Trial of JYB1904 Injection in Patients With Perennial Allergic Rhinitis
ConditionPerennial Allergic Rhinitis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJemincare
About this trial
This Phase II Trial is Meant to Evaluate the Efficacy, and Safety of JYB1904 Injection in Patients With Perennial Allergic Rhinitis.
Eligibility criteria
Qualifiers
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 .
Disqualifiers
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.
Trial design
Treatments tested in this trial
- JYB1904
- JYB1904
- Placebo+JYB1904
Treatment groups
135 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov