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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-79
SponsorUniversité de Sherbrooke

About this trial

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

Eligibility criteria

Qualifiers

Participant must be 18-<80 years of age at the time of signing the informed consent.

Positive reversibility test: ≥12% and 200 ml in FEV1 after SABA administration at any point prior to randomisation

Airflow variability in clinic FEV1 >12% and 200 mL between historical clinical visits

Positive bronchial challenge test: fall in FEV1 of ≥20% with standard doses of methacholine (<16 mg/mL or <400mcg); or ≥10% with standardised hyperventilation, or exercise challenge test; or ≥15% with hypertonic saline or mannitol challenge

Disqualifiers

Use of SCS < 1 months prior to screening or on maintenance SCS.

Current tobacco smoker or recently stopped smoker (<6 months)

Ex-smoker with greater than 10 pack-years AND post bronchodilator FEV1/FVC ratio below the lower limit of normal according to GLI race-neutral standards. 69

Documented nonadherence to ICS, defined as dispensing of less than 75% of the prescribed ICS dose over the past 12 months (or annualised if less than 12 months), based on pharmacy refill records checked at screening.

Trial design

Treatments tested in this trial

  • Dupilumab Prefilled Syringe
  • Placebo Injection

Treatment groups

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Université de Sherbrooke

Lead sponsor

Sanofi

Collaborator

University of Oxford

Collaborator

The University of Western Australia

Collaborator

Regeneron Pharmaceuticals

Collaborator

Fonds de la Recherche en Santé du Québec

Collaborator

Association Pulmonaire du Quebec

Collaborator