A Phase 1/2 interventional study of GNR-127, 20 mcg and GNR-127, 40 mcg in Rhinitis, Allergic, Seasonal, sponsored by AO GENERIUM. Completed at 1 site in Russia. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by AO GENERIUM · Phase 1/2, Interventional, and Treatment
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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.
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.
404 studies on the registry are indexed under Rhinitis, Allergic, Seasonal; 24 are open to participants now.
This study's enrollment of 150 is above the median of 131 across 366 interventional studies indexed under Rhinitis, Allergic, Seasonal.
Browse Rhinitis, Allergic, Seasonal studies →AO GENERIUM is the lead sponsor of 31 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The use of the following medications (the use of hormonal is allowed):
i. parenteral administration of 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 or genetically engineered biological drugs (GBPS), within 24 weeks prior to signing the informed consent.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GNR-127, 20 mcg, suspension for subcutaneous administration, 0.5 ml / dose
Biological: GNR-127, 20 mcg
GNR-127 40 mcg, suspension for subcutaneous administration, 0.5 ml / dose
Biological: GNR-127, 40 mcg
GNR-127 80 mcg, suspension for subcutaneous administration, 0.5 ml / dose
Biological: GNR-127, 80 mcg
Suspension for subcutaneous administration, 0.5 ml / dose
Biological: GNR-127 placebo
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, 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, 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 placebo 0.5 ml administered 5 times every 4 weeks
Also known as: Placebo
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.
Time frame: 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).
Time frame: 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.
Time frame: Up to 3 months after the end of treatment.
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.
Time frame: 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)
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.
Time frame: Uo to 3 months after the end of therapy.
Antibody level to the Betv1, Mald1 and PreS antigens.
IgG, IgE, IgA, IgM antibody level to all three antigen will be assessed.
Time frame: Day 1, week 8, week 16 and up to 3 months after the end of treatment.
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.
Time frame: Day 1, week 8, week 16 and up to 3 months after the end of treatment.
Cytokines level
Cytokins level: IL-1β, IFNγ, IL-2, IL-4, IL-5, IL-10, IL-13 will be assessed.
Time frame: Day 1, week 8, week 16 and up th 3 months after the end of treatment.
Plan to share: No
Ran from Oct 2024 to primary completion in May 2025, 7 months.
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Rhinitis, Allergic, Seasonal →