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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-11

Study Completion Date

2021-05-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Birch Pollen Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

4 sequential study cohorts with ascending DM-101 doses. In each cohort two treatment arms: placebo and active drug

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DM-101 Single Dose

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

Group Type EXPERIMENTAL

DM-101

Intervention Type BIOLOGICAL

DM-101 administered by subcutaneous (SC) injection

Placebo Single Dose

Participants received a single SC injection of placebo on Day 1

Group Type PLACEBO_COMPARATOR

Placebo to match DM-101

Intervention Type BIOLOGICAL

Placebo to match DM-101 administered by SC injection

DM-101 Low Multiple Ascending Doses (MAD)

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.

Group Type EXPERIMENTAL

DM-101

Intervention Type BIOLOGICAL

DM-101 administered by subcutaneous (SC) injection

Placebo Low MAD

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

Group Type PLACEBO_COMPARATOR

Placebo to match DM-101

Intervention Type BIOLOGICAL

Placebo to match DM-101 administered by SC injection

DM-101 High MAD

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.

Group Type EXPERIMENTAL

DM-101

Intervention Type BIOLOGICAL

DM-101 administered by subcutaneous (SC) injection

Placebo High MAD

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.

Group Type PLACEBO_COMPARATOR

Placebo to match DM-101

Intervention Type BIOLOGICAL

Placebo to match DM-101 administered by SC injection

DM-101 2-Day Ultra-Rush Dose Escalation

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.

Group Type EXPERIMENTAL

DM-101

Intervention Type BIOLOGICAL

DM-101 administered by subcutaneous (SC) injection

Placebo 2-Day Ultra-Rush Dose Escalation

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

Group Type PLACEBO_COMPARATOR

Placebo to match DM-101

Intervention Type BIOLOGICAL

Placebo to match DM-101 administered by SC injection

Interventions

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DM-101

DM-101 administered by subcutaneous (SC) injection

Intervention Type BIOLOGICAL

Placebo to match DM-101

Placebo to match DM-101 administered by SC injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No