CTIS2023-506704-14-00进行中（未招募）1 期
A Phase 2b, Multicenter, Randomized, Double-blind Induction, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects with Moderately to Severely Active Crohn’s Disease - TAK-279-CD-2001
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 268
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •The subject is willing and able to understand and fully comply with study procedures and requirements (including digital tools and applications), in the opinion of the investigator. The subject has provided informed consent (that is, in writing, documented via a signed and dated ICF) and any required privacy authorization prior to the initiation of any study procedures., Subjects must be =18 and =75 years of age at the time of the signing of the ICF., Disease-Specific Inclusion Criteria: Subjects must have active moderate to severe ileal (terminal ileum), ileocolonic, or colonic CD at baseline during screening period as defined by: a) CDAI score between 220 and 450 (inclusive) and b) Presence of ulcerations that are characteristic to CD, as determined by ileocolonoscopy performed during screening, and as defined by the SES-CD =6 (SES-CD =4 for isolated ileitis), Disease-Specific Inclusion Criteria: Subjects must have a documented diagnosis (endoscopic with histology) of CD for at least 30 days before screening. Documented diagnosis is defined as: a) A biopsy report to confirm the histological diagnosis AND b) A report documenting disease duration based upon prior ileocolonoscopy. Note: If a biopsy report is not available in the source document at the time of screening, a local histology report of a biopsy performed during the screening ileocolonoscopy should be consistent with a CD diagnosis. If the histology diagnosis is not clear and the endoscopy is inconsistent with CD at this time point, the subject will not be randomized., Disease-Specific Inclusion Criteria: Subjects with a family history of colorectal cancer, personal history of increased colorectal cancer risk, aged >50 years, or other known risk factors must be up to date on colorectal cancer surveillance (may be performed during screening)., Disease-Specific Inclusion Criteria: Subjects must be willing and able to undergo ileocolonoscopy with biopsies during screening after all other inclusion criteria have been met., Prior Treatment Failure Criteria: Subjects must have received prior treatment(s) for CD (according to either (a) or (b) below or a combination of both): a) History of inadequate response to, loss of response to, or intolerance to these therapies based on Physician assessment: 6-mercaptopurine or azathioprine, oral or IV corticosteroids or history of corticosteroid dependence (an inability to successfully taper corticosteroids without return of CD symptoms) (Details provided in Appendix 2). AND/OR b)Have received treatment with =1 biologic agents (such as TNF antagonists, antibodies to IL-23p19, IL-12/23p40, vedolizumab) or any advanced therapy (such as JAKi or S1P receptor modulators)., Other General Inclusion Criteria: Subjects agree to comply with the contraceptive requirements of the protocol, or females of nonchildbearing potential. Females of reproductive potential who are sexually active must agree to use appropriate contraception for the duration of the study and 10 days after the last dose of the study drug. The following birth control requirements must be met: b)
排除标准
- •Exclusion Criteria Related to GI Tract: Subjects with IBD indeterminate or unclassified, microscopic colitis, ischemic colitis, infectious colitis, or radiation colitis, and diverticular disease associated with colitis, and/or clinical/histologic findings suggestive of ulcerative colitis., Exclusion Criteria Related to GI Tract: Subjects with evidence or suspicion of liver disease or primary sclerosing cholangitis., Exclusion Criteria related to Medication:, Exclusion Criteria Related to Other Prohibited Concomitant Medications: Subjects on CD-related antibiotics who have not been on stable doses for greater than or discontinued within 14 days prior to the first administration of study drug., Exclusion Criteria Related to Other Prohibited Concomitant Medications: Subjects on oral aminosalicylates who have not been on stable doses for greater than, or discontinued within, at least 14 days prior to the first administration of study drug or receiving mesalamine >4.8g/day (or equivalent)., Subjects on high dose corticosteriods, Subjects on prohibited medications as listed in the protocol, Exclusion Criteria related to Infectious Diseases: Tuberculosis (TB): a) Subject has current active TB infection, regardless of treatment status. b) Subject who has positive QuantiFERON will require to start treatment for latent TB at least 2 weeks prior to randomization. c) Subject has a positive QuantiFERON-TB Gold (QFT) or T-Spot, TB skin test (TST) result or 2 indeterminate QFT or TST results. TST is considered positive if reaction =10 mm, unless there are no signs/symptoms of active TB and documentation of prior and complete treatment for latent TB (appropriate in duration and type according to current local country guidelines) has been completed or subject has initiated prophylaxis based on local guidelines a minimum of 2 weeks prior to the first administration of study drug and documentation of no history of active TB can be provided. Note: TB prophylaxis regimens should be administered according to local guidelines. However, because of potential interactions with TAK-279, rifampin should not be used. Note: QFT or TST may be used based on country and site-specific guidelines. d) Subject has had any imaging study during or 6 months prior to screening, including x-ray, chest computed tomography, magnetic resonance imaging, or other chest imaging suggesting evidence of current active of TB., Exclusion Criteria related to Infectious Diseases: Herpes infections: a) Subject has active herpes virus infection, including herpes zoster or herpes simplex 1 and 2 (demonstrated on physical examination and/or medical history) at screening or prior to the first administration of study drug, b) Subject has a history of her
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