DW1807 versus DW1807-R2 for adults with perennial allergic rhinitis and asthma
Official title: A Randomized, Double-blind, Active-controlled, Parallel, Multi-center, Phase 3 Trial to Compare and Evaluate the Efficacy and Safety of DW1807 and DW1807-R2 in Perennial Allergic Rhinitis Patients With Asthma
Run by Daewon Pharmaceutical Co., Ltd. · NCT07168473 · Data updated 2026-11-12
This trial tests whether DW1807 works better than DW1807-R2 to reduce nasal symptoms in adults who have perennial allergic rhinitis and asthma.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 274 (estimated) |
| Sponsor | Daewon Pharmaceutical Co., Ltd. Industry-sponsored |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | September 9, 2024 |
| Main results expected | August 31, 2026 |
| Study ends | September 18, 2026 |
| Registry record updated | September 11, 2025 |
| Trial ID | NCT07168473 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 19 or older with at least two years of perennial allergic rhinitis, a positive allergy skin or specific IgE test, and physician-diagnosed asthma at Step 2–4 are the intended participants.
✕Probably not a fit
People under 19, those without perennial allergen sensitization, or those with asthma outside Step 2–4 or other uncontrolled comorbidities are unlikely to meet eligibility or gain benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 3 randomized interventional study compares DW1807 with DW1807-R2 in adults who have perennial allergic rhinitis and comorbid asthma. Eligible participants must have at least a two-year history of perennial allergic rhinitis, positive allergy testing, and asthma classified as Step 2–4. After a 7-day run-in with twice-daily symptom diaries, participants are randomized to receive either DW1807 or DW1807-R2 and are followed for safety and efficacy, with the primary endpoint being change in reflective total nasal symptom score (rTNSS) after 4 weeks. The trial is sponsored by Daewon Pharmaceutical and conducted at Konkuk University Medical Center in Seoul.
Why it matters
Potential benefit: If successful, DW1807 could provide better nasal symptom relief than DW1807-R2 for people with perennial allergic rhinitis and asthma.
How similar studies have gone: While many allergy treatments have improved symptoms in past trials, DW1807 and its comparator are relatively new and there is limited published Phase 3 evidence for this specific comparison.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \<Screening Visit\> 1. Male or female adults aged 19 years or older. 2. Individuals with a confirmed history or treatment record of perennial allergic rhinitis for at least 2 years at the time of screening. 3. 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.). 4. Individuals diagnosed with asthma classified as Step 2 to Step 4. 5. Individuals who voluntarily provide written informed consent to participate in this clinical trial. \<Randomization Visit\> 1. 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). 2. Subjects with medication compliance of ≥80% during the 7-day run-in period. Exclusion Criteria: \<A. Disease and Medical History-Related Exclusion Criteria\> 1. Individuals diagnosed with non-allergic rhinitis of other causes. 2. Individuals with a documented acute exacerbation of asthma within 12 weeks prior to screening. 3. Individuals diagnosed with pulmonary diseases other than asthma. 4. 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. 5. Individuals with nasal polyps or other clinically significant nasal structural abnormalities. 6. Individuals who have undergone nasal or perinasal surgery within 12 weeks prior to screening. 7. 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\> 1. Subjects who have initiated immunotherapy or changed the dosage within 4 weeks prior to the screening visit. 2. 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). 3. 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\> 1. Subjects with serum AST (GOT) or ALT (GPT) levels \> 2 × the upper limit of normal (ULN) based on screening test results. 2. Subjects with an estimated glomerular filtration rate (eGFR, calculated by CKD-EPI) \< 30 mL/min/1.73 m² based on screening test results.
Where it's running
-
Konkuk University Medical Center
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Jong-in Son
- Email: jonginson112@daewonpharm.com
- Phone: +82-2-2204-7053
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.