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.
The study will be carried out in two study sites located in Canada
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Cliantha Research
Mississauga, Ontario, Canada
Change in Total Nasal Symptom Score (TNSS) after treatment
Change in AUC for TNSS from baseline to post-treatment visit. TNSS is a symptom score consisting of 4 nasal symptoms, each symptom is rated as follows: 0 (none), 1 (mild), 2 (moderate), 3 (severe). TNSS score can very between 0-12.
Time frame: From baseline to 3 weeks after the last dose
Adverse events (AEs)
Incidence and characteristics of AEs from the start of treatment to the post-treatment NAC visit.
Time frame: from the start of treatment to 3 weeks after the last dose
Laboratory safety evaluations
Number and percentage of participants with new onsets of clinically significant abnormalities (as assessed by the investigator) in laboratory safety evaluations
Time frame: from the start of treatment to 3 weeks after the last dose
Vital signs
Number and percentage of participants with new onsets of clinically significant abnormalities (as assessed by the investigator) in vital signs
Time frame: From the start of treatment to 3 weeks after the last dose
Adverse Events of Special Interest (AESIs)
Incidence and characteristics AESIs: local injection site reactions and systemic allergic reactions
Time frame: From the start of treatment to 3 weeks after the last dose
Change in TNSS after follow-up period
Change in AUC for TNSS from baseline to follow-up visit.
Time frame: from baseline to 20-30 weeks after the last dose
Change in Total Symptom Score (TSS)
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Change in AUC for TSS from baseline to 1) post-treatment, 2) follow-up visit
Time frame: From baseline to 1) 3 weeks, 2) 20-30 weeks after the last dose
Change in Peak Nasal Inspiratory Flow (PNIF)
Change in AUC for PNIF from baseline to 1) post-treatment visit, 2) follow-up visit
Time frame: from baseline to 1) 3 weeks, 2) 20-30 weeks after the last dose
Change in blood allergy biomarker levels
Change from baseline to the 7th injection, the 10th injection, post-treatment and follow-up visit in the levels of Bet v 1-specific IgE, IgG1 and IgG4.
Time frame: From baseline to the 7th injection, the 10th injection, 3 weeks after the last dose, and 20-30 weeks after the last dose.