at both Week 12 and Week 52
Stage 1. Percentage of patients with endoscopic remission
Time Frame: at Week 52
Endoscopic remission is defined as achieving the 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
at Week 52
Stage 1. Percentage of patients with clinical remission
Time Frame: at Week 52
Clinical remission is defined for a participant to satisfy the following two response thresholds simultaneously: 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 (measured by PRO questionnaire).
at Week 52
Stage 1. Percentage of patients with CDAI response
Time Frame: at Week 52
CDAI response is defined as achieving the CDAI score of < 150 points or CDAI reduction from Baseline of ≥ 100 points (measured by PRO questionnaire and objective items (i.e. weight, hematocrit)).
at Week 52
Stage 1. Percentage of patients with CDAI remission
Time Frame: at Week 52
CDAI remission is defined as achieving the CDAI score below 150 (measured by PRO questionnaire and objective items (i.e. weight, hematocrit)).
at Week 52
Stage 1. Percentage of patients with endoscopic response
Time Frame: at Week 52
Endoscopic response is described as minimum of 50% decrease from Baseline in SES-CD total score.
at Week 52
Stage 1. Percentage of patients with SES-CD total score of 0-2
Time Frame: at Week 52
SES-CD total score of 0-2
at Week 52
Stage 1. Percentage of patients with endoscopic response and endoscopic remission
Time Frame: Endoscopic response at Week 12, endoscopic remission at Week 52
Endoscopic response: Minimum of 50% decrease from Baseline in SES-CD total score Endoscopic remission: 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
Endoscopic response at Week 12, endoscopic remission at Week 52
Stage 1. Serum concentration of brazikumab
Time Frame: Through Week 68
Pharmacokinetics: concentration of brazikumab in serum
Through Week 68
Stage 1. Incidence of anti-drug antibodies
Time Frame: Through Week 68
Immunogenicity: incidence of brazikumab anti-drug antibodies in serum
Through Week 68
Stage 1. Exposure-response
Time Frame: Through Week 68
Derive exposure response model linking primary endpoint to metrics of model predicted individual brazikumab exposures
Through Week 68
Stage 1. Serum IL-22 concentration clinical cutoff for Stage 2
Time Frame: at Week 12
Derive the relationship between baseline serum IL-22 concentration and efficacy of brazikumab through CDAI remission and endoscopic response
at Week 12
Stage 1. Number and percentage of patients with adverse events
Time Frame: Through Week 68
Number and percentage of patients with reported adverse events.
Through Week 68
Stage 1. Percentage of patients with potentially clinically significant changes in laboratory values
Time Frame: Through Week 68
Percentage of patients with clinically significant changes in hematology, clinical chemistry, urinalysis.
Through Week 68
Stage 1. Percentage of patients with potentially clinically significant changes in vital signs
Time Frame: Through Week 68
Percentage of patients with potentially clinically significant changes in systolic, diastolic pulse rate.
Through Week 68
Stage 1. Percentage of patients with potentially clinically significant changes in physical exams
Time Frame: Through Week 68
Percentage of patients with potentially clinically significant changes in full physical exams.
Through Week 68
Stage 1. Percentage of patients with potentially clinically significant changes in ECGs
Time Frame: Through Week 68
Percentage of patients with potentially clinically significant changes in 12-lead ECG recordings
Through Week 68
Stage 2. Percentage of patients with endoscopic response
Time Frame: at both Week 12 and Week 52
Endoscopic response is described as minimum of 50% decrease from Baseline in SES-CD total score
at both Week 12 and Week 52
Stage 2. Percentage of patients with clinical remission
Time Frame: at both Week 12 and Week 52
Clinical remission is defined for a participant to satisfy the following two response thresholds simultaneously: 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 (measured by PRO questrionare)
at both Week 12 and Week 52
Stage 2: Percentage of patients with endoscopic remission
Time Frame: at Week 52
Endoscopic remission: - 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
at Week 52
Stage 2. Percentage of patients with clinical remission
Time Frame: at Week 52
Clinical remission is defined for a participant to satisfy the following two response thresholds simultaneously: 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 (measured by PRO questrionare)
at Week 52
Stage 2: Percentage of patients with CS-free endoscopic remission
Time Frame: at Week 52
Percentage of patients achieving Endoscopic remission and are CS-free where 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
at Week 52
Stage 2. Percentage of patients with CS-free clinical remission
Time Frame: at Week 52
Percentage of patients achieving CS-free 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 Week 52
Stage 2: Percentage of patients with CS-free endoscopic remission
Time Frame: at Week 52
For participants taking CS at Baseline, percentage of patients achieving CS-free endoscopic remission
at Week 52
Stage 2: Percentage of patients with CS-free clinical remission
Time Frame: at Week 52
For participants taking CS at Baseline, percentage of patients achieving CS-free clinical remission
at Week 52
Stage 2. Percentage of patients with endoscopic response
Time Frame: at Week 12
Endoscopic response is described as minimum of 50% decrease from Baseline in SES-CD total score
at Week 12
Stage 2. Percentage of patients with clinical remission
Time Frame: at Week 12
Clinical remission is defined for a participant to satisfy the following two response thresholds simultaneously: 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 (measured by PRO questrionare)
at Week 12
Stage 2. Percentage of patients with endoscopic response and endoscopic remission
Time Frame: Endoscopic response at Week 12, endoscopic remission at Week 52
Endoscopic response is defined as minimum of 50% decrease from Baseline in SES-CD total score Endoscopic remission: - 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
Endoscopic response at Week 12, endoscopic remission at Week 52
Stage 2. Percentage of patients with clinical remission
Time Frame: at both Week 12 and Week 52
Clinical remission is defined for a participant to satisfy the following two response thresholds simultaneously: 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 (measured by PRO questionnaire)
at both Week 12 and Week 52
Stage 2. Percentage of patients achieving CS-free endoscopic response
Time Frame: at Week 52
Endoscopic response is described as minimum of 50% decrease from Baseline in SES-CD total score
at Week 52
Stage 2. Percentage of patients with clinical remission
Time Frame: at Week 52
Percentage of patients achieving CS-free clinical remission Clinical remission is defined for a participant to satisfy the following two response thresholds simultaneously: 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.(measured by PRO questionnaire)
at Week 52
Stage 2. Serum concentration of brazikumab
Time Frame: Through Week 68
Pharmacokinetics: concentration of brazikumab in serum
Through Week 68
Stage 2. Incidence of anti-drug antibodies
Time Frame: Through Week 68
Immunogenicity: incidence of brazikumab anti-drug antibodies in blood serum
Through Week 68
Stage 2. Exposure-response
Time Frame: Through Week 68
Derive exposure response model linking primary endpoint to metrics of model predicted individual brazikumab exposures
Through Week 68
Stage 2. Number and percentage of patients with adverse events
Time Frame: Through Week 68
Number and percentage of patients with reported adverse events
Through Week 68
Stage 2. Percentage of patients with potentially clinically significant changes in laboratory values
Time Frame: Through Week 68
Percentage of patients with clinically significant changes in hematology, clinical chemistry, urinalysis.
Through Week 68
Stage 2. Percentage of patients with potentially clinically significant changes in vital signs
Time Frame: Through Week 68
Percentage of patients with potentially clinically significant changes in systolic, diastolic pulse rate
Through Week 68
Stage 2. Percentage of patients with potentially clinically significant changes in physical exams
Time Frame: Through Week 68
Percentage of patients with potentially clinically significant changes in full physical exams
Through Week 68
Stage 2. Percentage of patients with potentially clinically significant changes in ECGs
Time Frame: Through Week 68
Percentage of patients with potentially clinically significant changes in 12-lead ECG recordings
Through Week 68

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Kathy Bohannon, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 7, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 18, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 18, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D5271C00001
  • 2018-004346-42 (EudraCT Number)
  • #3150-301-008 (Other Identifier: Legacy - Allergan)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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