A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of ABY-035 in the Treatment of Subjects With Ankylosing Spondylitis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Inmagene LLC
- 入组人数
- 25
- 试验地点
- 47
- 主要终点
- Proportion of subjects achieving an ASAS40 response
研究概览
简要总结
ABY-035-204 is a clinical study to assess the efficacy of IL-17 blocker ABY-035 in ankylosing spondylitis(AS). The primary objective is to estimate the relationship between different dose regimens of ABY-035 and clinical response as assessed by Assessment of Spondyloarthritis International Society 40 (ASAS40) response at Week 16 in subjects with active AS.
详细描述
ABY-035-204 is a double-blind, randomized, parallel-group, placebo-controlled study.
The primary objective is to estimate the relationship between different dose regimens of ABY-035 and clinical response as assessed by Assessment of Spondyloarthritis International Society 40 (ASAS40) response at Week 16 in subjects with active AS.
The study will include the following 3 periods:
- Screening Period: Up to 35 days prior to baseline randomization.
- Treatment Period 1: Day 0-Week 16
Cohort 1: Eligible subjects will be randomized 1:1:1:1 to receive 1 of 4 treatments (ABY-035 High Dose every 2 weeks (Q2W), ABY-035 Low Dose every 2 weeks (Q2W), ABY-035 High Dose every 4 weeks (Q4W), or placebo Q2W), and will remain on their allowable background medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female at least 18 years of age.
- •Subjects with active AS, determined by documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984).
- •AND At least one SpA feature, according to ASAS criteria.
- •Subjects have moderate to severe active disease
- •Subjects must have inadequate response or intolerance to at least 2 NSAIDs, or contraindication to NSAID therapy.
- •Subjects may be TNFα inhibitor-naïve or may have received up to 2 prior TNFα inhibitor(s)..
排除标准
- •Subjects have active fibromyalgia or total spinal ankylosis ('bamboo spine'), or any other inflammatory arthritis.
- •Subjects have used medications in the manner as detailed by the exclusion criteria as detailed in the study protocol.
- •Subjects have received technetium-99 conjugated with methylene diphosphonate other than for diagnostic purpose within 5 years prior to baseline.
- •Have received any live (includes attenuated) vaccination within the 12 weeks prior to the baseline.
- •Subjects have received any non-biological therapy for AS not listed as detailed in the study protocol within or outside a clinical study in the 3 months or within 5 half-lives prior to the Baseline Visit (whichever is longer).
- •Subject has an active infection or history of infections
- •Have evidence of or test positive for hepatitis B virus (HBV)
- •Have evidence of or test positive for hepatitis C virus (HCV).
- •Have a historically positive human immunodeficiency virus (HIV) test or test positive at screening for HIV.
- •Subjects have known tuberculosis (TB) infection, at high risk of acquiring TB infection, or current or history of nontuberculous mycobacterium (NTMB) infection, or LTB.
- •Have a history of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease.
- •Subjects have active Crohn's disease (CD) or active ulcerative colitis (UC).
- •Subjects have active uveitis within 6 weeks prior to baseline.
- •Subjects have laboratory abnormalities at Screening.
研究组 & 干预措施
#1: Cohort 1-High Dose Q2W
Cohort 1: ABY-035 High Dose, every 2 weeks, subcutaneous injection
干预措施: ABY-035 (Drug)
#2: Cohort 1-High Dose Q4W
Cohort 1: ABY-035 High Dose, every 4 weeks, subcutaneous injection
干预措施: ABY-035 (Drug)
#3: Cohort 1-Low Dose Q2W
Cohort 1: ABY-035 Low Dose, every 2 weeks, subcutaneous injection
干预措施: ABY-035 (Drug)
#4: Cohort 2-Low Dose QW
Cohort 2: ABY-035 Low Dose, every week, subcutaneous injection
干预措施: ABY-035 (Drug)
#5: Cohort 2-High Dose QW
Cohort 2: ABY-035 High Dose, every week, subcutaneous injection
干预措施: ABY-035 (Drug)
#1: Cohort 1-Placebo Q2W
Cohort 1: Placebo, every 2 weeks, subcutaneous injection
干预措施: Placebo (Drug)
#2: Cohort 2-Placebo QW
Cohort 2: Placebo, every week, subcutaneous injection
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of subjects achieving an ASAS40 response
时间窗: 16 weeks
The treatment effect
次要结局
- Change from baseline in BASDAI(16 weeks)
- Change from baseline in BASFI(16 weeks)
- Proportion of subjects reaching ASDAS-MI(16 weeks)
- Incidence of serious adverse events (SAEs) and adverse events of special interests (AESIs)(74 weeks)
- Proportion of subjects achieving an ASAS40 response, ASAS20 response, ASAS partial remission, and ASAS 5/6 response respectively at required timepoints(52 weeks)
- Proportion of subjects reaching BASDAI50 and ASDAS-MI at required timepoints(52 weeks)
- Change in safety laboratory parameters and vital signs compared to baseline(74 weeks)
- AEs leading to withdrawal from investigational medicinal product (IMP)(74 weeks)
- Change from baseline in BASDAI and BASFI at required timepoints(52 weeks)
- Proportion of subjects experiencing clinically important improvement at required timepoints(52 weeks)
- Incidence of AEs(74 weeks)
- ASDAS-CRP and ASDAS status at required timepoints(52 weeks)
- Change from baseline in total and nocturnal pain at required timepoints(52 weeks)