Actively Recruiting

Phase 3
Age: 18Years - 79Years
All Genders
NCT07309614

A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma

Led by Université de Sherbrooke · Updated on 2026-03-04

150

Participants Needed

5

Research Sites

204 weeks

Total Duration

On this page

Sponsors

U

Université de Sherbrooke

Lead Sponsor

S

Sanofi

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study tests whether an asthma medication called dupilumab can help people achieve complete asthma control (called "remission") when given earlier in their disease, before asthma becomes severe. Currently, most people with asthma only receive advanced treatments like biologics after their condition has worsened significantly and caused lung damage. This study explores whether treating high-risk patients earlier could prevent asthma attacks and lung function decline, potentially achieving remission before permanent damage occurs. The study is looking for adults aged 18-79 with moderate asthma who have had at least one asthma attack requiring steroid pills in the past 2 years, use medium or high-dose inhaled steroids regularly, have high levels of inflammation markers in their blood and breath tests, but don't yet meet criteria for severe asthma requiring biologic therapy. Participants receive either dupilumab or placebo injections every 2 weeks for one year, alongside their regular asthma medications. They attend clinic visits every 3 months for breathing tests, questionnaires, and safety monitoring. Neither participants nor doctors know who receives the real medication until the study ends. The goal is to learn whether early treatment with dupilumab helps more people achieve complete asthma control compared to standard care alone, potentially changing how asthma is treated from "waiting until severe" to "preventing severe disease." The study runs in Canada, the United Kingdom, and Australia, involving 150 participants

CONDITIONS

Official Title

A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma

Who Can Participate

Age: 18Years - 79Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and under 80 years at signing informed consent
  • Physician diagnosis of asthma for at least 6 months with documented airflow variability
  • Elevated type-2 inflammation markers: blood eosinophils ≥ 0.3 x10⁹/L and exhaled nitric oxide ≥ 35 ppb at screening
  • At least 1 asthma attack in the last 2 years requiring systemic corticosteroids or emergency/hospital visit
  • Treatment and adherence to stable medium-dose or higher inhaled corticosteroids for at least 3 months
  • Presence of additional risk factors such as uncontrolled asthma symptoms, impaired lung function, or severe asthma attack in the past 1-12 months
  • Female participants must not be pregnant or breastfeeding and must meet contraception requirements if of childbearing potential
  • Capable of providing signed informed consent
Not Eligible

You will not qualify if you...

  • Use of systemic corticosteroids less than 1 month before screening or on maintenance systemic corticosteroids
  • Current tobacco smoker or stopped smoking less than 6 months ago
  • Ex-smoker with more than 10 pack-years and abnormal lung function
  • Documented nonadherence to inhaled corticosteroids (less than 75% dose dispensed in past 12 months)
  • Significant inhaler technique problems
  • Contraindication to study drug
  • Immunological diseases or medications affecting inflammation
  • History of significant lung diseases such as fibrosis, sarcoidosis, bronchiectasis, COPD
  • Severe illness or immunodeficiency affecting study participation
  • Active or recent malignancy within 5 years (except basal cell skin cancer)
  • Recent exposure to monoclonal antibody therapy or investigational asthma drugs
  • Eligibility for dupilumab based on other approved indications
  • Treatment with live vaccines in past 4 weeks
  • Use of prohibited medications

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 5 locations

1

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia, 6009

Not Yet Recruiting

2

McGill University Health Centre

Montreal, Quebec, Canada, H4A 3S5

Not Yet Recruiting

3

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, Canada, G1V 4G5

Not Yet Recruiting

4

CIUSSS de l'Estrie- CHUS

Sherbrooke, Quebec, Canada, J1H 5H6

Actively Recruiting

5

Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital

Oxford, Oxfordshire, United Kingdom, OX3 9DU

Not Yet Recruiting

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here