A Clinical Trial for Evaluation of Efficacy, Safety and Immunogenicity of GNR-127 (Recombinant AB… (NCT07155499) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Clinical Trial for Evaluation of Efficacy, Safety and Immunogenicity of GNR-127 (Recombinant ABP Antigen Protein Which Carries a Birch Pollen Allergen [BET V 1] and an Apple Allergen [MAL D 1]) in Patients With Birch Pollen Allergic Rhinitis.
Russia150 participantsStarted 2024-10-07
Plain-language summary
This is first-in-human phase 1/2 clinical trial to evaluate the safety, systemic and local reactogenicity of GNR-127 at the first stage in sequential cohorts of patients with allergic rhinitis with sensitization to the birch pollen, and then to determine and evaluate an effective and safe dose of the GNR-127 after five monthly administrations compared to placebo at the second stage.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Having written informed consent to participate in the study obtained from the patient prior to the start of any procedures related to the study.
✓. Men and women aged 18-55 years at the time of signing the informed consent.
✓. Documented allergic rhinitis (AR) with a history of sensitization to birch pollen for at least 2 years prior to signing an informed consent.
✓. Body mass index (BMI) 18.5≤BMI≤29.9 kg / m2.
✓. Positive skin test (pric test) for the birch pollen allergen papule (blister) ≥ 3 mm at Screening.
✓. A positive result for the presence of specific IgE to birch pollen in blood serum (sensitization level of class 2 and higher, which corresponds to quantitative indicators ≥ 0.7 kU/l) at Screening.
✓. Consent to use a reliable method of contraception in accordance with the clinical trial protocol for the entire duration of participation in the study.
Exclusion criteria
✕. Structural abnormalities of the nose or nasal polyposis, a history of frequent nosebleeds (more than once a month), nasal surgery (performed less than 12 months prior to signing the informed consent form), or ongoing upper respiratory tract infection.
✕. Any respiratory disease, or any other acute infectious disease that has resolved less than 4 weeks prior to signing the informed consent form.
✕. Any allergenspecific therapy (AIT) less than 3 years before signing the informed consent form.
What they're measuring
1
Daily Symptom Score (dSS)
Timeframe: Up to 3 months after the end of treatment.
2
Daily Medication Score (dMS)
Timeframe: Up to 3 months after the end of treatment.
3
Combined Symptom and Medication Score (CSMS)
Timeframe: Up to 3 months after the end of treatment.
✕. Anaphylactic shock during AIT in the anamnesis.
✕. Any immunopathological conditions and immunodeficiency.
✕. Uncontrolled bronchial asthma that requires medical treatment.
✕. Presence of clinically significant sensitization to year-round allergens (epidermal allergens, house dust allergens, etc.) at the time of screening.
✕. Severe chronic or recurrent diseases that, according to the researcher, may interfere with AIT.