Trial of JYB1904 Injection in Patients With Perennial Allergic Rhinitis

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Study to Evaluate the Efficacy and Safety of JYB1904 Injection Combined With Background Therapy in Patients With Perennial Allergic Rhinitis

This Phase II Trial is Meant to Evaluate the Efficacy, and Safety 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:

1. Adult participants ≥18 years and ≤65 years of age at the time of signing the informed consent form (ICF).
2. Physician-diagnosed PAR at screening, symptoms of allergic rhinitis present for a minimum of 2 years.
3. 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.
4. 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 .
5. 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.
6. 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.
7. Is willing and able to comply with daily eDiary.
8. 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:

1. Is currently on AIT subcutaneous immunotherapy or sublingual immunotherapy.
2. Have received treatment with any rescue medication or adjustment to background therapy medications during the baseline evaluation period.
3. Prior intolerance or inadequate response to omalizumab.
4. Contraindications or hypersensitivity to antihistamines or intranasal corticosteroids, or history of anaphylaxis.
5. 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.
6. Anticipates significant changes in their daily environmental exposure during the 2-week baseline evaluation period and the 24-week double-blind induction period.
7. Has a history of nasal polyps or nasal polyps present at screening, moderate-to-severe nasal septum deviation, or rhinitis secondary to other causes.
8. Has a known history of recurrent acute or chronic sinusitis.