Clinical trial NCT04266028: Study to Evaluate Safety and Tolerability of sc Immunotherapy With DM-101 in Adults With Birch Pollen Allergy
Official title: A Randomized, Double-blind, Placebo-controlled, Dose Escalation Study to Evaluate the Safety and Tolerability of Subcutaneous Immunotherapy With DM-101 in Adults With Birch Pollen Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Birch Pollen Allergy
Lead sponsor: Desentum Oy
Sponsor class: INDUSTRY
First posted: 2020-02-12
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 4 sequential study cohorts with ascending DM-101 doses. In each cohort two treatment arms: placebo and active drug
Primary purpose: OTHER

Brief summary: Randomized, double-blind placebo-controlled phase I study to investigate the safety and tolerability of ascending doses of DM-101 in adult subjects with birch pollen allergy.

Detailed description: The study will be carried out in a single study site located in Finland.

Eligibility criteria: Key Inclusion Criteria:

* Males or females, aged 18 to 65 years
* Good general health
* A 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 allergy seasons.
* Bet v 1 specific serum IgE ≥ 0.7 kU/L
* Positive SPT 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.

Key Exclusion Criteria:

* History or findings on physical examination of any significant disease or disorder which, in the opinion of the Investigator, may put the subject at risk because of participation in the study, influence the results of the study or the subject's ability to participate in the study.
* Current diagnosis of asthma (other than seasonal during the birch pollen allergy season), requiring Global Initiative for Asthma (GINA) Step 2 or higher treatment, or asthma partially controlled or uncontrolled according to GINA classification in the 6 months before Screening.
* History of asthma deterioration that resulted in emergency treatment or hospitalisation 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) \< 70% of predicted, regardless of asthma status at screening or baseline assessment at the first dosing visit.
* 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.

Primary outcomes:
measure: Treatment Emergent Adverse Events
timeFrame: From the first dose until 28 days following the last dose.
Secondary outcomes:
measure: Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo
timeFrame: From the first dose until 28 days following the last dose.
measure: Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo
timeFrame: From the first dose until 28 days following the last dose.
measure: Subjects Reaching the Pre-defined DM-101 Dose
timeFrame: From the first dose until 28 days following the last dose.
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Clinical Research Services Turku
Study officials:
affiliation: Desentum Oy
name: Anna Nilson
role: STUDY_DIRECTOR
affiliation: Clinical Research Services Turku
name: Mika Scheinin
role: PRINCIPAL_INVESTIGATOR
References: