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

Primary Purpose

Birch Pollen Allergy

Status

Completed

Phase

Phase 1

Locations

Finland

Study Type

Interventional

Intervention

DM-101

Placebo to match DM-101

About this trial

This is an interventional other trial for Birch Pollen Allergy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Clinical Research Services Turku

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

DM-101 Single Dose

Placebo Single Dose

DM-101 Low Multiple Ascending Doses (MAD)

Placebo Low MAD

DM-101 High MAD

Placebo High MAD

DM-101 2-Day Ultra-Rush Dose Escalation

Placebo 2-Day Ultra-Rush Dose Escalation

Arm Description

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

Participants received a single SC injection of placebo on Day 1

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.

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

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.

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.

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.

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

Outcomes

Primary Outcome Measures

Treatment Emergent Adverse Events

Number of All Treatment Emergent Adverse Events (TEAEs) in Subjects Receiving DM-101 Compared to Placebo

Secondary Outcome Measures

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.

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.

Subjects Reaching the Pre-defined DM-101 Dose

Proportion of subjects reaching the pre-defined, admissible dose in each DM-101 dosing group

Full Information

NCT ID

NCT04266028

First Posted

February 10, 2020

Last Updated

June 7, 2022

Sponsor

Desentum Oy

1. Study Identification

Unique Protocol Identification Number

NCT04266028

Brief Title

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

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

February 11, 2020 (Actual)

Primary Completion Date

May 31, 2021 (Actual)

Study Completion Date

May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Desentum Oy

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Birch Pollen Allergy

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Model Description

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

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DM-101 Single Dose

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo Single Dose

Arm Type

Placebo Comparator

Arm Description

Participants received a single SC injection of placebo on Day 1

Arm Title

DM-101 Low Multiple Ascending Doses (MAD)

Arm Type

Experimental

Arm 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.

Arm Title

Placebo Low MAD

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

DM-101 High MAD

Arm Type

Experimental

Arm Description

Arm Title

Placebo High MAD

Arm Type

Placebo Comparator

Arm 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.

Arm Title

DM-101 2-Day Ultra-Rush Dose Escalation

Arm Type

Experimental

Arm 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.

Arm Title

Placebo 2-Day Ultra-Rush Dose Escalation

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

DM-101

Intervention Description

DM-101 administered by subcutaneous (SC) injection

Intervention Type

Biological

Intervention Name(s)

Placebo to match DM-101

Intervention Description

Placebo to match DM-101 administered by SC injection

Primary Outcome Measure Information:

Title

Treatment Emergent Adverse Events

Description

Number of All Treatment Emergent Adverse Events (TEAEs) in Subjects Receiving DM-101 Compared to Placebo

Time Frame

From the first dose until 28 days following the last dose.

Secondary Outcome Measure Information:

Title

Number and Severity of Systemic Allergic Reactions (SARs) in Subjects Receiving DM-101 Compared to Placebo

Description

Severity of SARs are graded from Grade 1 to 5 (Grade 5 being fatal) as defined by WAO Subcutaneous Immunotherapy Systemic Reaction Grading System.

Time Frame

From the first dose until 28 days following the last dose.

Title

Number and Severity of Local Injection Site Reactions (LISRs) in Subjects Receiving DM-101 Compared to Placebo

Description

Time Frame

From the first dose until 28 days following the last dose.

Title

Subjects Reaching the Pre-defined DM-101 Dose

Description

Proportion of subjects reaching the pre-defined, admissible dose in each DM-101 dosing group

Time Frame

From the first dose until 28 days following the last dose.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anna Nilson

Organizational Affiliation

Desentum Oy

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Mika Scheinin

Organizational Affiliation

Clinical Research Services Turku

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinical Research Services Turku

City

Turku

Country

Finland

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

All individual participant data that underlie publicly available results will be considered for sharing

IPD Sharing Time Frame

Anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.

IPD Sharing Access Criteria

Qualified researchers may request access to patient level data and related study documents. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants after Desentum has received marketing authorization from major health authorities (e.g., FDA, EMA), has the legal authority to share the data, and has made the study results publicly available.

Learn more about this trial

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

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