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.

NCT07155499 | Active Not Recruiting Phase 1

• 1 other identifier: GNR127-BET01
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rhinitis, Allergic, Seasonal

Keywords

Hypersensitivity; Birch Pollen Allergy; Seasonal Allergy; Birch Pollen; Immune System Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity

Outcome Measures

Primary Outcomes (3)

• Daily Symptom Score (dSS)

  According to the dSS scale, the patient will need to assess the presence and severity of 4 symptoms of AR (itchy nose, sneezing, runny nose and nasal congestion) and 2 symptoms of AK (itchy eyes/redness of the eyes and lacrimation) on a 3-point scale, where 0 - no symptoms, 1-mild symptoms (the sign/symptom is clearly present, but causes minimal anxiety; easily tolerated), 2 - moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), 3 - severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). 4 nasal and 2 conjunctival symptoms to be assessed from 0 to 3 score each. Total (dayli) symptoms score: 0-3 (max score is 3, i.e. 18 points/divided by 6 symptoms): 0 - no symptoms, 3 - severe symptoms.

  Up to 3 months after the end of treatment.

• Daily Medication Score (dMS)

  The use of the following medications that can be used to relieve symptoms of allergic rhinitis and allergic conjunctivitis will need to be evaluated by the patient * Non-sedative H1-antihistamines (H1A) for oral and / or topical use (eyes or nose) = 1 point; * Intranasal corticosteroids (InCS) with / without H1A = 2 points; * Oral corticosteroids with / without InKS, with / without H1A = 3 points. Points are not added up, and the maximum score is set. Thus, the minimum dMS value is 0 and means no need for medication, and the maximum dMS value is 3 and means the need for third-line medications).

  Up to 3 months after the end of treatment.

• Combined Symptom and Medication Score (CSMS)

  The eDP automatically calculates total dSS and dMS scores based on the patient's daily scores: * The (Total) Daily Symptoms Score (dSS) is the sum of the scores for each of the symptoms and can range from 0 to 3 points * The (Total) Daily Medication Score (dMS): 0-3 (max score is 3) СSMS= dSS (0-3) + dMS (0-3) CSMS can range from 0 to 6 points, where the minimum value is 0 points and means no symptoms and no need for medication, and the maximum value is 6 points and means the maximum severity of rhinitis symptoms, despite the use of third-line medications.

  Up to 3 months after the end of treatment.

Secondary Outcomes (5)

• 36-Item Short Form Health Survey (36-SF)

  Day 0, week 16 (end of treatment) and up to 3 months after the end of treatment.

• Severity of allergic rhinitis symptoms on a Visual-analog scale (VAS)

  Uo to 3 months after the end of therapy.

• Antibody level to the Betv1, Mald1 and PreS antigens.

  Day 1, week 8, week 16 and up to 3 months after the end of treatment.

• Percentage of the CD3+CD69+ T-cells

  Day 1, week 8, week 16 and up to 3 months after the end of treatment.

• Cytokines level

  Day 1, week 8, week 16 and up th 3 months after the end of treatment.

Study Arms (4)

GNR-127, 20 mcg

EXPERIMENTAL

GNR-127, 20 mcg, suspension for subcutaneous administration, 0.5 ml / dose

Biological: GNR-127, 20 mcg

GNR-127, 40 mcg

EXPERIMENTAL

GNR-127 40 mcg, suspension for subcutaneous administration, 0.5 ml / dose

Biological: GNR-127, 40 mcg

GNR-127, 80 mcg

EXPERIMENTAL

GNR-127 80 mcg, suspension for subcutaneous administration, 0.5 ml / dose

Biological: GNR-127, 80 mcg

Placebo

PLACEBO COMPARATOR

Suspension for subcutaneous administration, 0.5 ml / dose

Biological: GNR-127 placebo

Interventions

GNR-127, 20 mcg BIOLOGICAL

GNR-127, 20 mcg in 0.5 ml administered 5 times every 4 weeks

Also known as: Recombinant antigen protein carries a birch pollen allergen [BET V 1]

GNR-127, 20 mcg

GNR-127, 40 mcg BIOLOGICAL

GNR-127, 40 mcg in 0.5 ml administered 5 times every 4 weeks

Also known as: Recombinant antigen protein carries a birch pollen allergen [BET V 1]

GNR-127, 40 mcg

GNR-127, 80 mcg BIOLOGICAL

GNR-127, 80 mcg in 0.5 ml administered 5 times every 4 weeks

Also known as: Recombinant antigen protein carries a birch pollen allergen [BET V 1]

GNR-127, 80 mcg

GNR-127 placebo BIOLOGICAL

GNR-127 placebo 0.5 ml administered 5 times every 4 weeks

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Convulsive seizures or a history of epilepsy.
• Any chronic or recurrent infectious diseases in the anamnesis in the acute stage.
• The presence of significant deviations according to physical examination, vital signs measurement, as well as laboratory tests, electrocardiography and fluorography / radiography of the lungs performed on analog (film) or digital fluorographs/X-ray machines, which in the opinion of the researcher may interfere with ASIT.
• Malignancy of any nature and localization in the anamnesis.
• A history of bone marrow transplantation (BMT) or peripheral blood hematopoietic stem cells (TSCC).
• The presence of clinically significant cardiovascular and mental illnesses that, according to the researcher, may hinder the implementation of ASIT.
• Dehydration due to diarrhea, vomiting, or other causes within 24 hours prior to subcutaneous injection of the test drug or placebo.

Sponsors & Collaborators

• AO GENERIUM: lead

Study Sites (1)

National Research Center - Institute of Immunology Federal Medical-Biological Agency

Moscow, 115522, Russia

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Hypersensitivity; Immune System Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate

Study Officials

• Oksana A. Markova, MD

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participant - for the second stage None (open label) - for the first stage
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential - for first stage Parallel - for second stage

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: September 4, 2025
• Study Start: October 7, 2024
• Primary Completion: May 31, 2025
• Study Completion: December 20, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)