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 Plaque-Type Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 202
- 试验地点
- 33
- 主要终点
- Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) 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 plaque-type psoriasis. The purpose of the study is to assess the effect of orismilast modified release in moderate-to-severe plaque-type psoriasis 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 chronic, stable plaque-type psoriasis. If the patient is diagnosed with psoriasis arthritis, the arthritis should be stable.
- •Moderate-to-severe plaque-type psoriasis as defined by Psoriasis Activity and Severity Index (PASI) ≥12, body surface area (BSA) ≥10%, and Investigator Global Assessment (IGA) ≥
- •Candidate for systemic antipsoriatic treatment or phototherapy.
排除标准
- •Therapy-resistant psoriasis
- •Unstable psoriasis or psoriatic arthritis with acute deterioration within 4 weeks of the Screening visit.
- •History of allergy or hypersensitivity to any component of the study treatment.
- •Active infection (eg, bacteria, 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 carcinomas.
研究组 & 干预措施
Orismilast modified release tablets 20 mg BID
Oral, twice daily morning and evening for 16 weeks
干预措施: Orismilast modified release tablets (Drug)
Orismilast modified release tablets 30 mg BID
Oral, twice daily morning and evening for 16 weeks
干预措施: Orismilast modified release tablets (Drug)
Orismilast modified release tablets 40 mg BID
Oral, twice daily morning and evening for 16 weeks
干预措施: Orismilast modified release tablets (Drug)
Placebo tablets BID
Oral, twice daily morning and evening for 16 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Week 16
时间窗: Baseline and Week 16
The Psoriasis Activity and Severity Index (PASI) is a measure of psoriatic disease severity, taking into account qualitative lesion characteristics (erythema, induration, and desquamation) and percentage of affected skin surface area on defined anatomical regions. PASI score ranges from 0 to 72, with higher scores reflecting greater disease severity. Erythema, induration/thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The total qualitative score (sum of erythema, thickness, and scaling scores) is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant. The scores for each anatomic region are combined to yield the final PASI.
次要结局
- Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Week 16(At Week 16)
- Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 4, 8, 12, 16, and 20(Baseline and Weeks 4, 8, 12, 16, and 20)
- Percentage of Participants Who Achieved a Score of Clear (0) or Almost Clear (1) and an at Least 2-point Improvement in Investigator Global Assessment (IGA) at Week 16(At Week 16)
- Percentage of Participants Who Achieved a Score of Clear (0) or Almost Clear (1) and an at Least 2-point Improvement in Investigator Global Assessment (IGA) at Weeks 4, 8, 12, and 20(At Weeks 4, 8, 12, and 20)
- Percentage of Participants Who Achieved 75% Reduction in PASI (PASI75) Response at Weeks 4, 8, 12, and 20(At Weeks 4, 8, 12, and 20)
- Percentage of Participants Who Achieved 50%, 90%, and 100% Reduction in PASI Response at Weeks 4, 8, 12, 16, and 20(At Weeks 4, 8, 12, 16, and 20)
- Percent Change From Baseline in Psoriasis Activity and Severity Index (PASI) Score at Weeks 4, 8, 12, and 20(Baseline and Weeks 4, 8, 12, and 20)
- Percent Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 16 and 20(Baseline and Weeks 16 and 20)
- Percent Change From Baseline in Total Score of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20(Baseline and Weeks 4, 8, 12, 16, and 20)
- Percent Change From Baseline in Each Individual Item of Psoriasis Symptom Scale (PSS) at Weeks 4, 8, 12, 16, and 20(Baseline and Weeks 4, 8, 12, 16, and 20)
- Percentage of Participants Who Experienced Psoriasis Rebound by Week 20(At Week 20)