NCT07291284
Active, not recruiting
Phase 3
A 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
Longbio Pharma1 site in 1 country546 target enrollmentStarted: August 1, 2024Last updated:
Overview
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Longbio Pharma
- Enrollment
- 546
- Locations
- 1
- Primary Endpoint
- Mean daily reflective total nasal symptom score (rTNSS) during the pollen peak period (PPP)
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Received systemic glucocorticoids within 4 weeks prior to screening
- •Received intranasal glucocorticoids, mast cell membrane stabilizers, tricyclic antidepressants, leukotriene receptor antagonists, or antihistamine medications within 1 week prior to randomization
Arms & Interventions
Experimental: LP-003
Experimental
Participants received subcutaneous of LP-003 Injection at a dose of 100 mg once every 4 weeks.
Intervention: LP-003 (Biological)
Placebo Comparator：Placebo
Placebo Comparator
Participants received subcutaneous of Placebo Injection once every 4 weeks.
Intervention: Placebo (Biological)
Outcomes
Primary Outcomes
Mean daily reflective total nasal symptom score (rTNSS) during the pollen peak period (PPP)
Time Frame: Up to 4 Months
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.
Secondary Outcomes
- Mean daily rTNSS during the pollen period (PP)(Up to 4 Months)
- Mean daily total ocular symptom score (TOSS) during the PPP(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(Up to 4 Months)
- Mean daily rTNSS combined with rescue medication score (DNSMS) during the PPP(Up to 4 Months)
- Mean daily TOSS combined with rescue medication score (DNOMS) during the PPP(Up to 4 Months)
- Mean daily rescue medication score (RMS) during the PPP(Up to 4 Months)
- Incidence of adverse events (AEs)(Up to Week 28)
Investigators
Study Sites (1)
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