2023-508548-23-00招募中3 期
Prospective, randomised, double-blind, placebo-controlled multicenter clinical trial of efficacy and safety with Dermatophagoides pteronyssinus and Dermatophagoides farinae mannan-conjugated allergoids in patients with rhinitis/rhinoconjunctivitis, allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae _MM09-SIT-069
Inmunotek S.L.11 个研究点 分布在 2 个国家目标入组 250 人开始时间: 2025年5月7日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 11
- 主要终点
- Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (RCSMS) by means of the Subject’s Diary
研究概览
简要总结
The primary objective of this trial is to evaluate the clinical efficacy of EP-088_MM09 at 3,000 mTU/mL administered subcutaneously, compared to placebo in subjects aged 12 to 65 years old with moderate-to-severe persistent rhinitis/rhinoconjunctivitis with or without mild-to-moderate intermittent or persistent controlled asthma, allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae
入排标准
- 年龄范围
- 0 years 至 65+ years（18-64 Years, 0-17 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Subjects who have signed and dated Informed Consent Form (ICF).
- •Subjects capable of complying with dosage regimen
- •Subjects must record symptoms and medication consumption in an electronic diary via smartphone (preferably) or in a paper diary.
- •To be confirmed at visit 1 (V1). Only subjects who meet the following criteria will be eligible for randomization:
- •Subjects with a rhinitis/rhinoconjunctivitis combined symptom and medication score (RCSMS) ≥ 2 out of 6, recorded for at least 10 days, corresponding to moderate-to-severe allergic rhinitis/rhinoconjunctivitis (See Section 6.2).
- •Women of childbearing age must commit to using a highly effective contraception method during the trial and up to 1 months after the end of the investigational medicinal product. Such methods include combined (estrogen and progestogen containing) hormonal, contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), male condom, diaphragm used with spermicide, bilateral tubal occlusion, vasectomised partner, or sexual abstinence.
- •Subjects capable of complying with dosage regimen.
- •Subjects with negative skin prick test for moulds.
- •Subjects must record symptoms and medication consumption in an electronic diary via smartphone (preferably) or in a paper diary.
- •To be confirmed at visit 1 (V1) Only subjects who meet the following criteria will be eligible for randomization: Subjects with a rhinitis/rhinoconjunctivitis combined symptom and medication score (RCSMS) ≥ 2 out of 6, recorded for at least 10 days, corresponding to moderate-to-severe allergic rhinitis/rhinoconjunctivitis (See Section 6.2).
- •Subjects with negative skin prick test for moulds.
- •Women of childbearing age (i.e., following menarche and until postmenopause, defined as no menses for 12 months without an alternative medical cause, or non-subject to permanent sterilisation methods, such as hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) must confirm menarche and have a urine pregnancy test negative result before enrolling the study
- •Women of childbearing age must commit to using a highly effective contraception method during the trial and up to 1 months after the end of the investigational medicinal product. Such methods include combined (estrogen and progestogen containing) hormonal, contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), male condom, diaphragm used with spermicide, bilateral tubal occlusion, vasectomised partner, or sexual abstinence.
排除标准
- •Subjects sensitised (positive prick test) to one or more pollens where the time interval between baseline visit (BV) and additional baseline visit (ABV) is more than 7 months.
- •Use of drugs that could interfere with skin prick test reactions (e.g., antihistamines) within the deadlines set out in the protocol (See Section 9.2).
- •Subjects having any nasal condition (e.g., nasal polyp or non-allergic rhinitis) that could affect an appropriate evaluation of the efficacy and/or safety, according to investigator’s criteria.
- •Subjects who have received previous immunotherapy to allergens under study (D. pteronyssinus and D. farinae) during the last 5 years or currently receiving immunotherapy with any other allergen.
- •Subjects who required regular treatment with antihistamines and/or corticosteroids (systemic – oral or injectable-, topical, cutaneous, or inhaled) for other purposes than alleviating symptoms of allergic rhinitis, except temporal use (≤ 15 days) for diseases including common colds.
- •Breastfeeding or pregnant women.
- •Subjects who are immediate family members of the investigator.
- •Concurrent participation in other clinical trials or previous participation within 30 days prior to the screening/baseline visit.
- •Subjects with history of serious systemic reactions, including food, Hymenoptera venom, drugs, etc.
- •Subjects who have undergone any desensitisation process (e.g., oral immunotherapy [OIT], milk, or egg) except those in the maintenance phase since at least 12 months.
- •Those cases in which allergen-specific immunotherapy (AIT) would be a contraindication according to the criteria of European Allergy and Clinical Immunology Immunotherapy Subcommittee.
- •Unstable subjects who have suffered a respiratory tract infection and/or asthma exacerbation within 4 weeks prior to the screening/baseline visit.
- •Subjects with uncontrolled asthma, according to GINA 2023,asthma with poor symptom control (frequent symptoms or reliever use, activity limited by asthma, night waking due to asthma) and/or frequent exacerbations (≥2/year) requiring oral corticosteroids (OCS), or serious exacerbations (≥1/year) requiring hospitalization.
- •Asthmatic subjects with forced expiratory volume in the first second (FEV1) <80% despite pharmacological treatment. The result shall be valid up to 12 months prior to signing of informed consent (See Section 9.2).
- •Subjects with severe asthma, according to GINA 2023, on Step 4 or 5 treatment, who had poor symptom control and had good adherence and inhaler technique.
- •Subjects on treatment with β-blockers, except those administered topically, or angiotensin-converting enzyme (ACE) inhibitors.
- •Subjects on treatment with immunosuppressive (not including corticosteroids), except those administered topically, or biological drug
- •Subjects requiring regular treatment with systemic corticosteroids (oral or injectable) for the treatment of rhinitis/rhinoconjunctivitis and asthma. The regular use of topical, cutaneous, or inhaled corticosteroids for the treatment of the pathologies mentioned above and atopic dermatitis is permitted.
- •Subjects with controlled or uncontrolled cancer.
- •Subjects who have suffered chronic urticaria, severe anaphylaxis, or family history of angioedema within 2 years prior to the screening/baseline visit.
- •Subjects having any contraindication for the use of adrenaline (e.g., hyperthyroidism, heart disease, or hypertension) according to the investigator’s criteria.
- •Subjects with other severe disease not related asthma or rhinitis/rhinoconjunctivitis that could interfere in the study treatment or the follow-up (e.g., epilepsy or nephropathy) according to investigator’s criteria.
- •Subjects with uncontrolled autoimmune diseases (e.g., thyroiditis or lupus), tumoral diseases, or immunodeficiencies.
- •Subjects that could not comply with the study protocol, according to investigator’s criteria, or have a serious mental illness.
- •Subjects with known allergy to any of the components of the investigational medicinal products (IMPs) other than study allergens.
- •Subjects with lower respiratory tract diseases, different from asthma, as emphysema, bronchiectasis, or chronic obstructive pulmonary disease.
结局指标
主要结局
Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (RCSMS) by means of the Subject’s Diary
Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (RCSMS) by means of the Subject’s Diary
次要结局
- Asthma-Combined Symptom and Medication Score (ACSMS)
- Rhinitis/Rhinoconjunctivitis Symptom Score (RSS)
- Rhinitis/Rhinoconjunctivitis Medication Score (RMS)
- Asthma Symptom Score (ASS)
- Asthma Medication Score (AMS)
- Asthma and Rhinitis/Rhinoconjunctivitis Symptom Score (ARSS)
- Asthma and Rhinitis/Rhinoconjunctivitis Medication Score (ARMS)
- Asthma and Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (ARCSMS)
- Asthma exacerbations: time to first asthma exacerbation; number, duration, and severity
- Immunological parameters: Total IgE Specific IgE and IgG4 Specific IgE/Total IgE ratio Anti-Saccharomyces cerevisiae antibodies (ASCA) IgA and IgG
- Allergen profiling (ALEX technique)
- Asthma Quality of Life Questionnaire (AQLQ)
- Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
- Asthma Control Questionnaire (GINA 2023)
- Visual Analogue Scale (VAS)
- Consumption of Health Resources
- Safety parameters: • Overall rate and severity of adverse events (AEs) per administration and per subject. • Evaluation of reactions at the site of administration, systemic reactions and of any medications administered for the treatment of the adverse reaction (AR).
研究者
Medical Department
Scientific
Inmunotek S.L.
研究点 (11)
Loading locations...
相似试验
招募中
2 期
Study that aims to investigate how effective and safe the use of a novel modified release tablet formulation of Colesevelam hydrochloride-MMX is for patients with idiopathic bile acid diarrhoea (BAD), randomly allocated to 2 different dose regimens of the active product or to the inactive placebo formulation.2024-511993-55-00Cosmo Technologies Limited120
已完成
4 期
This is a study to evaluate dose-flexibility of Upadacitinib in Adult Subjects with Moderate to Severe Atopic Dermatitis2023-504869-23-00AbbVie Deutschland GmbH & Co. KG272
尚未招募
2 期
Efficacy, Safety, and Pharmacokinetics of LP-005 Injection in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)NCT07266155Longbio Pharma30
招募中
1 期
Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid TumorsColorectal CancerNon-Small Cell Lung CancerNCT07261631Novartis Pharmaceuticals180
招募中
1 期
TCR-engineered T Cells (NW-101C) in Patients With Solid Malignant TumorsNCT07266298Neowise Biotechnology24