DERMATOPHAGOIDES PTERONYSSINUS ENRICHED ALLERGOID, MANNAN-CONJUGATED, POLYMERISED; DERMATOPHAGOIDES FARINAE ENRICHED ALLERGOID, MANNAN-CONJUGATED, POLYMERISED for Allergic rhinitis | Allergic rhinoconjunctivitis | Allergic asthma

Inclusion criteria

• {"criterion_text":"- Subjects who have signed and dated Informed Consent Form (ICF).\n- 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.\n- Subjects capable of complying with dosage regimen.\n- Subjects with negative skin prick test for moulds.\n- Subjects must record symptoms and medication consumption in an electronic diary via smartphone (preferably) or in a paper diary.\n- To be confirmed at visit 1 (V1). Only subjects who meet the following criteria will be eligible for randomization: 12.\tSubjects 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).\n- Subjects with negative skin prick test for moulds.\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 confirm menarche and have a urine pregnancy test negative result before enrolling the study\n- 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.\n- Subjects capable of complying with dosage regimen.\n- Subjects must record symptoms and medication consumption in an electronic diary via smartphone (preferably) or in a paper diary."}

Exclusion criteria

• {"criterion_text":"- 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.\n- 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).\n- 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.\n- 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.\n- 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.\n- Breastfeeding or pregnant women.\n- Subjects who are immediate family members of the investigator.\n- Concurrent participation in other clinical trials or previous participation within 30 days prior to the screening/baseline visit.\n- Subjects with history of serious systemic reactions, including food, Hymenoptera venom, drugs, etc.\n- 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.\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- Unstable subjects who have suffered a respiratory tract infection and/or asthma exacerbation within 4 weeks prior to the screening/baseline visit.\n- 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.\n- 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).\n- 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.\n- Subjects on treatment with β-blockers, except those administered topically, or angiotensin-converting enzyme (ACE) inhibitors.\n- Subjects on treatment with immunosuppressive (not including corticosteroids), except those administered topically, or biological drug\n- 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.\n- Subjects with controlled or uncontrolled cancer.\n- Subjects who have suffered chronic urticaria, severe anaphylaxis, or family history of angioedema within 2 years prior to the screening/baseline visit.\n- Subjects having any contraindication for the use of adrenaline (e.g., hyperthyroidism, heart disease, or hypertension) according to the investigator’s criteria.\n- 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.\n- Subjects with uncontrolled autoimmune diseases (e.g., thyroiditis or lupus), tumoral diseases, or immunodeficiencies.\n- Subjects that could not comply with the study protocol, according to investigator’s criteria, or have a serious mental illness.\n- Subjects with known allergy to any of the components of the investigational medicinal products (IMPs) other than study allergens.\n- Subjects with lower respiratory tract diseases, different from asthma, as emphysema, bronchiectasis, or chronic obstructive pulmonary disease."}

Primary endpoints

• {"endpoint_text":"- Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (RCSMS) by means of the Subject’s Diary","definition_or_measurement_approach":"Measured by the Subject's Diary (daily diary), i.e., RCSMS (combined symptom and medication score) recorded in the subject diary."}

Secondary endpoints

• {"endpoint_text":"- Rhinitis/Rhinoconjunctivitis Symptom Score (RSS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Rhinitis/Rhinoconjunctivitis Medication Score (RMS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Asthma-Combined Symptom and Medication Score (ACSMS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Asthma Symptom Score (ASS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Asthma Medication Score (AMS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Asthma and Rhinitis/Rhinoconjunctivitis Symptom Score (ARSS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Asthma and Rhinitis/Rhinoconjunctivitis Medication Score (ARMS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Asthma and Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (ARCSMS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Asthma exacerbations: time to first asthma exacerbation; number, duration, and severity","definition_or_measurement_approach":"Time-to-event and counts/duration/severity metrics for exacerbations"}
• {"endpoint_text":"- Immunological parameters:  Total IgE  Specific IgE and IgG4  Specific IgE/Total IgE ratio  Anti-Saccharomyces cerevisiae antibodies (ASCA) IgA and IgG","definition_or_measurement_approach":"Laboratory measurement of total IgE, specific IgE and IgG4, specific IgE/total IgE ratio, ASCA IgA and IgG"}
• {"endpoint_text":"- Allergen profiling (ALEX technique)","definition_or_measurement_approach":"Allergen profile measured using the ALEX technique"}
• {"endpoint_text":"- Asthma Quality of Life Questionnaire (AQLQ)","definition_or_measurement_approach":"Patient-reported QoL via AQLQ questionnaire"}
• {"endpoint_text":"- Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)","definition_or_measurement_approach":"Patient-reported QoL via RQLQ questionnaire"}
• {"endpoint_text":"- Asthma Control Questionnaire (GINA 2023)","definition_or_measurement_approach":"Asthma control assessed using GINA 2023 questionnaire"}
• {"endpoint_text":"- Visual Analogue Scale (VAS)","definition_or_measurement_approach":"Patient-reported VAS for symptoms"}
• {"endpoint_text":"- Consumption of Health Resources","definition_or_measurement_approach":"Assessment of health resource utilization related to study pathologies"}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"AE collection and assessment per administration and per subject; evaluation of local and systemic reactions and treatments given"}

Methods

• Recruitment via participating clinical sites (Allergology departments) in Spain and Portugal (site list in trialSites).
• Advertising/recruitment materials and arrangements (documents: K2_Advertising material; K1_Recruitment arrangements_Redacted).

Portugal

Earliest CTIS Part Ii Submission Date

05-02-2025

Latest Decision Or Authorization Date

19-09-2025

Processing Time Days

226

Number Of Sites

3

Number Of Participants

125

Spain

Earliest CTIS Part Ii Submission Date

13-06-2025

Latest Decision Or Authorization Date

26-09-2025

Processing Time Days

105

Number Of Sites

8

Number Of Participants

125

Primary sponsor

Full Name

Inmunotek S.L.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain

Third parties

• {"country":"Portugal","full_name":"Blueclinical Investigacao E Desenvolvimento Em Saude Lda.","duties_or_roles":"1,12,2,5","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Bioclever 2005 S.L.","duties_or_roles":"1,10,11,12,2,5,6","organisation_type":"Hospital/Clinic/Other health care facility"}