Study of DM-101PX in Adults With Birch Pollen Allergy (NCT07254871) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study of DM-101PX in Adults With Birch Pollen Allergy
Canada100 participantsStarted 2025-09-26
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* History or findings on physical examination at screening visit of any significant disease or disorder which, in the opinion of the Investigator, could put the participant at risk because of participation in the study, influence the results of the study or the participant's ability to participate in the study.
* History of significant rhinitis, sinusitis, and/or presence of significant symptoms of respiratory allergy due to regular contact with other allergens, not associated with the birch pollen season, that are expected to coincide or potentially interfere with the study allergen challenge assessments, as assessed by the Investigator.
* History of nasal polyps or other nasal oropharyngeal conditions that in the judgement of the Investigator may interfere with study outcome assessments.
* History of chronic obstructive pulmonary disease requiring regular treatm…
What they're measuring
1
Change in Total Nasal Symptom Score (TNSS) after treatment
Timeframe: From baseline to 3 weeks after the last dose