A 52-Week, Multicenter, Randomized, Double-blind, Double-dummy, 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 - 52-Week Phase 2b/3 Crohn’s Disease Study

Allergan Ltd.0 个研究点目标入组 2,000 人开始时间: 2020年3月3日最近更新: 2020年4月20日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 2,000

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Aged 16 to 80 years, inclusive, or minimum age of adult consent according to local regulations, at Screening. For participants less than 18 years of age, the participant must weigh at least 40 kg at Screening.
•2. 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 oral aminosalicylates, oral CS, azathioprine, methotrexate, or 6-mercaptopurine, or demonstrated CS dependence for the treatment of CD.
•5. Participants taking 5-aminosalicylates, Oral prednisone (or equivalent), Budesonide, Immunomodulators, Oral antibiotics, Probiotics must be at a stable dose.
•6. Meets the following TB criteria: Participant has no known history of active TB; Participant has no known history of latent TB without completion of an appropriate course of intervention or is presently taking appropriate ongoing prophylactic intervention; Meets 1 of the following acceptable TB test results: Negative QFT-TB obtained from central laboratory within 4 weeks prior to randomization or For a positive QFT-TB test obtained during Screening from the central laboratory, active TB must be ruled out or Indeterminate QFT-TB test obtained during the Screening period from the central laboratory with ongoing QFT-TB testing; A negative tuberculin skin test is required if the QFT-TB test is not approved/registered in that country; Participants with a history of using anti-TNFa agents for a treatment course of 1 year or longer who have discontinued an anti-TNFa agent within 6 months prior to Screening must obtain a chest x-ray showing no evidence of active TB within 8 weeks prior to Screening or during Screening.
•7. Females of childbearing potential who are sexually active with a nonsterilized male partner must use 2 acceptable methods of contraception from Screening.
•8. Female participants who are post-menopausal and of non-childbearing potential must have an elevated FSH at or above the range for post-menopausal women by the central laboratory during Screening.
•9. Nonsterilized males who are sexually active with a female partner of childbearing potential must comply with the methods of contraception
•10. Ability to provide written informed consent prior to any study procedures
•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
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 150
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 1250
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 600

排除标准

•1. Participant has previously received Humira® and was intolerant to treatment or had met the criteria for primary or secondary non-response to treatment:
•a. Primary non-response: Signs and symptoms of persistently active disease despite a history of at least 1 induction regimen of Humira® per the local label consisting of at least 2 doses at least 2 weeks apart
•b. Secondary non-response: Recurrence of symptoms of persistently active disease during scheduled maintenance dosing of Humira® per the local label following prior clinical benefit
•c. Intolerance: AE associated with discontinuation of Humira® therapy, including, but not limited to, hypersensitivity, infusion-related reaction, infection, or congestive heart failure
•2. Participant is unable or unwilling to have endoscopic procedures performed during the study.
•3. History or current diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, colonic mucosal dysplasia, primary sclerosing cholangitis, or untreated bile acid malabsorption.
•4. History of toxic megacolon within 3 months prior to Baseline (Visit 2).
•5. Any intra-abdominal surgery, bowel resection, diversion, placement of ostomy or stoma within 3 months prior to Screening. Participants with a draining stoma are excluded.
•6. Participant has an enterocutaneous or entovesicular fistula. Participants with active fistulas may be considered if there is no anticipation for surgery and there is no evidence of active infection (eg, abscess) after further discussion with the study medical monitor.
•7. Bowel perforation during the 6 months prior to Screening or evidence of obstruction within 3 months of Screening.
•8. 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.
•9. 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).
•10. Ongoing nutritional dependency for total parenteral nutrition or an elemental diet at Screening.
•11. Participant has any of the following related to infections:
•a. Evidence of a recent (within 6 months of Baseline [Visit 2]) systemic fungal infection, requiring inpatient hospitalization, and/or antifungal treatment. Participants treated for localized fungal infections (eg, oral, vaginal, and skin candidiasis, onychomycosis) are not excluded.
•b. Any infection requiring hospitalization or treatment with IV anti-infectives (including anti-viral treatment) within 4 weeks of Screening
•c. Cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 8 weeks prior to Screening
•d. Clinically significant chronic infection (eg, osteomyelitis) that has not resolved within 8 weeks of Screening
•e. Non-serious infection requiring oral anti-infectives within 2 weeks prior to randomization must be further discussed with the study medical monitor. Chronic suppressive antiviral treatment for herpes simplex virus in the absence of active lesions or uncomplicated urinary tract infections are not considered exclusionary.
•f. Participant has clinical evidence of or suspected to have an abscess during Screening. Cu

研究者

发起方

Allergan Ltd.

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