EUCTR2017-000957-37-NL进行中（未招募）1 期
A Multicenter, Phase 2A, Randomized, Investigator-Blind, Subject-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Subjects with Active Ankylosing Spondylitis
CB Biopharma SPR0 个研究点目标入组 60 人开始时间: 2017年10月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- •- Documented diagnosis of active adult-onset Ankylosing Spondylitis (AS) as defined by documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984) of at least 3 months’ symptom duration and age of onset <45 years
- •- Subject has moderate to severe active disease at the Screening Visit as defined by each of the following:
- •a) Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >=4
- •b) Spinal pain >=4 on a 0 to 10 numeric rating scale (NRS) (from BASDAI Item 2)
- •- Subjects must have had an inadequate response to, have a contraindication to, or have been intolerant to at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs)
- •- Subjects taking corticosteroids must be on a maximum daily dose of <=10mg/day oral prednisolone or equivalent
- •- Subjects taking methotrexate (MTX; <=25mg/week) are allowed to continue their medication if they received a stable dose for at least 12 weeks before randomization
- •- Subjects taking sulfasalazine (up to 3grams/day) or hydroxychloroquine (up to 400mg per day total) are allowed to continue their medication if started at least 12 weeks prior to randomization
- •- Subject who has been on an anti-tumor necrosis factor alpha (TNFa) agent must have experienced an inadequate response to previous or current treatment given at an approved dose for at least 3 months or have been intolerant to at least 1 administration of an anti-tumor necrosis factor alpha (TNF) agent. Subjects may not have been on more than 1 anti-TNF agent.
- •- Subject has high-sensitive C-Reactive Protein (hsCRP) levels above ULN at the Screening Visit
- •- 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 Investigational Medicinal Product (IMP)
- •- 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 IMP
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- Subjects with a total ankylosis of the spine, or a diagnosis of any other inflammatory arthritis eg, rheumatoid arthritis (RA), sarcoidosis, systemic lupus erythematosus, or reactive arthritis
- •- Subjects with any current sign or symptom that may indicate an active infection (except for the common cold)
- •- Subject has received previous or current biological treatment other than TNFa inhibitor treatment
- •- Subject has chronic, recurrent, recent serious / life-threatening or current infection, as defined in the protocol
- •- Subject has history of certain atypical infections, viral hepatitides, human immunodeficinecy virus (HIV) infection, tuberculosis, as defined in the protocol
- •- Subjects receiving any live vaccination within the 8 weeks prior to Baseline
- •- Subjects with known tuberculosis (TB) infection, at high risk of acquiring TB infection, with latent TB infection or current or history of nontuberculous mycobacteria (NTMB) infection
- •- Subject has immunosuppressive condition or treatment, recent history of malignancy (some exceptions) or demyelinating disease
- •- Subjects with concurrent malignancy or a history of malignancy during the past 5 years will be excluded, with following exceptions that may be included:
- •a. <= 3 excised or ablated basal cell carcinomas of the skin
- •b. One squamous cell carcinoma of the skin (stage T1 maximum) successfully excised, or ablated only (other treatments, ie, chemotherapy, do not apply), with no signs of recurrence or metastases for more than 2 years prior to Screening
- •c. Actinic keratosis (-es)
- •d. Squamous cell carcinoma-in-situ of the skin successfully excised, or ablated, more than 6 months prior to Screening
- •- Subject has history of psychiatric disorder, including suicidality (as defined in the protocol
- •- Subject has major abnormalities on laboratory testing, as defined in the protocol
研究者
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