DM-101PX for Birch Pollen Allergy

Recruiting at 1 trial location

Overseen By Anna Nilson

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Desentum Oy

Must not be taking: Inhaled corticosteroids

Disqualifiers: Asthma, COPD, Severe drug allergy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

Duration: 10 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new treatment, DM-101PX, in reducing symptoms of birch pollen allergies. Participants will receive either the treatment or a placebo (a dummy treatment) through weekly injections for 10 weeks. The study seeks adults who have experienced bothersome birch pollen allergies for at least two allergy seasons, even while taking allergy medication. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that DM-101PX is likely to be safe for humans?

Research shows that DM-101PX is safe to use. Earlier studies found that this treatment was safe and well-tolerated by people allergic to birch pollen. Participants in those trials did not experience serious side effects, and the treatment helped their immune systems respond strongly to the allergen. These results suggest that DM-101PX is a promising and safe option for people with birch pollen allergies, with few negative effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for birch pollen allergy, which typically include antihistamines or corticosteroids, DM-101PX is an experimental therapy that offers a unique approach. It works by administering ascending doses subcutaneously, potentially allowing the immune system to build tolerance to birch pollen allergens. This method can directly address the allergy's root cause, rather than just alleviating symptoms. Researchers are excited because this could lead to longer-lasting relief and fewer side effects compared to traditional therapies.

What evidence suggests that DM-101PX might be an effective treatment for birch pollen allergy?

Research shows that DM-101PX, which participants in this trial may receive, might help reduce allergy symptoms caused by birch pollen. Earlier studies found that DM-101PX triggers a specific immune response that could lessen allergic reactions over time. Although detailed results are not widely available, initial findings are promising. These findings suggest that DM-101PX could help people with birch pollen allergies experience fewer symptoms. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

Adults with an allergy to birch pollen can join this study. Specific details about who can and cannot participate are not provided, but typically these would include health status and any other allergies or conditions that might interfere with the trial.

Inclusion Criteria

Bet v 1 specific serum IgE ≥ 0.7 kAU/L

Positive Skin Prick Test to birch pollen allergen, with a wheal diameter ≥ 5 mm

I am between 18 and 65 years old.

Exclusion Criteria

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 acute hypersensitivity and/or anaphylaxis to protein therapeutics or components of formulation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly subcutaneous administration of DM-101PX or placebo for 10 weeks

10 weeks

10 visits (in-person)

Post-treatment

Participants are monitored for changes in Total Nasal Symptom Score (TNSS) and adverse events

3 weeks

Follow-up

Participants are monitored for long-term safety and effectiveness, including changes in Total Symptom Score (TSS) and blood allergy biomarker levels

20-30 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DM-101PX

Trial Overview The trial is testing DM-101PX against a placebo to see if it reduces symptoms of birch pollen allergy. It's a phase 2 study where participants don't know if they're getting the real treatment or a dummy pill (double-blind).

How Is the Trial Designed?

Group I: DM-101PX Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

weekly subcutaneous administration of Placebo for 10 weeks

Who Is Running the Clinical Trial?

Desentum Oy

Lead Sponsor

Trials

2

Recruited

60+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07254871?cond=allergy&aggFilters=status%3Arec

Study to Evaluate Safety and Efficacy of DM-101PX in ... Randomized, double-blind placebo-controlled phase 2 trial with the aim to investigate safety and efficacy of DM-101-PX in reducing allergic ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06037148?term=AREA%5BConditionSearch%5D(Pollen)&rank=6

NCT06037148 | Study to Evaluate Safety, Tolerability and ... As an explorative objective, the trial will also investigate the effect of DM-101PX on the allergic symptoms following birch pollen allergen exposure in a ...

3. ctv.veeva.com ctv.veeva.com/study/study-to-evaluate-safety-tolerability-and-explorative-efficacy-of-dm-101px-in-birch-pollen-allergic

Study to Evaluate Safety, Tolerability and Explorative Efficacy ... As an explorative objective, the trial will also investigate the effect of DM-101PX on the allergic symptoms following birch pollen allergen ...

4. clinicaltrialsarena.com clinicaltrialsarena.com/news/desentum-to-advance-pollen-allergy-vaccine-after-positive-phase-i-trial/

Desentum to advance pollen allergy vaccine after positive ... The company has said that results from the Phase I trial saw DM-101PX able to induce an allergen-specific IgG4 response.

5. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06037148/

Trial | NCT06037148 As an explorative objective, the trial will also investigate the effect of DM-101PX on the allergic symptoms following birch pollen allergen exposure in a ...

6. businesswire.com businesswire.com/news/home/20250331869398/en/Desentum-Reports-Strong-Safety-and-Immunological-Data-From-Phase-1-Clinical-Study-With-Investigational-Birch-Pollen-Allergy-Vaccine-DM-101PX

Desentum Reports Strong Safety and Immunological Data ... The short-course treatment was found to be safe and well tolerated in birch pollen allergic patients and to induce a very strong and sustained allergen- ...

7. finance.yahoo.com finance.yahoo.com/news/desentum-reports-strong-safety-immunological-042000528.html

Desentum Reports Strong Safety and Immunological Data ... The short-course treatment was found to be safe and well tolerated in birch pollen allergic patients and to induce a very strong and sustained ...