Seasonal Allergic Rhinitis
Conditions
Interventions
Treatment group 1:Eligible patients randomized to this arm received LP-003 subcutaneously for 8 weeks
Treatment group 2:Eligible patients randomized to this arm received LP-003 subcutaneously for 8 weeks
placebo:Eligible patients randomized to this arm received placebo subcutaneously for 8 weeks
Sponsors
Beijing Shijitan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years at the screening period 2. Patients who met the diagnostic criteria of allergic rhinitis in Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (revised edition, 2022) : 1) Clinical symptoms: more than 2 (including 2 items) symptoms of sneezing, rhinorrhea, nasal congestion, nasal itching and other symptoms appear, which last or accumulate for more than 1h per day and may be accompanied by ocular symptoms such as itchy eyes/tearing/ redness and burning heat sensation; 2) Physical signs: pale, edema of the nasal mucosa and nasal watery discharge; 3) Allergen detection: positive of at least 1 allergen SPT and/or serum-specific IgE within 1 year before enrollment, or nasal provocation test positive 3. Had inadequately controlled symptoms (=TNSS score of 6 and = nasal congestion score of 2) of seasonal allergic rhinitis in last two years despite the use of nasal corticosteroid or in combination of one antihistamine recommended by Guidelines. 4. Having any nasal symptom last for at least 2 days or any nasal and eye symptom last for at least one day, and =TNSS score of 1 5. Subjects (including partners) have no pregnancy and sperm, egg donation plan and voluntarily take one or more non-pharmaceutical measures for contraception, such as complete abstinence, intrauterine ring, partner ligation at period from drug administration to 6 months after the last study drug administration 6. voluntary participation in this trial and signing the informed consent form
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to any content of the study drugs or its excipients. 2. Subjects with non-allergic rhinitis combined, such as drug rhinitis, vasomotor rhinitis, Nonallergic rhinitis with eosinophilia syndrome, acute and chronic sinusitis, rhinitis sicca anterior, atrophic rhinitis, obvious deviation of nasal septum 3. Subjects with perennial allergic rhinitis ( except for seasonal allergic rhinitis combined with perennial allergic rhinitis, which get attacks seasonally ) 4. Subjects who have undergone nasal surgery or sinus surgery within 1 year before screening 5. Subjects who suffer from glaucoma, cataracts, herpes simplex keratitis, infectious conjunctivitis or currently and other eye infections ( Except for allergic conjunctivitis ) 6. Subjects with active facial or systemic fungal, bacterial, viral or parasitic infection, and oral candida infection, who still require ongoing treatment 7. With clinically significant uncontrolled systemic disease (unstable ischemic heart disease, NYHA class III/IV left ventricular failure, arrhythmias, uncontrolled hypertension, cerebrovascular disease, neurodegenerative disease, other neurological disorders, uncontrolled hypothyroidism or hyperthyroidism and other autoimmune disorders, hypokalemia, hyperadrenergic status, diagnosed as a malignancy in the past, except for basal cell carcinoma or squamous cell skin cancer); History of myocardial infarction (MI) within 1 year prior to the screening 8. In screening period: a) WBC 2.0×ULN or TBIL > 1.5×ULN, c) Cr > 1.5×ULN 9. Subjects who have been treated by Omalizumab or other similar drugs within 6 months prior to the screening 10. Sujects who have taken systemic glucocorticoids within 4 weeks prior to the screening 11. Subjects who have taken intranasal glucocorticoids, mast cell membrane stabilizers, tricyclic antidepressants, leukotriene receptor antagonists, antihistamines within 1 week prior to the screening 12. Subjects who have taken traditional Chinese medicine for allergic rhinitis within 7 days prior to the screening 13. Subjects who have received allegen immunotherapy within half of year prior to the screening (in treatment), or who have received allegen immunotherapy within 3 years prior to the screening (completed treatment) 14. During the study period, in addition to standard treatment concomitant drugs and salvage therapy drugs specified in the protocol. Subjects are prohibited from taking medications such as anticholinergics (oral and intranasal anticholinergics, including ipratropium nasal sprays), glucocorticoids, leukotriene receptor antagonists, antihistamines, mast cell membrane stabilizers, decongestants, nasal saline flushing, tricyclic antidepressants, antiallergic Chinese herbal medicines, immunosuppressants, immunomodulators and immunotherapy 15. Subjects with serious organic diseases such as heart, lung, liver, kidney 16. Subjects with poor compliance, such as poor medication compliance, inability to fill in diary cards correctly, and use of prohibited medications 17. Who combined with nerve and mental illness that could not or unwilling to follow the study, and with disabilities as prescribed by law (blind, deaf, mute, mentally disabled, mentally disabled, etc.) 18. Who plan to travel to other regions in which there is no allegic pollen during the study period for more than two consecutive days or three accumulated days 19. Pregnant or lactating women and women who
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TNSS;Examination of the injection site; | — |
Secondary
| Measure | Time frame |
|---|---|
| TOSS;RQLQ; | — |
Countries
China
Contacts
Public ContactXueyan Wang
Beijing Shijitan Hospital
Outcome results
None listed