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

NCT04266028 | Completed Phase 1 Results

• 2 other identifiers: DM-101-C-0012019-001936-67
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Birch Pollen Allergy

Outcome Measures

Primary Outcomes (1)

• Treatment Emergent Adverse Events

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

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

Secondary Outcomes (3)

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

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

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

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

• Subjects Reaching the Pre-defined DM-101 Dose

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

Study Arms (8)

DM-101 Single Dose

EXPERIMENTAL

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

Biological: DM-101

Placebo Single Dose

PLACEBO COMPARATOR

Participants received a single SC injection of placebo on Day 1

Biological: Placebo to match DM-101

DM-101 Low Multiple Ascending Doses (MAD)

EXPERIMENTAL

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.

Biological: DM-101

Placebo Low MAD

PLACEBO COMPARATOR

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

Biological: Placebo to match DM-101

DM-101 High MAD

EXPERIMENTAL

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.

Biological: DM-101

Placebo High MAD

PLACEBO COMPARATOR

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.

Biological: Placebo to match DM-101

DM-101 2-Day Ultra-Rush Dose Escalation

EXPERIMENTAL

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.

Biological: DM-101

Placebo 2-Day Ultra-Rush Dose Escalation

PLACEBO COMPARATOR

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

Biological: Placebo to match DM-101

Interventions

DM-101 BIOLOGICAL

DM-101 administered by subcutaneous (SC) injection

DM-101 2-Day Ultra-Rush Dose Escalation; DM-101 High MAD; DM-101 Low Multiple Ascending Doses (MAD); DM-101 Single Dose

Placebo to match DM-101 BIOLOGICAL

Placebo to match DM-101 administered by SC injection

Placebo 2-Day Ultra-Rush Dose Escalation; Placebo High MAD; Placebo Low MAD; Placebo Single Dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Desentum Oy: lead

Study Sites (1)

Clinical Research Services Turku

Turku, Finland

Location

Results Point of Contact

• Title: Head of Clinical Operations
• Organization: Desentum Oy

Info@desentum.fi

+358400224892

Study Officials

• Anna Nilson

  Desentum Oy

  STUDY DIRECTOR

• Mika Scheinin

  Clinical Research Services Turku

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 12, 2020
• Study Start: February 11, 2020
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: March 21, 2023
• Results First Posted: March 21, 2023

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

FI (1)