Safety and Efficacy of Low-dose IL-2 in Birch Pollen Allergy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in nasal congestion expressed as area under the curve (AUC), during birch allergen exposure in ALYATEC's Environmental Exposure Chamber (EEC)
研究概览
简要总结
Several studies have reported a deficit and/or a defect in regulatory T cells in allergic subjects, which can be correlated with the allergic responses, especially for respiratory allergies. Low-dose IL-2 (ld-IL2) specifically targets and activates regulatory T cells (Tregs), which are cells that regulate immune responses. Thus by stimulating Tregs, ld-IL2 would control allergic responses.
This study is designed to evaluate the efficacy of ILT-101 (ld-IL-2), compared to placebo, on the nasal response assessed by Total Nasal Symptom Score (TNSS) during a controlled birch allergen exposure.
详细描述
Primary objective To evaluate the efficacy of ILT-101 (ld-IL-2), compared to placebo, on nasal response on day 40
Secondary objectives To evaluate the efficacy of ILT-101 on rhino-conjunctivitis symptoms, on inflammatory mediators, allergic specific immune responses and safety.
Experimental design This is a monocentric, randomized, placebo controlled, double-blind trial in parallel-groups, evaluating a treatment by ILT-101/placebo, 1 MIU daily for 5 days and 1 MIU every week, until day 36.
Population involved Male or female, aged between 18 and 55 years, with allergic rhinitis to birch pollen.
Number of subjects: 24
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
- Double (Participant, Investigator)
盲法说明
Double Blind
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
- 未提供
排除标准
- •Asthma: GINA 2 to 5
- •Eosinophilia > 0.6x109/mL;
- •Any history of anaphylactic reactions;
- •Specific immunotherapy treatment at the moment, including Omalizumab;
- •Specific immunotherapy for birch-pollens within 3 previous years;
- •Use of systemic corticosteroid or others immunosuppressive treatment within previous 6 months;
- •Moderate to severe allergic rhinoconjunctivitis with or without asthma due to grass pollen, if the study is performed during grass pollen season (according to ARIA)
- •Significant rhinitis, or sinusitis, due to daily contact with other allergen causing symptoms that are expected to coincide with exposures, as assessed by the investigator
- •Contraindications known to treatment with IL-2:
- •Hypersensitivity to the active substance or to any of the excipients;
- •Immunosuppressed patient;
- •Psychotropic, hepatotoxic, nephrotoxic, myelotoxic or cardiotoxic drugs;
- •Other chronic diseases not clinically controlled;
- •Signs of active infection requiring treatment;
- •Previous history of organ transplantation.
- •Heart failure (≥ grade II, class. NYHA), kidney failure (Cockroft <60 ml/min/1.73m2), liver failure (transaminase> 3N), pulmonary insufficiency (any grade);
- •Leukocytes <3000 / mm3 lymphocytes <800 / mm3, platelets <80 000 / mm3, Hemoglobin < 10.0 g/dL or 6.2 mmol/L, red cell blood < 3.5 T/L;
- •Positivity of at least one of the thyroid-specific antibodies (anti-TPO, anti-TG, or anti-TRAKS) associated with an abnormal thyroid workup (TSH, T3, or T4) at inclusion;
- •Chronic uncontrolled arterial hypertension (Systolic BP > 140 mmHg and/or Diastolic BP > 90 mmHg);
- •Poor venous capital will forbid blood samples;
- •Vaccination with attenuated live vaccine in the month before the inclusion or planned during the study;
- •Vaccination against COVID-19 during the study period or if the 2nd dose of vaccine is planned during the 15 days preceding Visit 3
- •Surgery in the previous three months or anticipated under study;
- •Participation in other interventional research with study drug in the previous month and during the study;
- •Psychiatric illness or any other concomitant chronic illness or addiction that could interfere with the ability to meet the requirements of the protocol or provide informed consent;
- •Presence or history of unhealed cancer for more than five years, presence or history of healed cancer for less than five years, except carcinoma in situ of the cervix or basal cell carcinoma;
- •Pregnant or lactating women;
- •Men and women of childbearing age without effective contraception during the treatment period;
研究组 & 干预措施
ILT-101 (ld-IL2)
Subcutaneous injections of ILT-101
干预措施: ILT-101 ld-(IL2) (Drug)
placebo
Subcutaneous injections of placebo
干预措施: ILT-101 ld-(IL2) (Drug)
结局指标
主要结局
Change in nasal congestion expressed as area under the curve (AUC), during birch allergen exposure in ALYATEC's Environmental Exposure Chamber (EEC)
时间窗: on day 40
Change in nasal congestion expressed as area under the curve (AUC), during birch allergen exposure in ALYATEC's Environmental Exposure Chamber (EEC)
次要结局
- Change in nasal response intensity(at Day 8)
- Changes in Tregs expressed in percentag (%)(at day 70)
- Incidence of adverse events at 70(up to Day 70)
- Change in nasal congestion expressed as area under the curve (AUC), assessed during 4 hours of exposure(at Day 8)
- Changes in absolute count in Inate Lymphoid Cell type 2(ILC2)(at day 70)
- Changes of antigen-specific T-cell immune responses(at day 70)
- Changes of antigen-specific T-cell immune responses (cytokine IL-4 )(at day 70)
- Changes in absolute count in Tregs(at day 70)
- Changes in eosinophils expressed in percentag (%)(at day 70)
- Changes in absolute count in eosinophils(at day 70)
- Changes in Inate Lymphoid Cell type 2(ILC2) expressed in percentag (%)(at day 70)
- Incidence of adverse events at day 8(up to Day 8)
- Incidence of adverse events at day 40(up to Day 40)
- Changes of antigen-specific T-cell immune responses (cytokine IL-5)(at day 70)
- Changes in allergen-specific IgE dosages basophil activation test with pollen allergen(at day 40)