NCT02683785已完成2 期
A Multi-centre Phase IIa Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of GSK3196165 in Subjects With Inflammatory Hand Osteoarthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change From Baseline in 24-hour Average Hand Pain Intensity, Averaged Over the 7 Days Prior to Week 6
研究概览
简要总结
This is a randomized, Phase IIa, multicentre, double-blind, placebo-controlled parallel group study with the primary objective to assess the efficacy potential of GSK3196165 on pain, in subjects with active inflammatory hand osteoarthritis (HOA).
Approximately 40 subjects will be enrolled into the study, following a screening period of up to 4 weeks. The total treatment period will be 12 weeks, with the follow up period completing at Week 22. At least 40 subjects will be randomized across the two treatment arms, to either placebo or GSK3196165 in a 1:1 ratio.
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
- Triple (Participant, 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
- •Age >=18 years at the time of signing informed consent.
- •Meets American College of Rheumatology (ACR) classification of osteoarthritis (OA) and have not responded to analgesics (level 1 and 2) or to non-steroidal anti-inflammatory drugs (NSAIDs) for at least 10 days in the past 3 months.
- •Active disease at screening and randomization with at least two swollen and tender proximal interphalangeal (PIP) and/or distal interphalangeal (DIP) joints in the affected hand.
- •Signs of inflammation such as synovitis in the MRI scan of the affected hand.
- •Must have a subject's self assessment of 24-hour average hand pain intensity at baseline of at least '5' on an 11-point Numerical Rating Scale (NRS, 0-10).
- •Weight >=45 kilogram (kg).
- •Male or female subjects are eligible to participate so long as they meet and agree to abide by the contraceptive criteria.
- •Diffusing capacity of the lung for carbon monoxide (DLCO) >=70% predicted; forced expiratory volume in 1 second (FEV1) >=80% predicted.
- •No evidence of active or latent infection with Mycobacterium tuberculosis (TB).
排除标准
- •Pregnant or lactating women.
- •History of any clinically significant inflammatory disease other than inflammatory HOA, especially, but not limited to, rheumatoid arthritis or spondylarthropathies.
- •Diagnosis of rheumatoid arthritis, fibromyalgia, gout, calcium pyrophosphate deposition disease (CPPD), pseudogout, hemochromatosis or other inflammatory rheumatological or autoimmune disorders.
- •Clinical suspicion of, or previous investigation for CPPD or pseudogout, or history of chondrocalcinosis.
- •Any injury, medical or surgical procedure to the affected joint(s) that may interfere with evaluation of the target HOA joint(s).
- •History of infected joint prosthesis at any time, with the prosthesis still in situ. History of leg ulcers, catheters, chronic sinusitis or recurrent chest or urinary tract infections.
- •Any surgical procedure, including bone or joint surgery/synovectomy within 12 weeks prior to Day 1 or any planned surgery within the duration of the study or follow-up period.
- •History of any respiratory disease which (in the opinion of the investigator) would compromise subject safety or the ability of the subject to complete the study (e.g. significant interstitial lung disease, such as pulmonary fibrosis, chronic obstructive pulmonary disease (COPD), moderate-severe asthma, bronchiectasis, previous pulmonary alveolar proteinosis [PAP]).
- •Clinically-significant or unstable (in the opinion of the investigator) persistent cough or dyspnea that is unexplained.
- •Significant unstable or uncontrolled acute or chronic disease which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk.
- •A history of malignancy.
- •Hereditary or acquired immunodeficiency disorder, including immunoglobulin deficiency.
- •Current/previous Hepatitis B virus (HBV), Hepatitis C virus (HCV) or human immunodeficiency virus (HIV) 1 or 2 infection.
研究组 & 干预措施
GSK3196165
Experimental
Subjects will receive a total of 8 doses of GSK3196165 over a 12-week treatment period.
干预措施: GSK3196165 (Drug)
Placebo
Placebo Comparator
Subjects will receive a total of 8 doses of placebo over a 12-week treatment period.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in 24-hour Average Hand Pain Intensity, Averaged Over the 7 Days Prior to Week 6
时间窗: Baseline (Day 1 Pre-dose) and Week 6
Participants were required to complete a daily pain NRS based on their 24-hour average hand pain intensity with the anchors "0" (no pain) and "10" (worst imaginable pain), which was averaged over the 7 days prior to assessment visit. The 7 day average score was calculated as sum of daily 24 hours average hand pain NRS scores in the 7 days prior to assessment visit, divided by number of entries recorded in those 7 days. Baseline visit was at Day 1 and Baseline value was defined as the average of the 7 days prior to baseline visit (Day 1 pre-dose). Change from Baseline is equal to post-dose visit value minus Baseline value. Intent-To-Treat Population comprised of all randomized participants who received at least one dose of study treatment (GSK3196165 or placebo).
次要结局
- Change From Baseline in 24 Hours Average Hand Pain Intensity Averaged Over the 7 Days Prior to Each Visit(Baseline (Pre-dose Day 1), Weeks 1, 2, 3, 4, 6, 8, 10 and 12)
- Change From Baseline of Worst Hand Pain Intensity Over 24 Hours Averaged Over the 7 Days Prior to Each Visit(Baseline (Pre-dose Day 1), Weeks 1, 2, 3, 4, 6, 8, 10 and 12)
- Percentage of Participants Achieving a 30 Percentage Reduction From Baseline in 24 Hours Average Hand Pain Intensity at Each Visit(Baseline (Pre-dose, Day 1), Weeks 1, 2, 3, 4, 6, 8, 10, 12 and follow up (Week 22))
- Percentage of Participants Achieving a 50 Percentage Reduction From Baseline in 24 Hours Average Hand Pain Intensity at Each Visit(Baseline (Pre-dose, Day 1), Weeks 1, 2, 3, 4, 6, 8, 10, 12 and follow up (Week 22))
- Change From Baseline in Number of Tender Hand Joints at Each Visit(Baseline, Weeks 1, 2, 4, 6, 8, 10, and 12)
- Change From Baseline in Physician Global Assessment (PhGA) of Disease Activity(Baseline (Day 1 Pre-dose), Weeks 2, 4, 8, and 12)
- Percentage of Participants Achieving a 30 Percentage Reduction From Baseline in 24 Hours Worst Hand Pain Intensity at Each Visit(Baseline (Pre-dose, Day 1), Weeks 1, 2, 3, 4, 6, 8, 10, 12 and follow up (Week 22))
- Percentage of Participants Achieving a 50 Percentage Reduction From Baseline in 24 Hours Worst Hand Pain Intensity at Each Visit(Baseline (Pre-dose, Day 1), Weeks 1, 2, 3, 4, 6, 8, 10, 12 and follow up (Week 22))
- Change From Baseline in Australian Canadian Hand Osteoarthritis Index (AUSCAN) 3.1 NRS Scores at Each Visit.(Baseline (Day 1 Pre-dose), Weeks 1, 2, 4, 6, 8, 10, and 12)
- Change From Baseline in Number of Soft Tissue Swollen Hand Joints at Each Visit(Baseline (Day 1 Pre-dose), Weeks 1, 2, 4, 6, 8, 10, and 12)
- Change From Baseline in Patient Global Assessment (PtGA) of Disease Activity(Baseline, Weeks 2, 4, 8, and 12)
- Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)(Up to Week 22)
- Number of Participants With Infections(Up to Week 22)
- Number of Participants With Pulmonary Events(Up to Week 22)
- Number of Participants With Anti-GSK3196165 Binding Antibodies(Up to Week 22)
- Apparent Clearance After Subcutaneous Administration (CL/F) of GSK3196165(Day 3 and Pre-dose on Week 1, Week 4, Week 6, Week 12 and Week 22)
- Apparent Steady State Volume of Distribution After Subcutaneous Administration (Vss/F) of GSK3196165(Day 3 and Pre-dose on Week 1, Week 4, Week 6, Week 12 and Week 22)
- Absoption Rate Constant (Ka) of GSK3196165(Day 3 and Pre-dose on Week 1, Week 4, Week 6, Week 12 and Week 22)
- Serum Concentration of GSK3196165 by Visit(Pre-dose on Day 3, Weeks 1, 4, 6, 12, follow up (Week 22))
研究者
研究点 (1)
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