Efficacy and Safety of 3 Doses of S201086/GLPG1972 Administered Orally Once Daily in Patients With Knee Osteoarthritis. A 52-week International, Multi-regional, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Galapagos NV
- 入组人数
- 932
- 试验地点
- 44
- 主要终点
- Change From Baseline in Cartilage Thickness of the cMTFC as Assessed by qMRI on the Target Knee to Week 52
研究概览
简要总结
This study is a phase 2, 52-week international, multi-regional, multi-center, randomized, double-blind, placebo-controlled dose-ranging study for the treatment of osteoarthritis.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male participants or female participants of non-childbearing potential and not breastfeeding.
- •Body weight > 40 kg, body mass index (BMI) < 40 kg/m^
- •Diagnosed for knee osteoarthritis based on clinical and radiological criteria of the American College of Rheumatology.
- •History of knee pain for at least 6 months and on the majority of days (> 50%) during the preceding month.
- •Symptom severity defined by a pain ≥ 40 mm and ≤ 90 mm on visual analogue scale (VAS, 100 mm) at screening and inclusion visits.
- •Documented need for symptomatic as needed-treatment for osteoarthritis (OA) in the target knee with systemic non-steroidal anti-inflammatory drugs (NSAIDs) and/or other analgesics
排除标准
- •Severe clinical knee malalignment according to the investigator.
- •Knee prosthesis already implanted (< 1 year) or not well-tolerated (contralateral side).
- •Knee prosthesis already foreseen within the study period (whichever side).
- •Hip prosthesis recently implanted (< 1 year) or foreseen within the study period (whichever side).
- •Previous osteotomy on the inferior limbs (whichever side).
- •Surgical operation on the target knee within the 12 months prior to the screening visit or planned during the study.
- •Diagnostic arthroscopy of the target knee within the 6 months prior to the screening visit or planned during the study.
- •Other pathologies affecting the target knee.
- •Any contraindication to magnetic resonance imaging (MRI) including the inability to undergo a knee MRI exam because of inability to fit in the scanner or knee coil.
研究组 & 干预措施
GLPG1972 75 mg
Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
干预措施: GLPG1972 (Drug)
GLPG1972 75 mg
Participants received 1 film-coated tablet of GLPG1972 75 mg and 3 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
干预措施: Placebo (Drug)
GLPG1972 150 mg
Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
干预措施: GLPG1972 (Drug)
GLPG1972 150 mg
Participants received 2 film-coated tablets of GLPG1972 75 mg (total dose 150 mg) and 2 GLPG1972 matching placebo tablets, orally once daily for 52 weeks.
干预措施: Placebo (Drug)
GLPG1972 300 mg
Participants received 4 film-coated tablets of GLPG1972 75 mg (total dose 300 mg), orally once daily for 52 weeks.
干预措施: GLPG1972 (Drug)
Placebo
Participants received 4 film-coated tablets of GLPG1972 matching placebo, orally once daily for 52 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Cartilage Thickness of the cMTFC as Assessed by qMRI on the Target Knee to Week 52
时间窗: Baseline, Week 52
Reduction in cartilage loss was assessed by cartilage thickness as measured in the medial cMTFC of the target knee using qMRI.
次要结局
- Plasma Concentrations of GLPG1972(Pre-dose at Weeks 4, 12, and 52; Pre-dose and one post-dose sample (2-4 hours interval) at Week 28; one post dose sample (interval 4-8 hours) at Week 40)
- Number of Participants With Treatment-emergent Adverse Event (TEAE)(Baseline up to 2-weeks after last dose of IMP (up to Week 54))
- Change From Baseline in Bone Area of the Medial Femoral Condyle Surface of the Target Knee by qMRI to Week 28(Baseline, Week 28)
- Change From Baseline in Joint Space Width (JSW) of the Target Knee to Week 52(Baseline, Week 52)
- Change From Baseline in Bone Area of the Medial Femoral Condyle Surface of the Target Knee by qMRI to Week 52(Baseline, Week 52)
- Number of Participants Who Have Used at Least 1 Systemic Analgesic During the Study(Baseline up to Week 52)
- Number of Participants Who Were Osteoarthritis (OA) Structural Progressors Based on Cartilage Thickness in the cMTFC Assessed by qMRI on the Target Knee(Week 52)
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score and Subscales Scores for Pain, Function, and Stiffness to Week 52(Baseline, Week 52)
- Change From Baseline in Pain Assessment in the Target Knee as Measured by Visual Analog Scale (VAS) to Week 52(Baseline, Week 52)
- Change From Baseline in Patient Global Assessment (PGA) of Disease Activity as Measured by VAS to Week 52(Baseline, Week 52)
- Number of Participants Who Were Responders Based on the Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Criteria(Week 52)
- Change From Baseline in Cartilage Thickness of the Total Tibiofemoral Compartment (tTFC) of the Target Knee by qMRI to Week 52(Baseline, Week 52)