A Study to Determine the Optimal Dose and Frequency of ALDP001 Nasal Spray in Adults With Seasonal Allergic Rhinitis Under Allergen Exposure

NCT07219849 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ALK45-ALDP001/ C2D05456
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Seasonal Allergic Rhinitis (SAR)

Keywords

ALDP001 Nasal Spray

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Total Nasal Symptom Score

  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.

  Day 9

Secondary Outcomes (1)

• Change from baseline in the Area Under the Curve of the Total Nasal Symptom Score at Day 9

  Day 9

Other Outcomes (1)

• Number of participants with Adverse events (AEs), with abnormal Clinical Laboratory Parameters, abnormal ECG readings

  From enrollment to End of Study i.e. 10 days

Study Arms (4)

ALDP001 0.125% w/v

EXPERIMENTAL

Participants will self-administer one spray in each nostril, either once or twice daily, using the assigned nasal spray kit for a duration of eight days

Drug: ALDP001 Nasal Spray

ALDP001 (0.25% w/v)

EXPERIMENTAL

Participants will self-administer one spray in each nostril, either once or twice daily, using the assigned nasal spray kit for a duration of eight days

Drug: ALDP001 Nasal Spray

ALDP001 (0.5% w/v) Nasal Spray

EXPERIMENTAL

Participants will self-administer one spray in each nostril, either once or twice daily, using the assigned nasal spray kit for a duration of eight days

Drug: ALDP001 Nasal Spray

Placebo Nasal Spray

PLACEBO COMPARATOR

Participants will self-administer one spray in each nostril, either once or twice daily, using the assigned nasal spray kit for a duration of eight days

Drug: Placebo Nasal spray

Interventions

ALDP001 Nasal Spray DRUG

Experimental Arm

ALDP001 (0.25% w/v); ALDP001 (0.5% w/v) Nasal Spray; ALDP001 0.125% w/v

Placebo Nasal spray DRUG

Controlled arm

Placebo Nasal Spray

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Allergic Rhinitis (AR), as determined by the presence of seasonal rhinitis symptoms for several months per year, for more than 1 year and are not attributed to infections or nasal abnormalities
• Positive skin prick test (SPT) response to ragweed pollen (allergen induced wheal diameter at least 3 mm larger than the negative control) in the previous 12 months
• Healthy as determined by a responsible and experienced Investigator, based on a medical evaluation including medical history, physical examination, vital signs, ECG, and lab tests.

You may not qualify if:

• Nasal abnormalities likely to affect the outcome of the study, i.e. nasal septal perforation, nasal polyps, sinusitis and other nasal malformations.
• History of frequent nosebleeds.
• Participants with rhinitis medicamentosa.
• Current or chronic history of hepatic disease.
• A QTcF (Fridericia-corrected QT interval) \>450 ms in males or \>470 ms in females.

Sponsors & Collaborators

• Alixer Nexgen Therapeutics Limited: lead

Study Sites (1)

Cliantha Research

Mississauga, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Patricia Couroux, MD

  Cliantha Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Akhilesh Sharma

CONTACT

+912239829999; akhilesh.sharma@alkem.com

Yogesh Rane

CONTACT

+919820587254; yogesh.rane@alkem.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind pharmacy controlled randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2025
• First Posted: October 22, 2025
• Study Start: October 17, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)