Safety and tolerability of DM-101PX in birch pollen allergy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1, randomized, double-blind, placebo-controlled study investigates the safety and tolerability of DM-101PX in adults with moderate to severe birch pollen-induced allergic rhinitis or rhinoconjunctivitis. The trial also looks at how many participants receive the full planned DM-101PX dose and whether the treatment affects blood allergy biomarkers compared with placebo. It is conducted at a single site in Germany and expanded access is not available. Participants will undergo screening to confirm eligibility, including specific IgE and skin test criteria, and will be monitored for adverse events and pharmacodynamic signals. The study aims to establish initial safety, dosing feasibility, and biological effects to inform future development.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female, aged 18 to 65 years
* Good general health
* A documented clinical history of moderate to severe birch pollen-induced allergic rhinitis or rhinoconjunctivitis for at least 2 years with symptoms that interfere with daily activities or sleep
* Bet v 1-specific IgE ≥0.7 kU/L (class 2) measured by ImmunoCAP® performed at the trial site at Screening or within 12 months prior to Screening
* Positive SPT to Birch pollen whole allergen extract with a wheal diameter ≥3 mm (average of longest and orthogonal), with the negative control wheal diameter \<2 mm and the positive (histamine) control wheal diameter ≥3 mm, performed at the trial site at Screening or within 12 months prior to Screening
* Body weight ≥50 kg and body mass index within the range 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, may put the individual at risk because of participation in the trial, influence the results of the trial or the participant's ability to participate in the trial
* Significant rhinitis, sinusitis, and/or symptomatic respiratory allergy due to regular contact with allergens other than birch pollen that are expected to potentially interfere with the trial assessments, as assessed by the investigator
* Persistent asthma that requires GINA Step 2 or higher treatment during the trial period, or required treatment within 4 weeks prior to Screening
* History of uncontrolled asthma according to GINA classification in the 6 months prior to Screening or history of asthma deterioration that resulted in emergency treatment or hospitalization in the 12 months before Screening, or a life-threatening asthma attack (eg, one requiring intubation and mechanical ventilation) at any time in the past
* Forced Expiratory Volume in one second (FEV1) \<70 % of predicted, regardless of asthma status at Screening
* History of severe drug allergy, severe angioedema, or systemic allergic reaction of Grade 3 or greater, according to the WAO classification (2024, see Section 12.5), due to any cause
* History of acute hypersensitivity and/or anaphylaxis to protein therapeutics or components of formulation, including polyethylene glycol, or severe or significant allergies that in the opinion of the investigator could represent a substantial risk to the individual

Where it's running

• Fraunhofer Institute for Toxicology and Experimental Medicine ITEM
  Hanover, Germany Recruiting

Study contacts

• Principal investigator: Philipp Badorrek, MD — Fraunhofer Institute for Toxicology and Experimental Medicine ITEM
• Study coordinator: Birgitta Kalvi
• Email: birgitta.kalvi@desentum.fi
• Phone: +358453199009

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.