NCT04603300已完成1 期
Oral Mucosal Escalation Goal Assessment (OMEGA) Study: A Randomized Placebo-Controlled Phase 1 Study of the Safety and Feasibility of Up-titration With INT301 in Adults With Sensitivity to Peanut
Intrommune Therapeutics2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年5月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- To evaluate the safety of INT301 compared to placebo in adult peanut allergic participants as measured by dose escalation during study.
研究概览
简要总结
This is a phase 1, multi-center, randomized, double-blind, placebo-controlled study in adult participants with peanut allergy. Participants will be randomized in a 3:1 ratio to receive either an escalating dose of INT301 or placebo. The treatment group will be blinded to the investigator, participants, and the Intrommune study team.
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
Double blind is controlled by IWRS
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
- •Participant must be 18-55 years of age inclusive, at the time of signing the informed consent.
- •Female participants of childbearing potential or male participants with female partners of child-bearing potential must utilize highly effective birth control method(s) throughout the study and for 30 days after the final dose of study drug. Acceptable methods of contraception include: complete abstinence, male or female condoms with spermicide, oral or implanted contraceptives, or vasectomy.
- •For female participants of child-bearing potential: Negative serum beta human chorionic gonadotrophin (HCG) pregnancy test at screening.
- •Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •Meets at least one of the following conditions
- •Positive skin prick test (SPT) (wheal at least 3 mm greater than control) AND/OR Peanut specific IgE >0.35 kU/L
- •Convincing clinical history of allergic reaction to peanut within 1 hour of ingestion for at least 3 months prior to screening.
- •Failed an oral food challenge (OFC) of < 100mg of peanut protein at screening.
- •Participant willing and able to undergo the procedures required by the protocol, including, assessment completion, protocol compliance, and participation in the placebo dosing period(s).
排除标准
- •History of severe anaphylaxis to peanut, defined as hypoxia, hypotension, or neurologic compromise (cyanosis or oxygen saturations < 92% at any stage, hypotension, confusion, collapse, loss of consciousness, or incontinence)
- •Significant medical condition (e.g., liver, kidney, gastrointestinal, cardiovascular, hematologic, or pulmonary disease) which would make the subject unsuitable for induction of food reactions
- •Eosinophilic or other inflammatory (e.g. celiac) gastrointestinal disease
- •Psychiatric disorders that the Investigator believes will interfere with study assessments
- •Uncontrolled asthma, defined by at least one of the following conditions:
- •- FEV1 <80% of predicted, or ratio of FEV1 to forced vital capacity (FEV1/FVC) <75% of predicted, with or without controller medications.
- •- Inhaled corticosteroids (ICS) dosing of >500mcg daily fluticasone (or equivalent ICS based on NHLBI dosing chart.
- •- One hospitalization in the past year for asthma
- •- An ER visit for asthma within six months prior to screening
- •Planned dental surgery during from screening until study exit
- •Moderate or advanced periodontal disease.
- •Current pregnancy or lactating
研究组 & 干预措施
Active treatment
Active Comparator
INT301 dosing as determined by cohort assignment
干预措施: INT301 (Drug)
Placebo
Placebo Comparator
Placebo as determined by cohort assignment
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate the safety of INT301 compared to placebo in adult peanut allergic participants as measured by dose escalation during study.
时间窗: Forty-eight weeks
Percentage of participants able to consistently tolerate the protocol-specified highest dose; Incidence of systemic and non-systemic adverse reactions.
次要结局
- To evaluate pharmacologic requirements as interventions for peanut allergic participants experiencing adverse events on INT301.(Forty-eight weeks)
- To determine the maximally tolerated dose during the up-dosing phase for adults.(Twenty-six weeks)
研究者
研究点 (2)
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