Birch Pollen Allergy
Conditions
Brief summary
Randomized, double-blind placebo-controlled phase I trial with the primary aim to investigate safety and tolerability of three ascending dosing schemes of DM-101-PX in birch pollen allergic adults. As an explorative objective, the trial will also investigate the effect of DM-101PX on the allergic symptoms following birch pollen allergen exposure in a chamber. Expanded access to the study treatment is not available.
Detailed description
The study will be carried out in a single study site located in Canada
Interventions
BIOLOGICALDM-101PX
subcutaneous injection of DM-101PX
BIOLOGICALPlacebo to Match DM-101PX
Placebo to match DM-101PX administered subcutaneously
Sponsors
Desentum Oy
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
Double (Participant, Investigator)
Intervention model description
3 sequential dose cohorts with ascending DM-101PX doses. In each cohort two treatment arms: placebo and active drug
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Either sex or any race, aged 18 to 65 years * Good general health * A documented clinical history of moderate to severe 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 birch pollen seasons * Birch pollen specific IgE ≥ 0.7 kU/L * Positive SPT to birch pollen allergen, with wheal diameter ≥ 3 mm * Body weight ≥ 50 kg and body mass index within the range of 18-35 kg/m2
Exclusion criteria
* History or findings on physical examination of any significant disease or disorder which, in the opinion of the Investigator, could put the subject at risk because of participation in the trial, influence the results of the trial or subject's ability to participate in the trial * Current diagnosis of persistent asthma, or moderate to severe asthma requiring GINA Step 2 or higher treatment, or asthma partially controlled or uncontrolled according to GINA classification in the 6 months before screening * Significant rhinitis, sinusitis, significant and/or severe allergies not associated with the birch pollen season * History of asthma deterioration that resulted in emergency treatment or hospitalization in the past 12 months before screening, or a life-threatening asthma attack at any time in the past * A Forced Expiratory Volume in one second (FEV1) ≤ 75% of predicted value * History of severe drug allergy, severe angioedema, or systemic allergic reaction of Grade 3 or grater, according to World Allergy Organization (WAO) scale, due to any cause
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Emergent Adverse Events | From the first dose to until 14-28 days from the last dose | Occurrence of treatment emergent adverse events |
| Adverse Events of Special Interest | From the first dose to until 14-28 days from the last dose | Occurrence of local injection site reactions and systemic allergic reactions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjects Reaching the Maximum Intended Dose | Through the treatment period, an average of 10 weeks | Number of subjects in each cohort who reach the maximum intended dose |
Countries
Canada
Outcome results
None listed