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

Desentum

Status and phase

Completed

Phase 1

Conditions

Birch Pollen Allergy

Treatments

Biological: Placebo to match DM-101

Biological: DM-101

Study type

Interventional

Funder types

Industry

Identifiers

NCT04266028

2019-001936-67 (EudraCT Number)

DM-101-C-001

Details and patient eligibility

About

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.

Full description

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

Enrollment

27 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Double Blind

27 participants in 8 patient groups, including a placebo group

DM-101 Single Dose

Experimental group

Description:

Participants received a single subcutaneous (SC) dose of DM-101 30 ng on Day 1

Treatment:

Biological: DM-101

Placebo Single Dose

Placebo Comparator group

Description:

Participants received a single SC injection of placebo on Day 1

Treatment:

Biological: Placebo to match DM-101

DM-101 Low Multiple Ascending Doses (MAD)

Experimental group

Description:

Participants received 5 biweekly administered SC doses of DM-101 as follows: 30 ng on Day 1,50 ng on Day 14, 100 ng on Day 28, 42, and 56.

Treatment:

Biological: DM-101

Placebo Low MAD

Placebo Comparator group

Description:

Participants received 5 biweekly administered SC injections of placebo on Day 1,14, 28, 42, and 56.

Treatment:

Biological: Placebo to match DM-101

DM-101 High MAD

Experimental group

Description:

Participants received 5 biweekly administered SC doses of DM-101 as follows: 30 ng on Day 1,50 ng on Day 14, 100 ng on Day 28, 200 ng (dose divided into two SC injections) on Day 42, and 300 ng (dose divided into three SC injections) on Day 56.

Treatment:

Biological: DM-101

Placebo High MAD

Placebo Comparator group

Description:

Participants received 5 biweekly administered SC injections of placebo as follows: single injection on Day 1, 14 and 28; two injections on Day 42; three injections on Day 56.

Treatment:

Biological: Placebo to match DM-101

DM-101 2-Day Ultra-Rush Dose Escalation

Experimental group

Description:

Participants received 9 SC doses of DM-101 as follows: 100, 250, 500, 1000, 2500, 5000, 10000 and 25000 ng during Day 1 and Day 2.

Treatment:

Biological: DM-101

Placebo 2-Day Ultra-Rush Dose Escalation

Placebo Comparator group

Description:

Participants received 9 SC injections of placebo during Day 1 and Day 2.