Study to Evaluate Safety and Tolerability of sc Immunotherapy With DM-101 in Adults With Birch Pollen Allergy

Birch Pollen Allergy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04266028
• Other study ID #: DM-101-C-001
• Secondary ID: 2019-001936-67
• Status: Completed
• Phase: Phase 1
• Start date: February 11, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: June 2021
• Source: Desentum Oy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Birch Pollen Allergy
• Hypersensitivity
• Rhinitis, Allergic, Seasonal

Intervention

Biological:
• DM-101
DM-101 administered by subcutaneous (SC) injection
• Placebo to match DM-101
Placebo to match DM-101 administered by SC injection

Locations

Country	Name	City	State
Finland	Clinical Research Services Turku	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Desentum Oy

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Emergent Adverse Events	Number of All Treatment Emergent Adverse Events (TEAEs) in Subjects Receiving DM-101 Compared to Placebo	From the first dose until 28 days following the last dose.
Secondary	Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo	Severity of SARs are graded from Grade 1 to 5 (Grade 5 being fatal) as defined by WAO Subcutaneous Immunotherapy Systemic Reaction Grading System.	From the first dose until 28 days following the last dose.
Secondary	Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo	Pain, tenderness, erythema/redness and induration/swelling at the injection site was assessed after each injection using a 4-point scale (Grade 1 = mild, Grade 4 = severe) as defined in the study protocol.	From the first dose until 28 days following the last dose.
Secondary	Subjects Reaching the Pre-defined DM-101 Dose	Proportion of subjects reaching the pre-defined, admissible dose in each DM-101 dosing group	From the first dose until 28 days following the last dose.