Study to Evaluate Safety, Tolerability and Explorative Efficacy of DM-101PX in Birch Pollen Allergic Participants

Birch Pollen Allergy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06037148
• Other study ID #: DM-101-C-002
• Status: Completed
• Phase: Phase 1
• Start date: September 7, 2023
• Est. completion date: March 6, 2024

Study information

• Verified date: March 2024
• Source: Desentum Oy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The study will be carried out in a single study site located in Canada

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 6, 2024
• Est. primary completion date: March 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Birch Pollen Allergy
• Hypersensitivity
• Rhinitis, Allergic, Seasonal

Intervention

Biological:
• DM-101PX
subcutaneous injection of DM-101PX
• Placebo to Match DM-101PX
Placebo to match DM-101PX administered subcutaneously

Locations

Country	Name	City	State
Canada	Cliantha Research	Mississauga	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Desentum Oy

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Emergent Adverse Events	Occurrence of treatment emergent adverse events	From the first dose to until 14-28 days from the last dose
Primary	Adverse Events of Special Interest	Occurrence of local injection site reactions and systemic allergic reactions	From the first dose to until 14-28 days from the last dose
Secondary	Subjects Reaching the Maximum Intended Dose	Number of subjects in each cohort who reach the maximum intended dose	Through the treatment period, an average of 10 weeks