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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

Must not have

History of severe drug allergy, severe angioedema, or systemic allergic reaction of Grade 3 or greater, according to World Allergy Organization (WAO) scale, due to any cause

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the first dose to until 14-28 days from the last dose

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.

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.

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

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I weigh at least 50 kg and my BMI is between 18-35.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a severe allergic reaction to a drug or other cause.

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I've had severe asthma attacks requiring emergency care in the last year or ever had a life-threatening attack.

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I have asthma that needs more than basic treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the first dose to until 14-28 days from the last dose

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events of Special Interest

Treatment Emergent Adverse Events

Secondary study objectives

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

0 / 4Eligibility criteria met