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This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of LP-003 injection in patients with moderate to severe seasonal allergic rhinitis inadequately controlled by standard-of-care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: LP-003 | Experimental | Participants received subcutaneous of LP-003 Injection at a dose of 100 mg once every 4 weeks. |
|
| Placebo Comparator:Placebo | Placebo Comparator | Participants received subcutaneous of Placebo Injection once every 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LP-003 | Biological | Participants were administered LP-003 via subcutaneous injection every 4 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean daily reflective total nasal symptom score (rTNSS) during the pollen peak period (PPP) | The rTNSS is a patient self-reported questionnaire of four nasal symptoms: nasal itching, nasal congestion, sneezing and rhinorrhea. Patients will report their symptoms reflected or felt over the last 12 hours. Each symptom is scored on a 0-3 scale (0 = no symptoms, 1 = mild, 2 = moderate, 3 = severe). The total score is the sum of the four items, ranging from 0 to 12, with higher scores indicating greater symptom severity. | Up to 4 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean daily rTNSS during the pollen period (PP) | Up to 4 Months | |
| Mean daily instantaneous total nasal symptom score (iTNSS) during the PPP | Up to 4 Months | |
| Mean daily iTNSS during the PP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xueyan Wang | Beijing Shijitan Hospital, Capital Medical University (the formerly Beijing Railway General Hospital) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Shijitan Hospital, Capital Medical University (the formerly Beijing Railway General Hospital) | Beijing | China |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| Placebo | Biological | Participants were administered Placebo via subcutaneous injection every 4 weeks |
|
| Up to 4 Months |
| Mean daily rTNSS combined with rescue medication score (DNSMS) during the PPP | Integrates daily rTNSS (4 nasal symptoms, 0-3 each, total 0-12) and rescue medication score (0 for no rescue use and 1 for rescue use). | Up to 4 Months |
| Mean daily total ocular symptom score (TOSS) during the PPP | It is derived from 2 individual ocular symptoms (itching/burning/redness, and tearing/watering), and each symptom is scored on a 0-3 scale. The daily TOSS is the sum of the two items, ranging from 0 (no symptoms) to 6 (maximum severity) per day. | Up to 4 Months |
| Mean daily TOSS combined with rescue medication score (DNOMS) during the PPP | Integrates daily TOSS (2 individual ocular symptoms, 0-3 each, total 0-6) and rescue medication score (0 for no rescue use and 1 for rescue use). | Up to 4 Months |
| Mean daily rescue medication score (RMS) during the PPP | The RSM is assessed based on the usage of montelukast sodium tablets, with a scoring rule of 0 points for no use and 1 point for use on the day. The mean daily RSM during the PPP is calculated as the sum of the cumulative RSM during the PPP divided by the number of days in the PPP. | Up to 4 Months |
| Incidence of adverse events (AEs) | Up to Week 28 |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |