NCT05740748

Brief Summary

Asthma is a condition where small inhaled particles can cause inflammation in the lung leading to constriction of airways and wheeze. Mast cells are immune cells in airways that can release chemical causing constriction of the airways and wheeze. Tezepelumab is an injectable medication that improves asthma by stopping inflammation, but the effect on mast cells is not known. Tezepelumab was approved in Canada July 2022 for treatment of severe asthma. Tezepelumab is not approved for treatment of mild asthma by any health authority, except for use in research studies like this. This study will examine the effect of tezepelumab on mast cells and airway constriction to understand the mechanisms of asthma, and which patients will benefit most from drugs like tezepelumab.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 23, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

1.8 years

First QC Date

February 6, 2023

Last Update Submit

February 22, 2023

Conditions

Asthma, Allergic

Keywords

asthmaairway hyperresponsivenessmast cellThymic stromal lymphopoietintezepelumab

Outcome Measures

Primary Outcomes (1)

  • Methacholine PD20

    The provocative dose of methacholine causing 20% fall in FEV1

    Week -1 to Week 24

Secondary Outcomes (2)

  • Dose response ratio to mannitol

    Week -1 to Week 24

  • Mast cell tryptase levels.

    Week -1 to Week 24

Study Arms (2)

Tezepelumab

EXPERIMENTAL

tezepelumab 210 mg sc q4wks 20 weeks treatment

Drug: Tezepelumab

Placebo

PLACEBO COMPARATOR

placebo sc q4wks 20 weeks treatment

Drug: Placebo

Interventions

TezepelumabDRUG

tezepelumab 210 mg sc q4wks for 20 weeks

Tezepelumab
PlaceboDRUG

placebo sc q4wks for 20 weeks

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of informed consent prior to any study specific procedures
  • Male and female 18 through 65 years of age
  • Positive skin-prick test to a common aeroallergen
  • Methacholine PD20 ≤ 200mcg
  • Mannitol DRR ≤ 42.3mg/FEV1 %f all (equivalent to PD15 ≤ 635mg)
  • Baseline FEV1 ≥ 70% of the predicted value
  • Negative pregnancy test (urine) for female participants of childbearing potential.

You may not qualify if:

  • Current or former smoker with \>10-pack-year history
  • Current or previous history of lung disease other than mild stable allergic asthma
  • Significant systemic disease, including history of current malignancy or autoimmune disease
  • Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
  • Previous randomisation in the present study. Re-screening (Week -1) for FEV1 and AHR is permitted once for each test.
  • Participation in another clinical study with an investigational product during the last 30 days or 5 half-lives of the drug (whichever is longer)
  • Use of any medications for treatment of asthma other than prophylactic short-acting β2-agonists, or use of short-acting β2-agonists for relief of symptoms less than once weekly.
  • Participants with known hypersensitivity to tezepelumab or any of the excipients of the product.
  • Positive hepatitis C antibody, hepatitis B virus surface antigen or hepatitis B virus core antibody, at screening
  • Known to have tested positive for human immunodeficiency virus
  • Known history of drug or alcohol abuse within 1 year of screening
  • For women only - currently pregnant (confirmed with positive pregnancy test) or breast feeding.
  • Unwillingness or inability to comply with the study protocol for any other reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

MeSH Terms

Conditions

AsthmaRespiratory Hypersensitivity

Interventions

tezepelumab

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Gail Gauvreau, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gail M Gauvreau, PhD

CONTACT

9055259140gauvreau@mcmaster.ca

Paul M O'Byrne, MB

CONTACT

9055259140obyrnep@mcmaster.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2023

First Posted

February 23, 2023

Study Start

April 1, 2023

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

February 23, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)