A Study of the Efficacy and Safety of Brazikumab in Participants with Moderately to Severely Active Crohn's Disease

Phase 1

• Conditions: Crohn's Disease; MedDRA version: 20.0Level: LLTClassification code 10011402Term: Crohn's disease (colon)System Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2018-004346-42-HU
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-31
• Last Update Posted: 30 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 553

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
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, Probiotics must be at a stable dose.
6 No known history of active TB or latent TB without completion of appropriate intervention.
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.

For all detailed Inclusion criteria please refer to the section 5.1 of the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 51

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 (Day 1).
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.
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 [Day 1]) 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.
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 defined as:
• Hepatitis B: positive for hepatitis B surface antigen (HBsAg+) or positive for anti–hepatitis B core antibody (HBcAB+) and positive confirmatory PCR for HBV, regardless of anti–hepatitis B surface antibody status
• Hepatitis C: positive result for hepatitis C antibody and positive confirmatory PCR test for hepatitis C virus
13 Known history of primary immunodeficiency, splenectomy, or any underlying condition that predisposes the subject to infection, including HIV infection. Participants with positive results of HIV testing by the central laboratory will be excluded.
14 Participant has received the following treatment:
• Adalimumab, certolizumab pegol, infliximab, or golimumab: within 8 weeks prior to Randomization (Day 1)
• Vedolizumab or ustekinumab within 12 weeks prior to Randomization (Day 1)
• Other prohibited medication, biologic or small molecule treatment within 5 half-lives prior to Randomization (Day 1)
• Fecal microbiota transplantation: within 8 weeks prior to Screening ileocolonoscopy
15 Except for ustekinumab, prior exposure to any biologic agent targeting IL-12 or IL-23.

All exclusion criteria with all details cannot be list in this field, please refer to the section 5.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified