A Two-part Adaptive Double-blind Randomized Placebo-controlled Study to Assess the Appropriate Dose and the Appropriate Dosing Frequency of ALDP 001 in Adults With Seasonal Allergic Rhinitis (SAR) Assessed Using an Allergen Challenge Chamber/EEC (ALDP001)

NCT07219849 Phase 2 RECRUITING

This study aims to evaluate the effectiveness and safety of ALDP001 Nasal Spray in treating seasonal allergic rhinitis, and to identify the optimal dosage and administration frequency for this formulation.

Details

Lead sponsor	Alixer Nexgen Therapeutics Limited
Phase	Phase 2
Status	RECRUITING
Enrolment	164
Start date	2025-10-17
Completion	2026-04

Conditions

• Seasonal Allergic Rhinitis (SAR)

Interventions

• ALDP001 Nasal Spray
• Placebo Nasal spray

Primary outcomes

• Change from Baseline in Total Nasal Symptom Score — Day 9
  Total Nasal Symptom Score (TNSS) is calculated by summing scores from four nasal symptoms: itchy nose, nasal congestion, runny nose, and sneezing. Each symptom is rated on a scale from 0 to 3, where: 0 - None (no symptoms) 1. \- Mild (minimal awareness, easily tolerated) 2. \- Moderate (noticeable and bothersome, but tolerable) 3. \- Severe (difficult to tolerate, interferes with daily activities or sleep) The total score ranges from 0 to 12. Participants will record TNSS at multiple timepoints: 0, 30, 60, 90, 120, 180, and 240 minutes, both at baseline and after 8 days of treatment. The change from baseline (CFB) at each timepoint will be calculated and compared between study arms to evaluate the treatment effect of ALDP001 Nasal Spray.

Countries

Canada