EUCTR2016-001103-23-DE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 ACTIVE PSORIATIC ARTHRITIS
CB Biopharma SPR0 个研究点目标入组 200 人开始时间: 2016年11月16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
- 200
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
- •- Subject has a documented diagnosis of adult-onset PsA classified by CASPAR criteria with symptoms for at least 6 months prior to Screening, with active PsA at Baseline/Day 1, and must have at Baseline TJC >=3 out of 78 and SJC >=3 out of 76
- •- Subject must be rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative
- •- Subject must have a hs-CRP >=ULN
- •- Subject must have active psoriatic lesion(s) and/or a documented history of psoriasis
- •- Subjects who are regularly taking NSAIDs/COX-2 inhibitors as part of their PsA therapy are required to be on a stable dose/dose regimen 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 through the Week 16 visit
- •- 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 LEF (<=20mg/day or an average of 20mg/day if not dosed daily) are allowed to continue their medication if started at least 3 months prior to Baseline, with a stable dose for at least 8 weeks before randomization. Dose and dosing schedule should remain stable up to Week 16
- •- 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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •- Subjects with any current sign or symptom that may indicate an active infection (with the exception of the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of Baseline/Day 1
- •- 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 with concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
- •- Subjects with known history of or current clinically active infection with Histoplasma, Coccidioides, Paracoccidioides, Pneumocystis, Blastomyces, or Aspergillus or current active Candidiasis
- •- Subjects receiving any live (includes attenuated) 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 (LTBI), or current or history of nontuberculous mycobacteria (NTMB) infection
- •- Subjects with a diagnosis of inflammatory conditions other than psoriasis or psoriatic arthritis
- •- 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
研究者
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