A Phase 2, Randomized, Double-Blind, Placebo-controlled Study to Investigate the Safety and Efficacy in Reducing Nasal Allergen Challenge Provoked Symptoms of Treatment With DM-101PX in Adults With Birch Pollen Allergic Rhinitis or Rhinoconjunctivitis
Randomized, double-blind placebo-controlled phase 2 trial with the aim to investigate safety and efficacy of DM-101-PX in reducing allergic symptoms provoked by nasal allergen challenge in birch pollen allergic adults. Expanded access to the study treatment is not available.
• Participant of either sex and any race, aged 18 to 65 years inclusive.
• Documented clinical history of birch pollen-induced allergic rhinitis or rhinoconjunctivitis with symptoms that interfere with daily activities or sleep and remain bothersome despite the use of relevant symptomatic medication, and have been present over, at least, 2 previous allergy seasons.
• Bet v 1 specific serum IgE ≥ 0.7 kAU/L.
• Positive Skin Prick Test to birch pollen allergen, with a wheal diameter ≥ 5 mm.
• Body weight ≥ 50 kg and body mass index (BMI) within the range 18-35 kg/m2 inclusive.