NCT05469464已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2b Dose-Ranging Study to Evaluate the Efficacy and Safety of Orismilast in Adults With Moderate to Severe Atopic Dermatitis
UNION therapeutics46 个研究点 分布在 4 个国家目标入组 235 人开始时间: 2022年7月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 235
- 试验地点
- 46
- 主要终点
- Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16
研究概览
简要总结
This study investigates 3 different doses of orismilast modified release compared to placebo in adult patients with moderate-to-severe atopic dermatitis. The purpose of the study is to assess the effect of orismilast modified release in moderate-to-severe atopic dermatitis and assess the safety aspects of these 3 different doses. The patients will receive an oral treatment of either orismilast modified release tablets or placebo tablets 2 times a day for 16 weeks.
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
Tablets will be packaged in the same type of blister and the active and placebo tablets will have the same appearance (in terms of size, form, weight, and color).
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
- •Capable of giving signed informed consent.
- •Male and female patients ≥18 years of age
- •Body weight of >40 kg
- •Diagnosis of AD for a minimum of 1 year (before the Screening visit) using the Hanifin and Rajka criteria
- •Moderate to severe AD (affected BSA at least 10%, IGA-AD grade of at least 3, and EASI score of at least 16) at the screening and baseline visits
- •Candidate for systemic treatment or phototherapy for AD
排除标准
- •Therapy-resistant atopic dermatitis
- •Unstable AD with acute deterioration, requiring rescue therapy for AD within 4 weeks of the Screening visit or expected to require rescue therapy within 2 weeks after randomization
- •History of allergy or hypersensitivity to any component of the study treatment
- •Active infection (eg, bacterial, viral, fungal) requiring treatment with systemic antibiotics within 4 weeks of the Screening visit
- •Malignancy or history of malignancy except for treated (ie, cured) basal cell skin carcinoma
研究组 & 干预措施
Orismilast modified release tablets 20 mg BID
Experimental
Oral, twice daily morning and evening
干预措施: Orismilast modified release tablets (Drug)
Orismilast modified release tablets 30 mg BID
Experimental
Oral, twice daily morning and evening
干预措施: Orismilast modified release tablets (Drug)
Orismilast modified release tablets 40 mg BID
Experimental
Oral, twice daily morning and evening
干预措施: Orismilast modified release tablets (Drug)
Placebo tablets BID
Placebo Comparator
Oral, twice daily morning and evening
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16
时间窗: Baseline and Week 16
The EASI is a tool to measure the severity of clinical signs and the percentage of affected body surface area (BSA) in patients with atopic dermatitis (AD). The EASI is a composite scoring system to evaluate the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of 4 body regions, with adjustment for the percentage of BSA involved for each body region and for the proportion of the body region to the whole body. EASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/papulation, excoriation, and lichenification are scored on a scale of 0 (absent) to 3 (severe) for each body region: head and neck, upper limbs (including the external axillae and hands), trunk (including the internal axillae and groin), and lower limbs (including the buttocks and feet). The extent of affected skin in each body region is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).
次要结局
- Percentage of Participants Achieving 75% Reduction in Eczema Area and Severity Index EASI (EASI75) Response at Week 16(At Week 16)
- Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for AD (IGA-AD) at Week 16(At Week 16)
- Percentage of Participants Achieving a Score of Clear (0) or Almost Clear (1) and At Least a 2-point Improvement in Investigator Global Assessment for Atopic Dermatitis (IGA-AD) at Weeks 2, 4, 8, 12, and 20(At Weeks 2, 4, 8, 12, and 20)
- Number of Participants Achieving 75% Reduction in Eczema Area and Severity Index (EASI 75) at Weeks 2, 4, 8, 12, and 20(At Weeks 2, 4, 8, 12, and 20)
- Number of Participants Achieving 50% Reduction in Eczema Area and Severity Index (EASI 50) at Weeks 2, 4, 8, 12, 16, and 20(At Weeks 2, 4, 8, 12, 16, and 20)
- Number of Participants Achieving 90% Reduction in Eczema Area and Severity Index (EASI 90) at Weeks 2, 4, 8, 12, 16, and 20(At Weeks 2, 4, 8, 12, 16, and 20)
- Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Weeks 2, 4, 8, 12, and 20(Baseline and Weeks 2, 4, 8, 12, and 20)
- Change From Baseline in the Peak Pruritus Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20(Baseline, Weeks 1, 2, 4, 8, 12, 16, and 20)
- Percentage of Participants Achieving At Least a 4-point Improvement in the Peak Pruritus Numerical Rating Scale (NRS) From Baseline at Weeks 1, 2, 4, 8, 12, 16, and 20(At Weeks 1, 2, 4, 8, 12, 16 and 20)
- Change From Baseline in Affected Body Surface Area (BSA) at Weeks 2, 4, 8, 12, 16, and 20(Baseline and Weeks 2, 4, 8, 12, 16, and 20)
- Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 8, 16, and 20(Baseline and Weeks 8, 16, and 20)
- Change From Baseline in Patient Oriented Eczema Measure (POEM) Score at Weeks 2, 4, 8, 12, 16, and 20(Baseline and Weeks 2, 4, 8, 12, 16, and 20)
- Change From Baseline in Patient Global Impression of Severity Scale (PGIS) Score at Weeks 2, 4, 8, 12, 16, and 20(Baseline and Weeks 2, 4, 8, 12, 16, and 20)
- Change From Baseline in Patient Global Impression of Change (PGIC) Score at Weeks 2, 4, 8, 12, 16, and 20(Baseline and Weeks 2, 4, 8, 12, 16, and 20)
- Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12, 16, and 20(Baseline and Weeks 1, 2, 4, 8, 12, 16, and 20)
- Change From Baseline in Skin Pain Numerical Rating Scale (NRS) at Weeks 1, 2, 4, 8, 12, 16, and 20(Baseline and Weeks 1, 2, 4, 8, 12, 16, and 20)
- Number of Participants With Treatment Emergent Adverse Events (TEAE)(From Baseline through Week 20)
- Number of Participants With Abnormal Clinically Significant Findings in Physical Examination at Weeks 16(At Week 16)
- Change From Baseline in Body Temperature at Weeks 16 and 20(Baseline and Weeks 16 and 20)
- Change From Baseline in Respiration Rate at Weeks 16 and 20(Baseline and Weeks 16 and 20)
- Change From Baseline in Heart Rate at Weeks 16 and 20(Baseline and Weeks 16 and 20)
- Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 16 and 20(Baseline and Weeks 16 and 20)
- Change From Baseline in Body Mass Index (BMI) at Weeks 16 and 20(Baseline and Weeks 16 and 20)
- Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) at Week 16(At Week 16)
- Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin Concentration at Week 16(Baseline and Week 16)
- Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin at Week 16(Baseline and Week 16)
- Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume at Week 16(Baseline and Week 16)
- Change From Baseline in Hematology Parameter: Hematocrit at Week 16(Baseline and Week 16)
- Change From Baseline in Hematology Parameter: Hemoglobin at Week 16(Baseline and Week 16)
- Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, and Neutrophils at Week 16(Baseline and Week 16)
- Change From Baseline in Hematology Parameter: Platelets at Week 16(Baseline and Week 16)
- Change From Baseline in Hematology Parameter: Reticulocytes at Week 16(Baseline and Week 16)
- Change From Baseline in Hematology Parameter: Basophils/Leukocytes at Week 16(Baseline and Week 16)
- Change From Baseline in Hematology Parameter: Eosinophils/Leukocytes at Week 16(Baseline and Week 16)
- Change From Baseline in Hematology Parameter: Lymphocytes/Leukocytes at Week 16(Baseline and Week 16)
- Change From Baseline in Hematology Parameter: Monocytes/Leukocytes at Week 16(Baseline and Week 16)
- Change From Baseline in Hematology Parameter: Neutrophils/Leukocytes at Week 16(Baseline and Week 16)
- Change From Baseline in Chemistry Parameter: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Lactate Dehydrogenase at Week 16(Baseline and Week 16)
- Change From Baseline in Chemistry Parameter: Albumin at Week 16(Baseline and Week 16)
- Change From Baseline in Chemistry Parameter: Bilirubin, Creatinine, and Direct Bilirubin at Week 16(Baseline and Week 16)
- Change From Baseline in Chemistry Parameter: Calcium, Chloride, Potassium, Sodium, and Urea Nitrogen at Week 16(Baseline and Week 16)
- Change From Baseline in Chemistry Parameter: Phosphate at Week 16(Baseline and Week 16)
- Number of Participants With Worst Case Post-Baseline Urinalysis at Week 16(At Week 16)
- Change From Baseline in Hospital Anxiety and Depression Scale (HADS) at Weeks 2, 4, 8, 12, 16, and 20(Baseline and Weeks 2, 4, 8, 12, 16, and 20)
- Number of Participants With Suicidal Ideation, Suicidal Behavior, and Self-Injurious Behavior Without Suicidal Intent Based on the Columbia-Suicide Severity Rating Scale (C-SSRS)(At Weeks 2, 4, 8, 12, 16, and 20)
研究者
研究点 (46)
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