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

Sponsor
Université de Sherbrooke
Study ID
NCT07309614
Phase
PHASE3
Status
Recruiting
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Conditions

  • Asthma Control

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab Prefilled Syringe — DRUG
    Dupilumab 400mg subcut x1 followed by 200mg subcut every 2 weeks
  • Placebo Injection — DRUG
    Volume-matched placebo injected subcut every 2 weeks

Study Details

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

Key Dates

Start date
Jan 29, 2026
Status verified
Jan 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2030

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
  • Experimental: Dupilumab

Primary Outcome Measure

Win ratio based on remission criteria [ Time Frame: Week 4 to Week 56 (except FEV1 change: Week 0 values serve as baseline) ]

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