DERMATOPHAGOIDES PTERONYSSINUS ENRICHED ALLERGOID, MANNAN-CONJUGATED, POLYMERISED; DERMATOPHAGOIDES FARINAE ENRICHED ALLERGOID, MANNAN-CONJUGATED, POLYMERISED for Allergic rhinitis/rhinoconjunctivitis | House dust mite allergy | Allergic asthma

Inclusion criteria

• {"criterion_text":"- Subjects who have signed and dated Informed Consent Form (ICF)."}
• {"criterion_text":"- Subjects capable of complying with dosage regimen."}
• {"criterion_text":"- Subjects must record symptoms and medication consumption in an electronic diary via smartphone (preferably) or in a paper diary."}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- 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, bilateral tubal occlusion, vasectomised partner, or sexual abstinence."}
• {"criterion_text":"- Subjects capable of complying with dosage regimen."}
• {"criterion_text":"- Subjects with negative skin prick test for moulds."}
• {"criterion_text":"- Subjects must record symptoms and medication consumption in a n electronic diary (preferably) or in a paper diary."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Subjects with negative skin prick test for moulds."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}

Exclusion criteria

• {"criterion_text":"- Subjects sensitised (positive skin prick test) to one or more pollens where the time interval between baseline visit (BV) and additional baseline visit (ABV) os more than 7 months."}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Breastfeeding or pregnant women."}
• {"criterion_text":"- Subjects who are immediate family members of the investigator."}
• {"criterion_text":"- Concurrent participation in other clinical trials or previous participation within 30 days prior to the screening/baseline visit."}
• {"criterion_text":"- Subjects with history of serious systemic reactions, including food, Hymenoptera venom, drugs, etc."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Those cases in which allergen-specific immunotherapy (AIT) would be a contraindication according to the criteria of European Allergy and Clinical Immunology Immunotherapy Subcommittee.(3)"}
• {"criterion_text":"- Unstable subjects who have suffered a respiratory tract infection and/or asthma exacerbation within 4 weeks prior to the screening/baseline visit."}
• {"criterion_text":"- Subjects with uncontrolled asthma, according to GINA 2023(2),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."}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- Subjects with severe asthma, according to GINA 2023(2), on Step 4 or 5 treatment, who had poor symptom control and had good adherence and inhaler technique."}
• {"criterion_text":"- Subjects on treatment with β-blockers, except those administered topically, or angiotensin-converting enzyme (ACE) inhibitors."}
• {"criterion_text":"- Subjects on treatment with immunosuppressive (not including corticosteroids), except those administered topically, or biological drug."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Subjects with controlled or uncontrolled cancer."}
• {"criterion_text":"- Subjects who have suffered chronic urticaria, severe anaphylaxis, or family history of angioedema within 2 years prior to the screening/baseline visit."}
• {"criterion_text":"- Subjects having any contraindication for the use of adrenaline (e.g., hyperthyroidism, heart disease, or hypertension) according to the investigator’s criteria."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Subjects with uncontrolled autoimmune diseases (e.g., thyroiditis or lupus), tumoral diseases, or immunodeficiencies."}
• {"criterion_text":"- Subjects that could not comply with the study protocol, according to investigator’s criteria, or have a serious mental illness."}
• {"criterion_text":"- Subjects with known allergy to any of the components of the investigational medicinal products (IMPs) other than study allergens."}
• {"criterion_text":"- 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 using the Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (RCSMS)."}

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 (time to first exacerbation) and counts/measures of number, duration and severity of 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 immunological assays measuring total IgE, specific IgE, specific IgG4, specific IgE/total IgE ratio, and ASCA IgA/IgG."}
• {"endpoint_text":"- Allergen profiling (ALEX technique)","definition_or_measurement_approach":"Allergen profiling performed using the ALEX technique."}
• {"endpoint_text":"- Asthma Quality of Life Questionnaire (AQLQ)","definition_or_measurement_approach":"Patient-reported outcome via AQLQ questionnaire."}
• {"endpoint_text":"- Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)","definition_or_measurement_approach":"Patient-reported outcome via RQLQ questionnaire."}
• {"endpoint_text":"- Asthma Control Questionnaire (GINA 2023)","definition_or_measurement_approach":"Asthma control assessed per GINA 2023 questionnaire."}
• {"endpoint_text":"- Visual Analogue Scale (VAS)","definition_or_measurement_approach":"Symptom severity measured by VAS."}
• {"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":"Safety monitored by recording overall rate and severity of AEs per administration and per subject; evaluation of local and systemic reactions and medications used to treat adverse reactions."}

Portugal

Earliest CTIS Part Ii Submission Date

18-03-2025

Latest Decision Or Authorization Date

24-09-2025

Processing Time Days

190

Number Of Sites

5

Number Of Participants

125

Spain

Earliest CTIS Part Ii Submission Date

18-03-2025

Latest Decision Or Authorization Date

24-09-2025

Processing Time Days

190

Number Of Sites

10

Number Of Participants

125

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