Clinical trial NCT06037148: Study to Evaluate Safety, Tolerability and Explorative Efficacy of DM-101PX in Birch Pollen Allergic Participants
Official title: A Phase I Dose Escalation Trial to Investigate the Safety, Tolerability, and Explorative Efficacy, Following Environmental Allergen Exposure in a Chamber, of DM-101PX in Participants With Birch Pollen Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Birch Pollen Allergy
Lead sponsor: Desentum Oy
Sponsor class: INDUSTRY
First posted: 2023-09-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 3 sequential dose cohorts with ascending DM-101PX doses. In each cohort two treatment arms: placebo and active drug
Primary purpose: OTHER

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

Eligibility criteria: 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

Primary outcomes:
measure: Treatment Emergent Adverse Events
timeFrame: From the first dose to until 14-28 days from the last dose
measure: Adverse Events of Special Interest
timeFrame: From the first dose to until 14-28 days from the last dose
Secondary outcomes:
measure: Subjects Reaching the Maximum Intended Dose
timeFrame: Through the treatment period, an average of 10 weeks
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Cliantha Research
state: Ontario
Study officials:
affiliation: Desentum Oy
name: Anna Nilson
role: STUDY_DIRECTOR
affiliation: Cliantha Research
name: Patricia Couroux
role: PRINCIPAL_INVESTIGATOR
References: