A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy, and Safety Study of Povorcitinib in Participants With Chronic Spontaneous Urticaria
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 79
- 主要终点
- Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12
研究概览
简要总结
This study is being conducted to evaluate the efficacy and safety of povorcitinib in adults with CSU that is inadequately controlled using SOC treatments.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •CSU diagnosis for ≥ 3 months prior to screening.
- •CSU refractory to second-generation H1 antihistamines
- •Participants must have been on a stable dose of second-generation H1 antihistamine, and must agree to maintain the stable dose of second-generation H1 antihistamine throughout study.
- •Willingness and ability to comply with the study Protocol and procedures.
- •Further inclusion criteria apply
排除标准
- •Treatment with an anti-IgE biologic (eg, omalizumab) within 8 weeks prior to screening.
- •Clearly defined underlying etiology for chronic urticarias other than CSU
- •Other cutaneous or systemic diseases with chronic itching or with symptoms of urticaria or angioedema.
- •Women who are pregnant (or who are considering pregnancy) or breastfeeding.
- •Concurrent or history of Thrombocytopenia, coagulopathy, or platelet dysfunction, Venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, stroke, moderate to severe heart failure (NYHA Class III or IV), cerebrovascular accident, MI, coronary stenting, or CABG surgery, other significant cardiovascular diseases or uncontrolled hypertension
- •Recipient of an organ transplant that requires continued immunosuppression.
- •Any malignancies or history of malignancies with the exception of adequately treated or excised nonmetastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.
- •Chronic or recurrent infectious disease.
- •Further exclusion criteria apply.
研究组 & 干预措施
Povorcitinib Dose A
Participants will receive dose A of povorcitinib for a 12 week period, followed by dose A for an additional 24 week period.
干预措施: Povorcitinib (Drug)
Povorcitinib Dose B
Participants will receive dose B of povorcitinib for a 12 week period, followed by dose B for an additional 24 week period.
干预措施: Povorcitinib (Drug)
Povorcitinib Dose C
Participants will receive dose C of povorcitinib for a 12 week period, followed by dose C for an additional 24 week period.
干预措施: Povorcitinib (Drug)
Placebo followed by Povorcitinib Dose A, B, or C
Participants will receive placebo for a 12 week period, followed by randomization to either Dose A, Dose B, or Dose C for an additional 24 week period.
干预措施: Povorcitinib (Drug)
Placebo followed by Povorcitinib Dose A, B, or C
Participants will receive placebo for a 12 week period, followed by randomization to either Dose A, Dose B, or Dose C for an additional 24 week period.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Urticaria Activity Score Over 7 Days (UAS7) at Week 12
时间窗: Baseline; Week 12
The UAS7 is defined as the 7-day sum of the individual, daily recorded scores for the hive severity score (HSS) and the itch severity score (ISS). The ISS7 is defined as the 7-day sum of the daily ISS scores (ranging from 0 to 3), and the HSS7 is defined as the 7-day sum of the daily HSS scores (ranging from 0 to 3). The UAS7 score is calculated as the sum of the available UAS scores, divided by the number of days that have a UAS score, multiplied by 7. The UAS7 (ranging from 0 to 42) is equal to the ISS7 (ranging from 0 to 21) plus the HSS7 (ranging from 0 to 21). Higher scores represent more intense/severe hives and itching. Change from baseline was calculated as the post-baseline value minus the baseline value.
次要结局
- Percentage of Participants Who Achieved UAS7 ≤ 6 (Controlled Disease) at Week 12(Week 12)
- Time to First Achievement of UAS7 ≤ 6 (Controlled Disease) During the Placebo-controlled (PC) Period(up to Week 12)
- Percentage of Participants With UAS7 = 0 at Week 12(Week 12)
- Placebo-controlled Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)(up to Week 12)
- Extension Period: Number of Participants With Any TEAE(from Week 12 to Week 44)