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

NCT07254871 | Active Not Recruiting Phase 2

• 1 other identifier: DM-101-C-004
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Birch Pollen Allergy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Adverse events (AEs)

  from the start of treatment to 3 weeks after the last dose

• Laboratory safety evaluations

  from the start of treatment to 3 weeks after the last dose

• Vital signs

  From the start of treatment to 3 weeks after the last dose

• Adverse Events of Special Interest (AESIs)

  From the start of treatment to 3 weeks after the last dose

• Change in TNSS after follow-up period

  from baseline to 20-30 weeks after the last dose

Study Arms (2)

DM-101PX

EXPERIMENTAL

weekly subcutaneous administration of ascending doses of DM-101PX for 10 weeks

Biological: DM-101PX

Placebo

PLACEBO COMPARATOR

weekly subcutaneous administration of Placebo for 10 weeks

Biological: Placebo

Interventions

DM-101PX BIOLOGICAL

subcutaneous injection of DM-101PX

DM-101PX

Placebo BIOLOGICAL

Placebo to match DM-101PX administered subcutaneously

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Desentum Oy: lead

Study Sites (1)

Cliantha Research

Mississauga, Ontario, ON L4W 1A4, Canada

Location

Study Officials

• Dirk-Jan Opstelten, PhD

  Desentum Oy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: November 28, 2025
• Study Start: September 26, 2025
• Primary Completion: April 15, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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.

Locations

CA (1)