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Study to Evaluate Safety, Tolerability and Explorative Efficacy of DM-101PX in Birch Pollen Allergic Participants

Primary Purpose

Birch Pollen Allergy

Status
Recruiting
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
DM-101PX
Placebo to Match DM-101PX
Sponsored by
Desentum Oy
About
Eligibility
Locations
Arms
Outcomes
Full info

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

Inclusion Criteria: Either sex or any race, aged 18 to 65 years Good general health A documented clinical history of moderate to severe 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 previous birch pollen seasons Birch pollen specific IgE ≥ 0.7 kU/L Positive SPT to birch pollen allergen, with wheal diameter ≥ 3 mm Body weight ≥ 50 kg and body mass index within the range of 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, could put the subject at risk because of participation in the trial, influence the results of the trial or subject's ability to participate in the trial Current diagnosis of persistent asthma, or moderate to severe asthma requiring GINA Step 2 or higher treatment, or asthma partially controlled or uncontrolled according to GINA classification in the 6 months before screening Significant rhinitis, sinusitis, significant and/or severe allergies not associated with the birch pollen season History of asthma deterioration that resulted in emergency treatment or hospitalization in the past 12 months before screening, or a life-threatening asthma attack at any time in the past A Forced Expiratory Volume in one second (FEV1) ≤ 75% of predicted value History of severe drug allergy, severe angioedema, or systemic allergic reaction of Grade 3 or grater, according to World Allergy Organization (WAO) scale, due to any cause

Sites / Locations

  • Cliantha ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

DM-101PX low dose

Placebo

DM-101PX middle dose

DM-101PX high dose

Arm Description

10 subcutaneous doses starting from 0.05 ug of which first 8 doses are ascending. Thereafter the 8th dose is repeated twice. First 9 doses are administered at 1 week interval, and the 10th dose is administered 2 weeks after the 9th dose.

10 subcutaneous doses.First 9 doses are administered at 1 week interval, and the 10th dose is administered 2 weeks after the 9th dose.

10 subcutaneous doses starting from 0.1 ug of which first 8 doses are ascending. Thereafter the 8th dose is repeated twice. First 9 doses are administered at 1 week interval, and the 10th dose is administered 2 weeks after the 9th dose.

10 subcutaneous doses starting from 0.2 ug of which first 8 doses are ascending. Thereafter the 8th dose is repeated twice. First 9 doses are administered at 1 week interval, and the 10th dose is administered 2 weeks after the 9th dose.

Outcomes

Primary Outcome Measures

Treatment Emergent Adverse Events
Occurrence of treatment emergent adverse events
Adverse Events of Special Interest
Occurrence of local injection site reactions and systemic allergic reactions

Secondary Outcome Measures

Subjects Reaching the Maximum Intended Dose
Number of subjects in each cohort who reach the maximum intended dose

Full Information

First Posted
September 6, 2023
Last Updated
September 18, 2023
Sponsor
Desentum Oy
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1. Study Identification

Unique Protocol Identification Number
NCT06037148
Brief Title
Study to Evaluate Safety, Tolerability and Explorative Efficacy of DM-101PX in Birch Pollen Allergic Participants
Official Title
A Phase I Dose Escalation Trial to Investigate the Safety, Tolerability, and Explorative Efficacy, Following Environmental Allergen Exposure in a Chamber, of DM-101PX in Participants With Birch Pollen Allergy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2023 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Randomized, double-blind placebo-controlled phase I trial with the primary aim to investigate safety and tolerability of three ascending dosing schemes of DM-101-PX in birch pollen allergic adults. As an explorative objective, the trial will also investigate the effect of DM-101PX on the allergic symptoms following birch pollen allergen exposure in a chamber. Expanded access to the study treatment is not available.
Detailed Description
The study will be carried out in a single study site located in Canada

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
3 sequential dose cohorts with ascending DM-101PX doses. In each cohort two treatment arms: placebo and active drug
Masking
ParticipantInvestigator
Masking Description
Double (Participant, Investigator)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DM-101PX low dose
Arm Type
Experimental
Arm Description
10 subcutaneous doses starting from 0.05 ug of which first 8 doses are ascending. Thereafter the 8th dose is repeated twice. First 9 doses are administered at 1 week interval, and the 10th dose is administered 2 weeks after the 9th dose.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
10 subcutaneous doses.First 9 doses are administered at 1 week interval, and the 10th dose is administered 2 weeks after the 9th dose.
Arm Title
DM-101PX middle dose
Arm Type
Experimental
Arm Description
10 subcutaneous doses starting from 0.1 ug of which first 8 doses are ascending. Thereafter the 8th dose is repeated twice. First 9 doses are administered at 1 week interval, and the 10th dose is administered 2 weeks after the 9th dose.
Arm Title
DM-101PX high dose
Arm Type
Experimental
Arm Description
10 subcutaneous doses starting from 0.2 ug of which first 8 doses are ascending. Thereafter the 8th dose is repeated twice. First 9 doses are administered at 1 week interval, and the 10th dose is administered 2 weeks after the 9th dose.
Intervention Type
Biological
Intervention Name(s)
DM-101PX
Intervention Description
subcutaneous injection of DM-101PX
Intervention Type
Biological
Intervention Name(s)
Placebo to Match DM-101PX
Intervention Description
Placebo to match DM-101PX administered subcutaneously
Primary Outcome Measure Information:
Title
Treatment Emergent Adverse Events
Description
Occurrence of treatment emergent adverse events
Time Frame
From the first dose to until 14-28 days from the last dose
Title
Adverse Events of Special Interest
Description
Occurrence of local injection site reactions and systemic allergic reactions
Time Frame
From the first dose to until 14-28 days from the last dose
Secondary Outcome Measure Information:
Title
Subjects Reaching the Maximum Intended Dose
Description
Number of subjects in each cohort who reach the maximum intended dose
Time Frame
Through the treatment period, an average of 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Either sex or any race, aged 18 to 65 years Good general health A documented clinical history of moderate to severe 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 previous birch pollen seasons Birch pollen specific IgE ≥ 0.7 kU/L Positive SPT to birch pollen allergen, with wheal diameter ≥ 3 mm Body weight ≥ 50 kg and body mass index within the range of 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, could put the subject at risk because of participation in the trial, influence the results of the trial or subject's ability to participate in the trial Current diagnosis of persistent asthma, or moderate to severe asthma requiring GINA Step 2 or higher treatment, or asthma partially controlled or uncontrolled according to GINA classification in the 6 months before screening Significant rhinitis, sinusitis, significant and/or severe allergies not associated with the birch pollen season History of asthma deterioration that resulted in emergency treatment or hospitalization in the past 12 months before screening, or a life-threatening asthma attack at any time in the past A Forced Expiratory Volume in one second (FEV1) ≤ 75% of predicted value History of severe drug allergy, severe angioedema, or systemic allergic reaction of Grade 3 or grater, according to World Allergy Organization (WAO) scale, due to any cause
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Nilson
Phone
+358503106846
Email
anna.nilson@desentum.fi
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
Patricia Couroux
Organizational Affiliation
Cliantha Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliantha Research
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
ON L4W 1A4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Couroux
Phone
905-282-1808
Ext
2308
Email
pcouroux@cliantha.com
First Name & Middle Initial & Last Name & Degree
Radu Nanau
Phone
905-282-1808
Ext
2415
Email
rnanau@cliantha.com
First Name & Middle Initial & Last Name & Degree
Patricia Couroux, MD, FRCPC

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, Tolerability and Explorative Efficacy of DM-101PX in Birch Pollen Allergic Participants

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