Study to Evaluate Safety, Tolerability and Explorative Efficacy of DM-101PX in Birch Pollen Allergic Participants

Desentum

Status and phase: Completed; Phase 1

Conditions: Birch Pollen Allergy

Treatments: Biological: DM-101PX; Biological: Placebo to Match DM-101PX

Study type: Interventional

Funder types: Industry

Identifiers

NCT06037148

DM-101-C-002

Details and patient eligibility

About

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.

Full description

The study will be carried out in a single study site located in Canada

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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30 participants in 4 patient groups, including a placebo group

DM-101PX low dose

Experimental group

Description:

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.

Treatment:

Biological: DM-101PX

Placebo

Placebo Comparator group

Description:

10 subcutaneous doses.First 9 doses are administered at 1 week interval, and the 10th dose is administered 2 weeks after the 9th dose.

Treatment:

Biological: Placebo to Match DM-101PX

DM-101PX middle dose

Experimental group

Description:

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.

Treatment:

Biological: DM-101PX

DM-101PX high dose

Experimental group

Description:

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.

Treatment:

Biological: DM-101PX