Study to Evaluate Safety, Tolerability and Explorative Efficacy of DM-101PX in Birch Pollen Allergic Participants
NCT ID: NCT06037148
Last Updated: 2024-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2023-09-07
2024-03-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
OTHER
DOUBLE
Study Groups
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DM-101PX low dose
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.
DM-101PX
subcutaneous injection of DM-101PX
Placebo
10 subcutaneous doses.First 9 doses are administered at 1 week interval, and the 10th dose is administered 2 weeks after the 9th dose.
Placebo to Match DM-101PX
Placebo to match DM-101PX administered subcutaneously
DM-101PX middle dose
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.
DM-101PX
subcutaneous injection of DM-101PX
DM-101PX high dose
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.
DM-101PX
subcutaneous injection of DM-101PX
Interventions
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DM-101PX
subcutaneous injection of DM-101PX
Placebo to Match DM-101PX
Placebo to match DM-101PX administered subcutaneously
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Desentum Oy
INDUSTRY
Responsible Party
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Principal Investigators
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Anna Nilson
Role: STUDY_DIRECTOR
Desentum Oy
Patricia Couroux
Role: PRINCIPAL_INVESTIGATOR
Cliantha Research
Locations
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Cliantha Research
Mississauga, Ontario, Canada
Countries
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Other Identifiers
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DM-101-C-002
Identifier Type: -
Identifier Source: org_study_id
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