Study of DM-101PX in Adults With Birch Pollen Allergy (BASIT)

A Phase 2, Randomized, Double-Blind, Placebo-controlled Study to Investigate the Safety and Efficacy in Reducing Nasal Allergen Challenge Provoked Symptoms of Treatment With DM-101PX in Adults With Birch Pollen Allergic Rhinitis or Rhinoconjunctivitis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Birch Pollen Allergy
• Intervention / Treatment: Biological: DM-101PX; Biological: Placebo

Detailed Description

The study will be carried out in two study sites located in Canada

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

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: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DM-101PX; weekly subcutaneous administration of ascending doses of DM-101PX for 10 weeks	Biological: DM-101PX; subcutaneous injection of DM-101PX
Placebo Comparator: Placebo; weekly subcutaneous administration of Placebo for 10 weeks	Biological: Placebo; Placebo to match DM-101PX administered subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Total Nasal Symptom Score (TNSS) after treatment	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.	From baseline to 3 weeks after the last dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events (AEs)	Incidence and characteristics of AEs from the start of treatment to the post-treatment NAC visit.	from the start of treatment to 3 weeks after the last dose
Laboratory safety evaluations	Number and percentage of participants with new onsets of clinically significant abnormalities (as assessed by the investigator) in laboratory safety evaluations	from the start of treatment to 3 weeks after the last dose
Vital signs	Number and percentage of participants with new onsets of clinically significant abnormalities (as assessed by the investigator) in vital signs	From the start of treatment to 3 weeks after the last dose
Adverse Events of Special Interest (AESIs)	Incidence and characteristics AESIs: local injection site reactions and systemic allergic reactions	From the start of treatment to 3 weeks after the last dose
Change in TNSS after follow-up period	Change in AUC for TNSS from baseline to follow-up visit.	from baseline to 20-30 weeks after the last dose
Change in Total Symptom Score (TSS)	Change in AUC for TSS from baseline to 1) post-treatment, 2) follow-up visit	From baseline to 1) 3 weeks, 2) 20-30 weeks after the last dose
Change in Peak Nasal Inspiratory Flow (PNIF)	Change in AUC for PNIF from baseline to 1) post-treatment visit, 2) follow-up visit	from baseline to 1) 3 weeks, 2) 20-30 weeks after the last dose
Change in blood allergy biomarker levels	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.	From baseline to the 7th injection, the 10th injection, 3 weeks after the last dose, and 20-30 weeks after the last dose.

Collaborators and Investigators

• Sponsor: Desentum Oy
• Investigators: Study Director: Dirk-Jan Opstelten, PhD, Desentum Oy

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2025
• Primary Completion (Actual): April 15, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: September 23, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Actual): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: DM-101-C-004

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

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 reidentification.

• IPD Sharing Time Frame: Anonymized participant data will be considered for sharing once the product and 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 reidentification.
• 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