2025-521736-10-00招募中3 期
Clinical trial to evaluate the efficacy and safety of Depigoid Grass-Mix at 1000 DPP/mL and Depigoid FORTE Grass-Mix at 3000 DPP/mL compared with placebo in patients suffering from allergic rhinoconjunctivitis with or without controlled asthma due to clinically relevant sensitisation to grass pollen.
LETI Pharma S.L.U.54 个研究点 分布在 2 个国家目标入组 324 人开始时间: 2026年4月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 324
- 试验地点
- 54
- 主要终点
- Double-Blind, Randomised, Controlled Phase: Mean cSMS (0-6) at peak grass pollen season comparing active and placebo groups after at least 8 injections of treatment. o Medication score: 0 no medication, 0.5 antihistamine eye drops, 1 oral antihistamine, 1.5 intranasal corticoid o Symptom score:Please refer to the protocol for further details
研究概览
简要总结
Double-Blind, Randomised,Controlled Phase Primary Efficacy: Assessment of the clinical efficacy of grasses allergen immunotherapy for each concentration, evaluated by the combined symptom and medication score (0-6 collected through a mobile App) during the peak grass pollen compared with placebo after at least 8 injections of treatment. Open-label Phase Primary Efficacy: Assessment of the clinical efficacy of grasses allergen immunotherapy, evaluated by the change in the amount of allergen necessary to obtain a positive CPT (after the pollen season) compared to baseline.
入排标准
- 年龄范围
- 0 years 至 65+ years（65+ Years, 18-64 Years, 0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Participants aged ≥5 years of age at the time of signing consent or assent.
- •Participants suffering from moderate or severe allergic rhinoconjunctivitis (ARIA)
- •Asthmatic participants must be, in the Investigator’s judgement, with controlled disease according to Global Initiative on Asthma (GINA) guidelines
- •Participants/legal representatives who have understood and signed the informed consent or informed assent (see Section 10.1.4).
- •Participants or guardians need to have a mobile phone which can support the cSMS App and access to internet and/or mobile service.
- •Participants who are able to remain at their usual place of residence for the majority of the pollen season.
- •Participants are capable of complying with the study protocol.
- •Preexisting stable disease is allowed unless otherwise specified in the exclusion criteria in Section 5.2, as established by medical history and physical examination and as determined by the Investigator. Preexisting stable disease is defined as not requiring significant change in therapy or hospitalization for worsening disease during the 28 days before enrolment.
- •Agree to actively stay in contact with the trial site for the duration of the trial for the participant’s own safety
排除标准
- •Previous treatment with any type of AIT in the previous 5 years
- •Any contraindication for treatment with SC allergen specific immunotherapy according to information of product use.
- •Participants who have required systemic corticosteroids in the 12 weeks prior to the inclusion (screening) in the trial.
- •Participants who have previously suffered a serious secondary reaction during the skin prick test (systemic reactions after SPT, which can be classified using World Allergy Organisation 2010 (WAO-2010) reactions and serious according to regulatory definition of serious adverse reaction).
- •Participants clinically unstable at the time of the inclusion (screening) in the trial (acute asthmatic exacerbation, respiratory infection, febrile fever, acute urticaria, etc); rescreening is permitted (see Section 5.4).
- •Any other clinical condition that, in the opinion of the Investigator, might pose additional risk to the participant due to participation in the study.
- •Participants with Investigator-determined chronic urticaria, severe dermographism, severe atopic dermatitis, sunburn, active psoriasis with lesions in areas where skin tests will be performed, or a history of hereditary angioedema.
- •Participants with any condition that represents an absolute contraindication to the administration of adrenaline (heart disease, etc).
- •Participants undergoing immunosuppressive treatment (except topical immunosuppressants).
- •Participants with any other disease not associated with the moderate or severe rhinoconjunctivitis or asthma, but of potential severity and that could interfere with the treatment and follow-up (epilepsy, psychomotor deterioration, malformations, multi-operated, kidney diseases, etc).
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •Sensitisation to Alternaria alternata
- •Participants whose status prevents them from providing cooperation and/or who presents with severe psychiatric disorders.
- •Participants with known allergy to other vaccine components different from grass allergen extract.
- •Participants with chronic lower airway diseases other than asthma such as emphysema or bronchiectasis.
- •Direct relatives of the Investigator.
- •Sensitisation to mites if clinically relevant
- •Sensitisation to epithelia if the participant lives or has frequent contact with animals.
- •Sensitisation to other co-seasonal allergens
- •Participants receiving treatment with biologics
- •Uncontrolled asthma at the time of immunotherapy administration, according to the GINA guidelines or unstable asthma
- •Female participants of non-childbearing potential may be enrolled in the study. Nonchildbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy. Female participants of childbearing potential may be enrolled in the study, if the participant: o has practiced adequate contraception for 1 month prior to study intervention administration, and o has a negative pregnancy test on the first day of study intervention administration, and o has agreed to continue adequate contraception during the entire study treatment period (see Section 10.4).
研究组 & 干预措施
The placebo to be used in the clinical trial is the solvent used in the investigational medicinal products’ (IMPs) formulation. The resulting product is a suspension.
Placebo
干预措施: The placebo to be used in the clinical trial is the solvent used in the investigational medicinal products’ (IMPs) formulation. The resulting product is a suspension. (Drug)
Conjunctival Provocation Test Grass-Mix LETI 30 HEP/ml
Auxiliary
干预措施: Conjunctival Provocation Test Grass-Mix LETI 30 HEP/ml (Drug)
Depigoid Grass-Mix (1000 DPP/ml), Depigoid FORTE Grass-Mix (3000 DPP/ml)
Test
干预措施: Depigoid FORTE Grass-Mix (3000 DPP/ml) (Drug)
Depigoid Grass-Mix (1000 DPP/ml), Depigoid FORTE Grass-Mix (3000 DPP/ml)
Test
干预措施: Depigoid Grass-Mix (1000 DPP/ml) (Drug)
结局指标
主要结局
Double-Blind, Randomised, Controlled Phase: Mean cSMS (0-6) at peak grass pollen season comparing active and placebo groups after at least 8 injections of treatment. o Medication score: 0 no medication, 0.5 antihistamine eye drops, 1 oral antihistamine, 1.5 intranasal corticoid o Symptom score:Please refer to the protocol for further details
Double-Blind, Randomised, Controlled Phase: Mean cSMS (0-6) at peak grass pollen season comparing active and placebo groups after at least 8 injections of treatment. o Medication score: 0 no medication, 0.5 antihistamine eye drops, 1 oral antihistamine, 1.5 intranasal corticoid o Symptom score:Please refer to the protocol for further details
次要结局
- Double-Blind, Randomised, Controlled Phase: Absolute values and changes from baseline (if applicable) during active pollen season comparing active and placebo groups after at least 8 injections: - Mean cSMS during the whole grass pollen season-Asthma symptoms and asthma medication score. Please refer to the Protocol for further details.Open-label Phase:Please refer to the Protocol for further details
研究者
Mónica Ruiz García
Scientific
LETI Pharma S.L.U.
研究点 (54)
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