EUCTR2016-002368-15-DE进行中（未招募）1 期
A Multicenter, Randomized, Subject-Blind, Investigator-Blind Study to Evaluate the Time Course of Pharmacodynamic Response, Safety and Pharmacokinetics of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
CB Biopharma SPR0 个研究点目标入组 45 人开始时间: 2016年8月22日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
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
- •- Male or female at least 18 years of age and less than or equal to 70
- •- Chronic plaque psoriasis for at least 6 months prior to Screening
- •- Psoriasis Area and Severity Index (PASI) >=12 and body surface area (BSA) >=10% and Investigator’s Global Assessment (IGA) score >=3 on a 5-point scale
- •- Candidates for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy
- •- Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception up till 20 weeks after last administration of study drug, and have a negative pregnancy test at Visit 1 (Screening) and immediately prior to first dose
- •- Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active, up till 20 weeks after the last administration of study medication (anticipated 5 half-lives)
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •- Subjects previously participating in a bimekizumab study
- •- Subjects with erythrodermic, guttate, pustular form of psoriasis, or drug-induced psoriasis
- •- History of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline Visit (including herpes zoster)
- •- High risk of infection in the Investigator’s opinion
- •- Current sign or symptom that may indicate an active infection
- •- Concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
- •- Live (includes attenuated) vaccination within the 8 weeks prior to Baseline
- •- Subjects with concurrent malignancy or history of malignancy during the past 5 years (except for specific malignat condition as defined in the protocol)
- •- Primary immunosuppressive conditions
- •- TB infection, high risk of acquiring TB infection, latent TB infection (LTBI), or current or history of NTMB infection
- •- Laboratory abnormalities, as defined in the study protocol
- •- Any condition which, in the Investigator's judgement, would make the subject unsuitable for inclusion in the study
- •- Exposure to more than 1 biological response modifier (limited to anti-TNF or IL-12/-23) or any biologic response modifier during the three months prior to the Baseline Visit
- •- Subjects have received previous treatment with any anti-IL-17 therapy for the treatment of psoriasis or psoriatic arthritis
- •- Subjects with a diagnosis of inflammatory conditions other than psoriasis or psoriatic arthritis, including but not limited to rheumatoid arthritis, sarcoidosis, or systemic lupus erythematosus.
- •- Subjects with a diagnosis of Crohn’s disease or ulcerative colitis are allowed as long as they have no active symptomatic disease at Screening or Baseline
- •- Subjects taking psoriatic arthritis medications other than nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics
研究者
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