Efficacy and Safety of LP-003 Injection in Patients With Moderate to Severe Seasonal Allergic Rhi… (NCT07291284) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Efficacy and Safety of LP-003 Injection in Patients With Moderate to Severe Seasonal Allergic Rhinitis
China546 participantsStarted 2024-08-01
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female, aged 18 to 65 years
* Subjects with SAR for at least 2 years
* At least one serum-specific IgE test for an allergen associated with the onset of allergic rhinitis during the current season or the same period
* Subjects who did not achieve satisfactory efficacy from Standard-of-Care prior to screening
* Subjects who experienced nasal symptoms for ≥ 2 days, or nasal and ocular symptoms for ≥ 1 day; with rTNSS ≥ 1 prior to randomization
Exclusion Criteria:
* Combined with non-allergic rhinitis, such as drug-induced rhinitis, vasomotor rhinitis, non-allergic rhinitis with eosinophilia syndrome, a history of acute or chronic sinusitis
* Subjects with perennial allergic rhinitis (PAR)
* Underwent any nasal or sinus surgery within 1 year prior to screening
* Presence of glaucoma, cataract, ocular herpes simplex, infectious conjunctivitis, or other ocular infections
* Clinically significant conditions upon the judgement of investigator
* Subjects with concomitant asthma who, upon the judgement of investigator, require inhaled corticosteroid treatment during the study
* The laboratory results at screening: a) white blood cell (WBC) \< 2.5×10\^9/L; b) aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.0 ×upper limit of normal (ULN) or total bilirubin \> 1.5 ×ULN; c) Serum creatinine (Cr) \> 1.5 × ULN
* Received treatment with similar drugs (e.g., Omalizumab) or used LP-003 Injection within 6 months prior to screening
* Recei…
What they're measuring
1
Mean daily reflective total nasal symptom score (rTNSS) during the pollen peak period (PPP)