Phase III clinical trial to evaluate the efficacy and safety of specific immunotherapy with mannanconjugated allergoids for the treatment of rhinitis/rhinoconjunctivitis in patients allergic to house dust mites.

Trial details

Who runs it

Inmunotek S.L.

Trial code

EU 2023-508548-23-00

Record updated

2026. július 22.

Original description

The primary objective of this trial is to evaluate the clinical efficacy of EP-088_MM09 at 3,000 mTU/mL administered subcutaneously, compared to placebo in subjects aged 12 to 65 years old with moderate-to-severe persistent rhinitis/rhinoconjunctivitis with or without mild-to-moderate intermittent or persistent controlled asthma, allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinaeRead full original descriptionShow less

Prospective, randomised, double-blind, placebo-controlled multicenter clinical trial of efficacy and safety with Dermatophagoides pteronyssinus and Dermatophagoides farinae mannan-conjugated allergoids in patients with rhinitis/rhinoconjunctivitis, allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae _MM09-SIT-069

The primary objective of this trial is to evaluate the clinical efficacy of EP-088_MM09 at 3,000 mTU/mL administered subcutaneously, compared to placebo in subjects aged 12 to 65 years old with moderate-to-severe persistent rhinitis/rhinoconjunctivitis with or without mild-to-moderate intermittent or persistent controlled asthma, allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae

Inclusion: Subjects who have signed and dated Informed Consent Form (ICF); Subjects capable of complying with dosage regimen; Subjects must record symptoms and medication consumption in an electronic diary via smartphone (preferably) or in a paper diary; To be confirmed at visit 1 (V1). Only subjects who meet the following criteria will be eligible for randomization: 12. 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 (See Section 6.2); 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; Subjects capable of complying with dosage regimen; Subjects with negative skin prick test for moulds; Subjects must record symptoms and medication consumption in an electronic diary via smartphone (preferably) or in a paper diary; 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 (See Section 6.2); Subjects with negative skin prick test for moulds; 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; 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: 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); 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; 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; Concurrent participation in other clinical trials or previous participation within 30 days prior to the screening/baseline visit; 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; Unstable subjects who have suffered a respiratory tract infection and/or asthma exacerbation within 4 weeks prior to the screening/baseline visit; 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; 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); Subjects on treatment with β-blockers, except those administered topically, or angiotensin-converting enzyme (ACE) inhibitors; Subjects on treatment with immunosuppressive (not including corticosteroids), except those administered topically, or biological drug; 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; Subjects who have suffered chronic urticaria, severe anaphylaxis, or family history of angioedema within 2 years prior to the screening/baseline visit; 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; Subjects with history of serious systemic reactions, including food, Hymenoptera venom, drugs, etc; Those cases in which allergen-specific immunotherapy (AIT) would be a contraindication according to the criteria of European Allergy and Clinical Immunology Immunotherapy Subcommittee; Subjects with controlled or uncontrolled cancer; Subjects having any contraindication for the use of adrenaline (e.g., hyperthyroidism, heart disease, or hypertension) according to the investigator’s criteria; 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; Subjects with uncontrolled autoimmune diseases (e.g., thyroiditis or lupus), tumoral diseases, or immunodeficiencies; Subjects that could not comply with the study protocol, according to investigator’s criteria, or have a serious mental illness; Subjects with known allergy to any of the components of the investigational medicinal products (IMPs) other than study allergens; Subjects with lower respiratory tract diseases, different from asthma, as emphysema, bronchiectasis, or chronic obstructive pulmonary disease; 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; Breastfeeding or pregnant women; Subjects who are immediate family members of the investigator; 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.

EU CTIS 2023-508548-23-00