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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04266028
Recruitment Status : Recruiting
First Posted : February 12, 2020
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
Desentum Oy

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.

Condition or disease Intervention/treatment Phase
Birch Pollen Allergy Biological: DM-101 Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 6 sequential study cohorts with ascending DM-101 doses. In each cohort two treatment arms: placebo and active drug
Masking: Double (Participant, Investigator)
Primary Purpose: Other
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
Actual Study Start Date : February 11, 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Hay Fever

Arm Intervention/treatment
Experimental: Cohort 1
Cohort 1 randomized in 2:1 will receive a single s.c. dose of DM-101 or matching placebo
Biological: DM-101
Ascending DM-101 doses in each cohort
Other Name: Placebo

Experimental: Cohort 2
Cohort 2 randomized in 3:1 will receive multiple ascending s.c. doses of DM-101 or matching placebo during 5 biweekly dosing occasions
Biological: DM-101
Ascending DM-101 doses in each cohort
Other Name: Placebo

Experimental: Cohort 3
Cohort 3 randomized in 3:1 will receive multiple ascending s.c. doses of DM-101 or matching placebo during 5 biweekly dosing occasions
Biological: DM-101
Ascending DM-101 doses in each cohort
Other Name: Placebo

Experimental: Cohort 4
Group 4 randomized in 3:1 will receive multiple ascending s.c. doses of DM-101 or matching placebo during 5 biweekly dosing occasions
Biological: DM-101
Ascending DM-101 doses in each cohort
Other Name: Placebo

Experimental: Cohort 5
Cohort 5 randomized in 3:1 will receive multiple ascending s.c. doses of DM-101 or matching placebo during 5 biweekly dosing occasions
Biological: DM-101
Ascending DM-101 doses in each cohort
Other Name: Placebo

Experimental: Cohort 6
Cohort 6 randomized in 3:1 will receive multiple ascending s.c. doses of DM-101 or matching placebo during 5 biweekly dosing occasions
Biological: DM-101
Ascending DM-101 doses in each cohort
Other Name: Placebo




Primary Outcome Measures :
  1. Treatment Emergent Adverse Events [ Time Frame: From the first dose until 28 days following the last dose. ]
    Number of Treatment Emergent Adverse Events


Secondary Outcome Measures :
  1. Systemic allergic reactions [ Time Frame: From the first dose until 28 days following the last dose. ]
    Number and severity of systemic allergic reactions

  2. Local injection site reactions [ Time Frame: From the first dose until 28 days following the last dose. ]
    Number and severity of local injection site reactions

  3. Subjects reaching the pre-defined DM-101 dose [ Time Frame: From the first dose until 28 days following the last dose. ]
    Proportion of subjects reaching the pre-defined, admissible dose in each DM-101 dosing group



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04266028


Contacts
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Contact: Clinical Research Services Turku +358242064716 koivuallergia@crst.fi

Locations
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Finland
Clinical Research Services Turku Recruiting
Turku, Finland
Sponsors and Collaborators
Desentum Oy
Investigators
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Study Director: Anna Nilson Desentum Oy
Principal Investigator: Mika Scheinin Clinical Research Services Turku

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Responsible Party: Desentum Oy
ClinicalTrials.gov Identifier: NCT04266028    
Other Study ID Numbers: DM-101-C-001
2019-001936-67 ( EudraCT Number )
First Posted: February 12, 2020    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All individual participant data that underlie publicly available results will be considered for sharing
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
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.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rhinitis, Allergic, Seasonal
Hypersensitivity
Immune System Diseases
Rhinitis, Allergic
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate