Study to Evaluate the Efficacy and Safety of DW1807 in Perennial Allergic Rhinitis Patients With Asthma

NCT07168473 | Recruiting Phase 3

• 1 other identifier: DW1807-301
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the efficacy and safety of DW1807 and DW1807-R2 in patients with perennial allergic rhinitis and comorbid asthma. The primary objective is to demonstrate the superiority of DW1807 over DW1807-R2 in improving the reflective total nasal symptom score (rTNSS) after 4 weeks of treatment.

Conditions

Perennial Allergic Rhinitis Accompanied by Asthma

Outcome Measures

Primary Outcomes (1)

• The mean change in reflective Total Nasal Symptom Score (rTNSS)

  During the last 2 weeks of the treatment period (i.e., Weeks 3 to 4 of investigational product administration

Secondary Outcomes (7)

• The mean change from baseline in reflective Total Nasal Symptom Score (rTNSS)

  During the first two weeks of the treatment period (Weeks 1 through 2 of investigational product administration).

• The mean change from baseline in instantaneous Total Nasal Symptom Score (iTNSS)

  During both the first two weeks (Weeks 1 through 2) and the final two weeks (Weeks 3 through 4) of the treatment period.

• The mean change from baseline in Daytime Nasal Symptom Score (DNSS)

  During both the first two weeks (Weeks 1 through 2) and the final two weeks (Weeks 3 through 4) of the treatment period.

• The mean change from baseline in Nighttime Nasal Symptom Score (NNSS)

  During both the first two weeks (Weeks 1 through 2) and the final two weeks (Weeks 3 through 4) of the treatment period.

• The mean change from baseline in Nighttime Symptom Score (NSS)

  During both the first two weeks (Weeks 1 through 2) and the final two weeks (Weeks 3 through 4) of the treatment period.

Study Arms (2)

Experimental

EXPERIMENTAL

DW1807 \& DW1807-R2 placebo

Drug: Experimental

Comparator

ACTIVE COMPARATOR

DW1807 placebo \& DW1807-R2

Drug: Comparator

Interventions

Experimental DRUG

1. DW1807 Once daily with water regardless of meals without chewing or crushing for up to 4 weeks 2. DW1807-R2 placebo Once daily with water regardless of meals without chewing or crushing for up to 4 weeks

Experimental

Comparator DRUG

1. DW1807 placebo Once daily with water regardless of meals without chewing or crushing for up to 4 weeks 2. DW1807-R2 Once daily with water regardless of meals without chewing or crushing for up to 4 weeks

Comparator

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \<Screening Visit\>
• Male or female adults aged 19 years or older.
• Individuals with a confirmed history or treatment record of perennial allergic rhinitis for at least 2 years at the time of screening.
• Individuals who have a positive result on an allergy skin prick test or serum allergen-specific IgE antibody test (e.g., MAST or ImmunoCAP) conducted within 1 year prior to screening, and have a documented history of allergy to at least one perennial allergen (e.g., house dust mites, cats, dogs, molds, etc.).
• Individuals diagnosed with asthma classified as Step 2 to Step 4.
• Individuals who voluntarily provide written informed consent to participate in this clinical trial.
• \<Randomization Visit\>
• Subjects who meet all of the following criteria based on self-assessed nasal symptom scores recorded in the subject diary during the 7-day run-in period.
• ① Performed nasal symptom evaluations twice daily (morning and evening) on at least 4 days during the run-in period.
• ② Had an average daily Reflective Total Nasal Symptom Score (rTNSS) of ≥6 (maximum score: 12).
• Subjects with medication compliance of ≥80% during the 7-day run-in period.

You may not qualify if:

• Individuals diagnosed with non-allergic rhinitis of other causes.
• Individuals with a documented acute exacerbation of asthma within 12 weeks prior to screening.
• Individuals diagnosed with pulmonary diseases other than asthma.
• Individuals diagnosed with the following types of sinusitis:
• ① Acute sinusitis within 4 weeks prior to screening.
• ② Clinically significant chronic sinusitis, as determined by the investigator.
• Individuals with nasal polyps or other clinically significant nasal structural abnormalities.
• Individuals who have undergone nasal or perinasal surgery within 12 weeks prior to screening.
• Individuals with a documented upper respiratory tract infection (including the common cold) or systemic infection within 3 weeks prior to screening.
• \<B. Concomitant Medication Use\>
• Subjects who have initiated immunotherapy or changed the dosage within 4 weeks prior to the screening visit.
• Subjects who are on chronic use of medications that, in the opinion of the investigator, may interfere with the assessment of the investigational product's efficacy (e.g., tricyclic antidepressants).
• Subjects who are currently taking, or are expected to require during the study, any medications that are prohibited as per the protocol.
• \<C. Laboratory Criteria\>
• Subjects with serum AST (GOT) or ALT (GPT) levels \> 2 × the upper limit of normal (ULN) based on screening test results.

Sponsors & Collaborators

• Daewon Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Konkuk University Medical Center

Seoul, South Korea

RECRUITING

Central Study Contacts

Jong-in Son

CONTACT

+82-2-2204-7053; jonginson112@daewonpharm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 11, 2025
• Study Start: September 9, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 18, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)