Birch Pollen AllergyPhase 1UPSITNCT07898800
Safety, Tolerability And Pharmacodynamics of DM-101PX in Birch Pollen Allergy
A Phase 1 study testing DM-101PX in people with Birch Pollen Allergy, run by Desentum Oy at 1 site in Germany.
Trial summary
Randomized, double-blind placebo-controlled phase I trial with the primary aim to investigate safety and tolerability of DM-101-PX compared to placebo in birch pollen allergic adults. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Birch Pollen Allergy
- What is being tested?
- DM-101PX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 29 Oct 2026to May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Fraunhofer Institute for Toxicology and Experimental Medicine ITEM
Hanover, 30625
Philipp Badorrek, +49 511 5350-8130, philipp.badorrek@item.fraunhofer.de
About this study
Official title: A Randomised, Double Blind, Placebo-controlled Study to Evaluate the Safety, Tolerability And Pharmacodynamics of Subcutaneous Immunotherapy With DM-101PX in Subjects With Birch Pollen Allergy
Randomized, double-blind placebo-controlled phase I trial with the primary aim to investigate safety and tolerability of DM-101-PX compared to placebo in birch pollen allergic adults. As an secondary objectives, the trial will also assess the number of participants receiving the maximum intended DM-101PX dose and to assess the effect of treatment with DM-101PX compared with placebo on blood allergy biomarkers. Expanded access to the study treatment is not available.
Read the detailed description
The study will be carried out in a single study site located in Germany.
- Conditions
- Birch Pollen Allergy
- Being tested
- DM-101PX, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DM-101PXBiological
Subcutaneous injection of DM-101PX
PlaceboBiological
Placebo to match subcutaneous injection of DM-101PX
| Study group | Role | What they receive |
|---|---|---|
| DM-101PX for cohort 1 | Experimental | Weekly subcutaneous administration of ascending doses of DM-101PX for 10 weeks with dose escalation starting from 0.2 µg with slightly varying injection volumes. Receives: Biological: DM-101PX |
| Placebo for cohort 1 | Placebo comparator | Weekly subcutaneous administration of Placebo for 10 weeks Receives: Biological: Placebo |
| Experimental: DM-101PX for cohort 2 | Experimental | Weekly subcutaneous administration of ascending doses of DM-101PX for 10 weeks with dose escalation starting from 0.2 µg with varying injection volumes Receives: Biological: DM-101PX |
| Placebo for cohort 2 | Placebo comparator | Weekly subcutaneous administration of Placebo for 10 weeks Receives: Biological: Placebo |
| Experimental: DM-101PX for cohort 3 | Experimental | Weekly subcutaneous administration of ascending doses of DM-101PX for 10 weeks with regimens consisting of 2 initial placebo s.c. injections, followed by 8 s.c. injections with escalating doses starting from 0.2 µg and with varying injection volumes. Receives: Biological: DM-101PX |
| Placebo for cohort 3 | Placebo comparator | Weekly subcutaneous administration of Placebo for 10 weeks Receives: Biological: Placebo |
| Experimental: DM-101PX for cohort 4 | Experimental | Weekly subcutaneous administration of ascending doses of DM-101PX for 10 weeks with regimens consisting of 2 initial placebo s.c. injections, followed by 8 s.c. injections with escalating doses starting from 0.2 µg and with constant varying injection volume. Receives: Biological: DM-101PX |
| Placebo for cohort 4 | Placebo comparator | Weekly subcutaneous administration of Placebo for 10 weeks Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Events
Occurrence of treatment emergent adverse events
Measured: From the first dose to until 3 months from the last dose
Adverse Events of Special Interest
Occurrence of local injection site reactions and systemic allergic reactions
Measured: From the first dose to until 3 months from the last dose
Secondary outcomes (2)
Subjects Reaching the Maximum Intended Dose
Number of subjects in each cohort who reach the maximum intended dose
Measured: Through the treatment period, an average of 10 weeks
Change in blood allergy biomarker levels
Change in the levels of Bet v 1-specific IgE, IgG1 and IgG4
Measured: From baseline to 3 and 12 weeks, after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start29 Oct 2026
- Primary completionMar 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birch Pollen AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study consists of 4 cohorts, each receiving a different DM-101PX dosing regimen. Within each cohort, participants will be randomised in a 8:2 ratio to receive either DM-101PX or placebo in a double-blind manner. The primary comparison (safety) will be made between the active and placebo arms within each cohort, separately for each cohort. For the secondary endpoints on blood allergy biomarkers, each active treatment arm will be compared with the pooled placebo arms of all cohorts.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Desentum Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philipp Badorrek, MD, Principal investigator, Fraunhofer Institute for Toxicology and Experimental Medicine ITEM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898800
- Sponsor's protocol ID
- DM-101-C-005
- Acronym
- UPSIT
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data that underlie publicly available results will be considered for sharing
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blind, Placebo-controlled Study to Evaluate the Safety, Tolerability And Pharmacodynamics of Subcutaneous Immunotherapy With DM-101PX in Subjects With Birch Pollen Allergy
- ClinicalTrials.gov ID
- NCT07898800
- Acronym / sponsor ID
- UPSIT / DM-101-C-005
- Conditions
- Birch Pollen Allergy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Desentum OyIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, double-blind placebo-controlled phase I trial with the primary aim to investigate safety and tolerability of DM-101-PX compared to placebo in birch pollen allergic adults. As an secondary objectives, the trial will also assess the number of participants receiving the maximum intended DM-101PX dose and to assess the effect of treatment with DM-101PX compared with placebo on blood allergy biomarkers. Expanded access to the study treatment is not available.
Detailed description
The study will be carried out in a single study site located in Germany.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
- Model description
- The study consists of 4 cohorts, each receiving a different DM-101PX dosing regimen. Within each cohort, participants will be randomised in a 8:2 ratio to receive either DM-101PX or placebo in a double-blind manner. The primary comparison (safety) will be made between the active and placebo arms within each cohort, separately for each cohort. For the secondary endpoints on blood allergy biomarkers, each active treatment arm will be compared with the pooled placebo arms of all cohorts.
| Arm | Type | Receives |
|---|---|---|
| DM-101PX for cohort 1 | Experimental | Biological: DM-101PXWeekly subcutaneous administration of ascending doses of DM-101PX for 10 weeks with dose escalation starting from 0.2 µg with slightly varying injection volumes. |
| Placebo for cohort 1 | Placebo comparator | Biological: PlaceboWeekly subcutaneous administration of Placebo for 10 weeks |
| Experimental: DM-101PX for cohort 2 | Experimental | Biological: DM-101PXWeekly subcutaneous administration of ascending doses of DM-101PX for 10 weeks with dose escalation starting from 0.2 µg with varying injection volumes |
| Placebo for cohort 2 | Placebo comparator | Biological: PlaceboWeekly subcutaneous administration of Placebo for 10 weeks |
| Experimental: DM-101PX for cohort 3 | Experimental | Biological: DM-101PXWeekly subcutaneous administration of ascending doses of DM-101PX for 10 weeks with regimens consisting of 2 initial placebo s.c. injections, followed by 8 s.c. injections with escalating doses starting from 0.2 µg and with varying injection volumes. |
| Placebo for cohort 3 | Placebo comparator | Biological: PlaceboWeekly subcutaneous administration of Placebo for 10 weeks |
| Experimental: DM-101PX for cohort 4 | Experimental | Biological: DM-101PXWeekly subcutaneous administration of ascending doses of DM-101PX for 10 weeks with regimens consisting of 2 initial placebo s.c. injections, followed by 8 s.c. injections with escalating doses starting from 0.2 µg and with constant varying injection volume. |
| Placebo for cohort 4 | Placebo comparator | Biological: PlaceboWeekly subcutaneous administration of Placebo for 10 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DM-101PXSubcutaneous injection of DM-101PX | Biological | DM-101PX for cohort 1, Experimental: DM-101PX for cohort 2, Experimental: DM-101PX for cohort 3, Experimental: DM-101PX for cohort 4 |
| PlaceboPlacebo to match subcutaneous injection of DM-101PX | Biological | Placebo for cohort 1, Placebo for cohort 2, Placebo for cohort 3, Placebo for cohort 4 |
Primary outcome
Treatment Emergent Adverse Events
Time frame: From the first dose to until 3 months from the last dose
Occurrence of treatment emergent adverse events
Adverse Events of Special Interest
Time frame: From the first dose to until 3 months from the last dose
Occurrence of local injection site reactions and systemic allergic reactions
2 secondary outcomes
Subjects Reaching the Maximum Intended Dose
Time frame: Through the treatment period, an average of 10 weeks
Change in blood allergy biomarker levels
Time frame: From baseline to 3 and 12 weeks, after completion of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes. All individual participant data that underlie publicly available results will be considered for sharing
Related trials for Birch Pollen Allergy
Not yet recruitingObservational study
A Study to Identify and Characterize Adults and Pediatric Participants With Cat and/or Birch Allergy
Conjunctivitis Allergic
RecruitingPhase 3
Evaluation of the Efficacy of Oral Immunotherapy With Raw Apple in Patients Allergic to Birch Pollen and Apple: Prospective, Multicenter, Comparative Phase III Study
Allergies
Not yet recruitingObservational study
Factors Determining Tolerance to Nasal Allergen Exposure With Advanced Age in a Subset of Birch Pollen Allergic Subjects
Allergic Rhinitis, Allergic Conjunctivitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philipp Badorrek, MD principal investigator
Fraunhofer Institute for Toxicology and Experimental Medicine ITEM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DM-101PX in people with Birch Pollen Allergy, run by Desentum Oy at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Birgitta Kalvi (+358453199009, birgitta.kalvi@desentum.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Emergent Adverse Events (time frame: From the first dose to until 3 months from the last dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.