CTIS2023-505841-22-00招募中1 期
A Phase 3, Randomized, Multicenter, Double-Blind, Placebo- and Active Comparator-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-279 in Subjects with Moderate-to-Severe Plaque Psoriasis - TAK-279-3001
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 600
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
- •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, Subject has provided written informed consent and any required privacy authorization before the initiation of any study procedures, Subject has a diagnosis of chronic plaque psoriasis for =6 months prior to the screening visit, Subject has stable plaque psoriasis defined as no significant flare or change in morphology (as assessed by the investigator) in psoriasis for =6 months before screening (information obtained from medical chart or subject’s physician, or directly from the subject)., Subject has moderate-to-severe plaque psoriasis as defined by a PASI score =12 and a sPGA score =3 at screening and Day 1., Subject has plaque psoriasis covering =10% of his or her total BSA at screening and Day 1., Subject must be a candidate for phototherapy or systemic therapy., Subject is aged 18 years or older at the time of consent., Subject meets the following birth control requirement: A surgically sterile female subject; or a female subject of nonchildbearing potential with laboratory confirmation of postmenopausal status (ie, follicle-stimulating hormone levels >40 mIU/mL); or, if sexually active with a nonsterilized male partner, a female subject who agrees to use an effective method of contraception from the signing of informed consent throughout the duration of the study and for 10 days after the last dose
排除标准
- •Subject has evidence of non-plaque psoriasis (erythrodermic, pustular, predominantly guttate psoriasis, predominantly inverse, or drug-induced psoriasis)., Subject has received any of the following biologics or biosimilar versions within the time frame indicated: a) Antibodies to IL-12/-23, IL-17, or IL-23 (eg, ustekinumab, secukinumab, tildrakizumab, ixekizumab, or guselkumab) within 6 months prior to Day 1. b) TNF inhibitor(s) (eg, etanercept, adalimumab, infliximab, certolizumab) within 2 months prior to Day 1. c) Agents that modulate integrin pathways to impact lymphocyte trafficking (eg, natalizumab) or agents that modulate B cells or T cells (eg, alemtuzumab, abatacept, or visilizumab) within 3 months prior to Day 1. d) Rituximab or other immune cell-depleting therapy within 6 months prior to Day 1., Subject has used medicated shampoo and/or body wash, including formulations containing but not limited to salicylic acid, corticosteroids, coal tar, vitamin D3 analogues, or other compounds used for the management of psoriasis within 2 weeks prior to Day 1., Subject has used any topical medication that could affect psoriasis presentation (including but not limited to corticosteroids, salicylic acid, urea, alpha- or beta-hydroxy acids, anthralin, retinoids, vitamin D analogues [such as calcipotriol], methoxsalen, trimethylpsoralen, calcineurin inhibitors [eg, tacrolimus], tapinarof, roflumilast, JAK inhibitors, or tar) within 2 weeks prior to Day 1 Note: Low-potency topical steroids (World Health Organization Class VI and VII) are permitted on the palms, soles, face, and intertriginous areas but should not be used within 24 hours before any study visit. Low-potency topical steroids may be used to treat acute non-psoriatic conditions (eg, contact dermatitis) on all body regions for no more than 2 weeks but should not be used within 24 hours before any study visit. Bland emollients (defined as emollients ingredients that are pharmaceutically active) are allowed on all body regions but should not be used within 24 hours before any study visit., Subject has used any systemic nonbiologic treatment that could affect psoriasis presentation (including oral, intravenous, intramuscular, intra-articular, intrathecal, or intralesional corticosteroids; oral retinoids; immunosuppressive/immunomodulating medication; methotrexate; azathioprine; 6-thioguanidine; mercaptopurine; mycophenolate mofetil; hydroxyurea; cyclosporine; 1,25-dihydroxyvitamin D3 analogues; psoralens; sulfasalazine; fumaric acid derivatives; JAK inhibitors) within 4 weeks prior to Day 1. Note: Intranasal corticosteroids, inhaled corticosteroids, and eye and ear drops containing corticosteroids are permitted., Subject has used leflunomide within 6 months prior to Day 1., Subject has received phototherapy (including ultraviolet B [UV-B], psoralen and ultraviolet A [PUVA], tanning beds, therapeutic sunbathing) or excimer laser within 4 weeks prior to Day 1., Subject has used botanical preparations (eg, herbal supplements or traditional Chinese medicines derived from plants, minerals, or animals) intended to treat psoriasis or other immunological diseases within 4 weeks prior to Day 1., Subject has previous exposure to TAK-279 (also known as NDI-034858), other TYK-2 inhibitors (including deucravacitinib), or apremilast., Subject has received lithium, antimalarials, or intramuscular gold therapy within 4 weeks prior to Day 1., Subject is currently being treated with strong or mod
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