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

Phase 1

Completed

• Conditions: Birch Pollen Allergy
• Interventions: Biological: Placebo to Match DM-101PX; Biological: DM-101PX

• Registration Number: NCT06037148
• Lead Sponsor: Desentum Oy

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

Study Timeline

• Study First Submitted: 2023-09-06
• Study Start: 2023-09-07
• Study First Submitted QC: 2023-09-13
• Study First Posted: 2023-09-14
• Status Verified: 2024-03
• Primary Completion: 2024-03-06
• Study Completion: 2024-03-06
• Last Update Submitted: 2024-03-22
• Last Update Posted: 2024-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo to Match DM-101PX	10 subcutaneous doses.First 9 doses are administered at 1 week interval, and the 10th dose is administered 2 weeks after the 9th dose.
DM-101PX low dose	DM-101PX	10 subcutaneous doses starting from 0.05 ug of which first 8 doses are ascending. Thereafter the 8th dose is repeated twice. First 9 doses are administered at 1 week interval, and the 10th dose is administered 2 weeks after the 9th dose.
DM-101PX middle dose	DM-101PX	10 subcutaneous doses starting from 0.1 ug of which first 8 doses are ascending. Thereafter the 8th dose is repeated twice. First 9 doses are administered at 1 week interval, and the 10th dose is administered 2 weeks after the 9th dose.
DM-101PX high dose	DM-101PX	10 subcutaneous doses starting from 0.2 ug of which first 8 doses are ascending. Thereafter the 8th dose is repeated twice. First 9 doses are administered at 1 week interval, and the 10th dose is administered 2 weeks after the 9th dose.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cliantha Research; 🇨🇦 Mississauga, Ontario, Canada