This Phase Ⅲ randomized, double-blind, active- and placebo-controlled trial aims to assess the efficacy and safety of Rupatifen Fumarate Capsules for seasonal allergic rhinitis. Eligible participants will be randomized to Rupatifen Fumarate Capsules, Rupatadine Fumarate Tablets (active comparator), or matching placebo. All treatments are administered once daily at a consistent time with a 24 ± 2-hour interval between doses for 2 consecutive weeks.
Aged from 18 to 65 years inclusive, no restriction on gender.
Clinical diagnosis shall comply with Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (Revised 2022) issued by Rhinology Group, Chinese Society of Otorhinolaryngology Head and Neck Surgery, Chinese Medical Association; documented medical history of seasonal allergic rhinitis ≥2 years (subject's self-reported history is acceptable). Prior to randomization, subjects shall test positive for one or more locally prevalent seasonal allergens (e.g., tree pollen, grass pollen). Any of the following allergen testing results are recognized: skin prick test (SPT), intradermal test or serum specific immunoglobulin E (sIgE). Specific immunoglobulin E (sIgE) results obtained within 1 year prior to randomization demonstrating positivity to relevant seasonal allergens are acceptable. Clinical manifestations shall meet the following: a) Symptoms: ≥2 of paroxysmal sneezing, rhinorrhea, nasal pruritus and nasal congestion; total daily symptom duration ≥1 hour, with possible accompanying ocular manifestations including lacrimation, ocular pruritus and conjunctival hyperemia. b) Signs: typical pale and edematous nasal mucosa with watery nasal discharge. c) Allergic symptoms manifest seasonally in spring and/or autumn, and subjects are in an active symptomatic episode at screening.
At screening, reflective Total Nasal Symptom Score (rTNSS) ≥6 points, nasal congestion subscore ≥2 points, and at least one subscore ≥2 points among rhinorrhea, nasal pruritus and sneezing.
Subjects are willing to provide written informed consent and comply with study procedures, including proper completion of subject diary cards; capable of adhering to scheduled study medication, laboratory examinations and other trial-related assessments.
(Medical inquiry) Patients with asthma requiring long-term treatment (subjects with occasional asthmatic symptoms such as dyspnea or exercise-induced asthma who require no medication during the trial may be enrolled).
Subjects with infectious conjunctivitis or other ocular infections (allergic conjunctivitis excluded).
Subjects with concomitant nasal diseases or conditions at screening (e.g., acute/chronic sinusitis, nasal polyps, deviated nasal septum, rhinitis medicamentosa, cerebrospinal fluid rhinorrhea, status within 1 year post nasal surgery, etc.) that may interfere with efficacy assessment as judged by the investigator (self-reported history is acceptable).
(Medical inquiry) Active respiratory tract infection occurring within 14 days prior to screening or throughout the run-in period, including but not limited to bronchitis, pneumonia, upper respiratory tract infection or sinus infection.
Parallel
Rupatifen Fumarate Capsules
DrugOral administration, one capsule once daily for 14 consecutive days
Rupatadine Fumarate Tablets
DrugOral administration, one tablet once daily for 14 consecutive days
Rupatifen Fumarate Capsules Placebo
DrugOral administration, one capsule once daily for 14 consecutive days
Rupatadine Fumarate Tablets Placebo
DrugOral administration, one tablet once daily for 14 consecutive days
Change from baseline in the average reflective Total Nasal Symptom Score (rTNSS) during the treatment period
The reflective Total Nasal Symptom Score (rTNSS) assesses 4 core nasal symptoms: sneezing, rhinorrhea, nasal pruritus, and nasal congestion. Each symptom is scored from 0 (none) to 3 (severe). The total score ranges from 0 to 12 points, with higher scores indicating more severe nasal symptoms.
Change from baseline in average instant Total Nasal Symptom Score (iTNSS) during treatment
The instant Total Nasal Symptom Score (iTNSS) assesses 4 core nasal symptoms: sneezing, rhinorrhea, nasal pruritus, and nasal congestion. Each symptom is scored from 0 (none) to 3 (severe). The total score ranges from 0 to 12 points, with higher scores indicating more severe nasal symptoms.
Time to onset after the first dose on Day 1 (assessed based on instant Total Nasal Symptom Score (iTNSS) scores)
Time to onset after the first dose on Day 1 (assessed based on instant Total Nasal Symptom Score (iTNSS) scores); The instant Total Nasal Symptom Score (iTNSS) assessments will be conducted at 0.5 hour (±10 minutes), 1 hour (±10 min), 1.5 hours (±10 minutes), 2 hours (±10 minutes), 3 hours (±10 minutes), 4 hours (±30 minutes), 6 hours (±30 minutes) and 8 hours (±30 minutes) following the first dose during the treatment period. Time to onset is defined as the first time point after the first treatment dose at which the change from baseline in instant Total Nasal Symptom Score (iTNSS) for the investigational product group is statistically significantly superior to that of the placebo group, and this superiority is sustained from this time point through the end of the 24-hour dosing interval. The instant Total Nasal Symptom Score (iTNSS) ranges from 0 to 12 points, with higher scores indicating more severe nasal symptoms.
Number of days with nasal congestion score ≤ 1 during the treatment period
Nasal congestion is a sub-item of the Total Nasal Symptom Score (TNSS) scale, scored from 0 (none) to 3 (severe). Higher scores indicate more severe nasal congestion.
Change from baseline in average morning reflective Total Nasal Symptom Score (rTNSS) during the treatment period
Morning reflective Total Nasal Symptom Score (rTNSS) is assessed once daily before morning dosing. The score ranges from 0 to 12 points, with higher scores indicating more severe nasal symptoms.
Click on the lead sponsor to view all of their trials.
