NCT05511519终止2 期
A Phase 2a, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Zunsemetinib vs Placebo in Patients With Moderate-to-Severe Active Psoriatic Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Proportion of patients achieving ACR20 at Week 12
研究概览
简要总结
This is a Phase 2a study to investigate the efficacy, safety, tolerability, PK, and PD of ATI-450 versus placebo in patients with moderate to severe psoriatic arthritis.
详细描述
This is a Phase 2a, randomized, double-blind, placebo-controlled study to investigate the efficacy, safety, tolerability, PK, and PD of ATI-450 versus placebo in patients with moderate to severe psoriatic arthritis.
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)
盲法说明
The blinded placebo drug is packaged to match the active study drug and will be stored under the same conditions.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of PsA with symptom onset at least 6 months before the Screening Visit and fulfilment of the Classification Criteria for PsA.
- •Patient has moderate-to-severe PsA at Screening and Randomization Visits defined as
- •≥3 tender joints (based on 68 joint counts) and
- •≥3 swollen joints (based on 66 joint counts).
- •Diagnosis of active plaque psoriasis or documented history of plaque psoriasis.
排除标准
- •Any arthritis with onset before age 17 years, or current diagnosis of inflammatory joint disease other than PsA, or other immunological disease (including, but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus).
- •Patient has an uncontrolled non-immunoinflammatory disease that may place the patient at increased risk during the study or impact the interpretation of results, eg, cirrhosis, previous malignancy, previous venous thromboembolism.
- •Any clinically significant laboratory abnormality that would affect interpretation of study data or safety of the patient's participation in the study, per judgment of the investigator.
研究组 & 干预措施
ATI-450
Experimental
ATI-450 50mg oral tablet BID
干预措施: ATI-450 (Drug)
Placebo
Placebo Comparator
Placebo oral tablet BID
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Proportion of patients achieving ACR20 at Week 12
时间窗: Baseline to Week 12
次要结局
- Proportion of patients with ACR 50/70 at Week 12(Baseline to Week 12)
- Proportion of patients with ACR 20/50/70 response at weeks 2, 4, 6, 8(Baseline to Week 12)
- Change from baseline in tender joint count 68 at weeks 1, 2, 4, 6, 8, 12(Baseline to Week 12)
- Change from baseline in swollen joint count 66 at weeks 1, 2, 4, 8, 12(Baseline to Week 12)
- Change from baseline in Health Assessment Questionnaire - Disability Index at weeks 2, 4, 8, 12(Baseline to Week 12)
- Change from baseline in patient's global assessment of disease activity at weeks 2, 4, 8, 12(Baseline to Week 12)
- Change from baseline in physician's global assessment of disease activity at weeks 2, 4, 8, 12(Baseline to Week 12)
- Change from baseline in Patients Pain VAS assessment at Weeks 2, 4, 8, 12(Baseline to Week 12)
- Change from baseline in high sensitivity C-reactive protein (hs-CRP) at weeks 2, 4, 8, 12(Baseline to Week 12)
- Change from baseline in Leeds Enthesitis Index over 12 weeks(Baseline to Week 12)
- Change from baseline in Leeds Dactylitis Index over 12 weeks(Baseline to Week 12)
- Proportion of patients achieving at least a 30% reduction and at least 1 unit reduction from Baseline in the numerical rating scale (NRS30) in Patient's Daily Assessment of Skin Pain at Weeks 2, 4, 8, 12 among patients with Baseline NRS ≥3(Baseline to Week 12)
- Proportion of patients achieving a sIGA of Psoriasis of 0 or 1 and at least a 2-point improvement from baseline among those with a baseline investigator's global assessment of at least 3 over 12 weeks(Baseline to Week 12)
- Proportion of patients achieving MDA at weeks 2, 4, 8, 12(Baseline to Week 12)
- Change from baseline in DAS28CRP at Weeks 2, 4, 8, 12(Baseline to Week 12)
- Mean change from baseline in PASI score at weeks 2, 4, 8, 12(Baseline to Week 12)
- Change from baseline in Short-Form-36 Physical Component Summary at weeks 2, 4, 8, 12(Baseline to Week 12)
- Type and frequency of serious adverse events(Baseline to Week 12)
- Psoriasis Area Severity Index (PASI) 50/75/90 response (for patients with ≥3% body surface area psoriasis at baseline) at Week 12(Baseline to Week 12)
- Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Questionnaire at weeks 2, 4, 8, 12(Baseline to Week 12)
- Change from baseline in Self-Assessment of Psoriasis Symptoms Questionnaire at weeks 2, 4, 8, 12(Baseline to Week 12)
- Type and frequency of adverse events(Baseline to Week 12)
- Zunsemetinib trough concentration ng/mL(Baseline to Week 12)
- CDD-2164 metabolite trough concentration ng/mL(Baseline to Week 12)
- Zunsemetinib peak concentration (Cmax) ng/mL(Baseline to Week 12)
- CDD-2164 metabolite peak concentration (Cmax) ng/mL(Baseline to Week 12)
研究者
研究点 (2)
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