Trial of JYB1904 Injection in Patients With Perennial Allergic Rhinitis

This study is a randomized, double-blind, placebo-controlled Phase II study to evaluate the efficacy and safety of JYB1904 injection compared to placebo in patients with PAR.

Inclusion criteria

• Adult participants ≥18 years and ≤65 years of age at the time of signing the informed consent form (ICF).
• Physician-diagnosed PAR at screening, symptoms of allergic rhinitis present for a minimum of 2 years.
• Participants must have been on stable treatment with intranasal corticosteroids (INCS), with or without other background medications for at least four consecutive weeks before randomization, and rTNSS≥6 at screening.
• Within 1 year prior to screening or at screening, participants must have positive indoor allergen SPT and/or positive antigen-specific serum IgE to indoor allergens . Participants must have clinical symptoms associated with perennial allergen positivity (assessed by SPT) or positive serum antigen-specific IgE at study entry .
• A participant who has a known history of dermatographism or identified during the SPT may participate in this study with a positive serum antigen-specific IgE test.
• Participants who have concomitant asthma must use permitted regular asthma treatment during the study and have been stable in the 3 months prior to screening.
• Is willing and able to comply with daily eDiary.
• Participants must complete the eDiary during the baseline evaluation period (2 weeks prior to randomization) and meet the following criteria: (1) complete the eDiary for at least 4 days per week; and (2) rTNSS score ≥6 at randomization (average of Day-7 to Day-1).

Exclusion criteria

• Is currently on AIT subcutaneous immunotherapy or sublingual immunotherapy.
• Have received treatment with any rescue medication or adjustment to background therapy medications during the baseline evaluation period.
• Prior intolerance or inadequate response to omalizumab.
• Contraindications or hypersensitivity to antihistamines or intranasal corticosteroids, or history of anaphylaxis.
• Have a history of seasonal worsening of AR and if the seasonal worsening is expected during the 2-week baseline evaluation period and the 24-week double-blind induction period.
• Anticipates significant changes in their daily environmental exposure during the 2-week baseline evaluation period and the 24-week double-blind induction period.
• Has a history of nasal polyps or nasal polyps present at screening, moderate-to-severe nasal septum deviation, or rhinitis secondary to other causes.
• Has a known history of recurrent acute or chronic sinusitis.