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

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

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.

Study Overview

• Status: Completed
• Conditions: Birch Pollen Allergy
• Intervention / Treatment: Biological: DM-101PX; Biological: Placebo to Match DM-101PX

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada, ON L4W 1A4
      • Cliantha Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DM-101PX low dose; 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.	Biological: DM-101PX; subcutaneous injection of DM-101PX
Placebo Comparator: Placebo; 10 subcutaneous doses.First 9 doses are administered at 1 week interval, and the 10th dose is administered 2 weeks after the 9th dose.	Biological: Placebo to Match DM-101PX; Placebo to match DM-101PX administered subcutaneously
Experimental: DM-101PX middle dose; 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.	Biological: DM-101PX; subcutaneous injection of DM-101PX
Experimental: DM-101PX high dose; 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.	Biological: DM-101PX; subcutaneous injection of DM-101PX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Emergent Adverse Events	Occurrence of treatment emergent adverse events	From the first dose to until 14-28 days from the last dose
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Desentum Oy
• Investigators: Study Director: Anna Nilson, Desentum Oy; Principal Investigator: Patricia Couroux, Cliantha Research

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2023
• Primary Completion (Actual): March 6, 2024
• Study Completion (Actual): March 6, 2024

Study Registration Dates

• First Submitted: September 6, 2023
• First Submitted That Met QC Criteria: September 13, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Nose Diseases; Rhinitis, Allergic; Rhinitis; Hypersensitivity; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: DM-101-C-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All individual participant data that underlie publicly available results will be considered for sharing
• IPD Sharing Time Frame: Anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
• IPD Sharing Access Criteria: Qualified researchers may request access to patient level data and related study documents: patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants after Desentum has received marketing authorization from major health authorities (e.g. FDA, EMA), has the legal authority to share the data, and has made the study results publicly available.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No