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

ConditionAsthma Control

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

150 Participants

are divided into 2 treatment groups

Group A: PlaceboPlacebo comparator 1 intervention

Group B: DupilumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Win ratio based on remission criteria

Win ratio comparing patients achieving clinical remission outcomes in dupilumab group vs placebo group, based on remission criteria. The unmatched paired testing will follow this hierarchy: 1. Study participant has not had a severe asthma attack between weeks 4 and 56 2. Number of asthma attacks between weeks 4 and 56 3. Improved or stable lung function (defined as a decline from parent study baseline in pre- or postbronchodilator FEV1 by no more than 5%) at Week 56 4. No more than medium-dose ICS maintenance therapy (as defined by GINA 2025) at Week 56 5. 5-item Asthma Control Questionnaire mean score \<1.5 at Week 56

Time frame

Week 4 to Week 56 (except FEV1 change: Week 0 values serve as baseline)

Secondary outcomes

Annualised severe asthma attack rate

Reduction in annualised severe asthma attack rate with dupilumab vs placebo

Time frame

Week 4 to Week 56

Win ratio for clinical remission in medium-dose ICS subgroup

Win ratio comparing remission outcomes in dupilumab vs placebo among patients on medium-dose ICS at enrolment. The unmatched paired testing will follow this hierarchy: 1. Study participant has not had a severe asthma attack between weeks 4 and 56 2. Number of asthma attacks between weeks 4 and 56 3. Improved or stable lung function (defined as a decline from parent study baseline in pre- or postbronchodilator FEV1 by no more than 5%) at Week 56 4. No more than medium-dose ICS maintenance therapy (as defined by GINA 2025) at Week 56 5. 5-item Asthma Control Questionnaire mean score \<1.5 at Week 56

Time frame

Week 4 to Week 56 (except FEV1 change: Week 0 values serve as baseline)

Change in FEV1 postbronchodilator

Change in FEV1 postbronchodilator (L) with dupilumab vs placebo

Time frame

Week 0 to Week 56

Proportion of patients achieving clinical remission at 1 year

Proportion of patients achieving clinical remission at 1 year in dupilumab vs placebo group Study participants meet ALL of the follow criteria at Week 56: 1. Study participant has not had a severe asthma attack between weeks 4 and 56 2. Improved or stable lung function (defined as a decline from parent study baseline in pre- or postbronchodilator FEV1 by no more than 5%) at Week 56 3. No more than medium-dose ICS maintenance therapy (as defined by GINA 2025) at Week 56 4. ACQ5 \<1.5 at Week 56

Time frame

Week 4 to Week 56 (except FEV1 change: Week 0 values serve as baseline)

Other outcomes

To describe exacerbation phenotypes and SCS-responsiveness in the dupilumab and placebo arms.

Change in FEV1 post-BD (L) following SCS treatment

Time frame

Pre- (day 1 of exacerbation, pre-treatment) and Post-treatment visit (day 7)

To evaluate safety of dupilumab in this population of patients

Incidence of treatment-emergent adverse events (TEAE) and serious adverse events (SAE) in treatment group vs placebo

Time frame

Week 0 to Week 56

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Source ClinicalTrials.gov

Apply now