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 range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.
. 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.
. 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.