A Multicenter, Randomized, Double-blind, Placebo- Controlled Phase 2b Dose-finding Study to Investigate the Efficacy, Safety and Tolerability of LOU064 in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by H1-antihistamines
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 311
- 试验地点
- 1
- 主要终点
- Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 4
研究概览
简要总结
This was a multicenter, randomized, double-blind and placebo-controlled phase 2b dose-finding study to assess the efficacy and safety of LOU064 in adults chronic spontaneous urticaria (CSU) patients inadequately controlled by H1-antihistamines
详细描述
This was a global Phase 2b multicenter, randomized, double-blind, parallel-group, placebo-controlled study investigating the efficacy, safety and tolerability of six dosing groups of oral LOU064 in subjects with inadequately controlled CSU despite treatment with (second generation) H1-antihistamine. The study comprised of the 7 treatment arms: LOU064 10 mg q.d., LOU064 35 mg q.d., LOU064 100 mg q.d., LOU064 10 mg b.i.d, LOU064 25 mg b.i.d., LOU064 100 mg b.i.d. and placebo.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects aged ≥18 years of age
- •CSU diagnosis for ≥ 6 months prior to screening
- •Presence of itch and hives for ≥6 consecutive weeks prior to screening in spite of use of non-sedating H1-antihistamines according to local Treatment guidelines during this time period
- •UAS7 score (range 0-42) ≥16 and HSS7 score (range 0-21) ≥ 8 during 7 days prior to randomization (Day 1)
- •Willing and able to complete an Urticaria Participant Daily eDiary (UPDD) for the duration of the study
排除标准
- •Hypersensitivity to any of the study treatments
- •Clearly defined predominant or sole trigger of their chronic urticaria (chronic inducible urticaria)
- •Other diseases with symptoms of urticaria or angioedema
- •Other skin disease associated with chronic itching that might influence in the investigators opinion the study evaluations and results,
- •Known or suspected history of an ongoing, chronic or recurrent infectious disease including but not limited to opportunistic infections (eg tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis), HIV, Hepatitis B/C.
- •Pregnant or nursing (lactating) women
- •Women of child-bearing potential not using highly effective methods of contraception
研究组 & 干预措施
LOU064 Arm 2
35 mg capsule qd LOU064 once daily
干预措施: LOU064 Arm 2 (Drug)
LOU064 Arm 3
100 mg capsule qd LOU064 once daily
干预措施: LOU064 Arm 3 (Drug)
LOU064 Arm 1
10 mg LOU064 qd capsule once daily
干预措施: LOU064 Arm 1 (Drug)
LOU064 Arm 4
10 mg capsule LOU064 bid
干预措施: LOU064 Arm 4 (Drug)
LOU064 Arm 5
25 mg capsule LOU064 bid
干预措施: LOU064 Arm 5 (Drug)
LOU064 Arm 6
100 mg capsule LOU064 bid
干预措施: LOU064 Arm 6 (Drug)
Placebo Arm
Participants took matching placebo twice daily
干预措施: Placebo arm (Drug)
结局指标
主要结局
Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 4
时间窗: Baseline, Week 4
UAS7 score change (LS mean Change) from baseline at Week 4 estimated with a mixed-effect repeated measurement analysis of UAS7 score change from baseline (FAS) The Urticaria Activity Score (UAS) is a composite, diary-recorded score with numeric severity intensity ratings (0=none to 3=intense/severe) for the number of wheals (hives) and the intensity of the pruritus (itch) over the past 12 hours (twice daily). The daily UAS is calculated as the average of the morning and evening scores. The UAS7 is the weekly sum of the daily UAS, which is the composite score of the intensity of pruritus and the number of wheals. The maximum UAS7 value is 42. A higher score indicates worse disease. A negative change score (week 4 score minus Baseline score) indicates improvement.
次要结局
- Percentage of Participants With Either Complete Absence of Hives and Itch (UAS7=0) or Well-controlled Disease (UAS7<=6)(Week 12)
- Cumulative Number of Weeks With an AAS7=0 Response(Baseline to Week 12)
- Change From Baseline in Weekly Urticaria Activity Score (UAS7) at Week 12(Week 12)
- Mean Change From Baseline in DLQI Score(Baseline, Week 4 and Week 12)
- Observed Maximum Blood Concentration (Cmax) of LOU064(Week 4 and Week 12)
- Percentage of Participants With DLQI Score of 0 or 1(Week 4 and Week 12)
- Area Under the Blood Concentration-time Curve (AUC) of LOU064(Week 4 and Week 12)
- Time to Reach the Maximum Concentration (Tmax) of LOU064(Week 4 and Week 12)