DERMATOPHAGOIDES FARINAE EXTRACT; DERMATOPHAGOIDES PTERONYSSINUS EXTRACT for House dust mite allergy|Allergic rhinitis|Allergic rhinoconjunctivitis|Allergic asthma

Inclusion criteria

• {"criterion_text":"- Participants who have signed and dated Informed Consent Form (ICF)\n- Participants not sensitized to moulds, cockroach, Blomia tropicalis or other geographically relevant mites (negative skin prick test or IgE < 0.7 kU/L)\n- Participants with a RCSMS ≥ 3 out of 6 recorded for at least 10 days in the baseline evaluation period, corresponding to moderate-to-severe allergic rhinitis /rhinoconjunctivitis\n- Participants with specific IgE against a complete extract of D. pteronyssinus and / or D. farinae or any of the molecular components of allergenic sources with a value ≥ 3.5 kU/L\n- Female or male aged 12 to 65 years, both included, at the time of signature of the ICF\n- Participants with confirmed clinical history of inhalation allergy with intermittent or persistent moderate-severe rhinitis/ rhinoconjunctivitis according to the ARIA classification of at least 1 year of duration (treated with anti-allergic medication) with or without mild-moderate controlled intermittent or persistent asthma according to the definition of GINA 2022 caused by Dermatophagoides pteronyssinus and / or Dermatophagoides farinae).\n- Participants with positive skin prick test and a wheal major diameter ≥ 5 mm to a standardized allergen extract of Dermatophagoides pteronyssinus and/or Dermatophagoides farinae\n- 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 have a urine pregnancy test negative result before enrolling the study\n- Women of childbearing age must commit to using an adequate contraception method\n- Participants capable of complying with dosage regimen.\n- Participants owning a smartphone to register symptoms and medication consumption\n- Participants not sensitized to any other clinically relevant allergen or sensitized with the following characteristics (sensitization to other allergens will be assessed through skin prick test in Europe and LATAM and through IgE levels in China): a. Participants sensitized to dander (with a positive skin prick test for dander or IgE ≥ 0.35 kU/L), provided that they have occasional exposure and symptoms. b. Participants sensitized to endemic pollen (with a positive skin prick test or IgE ≥0.35 kU/L) will be scheduled to be included so that the pollen season does not coincide with the Baseline Evaluation Period nor with one month before and after the Main Evaluation Period. In LATAM, grass sensitized participants will not be included"}

Exclusion criteria

• {"criterion_text":"- Participants who have received previous immunotherapy to any of the tested allergen during the last 5 years or any desensitization process in the last 2 years (e.g., oral immunotherapy [OIT], milk, or egg) before the second screening visit (S2), or currently receiving immunotherapy with any other allergen\n- Participants who have suffered chronic urticaria severe anaphylaxis, or with hereditary angioedema history within 2 years prior to first screening visit (S1)\n- Participants having any contraindication for the use of adrenaline (e.g., hyperthyroidism, heart disease, or hypertension) according to the investigator’s criteria\n- Participants with other severe diseases not related to allergic rhinitis or asthma that could interfere with the study treatment or the follow-up\n- Participants with severe and unresponsive to treatment autoimmune diseases (e.g., thyroiditis or lupus), tumoral diseases or immunodeficiencies\n- Participants that could not comply with the study protocol, according to the investigator's criteria, or have a serious mental illness\n- Participants with known allergy to any of the components of the study treatment other than study allergens\n- Participants who had a complication(s) of any nasal disease (including nasal polyp, nasal septal deviation, and hypertrophic rhinitis, drug-induced rhinitis and/or non-allergic rhinitis) affecting an appropriate evaluation of the efficacy and/or safety, according to investigator's criteria\n- Participants who had a nasal surgery within 6 months prior to the first screening visit (S1) or have programmed or anticipated nasal surgery during the trial period\n- Participants with a lesion in the oral cavity that could confound the safety profile of the study treatment, according to the investigator's criteria\n- Participants who required treatment with antihistamines and/or corticosteroids for other purposes than alleviating symptoms of allergic rhinitis (except temporal use for diseases such as common colds)\n- Those cases in which allergen-specific immunotherapy (AIT) would be a contraindication according to the criteria of European Allergy and Clinical Immunology Immunotherapy Subcommittee\n- Participants with lower respiratory tract diseases different from asthma as emphysema, bronchiectasis or chronic obstructive pulmonary disease\n- Breastfeeding or pregnant women\n- Participants who are immediate family members of the investigator\n- Concurrent participation in other clinical trials or previous participation within 30 days prior to first screening visit (S1)\n- Participants with history of serious systemic reactions, including food, Hymenoptera venom, medications, etc.\n- Participants expected to have marked changes (e.g, moving) in the circumstances of life during the study\n- Participants who plan to start using anti-mite bedding or similar equipment during the study\n- Participants who are considered inappropriate for the study, according to the investigator criteria\n- Asthmatic participants with forced expiratory volume in the first second (FEV1) <80% (following at least a 6-hour washout of short-acting beta2 agonists [SABA] and 12-hour washout of long-acting beta2 agonists [LABA]) despite pharmacological treatment by the time of enrolment\n- Participants with uncontrolled asthma, according to GINA 2022, 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\n- Participants with severe asthma, according to GINA 2022,(2) on Step 4 or 5 treatment, who had poor symptom control and had good adherence and inhaler technique\n- Participants on treatment with β-blockers or angiotensin-converting enzyme (ACE) inhibitor\n- Participants on treatment with immunosuppressive or biological drugs\n- Participants who had not had a long enough washout/withdrawal period at the first screening visit (S1) according to criteria in study protocol (See Table 6 in Section 9.5.3) before undergoing allergen diagnostic tests (skin prick test or IgE analysis)\n- Unstable participants who have suffered a respiratory tract infection and/or asthma exacerbation within 4 weeks prior to the first screening visit (S1)"}

Primary endpoints

• {"endpoint_text":"- The mean of the daily Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (RCSMS) during the Main Evaluation Period (the last 4 week of IMP treatment) by means of the Participant’s Diary","definition_or_measurement_approach":"Mean of the daily Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (RCSMS) during the Main Evaluation Period (the last 4 weeks of IMP treatment) collected via the Participant's Diary"}

Secondary endpoints

• {"endpoint_text":"- Rhinitis/Rhinoconjunctivitis Symptom Score (RSS)\n- Rhinitis/Rhinoconjunctivitis Medication Score (RMS).\n- Asthma and Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (ACSMS).\n- Asthma Symptom Score (ASS)\n- Asthma Medication Score (AMS)\n- Asthma and Rhinitis/Rhinoconjunctivitis Symptom Score (ARSS)\n- Asthma and Rhinitis/Rhinoconjunctivitis Medication Score (ARMS)\n- Asthma and Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (ARCSMS)\n- Asthma exacerbations: Time to first exacerbation; number, duration, and severity of exacerbations\n- Immunological parameters in blood samples: - Total IgE - Specific IgE for D. pteronyssinus and D. farinae - Specific IgE for D. pteronyssinus and D. farinae /Total IgE ratio\n- Allergen profiling (ALEX technique), if serum is available\n- Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)\n- Participant and investigator health status perception through a Visual Analogue Scale (VAS)\n- Consumption of health resources.\n- Safety parameters: - Overall rate and severity of adverse events (AE) per administration and per participant. - Evaluation of reactions at the site of administration, systemic reactions and of any medication administered for the treatment of the AE","definition_or_measurement_approach":"Secondary endpoints are measured using symptom and medication scores (RSS, RMS, ACSMS, ASS, AMS, ARSS, ARMS, ARCSMS), time-to-event and counts for exacerbations, immunological assays (Total IgE, specific IgE, ratios), allergen profiling by ALEX if serum available, quality of life (RQLQ), health status by VAS, health resource consumption metrics, and safety assessments including AE rates and evaluation of local/systemic reactions and treatments used for AEs."}

Spain

Earliest CTIS Part Ii Submission Date

03-06-2024

Latest Decision Or Authorization Date

19-05-2025

Processing Time Days

350

Number Of Sites

2

Number Of Participants

37

Portugal

Earliest CTIS Part Ii Submission Date

10-07-2024

Latest Decision Or Authorization Date

20-05-2025

Processing Time Days

314

Number Of Sites

3

Number Of Participants

110

Primary sponsor

Full Name

Inmunotek S.L.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain

Third parties

• {"country":"Spain","full_name":"Bioclever 2005 S.L.","duties_or_roles":"Codes: [1,10,12,2,5,6,7]","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Portugal","full_name":"Associacao Para Investigacao E Desenvolvimento Da Faculdade De Medicina","duties_or_roles":"Codes: [1,2]","organisation_type":"Pharmaceutical association/federation"}