perennial allergic rhinitis
Conditions
Interventions
Treatment Group:Stapokibart
Sponsors
The First Affiliated Hospital,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 65 years, inclusive, regardless of gender; 2.Volunteer to participate in this study and provide written informed consent; 3.Meet the diagnostic criteria for Perennial Allergic Rhinitis (PAR) as defined by the Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022, Revised Edition), with a documented history of PAR (with or without conjunctivitis) for at least 12 months, and have inadequate symptom control with intranasal corticosteroid spray (INCS) or other medications (e.g., antihistamines, leukotriene receptor antagonists); 4.Meet the diagnostic criteria for asthma as defined by the Chinese Guideline for the Prevention and Treatment of Asthma (2024 Edition), and deemed eligible for enrollment by the investigator or a specialist; 5.A positive test for a perennial allergen-specific serum IgE (>= class 2 [>=0.7 kU/L]) or skin prick test (SPT) (wheal diameter at least 3 mm larger than the negative control) prior to the baseline period, with a documented history consistent with these findings. Patients must have clinical symptoms consistent with the positive perennial allergen identified by SPT or specific serum IgE; 6.Throughout the treatment and follow-up periods, patients should remain in their usual environment(s) of exposure and have no plans to travel away from the area for 72 hours or more; 7.Have a baseline total nasal symptom Visual Analog Scale (VAS) score of >=4 (on a 10-point scale) and a baseline nasal congestion VAS score of >=4 (on a 10-point scale); 8.Have a peripheral blood absolute eosinophil count >=0.15 × 10^9/L at the baseline visit; 9.Be able to communicate well with the investigator and adhere to the protocol-required visit schedule.
Exclusion criteria
Exclusion criteria: 1.Treatment with anti-IL-4Ra monoclonal antibodies, thymic stromal lymphopoietin (TSLP) monoclonal antibodies, anti-IgE monoclonal antibodies, other monoclonal antibodies, or other biologic agents within 10 weeks prior to baseline or within 5 half-lives of the respective drug (whichever is longer); 2.Use of any investigational drug within 4 weeks prior to the baseline, or planned participation in another clinical study during the course of this investigation; 3.Use of systemic immunosuppressants (including but not limited to methotrexate, cyclosporine, mycophenolate mofetil, tacrolimus, penicillamine, sulfasalazine, hydroxychloroquine, azathioprine, cyclophosphamide) for inflammatory or autoimmune diseases (e.g., rheumatoid arthritis, inflammatory bowel disease, primary biliary cholangitis, systemic lupus erythematosus, multiple sclerosis) within 8 weeks prior to baseline or within 5 half-lives of the drug (whichever is longer); 4.Initiation of allergen-specific immunotherapy (desensitization therapy) within 3 months prior to baseline, or planned initiation of such therapy during the study period; 5.Treatment with systemic corticosteroids (SCS) of short or intermediate duration of action (oral, intravenous, or intramuscular) or Chinese herbal medicine for chronic sinusitis (systemic or topical) within 4 weeks prior to baseline; treatment with long-acting SCS (e.g., triamcinolone acetonide injection) within 6 weeks prior to baseline; or planned use of these medications during the study period; 6.Active infection requiring systemic antibacterial, antiviral, antifungal, antiparasitic, or antiprotozoal medication within 7 days prior to baseline; 7.Subjects with comorbid asthma who initiated inhaled corticosteroid (ICS) therapy within 4 weeks prior to baseline (subjects with asthma on a stable dose of ICS for >=4 weeks prior to baseline, assessed as requiring no change in dose during the study, and with a total daily ICS dose <=1000 µg fluticasone propionate or equivalent, and judged by the investigator to have stable disease, are eligible for participation); 8.Forced expiratory volume in 1 second (FEV1) <=50% of the predicted value at the baseline visit; 9.Previous treatment with anti-IL-4Ra monoclonal antibodies (e.g., stapokibart, dupilumab) for allergic rhinitis (AR) with inadequate response (e.g., treatment failure or intolerance); 10.Administration of a live attenuated vaccine within 12 weeks prior to the first dose of study drug or planned vaccination with a live attenuated vaccine during the study period; 11.Presence of other active nasal diseases besides PAR, such as acute or chronic rhinosinusitis (with or without nasal polyps) or nasal septum deviation, which in the investigator's judgment could interfere with the evaluation of the investigational product's efficacy; 12.Subjects with a history of seasonal exacerbation of AR should be excluded if their seasonal symptoms are anticipated to occur during the treatment period; 13.History of allergic granulomatous angiitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener's granulomatosis), Young's syndrome, Kartagener's syndrome, other ciliary motility disorders, or cystic fibrosis; 14.Acute sinusitis, nasal infection, or upper respiratory tract infection at the time of screening or within the 2 weeks prior to baseline; 15.Any nasal or sinus surgery within 1 year prior to baseline; 16.Malignant or benign nasal tumors; 17.Known hypersensitivity to anti-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from baseline in daily total nasal symptom VAS score at Week 16 of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change from baseline in daily total nasal symptom VAS score at Weeks 4 and 12 of treatment;The change from baseline in ACT score and ACQ score at Weeks 4, 12, and 16 of treatment;The change from baseline in daily total nasal symptom VAS score and daily individual nasal symptom VAS scores (runny nose, sneezing, nasal itching, nasal congestion) at Week 2 of follow-up;Adverse events and their incidence during the 16-week treatment period and the 2-week follow-up period;Change from baseline in RQLQ score and CSMS at Weeks 4, 12, and 16 of treatment.;The change from baseline in FVC, FEV1, PEF at Week 2 of follow-up;The change from baseline in FVC, FEV1, PEF at Weeks 4, 12 and 16 of treatment;The change from baseline in ACT score and ACQ score at Week 2 of follow-up;The change from baseline in the mean daily reflective individual nasal symptom scores (runny nose, nasal congestion, sneezing, nasal itching) at Weeks 4, 12, and 16 of treatment; | — |
Countries
China
Contacts
Public ContactWenbin Lei
The First Affiliated Hospital,Sun Yat-sen University
Outcome results
None listed