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DM-101PX for Birch Pollen Allergy

Phase 1
Waitlist Available
Led By Patricia Couroux
Research Sponsored by Desentum Oy
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body weight ≥ 50 kg and body mass index within the range of 18-35 kg/m2
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the first dose to until 14-28 days from the last dose
Awards & highlights

Study Summary

This trial will test a new drug to see if it's safe & tolerable for birch pollen allergies in adults. It'll also explore its effects on symptoms. No access to the study drug yet.

Who is the study for?
Adults aged 18-65 with moderate to severe birch pollen-induced allergic rhinitis or rhinoconjunctivitis, who've suffered for at least two previous seasons despite medication. Must be in good health, have a body weight ≥50 kg and BMI of 18-35 kg/m2. Not suitable for those with persistent or severe asthma, significant non-birch allergies, or history of severe drug allergy.Check my eligibility
What is being tested?
The trial is testing DM-101PX against a placebo in adults allergic to birch pollen. It's randomized and double-blind, meaning neither the participants nor the researchers know who gets the real treatment versus placebo. The goal is to check safety and how well it works on allergy symptoms after exposure.See study design
What are the potential side effects?
While specific side effects are not listed here, typical reactions may include irritation at the injection site, headache, fatigue or flu-like symptoms following administration of allergen immunotherapies like DM-101PX.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I weigh at least 50 kg and my BMI is between 18-35.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the first dose to until 14-28 days from the last dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the first dose to until 14-28 days from the last dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events of Special Interest
Treatment Emergent Adverse Events
Secondary outcome measures
Subjects Reaching the Maximum Intended Dose

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: DM-101PX middle doseExperimental Treatment1 Intervention
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.
Group II: DM-101PX low doseExperimental Treatment1 Intervention
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.
Group III: DM-101PX high doseExperimental Treatment1 Intervention
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.
Group IV: PlaceboPlacebo Group1 Intervention
10 subcutaneous doses.First 9 doses are administered at 1 week interval, and the 10th dose is administered 2 weeks after the 9th dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DM-101PX
2023
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Desentum OyLead Sponsor
1 Previous Clinical Trials
27 Total Patients Enrolled
1 Trials studying Birch Pollen Allergy
27 Patients Enrolled for Birch Pollen Allergy
Anna NilsonStudy DirectorDesentum Oy
1 Previous Clinical Trials
27 Total Patients Enrolled
1 Trials studying Birch Pollen Allergy
27 Patients Enrolled for Birch Pollen Allergy
Patricia CourouxPrincipal InvestigatorCliantha Research
~18 spots leftby Jun 2025
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