Clinical Trial to Evaluate the Efficacy and Safety of Polymerized, Mannan-Conjugated Dermatophago… (NCT05641272) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
Clinical Trial to Evaluate the Efficacy and Safety of Polymerized, Mannan-Conjugated Dermatophagoides Allergen Extract
Argentina90 participantsStarted 2023-11-01
Plain-language summary
Prospective, randomised, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of polymerized and mannan conjugated allergen extract of Dermatophagoides for the treatment of allergic rhinitis/rhinoconjunctivitis with or without asthma.
The main objective of the clinical trial is to evaluate the clinical efficacy of the investigational medicinal product, administered sublingually, compared to placebo for the treatment of moderate-severe rhinitis/rhinoconjunctivitis with or without mild to moderate asthma and controlled using the Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (R-CSMS).
Who can participate
Age range12 Years – 60 Years
SexALL
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Inclusion criteria
✓. Signed Informed Consent Form.
✓. Male or female, aged between 12 and 60 years, both included.
✓. Confirmed clinical history of inhalation allergy with moderate-severe rhinitis/rhinoconjunctivitis according to the ARIA classification with or without controlled mild-moderate intermittent or persistent asthma according to the definition of GEMA 5.0 y GINA caused by allergy to mites (D. pteronyssinus and/or D. farinae). The asthma diagnostic will be valid up to 24 months prior to signing the informed consent form.
✓. Combined Symptom and Medication Score for moderate to severe rhinitis/rhinoconjunctivitis (RCSMS) ≥ 1,8 out of 3.
✓. Positive skin prick test (wheal major diameter ≥ 5 mm) to a standardized allergen extract of Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. The results will be valid up to 12 months prior to signing the informed consent form.
✓. Specific IgE against a complete extract of Dermatophagoides pteronyssinus and/or D. farinae or any the molecular components of allergenic sources with a value ≥ 3.5 kU/L. The results will be valid up to 12 months prior to signing the informed consent form.
✓. Subjects shall preferably be monosensitised to the study allergens. In case of subjects sensitised to other aeroallergens, only those with the following characteristics may be included in the study (results will be valid up to 12 months prior to signing the informed consent form):
What they're measuring
1
Rhinitis/rhinoconjunctivitis Combined Symptom and Medication Score (RCSMS)
✓. Subjects with negative skin prick test to mold. In case specific IgE determination have been performed, the result must be \<0.35 kU/L.
Exclusion criteria
✕. Subjects polysensitized to other aeroallergens with clinically relevant symptoms.
✕. Subjects who have received previous immunotherapy in the preceding 5 years to any of the tested allergens or a cross-reactive allergen or are currently receiving immunotherapy with any allergen.
✕. Patients in whom immunotherapy may be subject to an absolute general contraindication according to the criteria of the Immunotherapy Committee of the Spanish Society of Allergy and Clinical Immunology and the European Allergy and Clinical Immunology Immunotherapy Subcommittee may not be included.
✕. Subjects with uncontrolled severe asthma, and/or with FEV1 \<80% of baseline despite adequate pharmacological treatment by the time of the enrolment.
✕. Subjects on treatment with ß-blockers.
✕. Subjects on treatment with immunosuppressive or biological drugs.
✕. Subjects who are unstable by the time of enrolment (respiratory infection, febrile process, acute pruritus, etc.).
✕. Subjects with chronic urticaria during the last 2 years, severe anaphylaxis or with hereditary angioedema history.