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Pumecitinib in moderate to severe seasonal allergic rhinitis
NCT06837233Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2025
- Primary completion
- May 2025
- Countries
- 1
- Sponsor
- Prime Gene Therapeutics
- Modality
- Small Molecules
- Drugs
- pumecitinib
- Conditions
- seasonal allergic rhinitis (SAR)
01
Overview
Phase 2, randomised, double-blind trial of pumecitinib in seasonal allergic rhinitis (SAR) (4 arms), sponsored by Prime Gene Therapeutics. Primary endpoint: Retrospective Total Nasal Symptom Score at 14 days. Started Mar 2025; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
PG-011 nasal spray 0.3% (twice daily)
2 sprays in each nostril, twice daily for 14-day treatment period.
PG-011 nasal spray 0.6% (once daily)
2 sprays in each nostril, once daily for 14-day treatment period.
PG-011 nasal spray 0.6% (twice daily)
2 sprays in each nostril, twice daily for 14-day treatment period.
Vehicle nasal spray (twice daily)
2 sprays in each nostril, twice daily for 14-day treatment period.
03
Who it enrols
Adults aged 18-65 with moderate to severe seasonal allergic rhinitis for at least 2 years, positive allergen test, and specific symptom severity scores. Excludes patients with asthma, active infections, recent nasal surgery, or specific viral infections (HIV, HBV, HCV).
04
Endpoints
Primary
Retrospective Total Nasal Symptom Score
Secondary
Retrospective Total Nasal Symptom Score
Instantaneous Total Nasal Symptom Score
Retrospective Ocular Symptom Total Score
Instantaneous Ocular Symptom Score
Rhinoconjunctivitis Quality of Life Questionnaire
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