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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.

StatusCompleted
PhasePhase 1/2
Started
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Record History

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  1. Trial completed Show 4 more changesShow less
    • Study completion date changed from estimate of Dec 20, 2025 to Sep 8, 2025
    • Eligibility criteria expanded, about 32 words
    • Secondary endpoints: details revised at 2 of 5 entries
    • Publications: details revised at 1 of 1 entry
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AO GENERIUM
9 trials monitored
See 1 trial at risk
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.
Trial Details
NCT Number NCT07155499
Lead Sponsor AO GENERIUM
Conditions
(from sponsor)		 Rhinitis, Allergic, Seasonal
Related terms Hypersensitivity, Immune System Diseases, Respiratory Hypersensitivity, Respiratory Tract Diseases, Rhinitis, Allergic, Seasonal
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov