CTRI/2016/10/007345已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Comparative, Prospective, Multicentre Trial to Assess Efficacy and Safety of Apremilast Tablets in Subjects with Moderate to Severe Plaque Psoriasis who are Candidates for Phototherapy or Systemic Therapy
Glenmark Pharmaceuticals Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
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
入选标准
- •1.Male or female subjects, aged >=18 years to <=65 years
- •2.Subjects who had moderate to severe plaque psoriasis for 6 months or longer and who are candidates for phototherapy or systemic therapy.
排除标准
- •1.Pregnant or lactating women.
- •2.Subjects with known hypersensitivity to the study drug or any of the excipient.
- •3.Subject with history of current erythrodermic, guttate or pustular psoriasis
- •4.Subjects with psoriasis flare or rebound within 4 weeks prior to screening
- •5.Subjects have used topical therapy within 2 weeks of randomization or systemic therapy or phototherapy (i.e., UVB, PUVA) for psoriasis within 28 days of randomization.
- •6.Subjects have used biological therapy for psoriasis within 6 months of randomization.
- •7.Subjects with history of malignancy (except for treated [i.e., cured] basal cell or squamous cell in situ skin carcinomas and treated [i.e., cured] cervical intraepithelial neoplasia [CIN] or carcinoma in situ of the cervix with no evidence of recurrence) within 5 years of screening
- •8.Subjects with evidence of skin conditions that would interfere with clinical assessments in the opinion of the investigator
- •9.Subjects with active substance abuse or a history of substance abuse within 6 months prior to Screening
- •10.Subjects with bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections.
- •11.Subject who have used any investigational drug or device within 30 days of randomization preceding informed consent or scheduled to participate in another clinical study involving an investigational product or investigational drug during the course of this study.
研究者
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