NCT06927999招募中2 期
An Outpatient, Randomized, Double-Blinded, Placebo-Controlled, Cross-Over Study of the Efficacy of ARS-2 in Patients With Chronic Spontaneous Urticaria
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 6
- 主要终点
- Determine the effect of ARS-2 (0.5 mg or 1 mg) versus placebo on itch and hive
研究概览
简要总结
This is a Phase 2b, outpatient, single-dose, randomized, double blind, placebo-controlled, three period crossover study that will consist of a screening period and three blinded treatment periods. Subjects enrolled will have CSU with a history of moderate to severe acute exacerbations (or flares).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Is a male or female between the ages of 18 and 65 years, inclusive.
- •Has been clinically diagnosed with CSU and experiences an acute flare of moderate to severe urticaria symptoms (itch and hive severity UAS score ≥ 2) approximately 1-2 times a month or every other month consistently during the past year while on a chronic treatment.
- •Has been on a daily chronic treatment for ≥ 6 weeks.
- •Is willing to use a smartphone study application to record study assessments and AEs.
- •Has body weight more than 15 kilogram (kg).
- •Has no medical history of clinically significant hypertension and cardiovascular disease in the last 10 years
- •If female, is not pregnant or breastfeeding based on a negative urine pregnancy test at baseline.
- •Is able to communicate clearly with the Investigator and staff; able to read, complete questionnaires, and perform study procedures on the smartphone study application.
- •Is willing and able to provide written informed consent prior to participating in the study.
- •Controlled hypertension without beta blocker confirmed by the Investigator is acceptable.
- •At screening, has stable vital signs in the following ranges (after 5 minutes of rest):
- •Systolic blood pressure (SBP) ≥90 and ≤140 milliliters of mercury (mmHg)
- •Diastolic blood pressure (DBP) ≥50 and ≤90 mmHg
- •Heart rate (HR) ≥45 and ≤100 beats per minute (bpm)
排除标准
- •Has a history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- •Has any clinically significant medical condition or PE finding as deemed inappropriate by the Investigator.
- •Has abnormal cardiovascular exam at screening including any prior history of myocardial infarction or clinically significant abnormal electrocardiogram (ECG)
- •Has had significant traumatic injury or major surgery within 30 days prior to study screening.
- •Known hypersensitivity to any compound in the test product, or any other closely related compound (e.g., dihydropyridine-derived molecules).
- •Has participated in a clinical trial within 30 days prior to the first dose of study drug.
- •Has an immediate family member of the Investigator, or an employee of the study center, with direct involvement in the proposed study, or other studies under the direction of the Investigator or study center or is in a dependent relationship with a study center employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling), or may consent under duress.
研究组 & 干预措施
0.5 mg
Active Comparator
0.5 mg epinephrine per spray
干预措施: 0.5 mg epinephrine (Drug)
Placebo
Placebo Comparator
Placebo solution nasal spray containing no active drug will be administered using the commercial sprayer device.
干预措施: Placebo (Drug)
1 mg
Active Comparator
1 mg epinephrine per spray
干预措施: 1 mg epinephrine (Drug)
结局指标
主要结局
Determine the effect of ARS-2 (0.5 mg or 1 mg) versus placebo on itch and hive
时间窗: 12 months
Change in itch and hive scores (Uniform Assessment System) \[UAS\] as compared to placebo at each timepoint on exacerbation days
Determine the effect of ARS-2 (0.5 mg or 1 mg) versus placebo on itch
时间窗: 12 months
Change in itch scores (Uniform Assessment System) - Range is a scale of 0-3. Zero is none and 3 is severe. \[UAS\] as compared to placebo at each timepoint on exacerbation days
次要结局
- Determine the effect of ARS-2 (0.5 mg or 1 mg) versus placebo on hive(12 months)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
2 期
Oral Baricitinib (LY3009104)Treatment in Japanese Participants With Active Rheumatoid Arthritis on Background Methotrexate TherapyArthritis, RheumatoidNCT01469013Eli Lilly and Company145
已完成
2 期
Scopolamine in Bipolar DepressionBipolar Disorder DepressionNCT04211961Dr. Brian Hallahan50
已完成
2 期
A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study of Elismetrep (K-304) in the Treatment of MigraineMigraineNCT06848075Kallyope Inc.431
已完成
2 期
International Study Evaluating the Safety and Efficacy of Inhaled, Human, Alpha-1 Antitrypsin (AAT) in Alpha-1 Antitrypsin Deficient Patients With EmphysemaEmphysemaNCT01217671Kamada, Ltd.168
已完成
2 期
A Study of MHAA4549A as Monotherapy for Acute Uncomplicated Seasonal Influenza A in Otherwise Healthy AdultsInfluenza ANCT02623322Genentech, Inc.124