NCT07155499

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 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.

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: AO GENERIUM · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Rhinitis, Allergic, Seasonal

Interventions

Type	Name	Description
BIOLOGICAL	GNR-127, 20 mcg	GNR-127, 20 mcg in 0.5 ml administered 5 times every 4 weeks
BIOLOGICAL	GNR-127, 40 mcg	GNR-127, 40 mcg in 0.5 ml administered 5 times every 4 weeks
BIOLOGICAL	GNR-127, 80 mcg	GNR-127, 80 mcg in 0.5 ml administered 5 times every 4 weeks
BIOLOGICAL	GNR-127 placebo	GNR-127 placebo 0.5 ml administered 5 times every 4 weeks

Timeline

• Start date: 2024-10-07
• Primary completion: 2025-05-31
• Completion: 2025-12-20
• First posted: 2025-09-04
• Last updated: 2025-09-04

Locations

1 site across 1 country: Russia