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
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