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

Summary

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

• Asthma Control

Interventions

DRUG

Dupilumab Prefilled Syringe

Dupilumab 400mg subcut x1 followed by 200mg subcut every 2 weeks

DRUG

Placebo Injection

Volume-matched placebo injected subcut every 2 weeks

Sponsors & Collaborators

• Sanofi

  collaborator INDUSTRY

• University of Oxford

  collaborator OTHER

• The University of Western Australia

  collaborator OTHER

• Regeneron Pharmaceuticals

  collaborator INDUSTRY

• Fonds de la Recherche en Santé du Québec

  collaborator OTHER_GOV

• Association Pulmonaire du Quebec

  collaborator OTHER

• Université de Sherbrooke

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

79 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-29

Primary Completion

2029-01-31

Completion

2030-01-31

Countries

• Australia
• Canada
• United Kingdom

Study Locations