Birch Pollen AllergyPhase 1NCT06037148
Study to Evaluate Safety, Tolerability and Explorative Efficacy of DM-101PX in Birch Pollen Allergic Participants
A Phase 1 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 I trial with the primary aim to investigate safety and tolerability of three ascending dosing schemes of DM-101-PX 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
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 7 Sep 2023to 6 Mar 2024
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Either sex or any race, aged 18 to 65 years
- Good general health
- A documented clinical history of moderate to severe 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 birch pollen seasons
- Birch pollen specific IgE ≥ 0.7 kU/L
- Positive SPT to birch pollen allergen, with wheal diameter ≥ 3 mm
- Body weight ≥ 50 kg and body mass index within the range of 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, could put the subject at risk because of participation in the trial, influence the results of the trial or subject's ability to participate in the trial
- Current diagnosis of persistent asthma, or moderate to severe asthma requiring GINA Step 2 or higher treatment, or asthma partially controlled or uncontrolled according to GINA classification in the 6 months before screening
- Significant rhinitis, sinusitis, significant and/or severe allergies not associated with the birch pollen season
- 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
- A Forced Expiratory Volume in one second (FEV1) ≤ 75% of predicted value
- History of severe drug allergy, severe angioedema, or systemic allergic reaction of Grade 3 or grater, according to World Allergy Organization (WAO) scale, due to any cause
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Dose Escalation Trial to Investigate the Safety, Tolerability, and Explorative Efficacy, Following Environmental Allergen Exposure in a Chamber, of DM-101PX in Participants With Birch Pollen Allergy
Randomized, double-blind placebo-controlled phase I trial with the primary aim to investigate safety and tolerability of three ascending dosing schemes of DM-101-PX in birch pollen allergic adults. 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 chamber. 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 Canada
- Conditions
- Birch Pollen Allergy
- Being tested
- DM-101PX, Placebo to Match DM-101PX
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
Placebo to Match DM-101PXBiological
Placebo to match DM-101PX administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| DM-101PX low dose | Experimental | 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. Receives: Biological: DM-101PX |
| Placebo | Placebo comparator | 10 subcutaneous doses.First 9 doses are administered at 1 week interval, and the 10th dose is administered 2 weeks after the 9th dose. Receives: Biological: Placebo to Match DM-101PX |
| DM-101PX middle dose | Experimental | 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. Receives: Biological: DM-101PX |
| DM-101PX high dose | Experimental | 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. Receives: Biological: DM-101PX |
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 14-28 days 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 14-28 days from the last dose
Secondary outcomes (1)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start7 Sep 2023
- Primary completion6 Mar 2024
- Study completion6 Mar 2024
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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 3 sequential dose cohorts with ascending DM-101PX doses. In each cohort two treatment arms: placebo and active drug
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Desentum Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anna Nilson, Study director, Desentum OyPatricia Couroux, Principal investigator, Cliantha Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037148
- Sponsor's protocol ID
- DM-101-C-002
- Status last verified
- Mar 2024
- First submitted
- 6 Sep 2023
- Last updated
- 25 Mar 2024
- 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 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Trial to Investigate the Safety, Tolerability, and Explorative Efficacy, Following Environmental Allergen Exposure in a Chamber, of DM-101PX in Participants With Birch Pollen Allergy
- ClinicalTrials.gov ID
- NCT06037148
- Acronym / sponsor ID
- DM-101-C-002
- Conditions
- Birch Pollen Allergy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Desentum OyIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- 6 Mar 2024 (actual)
- Study completion
- 6 Mar 2024 (actual)
- First posted
- 14 Sep 2023 (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 three ascending dosing schemes of DM-101-PX in birch pollen allergic adults. 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 chamber. Expanded access to the study treatment is not available.
Detailed description
The study will be carried out in a single study site located in Canada
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- 3 sequential dose cohorts with ascending DM-101PX doses. In each cohort two treatment arms: placebo and active drug
| Arm | Type | Receives |
|---|---|---|
| DM-101PX low dose | Experimental | Biological: DM-101PX10 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. |
| Placebo | Placebo comparator | Biological: Placebo to Match DM-101PX10 subcutaneous doses.First 9 doses are administered at 1 week interval, and the 10th dose is administered 2 weeks after the 9th dose. |
| DM-101PX middle dose | Experimental | Biological: DM-101PX10 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. |
| DM-101PX high dose | Experimental | Biological: DM-101PX10 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Either sex or any race, aged 18 to 65 years
- Good general health
- A documented clinical history of moderate to severe 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 birch pollen seasons
- Birch pollen specific IgE ≥ 0.7 kU/L
- Positive SPT to birch pollen allergen, with wheal diameter ≥ 3 mm
Key exclusion criteria (6 listed)
- History or findings on physical examination of any significant disease or disorder which, in the opinion of the Investigator, could put the subject at risk because of participation in the trial, influence the results of the trial or subject's ability to participate in the trial
- Current diagnosis of persistent asthma, or moderate to severe asthma requiring GINA Step 2 or higher treatment, or asthma partially controlled or uncontrolled according to GINA classification in the 6 months before screening
- Significant rhinitis, sinusitis, significant and/or severe allergies not associated with the birch pollen season
- 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
- A Forced Expiratory Volume in one second (FEV1) ≤ 75% of predicted value
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 high dose, DM-101PX low dose, DM-101PX middle dose |
| Placebo to Match DM-101PXPlacebo to match DM-101PX administered subcutaneously | Biological | Placebo |
Primary outcome
Treatment Emergent Adverse Events
Time frame: From the first dose to until 14-28 days from the last dose
Occurrence of treatment emergent adverse events
Adverse Events of Special Interest
Time frame: From the first dose to until 14-28 days from the last dose
Occurrence of local injection site reactions and systemic allergic reactions
1 secondary outcome
Subjects Reaching the Maximum Intended Dose
Time frame: Through the treatment period, an average of 10 weeks
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 25 Mar 2024.
- 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
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A Study to Identify and Characterize Adults and Pediatric Participants With Cat and/or Birch Allergy
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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
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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.
Anna Nilson study director
Desentum Oy
Patricia Couroux principal investigator
Cliantha Research
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 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 6 inclusion and 6 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 25 Mar 2024. 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 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?
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?
Treatment Emergent Adverse Events (time frame: From the first dose to until 14-28 days 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 25 Mar 2024.