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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 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

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

0 / 1Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are minors accepted into the parameters of this research trial?

"Eligible applicants must be between 18 and 65 years old to partake in this trial."

Answered by AI

Is it possible to participate in this research program?

"To qualify for this clinical trial, all applicants must be between 18 and 65 years old with birch pollen allergy. Approximately 30 participants will be selected to join the study."

Answered by AI

To what extent is this research study being participated in?

"Yes, clinicaltrials.gov confirms that this medical experiment is currently enlisting applicants. This study commenced on September 7th 2023 and was revised most recently on the 18th of the same month. 30 volunteers are needed to be recruited from 1 centre for the trial to succeed."

Answered by AI

Is this research still open to new participants?

"Affirmative. Clinicaltrials.gov attests to this medical study's active recruitment status; it was initially posted on September 7th, 2023 and the latest update occurred on the 18th of that same month. 30 participants are needed from a single site."

Answered by AI

Has DM-101PX been authorized by the FDA for use at reduced dosages?

"Our team at Power assigned the safety of DM-101PX low dose a 1 on our scale due to its Phase 1 designation, signifying that there is only minimal data available in regards to efficacy and safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate Safety, Tolerability and Explorative Efficacy of DM-101PX in Birch Pollen Allergic Participants

2023. "Study to Evaluate Safety, Tolerability and Explorative Efficacy of DM-101PX in Birch Pollen Allergic Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06037148.