Birch Pollen AllergyPhase 2BASITNCT07254871
Study of DM-101PX in Adults With Birch Pollen Allergy
A Phase 2 study testing DM-101PX in people with Birch Pollen Allergy, run by Desentum Oy at 1 site in Canada.
Trial summary
Randomized, double-blind placebo-controlled phase 2 trial with the aim to investigate safety and efficacy of DM-101-PX in reducing allergic symptoms provoked by nasal allergen challenge in birch pollen allergic adults. Expanded access to the study treatment is not available. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- 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
- 97 participants
- Where
- 1 siteCanada
- Study dates
- 26 Sep 2025to 10 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant of either sex and any race, aged 18 to 65 years inclusive.
- Documented clinical history of birch pollen-induced allergic rhinitis or rhinoconjunctivitis with symptoms that interfere with daily activities or sleep and remain bothersome despite the use of relevant symptomatic medication, and have been present over, at least, 2 previous allergy seasons.
- Bet v 1 specific serum IgE ≥ 0.7 kAU/L.
- Positive Skin Prick Test to birch pollen allergen, with a wheal diameter ≥ 5 mm.
- Body weight ≥ 50 kg and body mass index (BMI) within the range 18-35 kg/m2 inclusive.
Who cannot join
- History or findings on physical examination at screening visit of any significant disease or disorder which, in the opinion of the Investigator, could put the participant at risk because of participation in the study, influence the results of the study or the participant's ability to participate in the study.
- 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 chronic obstructive pulmonary disease requiring regular treatment.
- Current diagnosis of uncontrolled, partially controlled or persistent asthma requiring regular (> 6 weeks per year) maintenance use of inhaled corticosteroids. History of severe asthma during the pollen season. History of asthma deterioration that resulted in emergency treatment or hospitalization in the 12 months before screening, or a life-threatening asthma attack at any time in the past.
- Forced Expiratory Volume in one second (FEV1) < 75% of predicted. History of severe drug allergy, severe angioedema or systemic allergic reaction of Grade 3 or greater, according to the World Allergy Organization (WAO) scale, due to any cause.
- History of intolerance to the Investigational Product, rescue medications used for systemic allergic reactions (i.e., adrenaline, antihistamine, glucocorticoids, and beta-2 agonists such as salbutamol), or their excipients.
- History of acute hypersensitivity and/or anaphylaxis to protein therapeutics or components of formulation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-controlled Study to Investigate the Safety and Efficacy in Reducing Nasal Allergen Challenge Provoked Symptoms of Treatment With DM-101PX in Adults With Birch Pollen Allergic Rhinitis or Rhinoconjunctivitis
Randomized, double-blind placebo-controlled phase 2 trial with the aim to investigate safety and efficacy of DM-101-PX in reducing allergic symptoms provoked by nasal allergen challenge in birch pollen allergic adults. Expanded access to the study treatment is not available.
Read the detailed description
The study will be carried out in two study sites located in Canada
- 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 DM-101PX administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| DM-101PX | Experimental | weekly subcutaneous administration of ascending doses of DM-101PX for 10 weeks Receives: Biological: DM-101PX |
| Placebo | 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.
Change in Total Nasal Symptom Score (TNSS) after treatment
Change in AUC for TNSS from baseline to post-treatment visit. TNSS is a symptom score consisting of 4 nasal symptoms, each symptom is rated as follows: 0 (none), 1 (mild), 2 (moderate), 3 (severe). TNSS score can very between 0-12.
Measured: From baseline to 3 weeks after the last dose
Secondary outcomes (8)
Adverse events (AEs)
Incidence and characteristics of AEs from the start of treatment to the post-treatment NAC visit.
Measured: from the start of treatment to 3 weeks after the last dose
Laboratory safety evaluations
Number and percentage of participants with new onsets of clinically significant abnormalities (as assessed by the investigator) in laboratory safety evaluations
Measured: from the start of treatment to 3 weeks after the last dose
Vital signs
Number and percentage of participants with new onsets of clinically significant abnormalities (as assessed by the investigator) in vital signs
Measured: From the start of treatment to 3 weeks after the last dose
Adverse Events of Special Interest (AESIs)
Incidence and characteristics AESIs: local injection site reactions and systemic allergic reactions
Measured: From the start of treatment to 3 weeks after the last dose
Change in TNSS after follow-up period
Change in AUC for TNSS from baseline to follow-up visit.
Measured: from baseline to 20-30 weeks after the last dose
Change in Total Symptom Score (TSS)
Change in AUC for TSS from baseline to 1) post-treatment, 2) follow-up visit
Measured: From baseline to 1) 3 weeks, 2) 20-30 weeks after the last dose
Change in Peak Nasal Inspiratory Flow (PNIF)
Change in AUC for PNIF from baseline to 1) post-treatment visit, 2) follow-up visit
Measured: from baseline to 1) 3 weeks, 2) 20-30 weeks after the last dose
Change in blood allergy biomarker levels
Change from baseline to the 7th injection, the 10th injection, post-treatment and follow-up visit in the levels of Bet v 1-specific IgE, IgG1 and IgG4.
Measured: From baseline to the 7th injection, the 10th injection, 3 weeks after the last dose, and 20-30 weeks after the last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start26 Sep 2025
- Primary completion15 Apr 2026
- Study completion10 Aug 2026
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Desentum Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dirk-Jan Opstelten, PhD, Study director, Desentum Oy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254871
- Sponsor's protocol ID
- DM-101-C-004
- Acronym
- BASIT
- Status last verified
- Aug 2026
- First submitted
- 23 Sep 2025
- Last updated
- 31 Aug 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 Anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant reidentification.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-controlled Study to Investigate the Safety and Efficacy in Reducing Nasal Allergen Challenge Provoked Symptoms of Treatment With DM-101PX in Adults With Birch Pollen Allergic Rhinitis or Rhinoconjunctivitis
- ClinicalTrials.gov ID
- NCT07254871
- Acronym / sponsor ID
- BASIT / DM-101-C-004
- Conditions
- Birch Pollen Allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Desentum OyIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2025 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 10 Aug 2026 (actual)
- First posted
- 28 Nov 2025 (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 2 trial with the aim to investigate safety and efficacy of DM-101-PX in reducing allergic symptoms provoked by nasal allergen challenge in birch pollen allergic adults. Expanded access to the study treatment is not available.
Detailed description
The study will be carried out in two study sites located in Canada
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DM-101PX | Experimental | Biological: DM-101PXweekly subcutaneous administration of ascending doses of DM-101PX for 10 weeks |
| Placebo | Placebo comparator | Biological: Placeboweekly subcutaneous administration of Placebo for 10 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant of either sex and any race, aged 18 to 65 years inclusive.
- Documented clinical history of birch pollen-induced allergic rhinitis or rhinoconjunctivitis with symptoms that interfere with daily activities or sleep and remain bothersome despite the use of relevant symptomatic medication, and have been present over, at least, 2 previous allergy seasons.
- Bet v 1 specific serum IgE ≥ 0.7 kAU/L.
- Positive Skin Prick Test to birch pollen allergen, with a wheal diameter ≥ 5 mm.
- Body weight ≥ 50 kg and body mass index (BMI) within the range 18-35 kg/m2 inclusive.
Key exclusion criteria (8 listed)
- History or findings on physical examination at screening visit of any significant disease or disorder which, in the opinion of the Investigator, could put the participant at risk because of participation in the study, influence the results of the study or the participant's ability to participate in the study.
- 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 chronic obstructive pulmonary disease requiring regular treatment.
- Current diagnosis of uncontrolled, partially controlled or persistent asthma requiring regular (> 6 weeks per year) maintenance use of inhaled corticosteroids. History of severe asthma during the pollen season. History of asthma deterioration that resulted in emergency treatment or hospitalization in the 12 months before screening, or a life-threatening asthma attack at any time in the past.
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 |
| PlaceboPlacebo to match DM-101PX administered subcutaneously | Biological | Placebo |
Primary outcome
Change in Total Nasal Symptom Score (TNSS) after treatment
Time frame: From baseline to 3 weeks after the last dose
Change in AUC for TNSS from baseline to post-treatment visit. TNSS is a symptom score consisting of 4 nasal symptoms, each symptom is rated as follows: 0 (none), 1 (mild), 2 (moderate), 3 (severe). TNSS score can very between 0-12.
8 secondary outcomes
Adverse events (AEs)
Time frame: from the start of treatment to 3 weeks after the last dose
Laboratory safety evaluations
Time frame: from the start of treatment to 3 weeks after the last dose
Vital signs
Time frame: From the start of treatment to 3 weeks after the last dose
Adverse Events of Special Interest (AESIs)
Time frame: From the start of treatment to 3 weeks after the last dose
Change in TNSS after follow-up period
Time frame: from baseline to 20-30 weeks after the last dose
Change in Total Symptom Score (TSS)
Time frame: From baseline to 1) 3 weeks, 2) 20-30 weeks after the last dose
Change in Peak Nasal Inspiratory Flow (PNIF)
Time frame: from baseline to 1) 3 weeks, 2) 20-30 weeks after the last dose
Change in blood allergy biomarker levels
Time frame: From baseline to the 7th injection, the 10th injection, 3 weeks after the last dose, and 20-30 weeks after the last dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: Yes. All individual participant data that underlie publicly available results will be considered for sharing Anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant reidentification.
Related trials for Birch Pollen Allergy
RecruitingPhase 1
Safety, Tolerability And Pharmacodynamics of DM-101PX in Birch Pollen Allergy
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. This study is not recruiting at the moment.
Dirk-Jan Opstelten, PhD study director
Desentum Oy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DM-101PX in people with Birch Pollen Allergy, run by Desentum Oy at 1 site in Canada.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 31 Aug 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Nasal Symptom Score (TNSS) after treatment (time frame: From baseline to 3 weeks after the last dose). 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 31 Aug 2026.