Trial record 2 of 2 for:
3150-301-008
An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03759288 |
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Recruitment Status :
Recruiting
First Posted : November 29, 2018
Last Update Posted : February 15, 2023
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
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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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Crohn's Disease IBD | Drug: Brazikumab low dose Drug: Brazikumab high dose Drug: Humira® Drug: Placebo | Phase 2 Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 928 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| 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) |
| Actual Study Start Date : | December 7, 2018 |
| Estimated Primary Completion Date : | March 4, 2027 |
| Estimated Study Completion Date : | June 10, 2027 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Crohn disease
MedlinePlus related topics:
Crohn's Disease
| Arm | Intervention/treatment |
|---|---|
|
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
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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
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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. |
Primary Outcome Measures :
- 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)).
- 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.
- 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).
Secondary Outcome Measures :
- 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.
- 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).
- 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)).
- 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)).
- 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)).
- 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.
- 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).
- 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
- 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).
- 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)).
- 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)).
- 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.
- 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
- 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
- Stage 1. Serum concentration of brazikumab [ Time Frame: Through Week 68 ]Pharmacokinetics: concentration of brazikumab in serum
- Stage 1. Incidence of anti-drug antibodies [ Time Frame: Through Week 68 ]Immunogenicity: incidence of brazikumab anti-drug antibodies in serum
- Stage 1. Exposure-response [ Time Frame: Through Week 68 ]Derive exposure response model linking primary endpoint to metrics of model predicted individual brazikumab exposures
- 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
- Stage 1. Number and percentage of patients with adverse events [ Time Frame: Through Week 68 ]Number and percentage of patients with reported adverse events.
- 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.
- 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.
- 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.
- 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
- 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
- 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)
- 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
- 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)
- 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
- 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
- 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
- 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
- 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
- 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)
- 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
- 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)
- 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
- 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)
- Stage 2. Serum concentration of brazikumab [ Time Frame: Through Week 68 ]Pharmacokinetics: concentration of brazikumab in serum
- Stage 2. Incidence of anti-drug antibodies [ Time Frame: Through Week 68 ]Immunogenicity: incidence of brazikumab anti-drug antibodies in blood serum
- Stage 2. Exposure-response [ Time Frame: Through Week 68 ]Derive exposure response model linking primary endpoint to metrics of model predicted individual brazikumab exposures
- Stage 2. Number and percentage of patients with adverse events [ Time Frame: Through Week 68 ]Number and percentage of patients with reported adverse events
- 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.
- 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
- 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
- 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
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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:
- 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.
A TB worksheet must also be completed:
- Participant has no known history of active TB.
- Participant has no known history of latent TB without completion of an appropriate course of intervention.
- Meets 1 of the following acceptable TB test results:
i. Negative QFT-TB obtained from central laboratory during Screening, OR ii. For a positive QFT-TB test obtained during Screening from the central laboratory, active TB must be ruled out or treated and negative QFT-TB confirmed by central laboratory OR iii. Indeterminate QFT-TB test obtained during the Screening Period from the central laboratory with ongoing QFT-TB testing as outlined in Appendix G. Participants with an indeterminate QFT-TB test can continue with Screening if they have all of the following:
- no symptoms/risk factors per TB worksheet provided by the sponsor
- no known recent exposure to a case of active TB
- no evidence of active TB on chest x-ray within 8 weeks prior to Screening or during Screening
- confirmed QFT-TB negative by central laboratory
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:
- 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.
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03759288
Contacts
| Contact: AstraZeneca Clinical Study Information Center | 1-877-240-9479 | information.center@astrazeneca.com |
Locations
Show 354 study locations
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Kathy Bohannon | AstraZeneca |
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT03759288 |
| Other Study ID Numbers: |
D5271C00001 2018-004346-42 ( EudraCT Number ) #3150-301-008 ( Other Identifier: Legacy - Allergan ) |
| First Posted: | November 29, 2018 Key Record Dates |
| Last Update Posted: | February 15, 2023 |
| Last Verified: | February 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| 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. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
| Time Frame: | AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. |
| Access Criteria: | When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. |
| URL: | https://astrazenecagroup-dt.pharmacm.com/DT/Home |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by AstraZeneca:
|
Crohn's Disease Inflammatory bowel disease Brazikumab |
IL23 receptor IBD CD |
Additional relevant MeSH terms:
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
Intestinal Diseases Adalimumab Anti-Inflammatory Agents Antirheumatic Agents |