EUCTR2016-001102-42-CZ进行中（未招募）1 期
A MULTICENTER, PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS
CB Biopharma SPR0 个研究点目标入组 303 人开始时间: 2016年11月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 303
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
入选标准
- •- Subject has active AS, determined by documented radiologic evidence fulfilling the Modified New York criteria for AS including symptoms for >=3 months and age of onset <45 years
- •- Subject has moderate to severe active disease as defined by each of the following:
- •--BASDAI score >=4
- •--Spinal pain >=4 on a 0 to 10 NRS (from BASDAI item 2)
- •- Subjects must have at least 1 of the following:
- •-- inadequate response to nonsteroidal anti-inflammatory drug (NSAID) therapy
- •-- intolerance to administration of at least 1 NSAID
- •-- contraindication(s) to NSAID therapy
- •- Subjects who are regularly taking NSAIDs/COX-2 inhibitors as part of their AS therapy are required to be on a stable dose for at least 14 days before Baseline
- •- Subjects taking corticosteroids must be on an average daily dose of <=10mg/day prednisone or equivalent for at least 14 days before Baseline and should remain on a stable dose up to Week 16
- •- Subjects taking MTX (<=25mg/week) are allowed to continue their medication if started at least 12 weeks prior to Baseline, with a stable dose for at least 8 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 Baseline, with a stable dose for at least 8 weeks before randomization
- •- Subjects may be TNF inhibitor-naïve or may have received 1 prior TNF inhibitor. Subjects who have been on a TNF inhibitor previously must have:
- •--experienced an inadequate response to previous treatment given for at least 3 months
- •-- been intolerant to administration (eg, had a side effect/AE that led to discontinuation)
- •-- lost access to TNF inhibitor for other reasons
- •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 280
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •- Subjects with a total ankylosis of the spine, or a diagnosis of any other inflammatory arthritis eg,rheumatoid arhritis (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)
- •- Subjects with a history of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline Visit
- •- Subjects receiving any live vaccination within the 8 weeks prior to Baseline
- •- Subjects with known tubercolosis (TB) infection, at high risk of acquiring TB infection, with latent TB infection or current or history of nontuberculous mycobacteria (NTMB) infection
- •- Subjects with concurrent malignancy or a history of malignancy during the past 5 years will be excluded, with following exceptions that may be indlucded:
- •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
研究者
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