A One Month, Investigator and Participant Blinded Study to Investigate the Efficacy and Safety of Remibrutinib (LOU064) at Multiple Dose Levels in Adult Participants With Peanut Allergy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 24
- 主要终点
- Percentage of Participants Who Tolerated a Single Dose of >= 600 mg (1044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms
研究概览
简要总结
A study to evaluate the safety, efficacy and tolerability of remibrutinib at three doses versus placebo in adult participants who have a confirmed allergy to peanuts. The efficacy was measured by the ability of participants to tolerate increasing doses of peanut protein during an oral food challenge after 1 month of study treatment.
详细描述
This was a randomized, participant- and investigator-blinded, placebo-controlled study to assess the safety and clinical efficacy of oral LOU064 versus placebo across five treatment arms in participants with a medically confirmed diagnosis of IgE-mediated peanut allergy for one-month treatment period (up to 5 weeks). Participants had oral food challenges at the beginning of the study and at the end of the treatment period to assess their symptoms from increasing doses of peanut allergen.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Medical History of allergy to peanuts
- •Positive peanut IgE >= 0.35 kUA/L
- •Positive Skin Prick test for peanut allergen during screening for study
- •Positive Oral Food Challenge to peanut during screening for study
- •Willingness to comply with study schedule and procedures and avoid other allergens during study period
排除标准
- •History of severe or life-threatening hypersensitivity event leading to ICU admission or intubation within 60 days of screening
- •Uncontrolled asthma
- •Bleeding risk or coagulation disorder(s)
- •Use of anticoagulants or anti-platelets (aspirin or clopidogrel may be permitted)
- •History of splenectomy
- •Any significant disease that would put the safety of the patient at risk. This includes, but is not limited to: history of cancer, significant cardiac disease/history, hematology disorders, history of GI bleeding, active infectious process, liver disease, renal disease, immunologic disease (stable diabetes and thyroid disease may be permitted), alcohol or drug abuse, etc.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Placebo + LOU064 25 mg
Placebo was administered orally twice per day, on Days 1 through 21 followed by LOU064 25 mg twice per day, on Days 22 through 28.
干预措施: placebo (Drug)
Placebo
Placebo was administered orally twice per day, on Days 1 through 28.
干预措施: placebo (Drug)
LOU064 10 mg
LOU064 10 mg was administered orally twice per day, on Days 1 through 28.
干预措施: LOU064 (Drug)
LOU064 25 mg
LOU064 25 mg was administered orally twice per day, on Days 1 through 28.
干预措施: LOU064 (Drug)
LOU064 100 mg
LOU064 100 mg was administered orally twice per day, on Days 1 through 28.
干预措施: LOU064 (Drug)
Placebo + LOU064 25 mg
Placebo was administered orally twice per day, on Days 1 through 21 followed by LOU064 25 mg twice per day, on Days 22 through 28.
干预措施: LOU064 (Drug)
结局指标
主要结局
Percentage of Participants Who Tolerated a Single Dose of >= 600 mg (1044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms
时间窗: Week 4
Responder rate was defined as the percentage of participants tolerating a single dose of \>= 600 mg (1044 mg cumulative tolerated dose) of peanut protein without dose-limiting symptoms during the double blind placebo controlled food challenge (DBPCFC). The cumulative tolerated dose is the sum of the tolerated doses, not including the reactive dose. Dose-limiting symptoms indicate a true allergic reaction occurring during administration of a single dose of peanut protein at the DBPCFC that should preclude the administration of any further doses in the view of the investigator. Symptoms that require administration of any rescue medication were considered dose-limiting symptoms.
次要结局
- Percentage of Participants Who Tolerated a Single Dose of >= 1000 mg (2044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms(Week 4)
- Percentage of Participants Who Tolerated a Single Dose of 3000 mg (5044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms(Week 4)
- Percentage of Participants Who Tolerated a Single Dose of >= 600 mg (1044 mg Cumulative Tolerated Dose) of Peanut Protein Without Dose-limiting Symptoms - Placebo+LOU064 25 mg and Placebo(Week 4)
- Number of Participants Presenting Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 3000mg During the DBPCFC(4 weeks)
- Change From Baseline of Peanut-specific IgE (Including Peanut Components)(Baseline, Day 25 pre-dose and Day 31 (End of Study))
- Change From Baseline of Peanut-specific IgG4 (Including Peanut Components)(Baseline, Day 25 pre-dose and Day 31 (End of Study))
- Change From Screening in Allergen-specific Skin Prick Test (SPT) Mean Wheal Diameters(Baseline, Day 26)
- Maximum Observed Blood Concentration (Cmax) of LOU064(Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.)
- Area Under Blood Concentration-time Curve (AUClast) of LOU064(Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.)
- Area Under Plasma Concentration-time Curve (AUCtau) of LOU064(Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.)
- Time to Reach Maximum Observed Blood Concentration (Tmax) of LOU064(Day 8 and Day 25: pre-dose, 0.5, 1, 2, 3, 4 hours.)
- Number of Participants Presenting Maximum Severity of Symptoms Occurring at Any Challenge Dose of Peanut Protein up to and Including 1000mg During the DBPCFC(4 weeks)