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

  • STATUS
    Recruiting
  • End date
    Jun 10, 2027
  • participants needed
    928
  • sponsor
    AstraZeneca
Updated on 24 November 2021
antibiotics
methotrexate
endoscopy
prednisone
mercaptopurine
budesonide
conventional treatment
crohn's disease
azathioprine
humira
immunomodulators
aminosalicylate

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

Details
Condition Inflammatory bowel disease, Crohn's Disease, Irritable Bowel Syndrome, Irritable Bowel Syndrome (IBS), Irritable Bowel Syndrome (IBS- Pediatric), Crohn's Disease (Pediatric), ibudilast, inflammatory bowel diseases, crohns disease
Treatment Placebo, Humira®, Brazikumab low dose, Brazikumab high dose
Clinical Study IdentifierNCT03759288
SponsorAstraZeneca
Last Modified on24 November 2021

Eligibility

Yes No Not Sure

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
No known history of active TB or latent TB without completion of appropriate intervention. Acceptable TB test results from the central laboratory must be met
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
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
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
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol
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
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
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-Gurin 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 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
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
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