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

NCT06037148 | Completed Phase 1

• 1 other identifier: DM-101-C-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Birch Pollen Allergy

Outcome Measures

Primary Outcomes (2)

• Treatment Emergent Adverse Events

  Occurrence of treatment emergent adverse events

  From the first dose to until 14-28 days from the last dose

• Adverse Events of Special Interest

  Occurrence of local injection site reactions and systemic allergic reactions

  From the first dose to until 14-28 days from the last dose

Secondary Outcomes (1)

• Subjects Reaching the Maximum Intended Dose

  Through the treatment period, an average of 10 weeks

Study Arms (4)

DM-101PX low dose

EXPERIMENTAL

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.

Biological: DM-101PX

Placebo

PLACEBO COMPARATOR

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

Biological: Placebo to Match DM-101PX

DM-101PX middle dose

EXPERIMENTAL

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.

Biological: DM-101PX

DM-101PX high dose

EXPERIMENTAL

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.

Biological: DM-101PX

Interventions

DM-101PX BIOLOGICAL

subcutaneous injection of DM-101PX

DM-101PX high dose; DM-101PX low dose; DM-101PX middle dose

Placebo to Match DM-101PX BIOLOGICAL

Placebo to match DM-101PX administered subcutaneously

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Desentum Oy: lead

Study Sites (1)

Cliantha Research

Mississauga, Ontario, ON L4W 1A4, Canada

Location

Study Officials

• Anna Nilson

  Desentum Oy

  STUDY DIRECTOR

• Patricia Couroux

  Cliantha Research

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: 3 sequential dose cohorts with ascending DM-101PX doses. In each cohort two treatment arms: placebo and active drug

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 14, 2023
• Study Start: September 7, 2023
• Primary Completion: March 6, 2024
• Study Completion: March 6, 2024
• Last Updated: March 25, 2024

Record last verified: 2024-03

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

CA (1)