DERMATOPHAGOIDES PTERONYSSINUS, DEPIGMENTED/POLYMERIZED EXTRACT; DERMATOPHAGOIDES FARINAE, DEPIGMENTED/POLYMERIZED EXTRACT for Allergic rhinoconjunctivitis | Asthma (controlled)

Inclusion criteria

• {"criterion_text":"-Patients/legal representatives who have understood and signed the informed consent or assent form."}
• {"criterion_text":"-Patients/legal representatives have understood and signed the informed consent or assent form."}
• {"criterion_text":"-Patients aged ≥ 12 years."}
• {"criterion_text":"-Patients with moderate to severe persistent allergic rhinoconjunctivitis (according to the ARIA guidelines¹) for at least one year, with or without controlled asthma, caused by a clinically relevant sensitization to D. pteronyssinus and D. farinae."}
• {"criterion_text":"-The presence of allergy must be confirmed according to each of the following diagnostic criteria: Skin prick test ≥ 3 mm to D. pteronyssinus and D. farinae. If a positive skin prick test has been performed within the 12 months prior to inclusion, it will be considered valid for including the patient in the study. Specific IgE level > 0.7 kU/L to D. pteronyssinus and D. farinae. If a blood test within the 12 months prior to inclusion shows specific IgE levels ≥ 0.7 kU/L to D. pteronyssinus and D. farinae, it will be considered valid for inclusion. Specific IgE level > 0.7 kU/L to at least one of the following major allergens: Der p 1, Der p 2, or Der p 23 and Der f 1 or Der f 2. If a blood test within the 12 months prior to inclusion shows specific IgE levels > 0.7 kU/L to Der p 1, Der p 2, or Der p 23 and Der f 1 or Der f 2, it will be considered valid for inclusion. Positive conjunctival provocation test (CPT) with D. pteronyssinus extract. If a CPT (performed with LETI Pharma extracts) has tested positive within the 12 months prior to inclusion, it will be considered valid for inclusion.\""}
• {"criterion_text":"-Patients with a cSMS score ≥ 1.5 points at the time of inclusion."}
• {"criterion_text":"-Patients/legal representatives with a mobile phone compatible with the cSMS application and access to the Internet."}
• {"criterion_text":"-Asthmatic patients with controlled disease according to GINA guidelines and a FEV₁ ≥ 70% at the time of inclusion."}
• {"criterion_text":"-\"8. Women of childbearing potential must have a negative urine pregnancy test (childbearing potential is defined as the time from menarche to postmenopause, unless sterilization has occurred by hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) and must be willing to use an effective contraceptive method in accordance with recommendations on contraception and pregnancy testing in clinical trials³, from 14 days prior to the first administration until 4 weeks after the last administration of the investigational product."}
• {"criterion_text":"-Patients willing to comply with all study procedures and available for follow-up throughout the duration of the study."}

Exclusion criteria

• {"criterion_text":"-Patients previously or currently treated with any type of allergen immunotherapy (AIT) within the last 5 years."}
• {"criterion_text":"-Patients with any contraindication to skin prick testing or conjunctival provocation testing (CPT) with the studied allergens."}
• {"criterion_text":"-Patients with chronic urticaria, severe dermographism, severe atopic dermatitis, sunburn, active psoriasis with lesions on the areas where skin tests will be performed, or a history of hereditary angioedema."}
• {"criterion_text":"-Any condition or absolute contraindication that prevents the use of adrenaline."}
• {"criterion_text":"-Current treatment with any biological or immunosuppressive therapy (except topical immunosuppressants), or treatment received within the last 6 months."}
• {"criterion_text":"-Patients with uncontrolled autoimmune diseases, active malignant diseases, or diagnosed immunodeficiency disorders."}
• {"criterion_text":"-Patients with lower respiratory tract diseases other than asthma, such as emphysema or bronchiectasis."}
• {"criterion_text":"-Patients with any other condition not related to moderate allergic rhinoconjunctivitis or asthma, but of potential severity and that could interfere with treatment and follow-up (e.g., epilepsy, psychomotor impairment, congenital malformations, multiple surgeries, renal diseases, etc.)."}
• {"criterion_text":"-Patients with known allergy to any component of the vaccine other than the mite allergen extract (active substance)."}
• {"criterion_text":"-Patients with any medical or psychological condition that, in the investigator’s opinion, could interfere with the patient’s ability to comply with study procedures."}
• {"criterion_text":"-Simultaneous participation in another clinical trial."}
• {"criterion_text":"-Patients sensitized to other mites (Lepidoglyphus destructor and Blomia tropicalis — the latter only in the Canary Islands): if the IgE level is at most 20% of the IgE value for D. pteronyssinus or D. farinae (whichever is lower)."}
• {"criterion_text":"-Immediate family members of the investigational team."}
• {"criterion_text":"-Patients sensitized to fungi."}
• {"criterion_text":"-Patients sensitized to domestic animal dander who live with or have frequent contact with the animal."}
• {"criterion_text":"-Patients sensitized to clinically relevant pollens, as determined by the investigator."}
• {"criterion_text":"-Patients with severe or uncontrolled asthma according to GINA 2024 guidelines and a FEV₁ < 70%."}
• {"criterion_text":"-Pregnant women, women planning to become pregnant during the study period, or those who are breastfeeding."}
• {"criterion_text":"-Any contraindication to allergen immunotherapy (AIT) as defined in the product's Instructions for Use or the Investigator’s Brochure (IB)."}
• {"criterion_text":"-Patients who required oral corticosteroids within the 12 weeks prior to inclusion."}

Primary endpoints

• {"endpoint_text":"-The clinical efficacy of both concentrations of SCIT individually, compared to placebo, will be evaluated through the change in the cSMS score from baseline to the timepoint after 12 SCIT doses have been administered. Data collection will be carried out via an electronic diary installed on the patient's mobile device at the time of the first treatment administration.","definition_or_measurement_approach":"Change in cSMS score from baseline to after 12 SCIT doses; data collected via electronic diary (mobile app) installed on patient's device at first treatment administration."}

Secondary endpoints

• {"endpoint_text":"-Clinical efficacy for rhinoconjunctivitis will be evaluated by the change in the cSMS score from baseline to the timepoint after 6 SCIT administrations, as well as 1 and 2 years after the end of the first study period.","definition_or_measurement_approach":"Change in cSMS score from baseline to after 6 SCIT administrations, and at 1 and 2 years post first study period."}
• {"endpoint_text":"-Clinical efficacy based on the progression of rhinoconjunctivitis symptoms will be evaluated by the change in the dSS score from baseline to the timepoints after 6 and 12 SCIT administrations, as well as 1 and 2 years after the end of the first study period.","definition_or_measurement_approach":"Change in dSS score from baseline to after 6 and 12 SCIT administrations, and at 1 and 2 years post first study period."}
• {"endpoint_text":"-Clinical efficacy based on the evolution of medication use for rhinoconjunctivitis will be evaluated by the change in the dMS score from baseline to the timepoints after 6 and 12 SCIT administrations, as well as 1 and 2 years after the end of the first study period.","definition_or_measurement_approach":"Change in dMS (medication use) score from baseline to after 6 and 12 SCIT administrations, and at 1 and 2 years post first study period."}
• {"endpoint_text":"-Efficacy in terms of the allergen concentration required to elicit an allergic response will be evaluated by comparing the dose of D. pteronyssinus extract needed to trigger a positive response in the CPT at the start of treatment and after 12 SCIT administrations, as well as 1 and 2 years after the end of the first study period.","definition_or_measurement_approach":"Comparison of CPT (conjunctival provocation test) allergen dose required to elicit positive response at baseline vs after 12 administrations, and at 1 and 2 years follow-up."}
• {"endpoint_text":"-The severity of allergic rhinoconjunctivitis will be evaluated according to the ARIA guideline classification from baseline to the timepoints after 6 and 12 SCIT administrations, as well as 1 and 2 years after the end of the first study period.","definition_or_measurement_approach":"ARIA guideline classification change from baseline to after 6 and 12 administrations, and at 1 and 2 years."}
• {"endpoint_text":"-The progression of allergic rhinoconjunctivitis symptoms will be evaluated through the change in the patient-reported VAS (Visual Analogue Scale) score from baseline to the timepoints after 6 and 12 SCIT administrations, as well as 1 and 2 years after the end of the first study period. Patients will complete this scale manually, in paper format.","definition_or_measurement_approach":"Change in patient-reported VAS score (paper format) from baseline to after 6 and 12 administrations and at 1 and 2 years."}
• {"endpoint_text":"-The immune response will be evaluated at baseline, after 12 SCIT administrations, and 1 and 2 years after the end of the first study period by assessing changes in the levels of the following immunological parameters: Total and specific IgE against D. pteronyssinus and D. farinae Total and specific IgG4 against D. pteronyssinus and D. farinae Total IgA2.","definition_or_measurement_approach":"Laboratory measurement of total and specific IgE, total and specific IgG4, and total IgA2 at baseline, after 12 administrations, and at 1 and 2 years."}
• {"endpoint_text":"-Quality of life related to allergic rhinoconjunctivitis will be evaluated based on the following patient-reported outcomes (PROs): Mean change in the RQLQ questionnaire score from baseline to after 6 and 12 SCIT administrations, as well as 1 and 2 years after the end of the first study period. This PRO will be specifically assessed in adult patients. Patients will complete this questionnaire manually, in paper format.","definition_or_measurement_approach":"Mean change in RQLQ score from baseline to after 6 and 12 administrations, and at 1 and 2 years (adults); questionnaires completed on paper."}
• {"endpoint_text":"-Quality of life related to allergic rhinoconjunctivitis will be evaluated based on the following patient-reported outcome (PRO): Mean change in the AdolRQLQ questionnaire score from baseline to after 6 and 12 SCIT administrations, as well as 1 and 2 years after the end of the first study period. This PRO will be specifically assessed in adolescent patients aged 12 to 17 years.","definition_or_measurement_approach":"Mean change in AdolRQLQ score from baseline to after 6 and 12 administrations and at 1 and 2 years (adolescents 12–17); paper questionnaires."}
• {"endpoint_text":"-Patient satisfaction will be evaluated using the ESPIA score after 12 SCIT administrations, as well as 1 and 2 years after the end of the first study period. Patients will complete this questionnaire manually, in paper format.","definition_or_measurement_approach":"ESPIA score measured after 12 administrations and at 1 and 2 years (paper questionnaire)."}
• {"endpoint_text":"-The safety profile will be assessed based on the number and percentage of patients who have experienced at least one of the reported events, including the number of episodes/symptoms and the percentage per patient, during the 3-year SCIT treatment period. The severity and causality of each event will also be evaluated.","definition_or_measurement_approach":"Safety analysis: number/% patients with events, episodes/symptoms counts, severity and causality during 3-year treatment period."}
• {"endpoint_text":"-The clinical efficacy based on the evolution of asthma symptoms will be assessed by the change in the dSSa score from baseline to after the 6th and 12th SCIT administrations, as well as 1 and 2 years after the end of the first study period.","definition_or_measurement_approach":"Change in dSSa score from baseline to after 6th and 12th administrations and at 1 and 2 years."}
• {"endpoint_text":"-The clinical efficacy based on the evolution of medication use will be assessed by the change in the dMSa score from baseline to after the 6th and 12th SCIT administrations, as well as 1 and 2 years after the end of the first study period.","definition_or_measurement_approach":"Change in dMSa (medication use for asthma) from baseline to after 6 and 12 administrations and at 1 and 2 years."}
• {"endpoint_text":"-Pulmonary function will be assessed based on the mean change in FEV1 using spirometry, while pulmonary inflammation will be assessed based on the mean change in FeNO from baseline to after the 6th and 12th SCIT administrations, as well as 1 and 2 years after the end of the first study period.","definition_or_measurement_approach":"Mean change in FEV1 (spirometry) and mean change in FeNO from baseline to after 6th and 12th administrations and at 1 and 2 years."}
• {"endpoint_text":"-14. Asthma-related quality of life will be assessed in adult patients based on the mean change in AQLQ score, and in patients aged 12 to 17 years based on the mean change in pAQLQ score, from baseline to after the 6th and 12th SCIT administrations, as well as 1 and 2 years after the end of the first study period.","definition_or_measurement_approach":"Mean change in AQLQ (adults) and pAQLQ (12–17) from baseline to after 6th and 12th administrations and at 1 and 2 years."}
• {"endpoint_text":"-Asthma control will be assessed in all patients based on the mean change in ACT score from baseline to after the 6th and 12th SCIT administrations, as well as 1 and 2 years after the end of the first study period. Patients will complete these questionnaires manually, in paper format.","definition_or_measurement_approach":"Mean change in ACT score from baseline to after 6th and 12th administrations and at 1 and 2 years (paper)."}
• {"endpoint_text":"-The evolution of asthma severity will be assessed based on the change in asthma classification according to the GINA guidelines from baseline to after the 6th and 12th SCIT administrations, as well as 1 and 2 years after the end of the first study period.","definition_or_measurement_approach":"Change in asthma classification per GINA guidelines from baseline to after 6th and 12th administrations and at 1 and 2 years."}
• {"endpoint_text":"-The evolution of exacerbations will be assessed at each treatment administration based on the number, severity, and duration of exacerbations experienced by the patients from baseline to after the 12th SCIT administration, as well as 1 and 2 years after the end of the first study period.","definition_or_measurement_approach":"Assessment of number, severity and duration of exacerbations at each administration from baseline to after 12th administration and at 1 and 2 years."}

Methods

• Recruitment methods not specified in text fields. Recruitment materials listed in documents: 'K2_Recruitment material Poster', 'K2_Recruitment material Leaflet', and 'K1_Recruitment arrangements' (documents available for the Spain part II).

Spain

Earliest CTIS Part Ii Submission Date

30-09-2025

Latest Decision Or Authorization Date

11-05-2026

Processing Time Days

223

Number Of Sites

41

Number Of Participants

360

Primary sponsor

Full Name

LETI Pharma S.L.U.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain

Contract research organisations

Name

Laboratorio Echevarne S.A.

Responsibilities

code: 4

Name

Evidenze Health Espana S.L.

Responsibilities

codes: 1,10,11,5,6,7

Third parties

• {"country":"Spain","full_name":"Laboratorio Echevarne S.A.","duties_or_roles":"code: 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Spain","full_name":"Evidenze Health Espana S.L.","duties_or_roles":"codes: 1,10,11,5,6,7","organisation_type":"Pharmaceutical company"}