Birch Pollen Allergy
Conditions
Brief 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.
Detailed description
The study will be carried out in two study sites located in Canada
Interventions
BIOLOGICALDM-101PX
subcutaneous injection of DM-101PX
BIOLOGICALPlacebo
Placebo to match DM-101PX administered subcutaneously
Sponsors
Desentum Oy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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 treatment. * Current diagnosis of uncontrolled, partially controlled or persistent asthma requiring regular (\> 6 weeks per year) maintenance use of inhaled corticosteroids. History of severe asthma during the pollen season. History of asthma deterioration that resulted in emergency treatment or hospitalization in the 12 months before screening, or a life-threatening asthma attack at any time in the past. * Forced Expiratory Volume in one second (FEV1) \< 75% of predicted. History of severe drug allergy, severe angioedema or systemic allergic reaction of Grade 3 or greater, according to the World Allergy Organization (WAO) scale, due to any cause. * History of intolerance to the Investigational Product, rescue medications used for systemic allergic reactions (i.e., adrenaline, antihistamine, glucocorticoids, and beta-2 agonists such as salbutamol), or their excipients. * History of acute hypersensitivity and/or anaphylaxis to protein therapeutics or components of formulation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Nasal Symptom Score (TNSS) after treatment | From baseline to 3 weeks after the last dose | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events (AEs) | from the start of treatment to 3 weeks after the last dose | Incidence and characteristics of AEs from the start of treatment to the post-treatment NAC visit. |
| Laboratory safety evaluations | from the start of treatment to 3 weeks after the last dose | Number and percentage of participants with new onsets of clinically significant abnormalities (as assessed by the investigator) in laboratory safety evaluations |
| Vital signs | From the start of treatment to 3 weeks after the last dose | Number and percentage of participants with new onsets of clinically significant abnormalities (as assessed by the investigator) in vital signs |
| Adverse Events of Special Interest (AESIs) | From the start of treatment to 3 weeks after the last dose | Incidence and characteristics AESIs: local injection site reactions and systemic allergic reactions |
| Change in TNSS after follow-up period | from baseline to 20-30 weeks after the last dose | Change in AUC for TNSS from baseline to follow-up visit. |
| Change in Total Symptom Score (TSS) | From baseline to 1) 3 weeks, 2) 20-30 weeks after the last dose | Change in AUC for TSS from baseline to 1) post-treatment, 2) follow-up visit |
| Change in Peak Nasal Inspiratory Flow (PNIF) | from baseline to 1) 3 weeks, 2) 20-30 weeks after the last dose | Change in AUC for PNIF from baseline to 1) post-treatment visit, 2) follow-up visit |
| Change in blood allergy biomarker levels | From baseline to the 7th injection, the 10th injection, 3 weeks after the last dose, and 20-30 weeks after the last dose. | 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. |
Countries
Canada
Contacts
STUDY_DIRECTORDirk-Jan Opstelten, PhD
Desentum Oy
Outcome results
None listed