2023-503958-12-00招募中2 期
Prospective, open-label study to analyze the efficacy and safety of low-dose oral immunotherapy in children with severe IgE-mediated cow's milk allergy treated with omalizumab. ILO study.
Hospital Infantil Universitario Nino Jesus1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年9月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Proportion of subjects tolerating 300 mg cow's milk protein with no symptoms or only Grade 1 symptoms (oFASS-5) in the double-blind placebo-controlled oral cow's milk challenge trial (DBPCOC) without Omalizumab (without-Oz).
研究概览
简要总结
To analyze the safety and efficacy of a combined treatment of oral immunotherapy with low doses of milk and Omalizumab in patients with severe cow's milk allergy after reducing the dose of Omalizumab.
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Low-dose oral immunotherapy in children with severe cow's milk allergy treated with Omalizumab
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Men and women between the ages of 6 and 15 at the time of signing the consent/assent.
- •Signature of informed consent and/or assent (where applicable), which must be obtained prior to participation in the study. Parents/legal guardians and participants ages 12-15 must be able to understand and provide written consent and assent, respectively.
- •Documented medical history of allergy to milk or foods containing milk.
- •Episodes of anaphylaxis due to ingestion of cow's milk (> 0) and/or the diagnosis of asthma.
- •Serum IgE to cow's milk and casein > 49 kUA/L at Screening Visit
- •Positive skin tests for cow's milk and casein. It is defined as a mean wheal diameter (mean of the sum of the largest and smallest diameters) > 3 mm compared to the negative control.
- •Participants must weigh > 19 kg at Screening Visit
- •Participants must be able to receive injections (study drug), perform oral challenge testing, and must continue to be exposed to cow's milk throughout the study.
排除标准
- •Use of other investigational drugs within 5 half-lives or 30 days prior to Screening Visit 1 (whichever is longer).
- •History of allergy to omalizumab or its excipients.
- •Allergy to any of the components of the matrix used for the double-blind placebo-controlled oral challenge trial (PODCCP) with milk.
- •Inability to complete study procedures and follow-up.
- •Subjects having a combination of weight and IgE that requires Omalizumab doses greater than 1,200 mg/4 weeks.
- •History of life-threatening allergic reaction after ingestion of milk that required admission to the Intensive Care Unit in the 60 days prior to the Screening Visit.
- •Participants with uncontrolled asthma (according to GINA, GINA 2022 guidelines) who meet any of the following criteria: a. FEV1 < 80% predicted at Screening Visit
- •b. One hospitalization for asthma in the 12 months prior to Screening Visit
- •Patients with severe persistent asthma who require continued treatment with omalizumab.
- •History of eosinophilic esophagitis, other eosinophilic gastrointestinal disease, symptoms of dysphagia (eg, difficulty swallowing), recurrent gastrointestinal symptoms of undiagnosed etiology, or meeting clinical criteria for cow's milk protein-induced enterocolitis (FPIES) .
- •Current or past history of mast cell disorders, including mastocytosis.
- •Use of prohibited medication or medication not permitted under certain conditions.
- •Participants with evidence of parasitic helminthic infestation to a pathogenic organism evidenced by stool study at Screening Visit
- •History of malignancy in the previous 5 years.
- •Clinically significant cardiovascular diseases.
- •Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or calcium channel blockers.
- •Neurological, psychiatric or metabolic diseases that may interfere or compromise the safety of patients or the evaluation, interpretation of study results or prevent completion of the study.
- •History of, or current treatment for, liver disease or serum transaminase levels 1.5 times the upper limit of normal at Screening Visit
- •History of renal disease or serum creatinine levels 1.5 times the upper limit of normal at Screening Visit
- •Platelets < 100,000/µL at Screening Visit
- •Current participation in any other intervention study.
- •Subject is in dose escalation (dose escalation) phase of immunotherapy for another allergen (has not reached maintenance dose).
- •Pregnancy or lactation.
结局指标
主要结局
Proportion of subjects tolerating 300 mg cow's milk protein with no symptoms or only Grade 1 symptoms (oFASS-5) in the double-blind placebo-controlled oral cow's milk challenge trial (DBPCOC) without Omalizumab (without-Oz).
Proportion of subjects tolerating 300 mg cow's milk protein with no symptoms or only Grade 1 symptoms (oFASS-5) in the double-blind placebo-controlled oral cow's milk challenge trial (DBPCOC) without Omalizumab (without-Oz).
次要结局
- • Proportion of subjects tolerating the 300 mg dose of cow's milk protein with no or only Grade 1 symptoms (oFASS-5) in the double-blind placebo-controlled oral cow's milk challenge test (DBPCOC) at 4 months from initiation Omalizumab (Oz1). • Proportion of subjects tolerating >300 mg cow's milk protein with no or only Grade 1 symptoms (oFASS-5) in the open cow's milk oral challenge test (Oz1-a).
研究者
Carmelo Escudero
Scientific
Hospital Infantil Universitario Nino Jesus
研究点 (1)
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