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Rhinitis, Allergic, SeasonalPhase 1/2NCT07155499

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.

A Phase 1/2 study testing GNR-127, 20 mcg, GNR-127, 40 mcg and GNR-127, 80 mcg in people with Rhinitis, Allergic, Seasonal, run by AO GENERIUM at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Rhinitis, Allergic, Seasonal
What is being tested?
GNR-127, 20 mcg, GNR-127, 40 mcg and GNR-127, 80 mcg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
1 siteRussia
Study dates
7 Oct 2024to 8 Sep 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 26Show fewer
  • 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.
  • Blood donation or blood loss (450 ml of blood or more) less than 3 months before signing the informed consent.
  • Participation in clinical trials of any medications (less than 3 months or 5 half-lives from taking the study drug, whichever is longer) before subcutaneous administration of the study drug or placebo.
  • Regular alcohol consumption exceeding 5 units of alcohol per week or information about alcoholism, drug addiction, or drug abuse in the anamnesis.
  • Seropositive HIV status (presence of anti-HIV-1 and/or anti-HIV-2 in the blood) and/or detection of markers of acute hepatitis B (presence of HBsAg in the blood) and/or hepatitis C (presence of anti-HCV in the blood) and/or syphilis.
  • Surgery on ENT organs and/or any other surgical interventions planned for the period of participation in the study, except for those that can be performed on an outpatient basis and under local anesthesia (for example, tooth extraction, nevus removal, etc.).
  • The use of the following medications (the use of hormonal contraceptives is allowed):
  • parenteral administration of steroid drugs within 12 weeks prior to signing of informed consent; ii. oral steroid medications within 8 weeks prior to signing informed consent; iii. inhaled and topical steroid medications within 4 weeks prior to signing the informed consent form; iv. beta-blockers, including topical forms, within 1 week prior to signing informed consent; v. MAO inhibitors in combination with sympathomimetics for 1 week prior to signing of informed consent; vi. vaccination with any vaccine within 4 weeks before signing the informed consent; vii. immunotherapy, including treatment with immunosuppressive or genetically engineered biological drugs (GBPS), within 24 weeks prior to signing the informed consent.
  • Pregnancy or breast-feeding.
  • Hypersensitivity to any of the components of the drug/placebo, with the exception of hypersensitivity to a causally significant allergen (birch pollen).
  • Psychological, family, sociological, or geographical conditions that potentially hinder compliance with the study protocol and follow-up schedule.
  • Unwillingness or inability to comply with the requirements of this protocol.

Trial locations and contacts

1 site in 1 country.

Russia1 site

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

    Moscow, 115522

Other trials in Russia

About this study

Official title: A Two-stage Clinical Trial With Dose Escalation at the First Stage and a Single-blind, Placebo-controlled Clinical Trial for Evaluation of Efficacy, Safety, Reactogenicity and Immunogenicity of GNR-127 at the Second Stage in Patients With Allergic Rhinitis Sensitized to Birch Pollen.

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.

Read the detailed description

Allergic rhinitis (AR) is the most common disease in both children and adults and is a global health problem that affects approximately 400 million people worldwide. AR has a significant impact on the quality of life of patients, disrupting their sleep, physical and social activity.

AR is a disease characterized by IgE-mediated inflammation of the nasal mucosa (which develops under the influence of allergens) and the presence of at least two of the following symptoms that occur daily for an hour or more: nasal congestion (obstruction), nasal discharge (rhinorrhea), sneezing, itching in the nasal cavity. AR is often combined with other allergic diseases, such as allergic conjunctivitis, atopic dermatitis, and bronchial asthma.

The investigational product GNR-127 is a recombinant vaccine containing the ABP antigen protein, which includes the hypoallergenic peptides Bet v 1 (major birch allergen) and Mal d 1 (apple allergen), as well as the PreS protein of the hepatitis B virus as an immunogenic carrier. The drug is intended for the prevention of allergy to birch pollen - subcutaneous allergen immunotherapy (AIT) in patients suffering from AR with sensitization to birch pollen.

This study is a 'first-in-human' clinical trial and is aimed at evaluating the safety, systemic and local reactogenicity, preliminary efficacy and immunogenicity after the use of GNR-127.

This study is a two-stage study that combines phase I (Stage 1) and phase II (Stage 2) of a clinical trial.

Stage 1 (Phase I) is an open-label safety study of increasing doses of the investigational drug GNR-127 in patients with AR with sensitization to birch pollen.

Phase 1 is to evaluate the safety of three doses of GNR-127 and to determine the dose(s) to be studied in Phase 2. Patients enrolled in Phase 1 will continue to participate in the study in the appropriate dose cohort or prematurely complete their participation in the clinical study.

Phase 2 (Phase II) to be conducted as a single-blind, randomized, placebo-controlled trial. The main goal of Stage 2 is to determine the effective and safe dose of the investigational product in patients with AR with sensitization to birch pollen.

Being tested
GNR-127, 20 mcg, GNR-127, 40 mcg, GNR-127, 80 mcg, GNR-127 placebo
Keywords
Hypersensitivity, Birch Pollen Allergy, Seasonal Allergy, Birch Pollen, Immune System Diseases, Respiratory Tract Diseases, Respiratory Hypersensitivity
Medical subject headings
Rhinitis, Allergic, Seasonal, Hypersensitivity, Immune System Diseases, Respiratory Tract Diseases, Respiratory Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GNR-127, 20 mcgBiological

    Also called Recombinant antigen protein carries a birch pollen allergen [BET V 1]

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

  • GNR-127, 40 mcgBiological

    Also called Recombinant antigen protein carries a birch pollen allergen [BET V 1]

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

  • GNR-127, 80 mcgBiological

    Also called Recombinant antigen protein carries a birch pollen allergen [BET V 1]

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

  • GNR-127 placeboBiological

    Also called Placebo

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

Study groups in NCT07155499
Study groupRoleWhat they receive
GNR-127, 20 mcgExperimentalGNR-127, 20 mcg, suspension for subcutaneous administration, 0.5 ml / dose
Receives: Biological: GNR-127, 20 mcg
GNR-127, 40 mcgExperimentalGNR-127 40 mcg, suspension for subcutaneous administration, 0.5 ml / dose
Receives: Biological: GNR-127, 40 mcg
GNR-127, 80 mcgExperimentalGNR-127 80 mcg, suspension for subcutaneous administration, 0.5 ml / dose
Receives: Biological: GNR-127, 80 mcg
PlaceboPlacebo comparatorSuspension for subcutaneous administration, 0.5 ml / dose
Receives: Biological: GNR-127 placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 3 months after the end of treatment.

  2. 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).

    Measured: Up to 3 months after the end of treatment.

  3. 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.

    Measured: Up to 3 months after the end of treatment.

Secondary outcomes (5)

  1. 36-Item Short Form Health Survey (36-SF)

    The questionnaire reflects the overall well-being and degree of satisfaction with those aspects of a person's life that are affected by the state of health.

    The SF-36 consists of 36 questions, grouped into eight scales: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The scores for each scale are constructed so that a higher value (from 0 to 100) indicates a more favorable health state for that particular scale.

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

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

    VAS is a horizontal graded line 10 cm long on which the patient marks with a vertical line the assessment of the effect of AR on their well - being, expressed in points from 0 to 100 (from 0 to 10 cm), where 0 is the absence of complaints and symptoms, and 100 is the most pronounced manifestations of the disease. Results from 0 to 50 points (5 cm) indicate a controlled course of allergic AR, from 50 points and above (≥5 cm) - an uncontrolled course of AR.

    Measured: Uo to 3 months after the end of therapy.

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

    IgG, IgE, IgA, IgM antibody level to all three antigen will be assessed.

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

  4. Percentage of the CD3+CD69+ T-cells

    Assessment of CD3+CD69+ - percentage of cells expressing the marker and geometric mean fluorescence intensity in peripheral blood cells without in vitro activation.

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

  5. Cytokines level

    Cytokins level: IL-1β, IFNγ, IL-2, IL-4, IL-5, IL-10, IL-13 will be assessed.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2025
  2. Study start7 Oct 2024
  3. Primary completion31 May 2025
  4. Study completion8 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Sequential - for first stage Parallel - for second stage
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07155499
Sponsor's protocol ID
GNR127-BET01
Status last verified
Sep 2026
First submitted
18 Aug 2025
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Khaitov MR, Byazrova MG, Smolnikov EV, Turenko VN, Smirnov VV, Shilovskii IP, Shershakova NN, Medunitsyna EN, Elisyutina OG, Pashenkov MV, Pasikhov GB, Murugin VV, Parshina VA, Bolyakina DK, Primak AS, Lapyko MA, Danilycheva IV, Schubelko RV, Tsyvkina AA, Shartanova NV, Timoshenko DO, Isakova II, Latysheva TV, Shulzhenko AE, Latysheva EA, Kurbacheva OM, Fedenko ES, Markova OA, Korotkevich IA, Yan VV, Gavrilova NA, Tikhomirova MV, Shevchenko IV, Agafonova AA, Poroshin GN, Kudlay DA, Filatov AV, Nazarova EV, Kruchko DS, Goryachev DV, Merkulov VA, Ilina NI, Valenta R, Skvortsova VI. Pre-Seasonal Treatment With Recombinant Carrier-Based Birch Vaccine Improves Birch Pollen Allergy. Allergy. 2026 Sep 4. doi: 10.1111/all.70504. Online ahead of print.

    PubMed 42695588

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GNR-127, 20 mcg, GNR-127, 40 mcg and GNR-127, 80 mcg in people with Rhinitis, Allergic, Seasonal, run by AO GENERIUM at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Daily Symptom Score (dSS) (time frame: Up to 3 months after the end of treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07155499, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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