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

NCT07309614 | Recruiting Phase 3 DMC

• 1 other identifier: 2024ESR0000238
• Study Type: interventional
• Target: 150
• Locations: 3 countries
• Sites: 5

Brief 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

Keywords

Asthma; Asthma control; moderate asthma; dupilumab; remission; type-2 inflammation; blood eosinophils; feno; exacerbations; trial; RCT

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (18)

• Annualised severe asthma attack rate

  Week 4 to Week 56

• Win ratio for clinical remission in medium-dose ICS subgroup

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

• Change in FEV1 postbronchodilator

  Week 0 to Week 56

• Proportion of patients achieving clinical remission at 1 year

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

• Effect of dupilumab on corticosteroid use, compared to placebo

  Week 0 to Week 56

Other Outcomes (2)

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

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

• To evaluate safety of dupilumab in this population of patients

  Week 0 to Week 56

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo Injection

Dupilumab

EXPERIMENTAL

Drug: Dupilumab Prefilled Syringe

Interventions

Dupilumab Prefilled Syringe DRUG

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

Dupilumab

Placebo Injection DRUG

Volume-matched placebo injected subcut every 2 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Study participants are eligible to be included in the study only if all of the following criteria apply:
• Age
• Participant must be 18-\<80 years of age at the time of signing the informed consent.
• Type of participant and disease characteristics
• Physician diagnosis of asthma (according to GINA 2025) for ≥6 months, with documented historical airflow variability by one of the following:
• 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
• Peak flow variability of \>20% between two assessments
• Evidence of elevated type-2 biomarkers defined as both of:
• peripheral BEC ≥ 0.3×109/L at screening visit
• FeNO ≥ 35 ppb at screening visit
• At least 1 asthma attack in the last 2 years, defined as acute asthma requiring SCS for ≥ 3 days or an emergency/hospital visit requiring SCS.
• Treatment and evident adherence to a stable at-least medium-dose ICS (fluticasone propionate equivalent \>250 mcg/day) for at least 3 months (including run-in period) \[additional controllers e.g. LABA, LAMA or LTA are allowed\]. The ICS dosage will be defined as the dosage received on a regularly basis, excluding extra reliever doses taken in the context of anti-inflammatory reliever (AIR) therapy from the calculation. AIR is allowed in the context of the study. Thus, the high-dose ICS trial population (fluticasone propionate equivalent \>500 mcg/day)\* will represent patients who are not meeting the exacerbation criteria for biological reimbursement.
• \*As per section 6.2, we will cap recruitment to 60% of target population on medium-dose ICS, 40% on high-dose ICS, with randomisation also stratified by these categories.

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Medical conditions
• 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.
• Presence of significant and uncorrectable inhaler technique deficiencies, as assessed by the research team during inhaler technique evaluation at screening.
• Contra-indication to study drug
• Immunological disease, condition or medication that may affect the inflammatory response according to Investigator.
• History of other significant lung disease e.g. lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, clinically significant bronchiectasis, chronic obstructive lung disease, or Churg-Strauss.
• Severe concomitant illness (including known or suspected immunodeficiency) that, in the Investigator's judgement will adversely affect the participant's participation in the study.
• Active malignancy or history of malignancy within 5 years (except for basal cell carcinoma of the skin).
• Exposure to monoclonal antibody therapy for asthma or another investigational medicinal product within 5 half-lives of the drug.
• Eligibility to Dupilumab based on licensed and reimbursed indications in the participant's jurisdiction (e.g. nasal polyposis, atopic dermatitis, eosinophilic esophagitis, prurigo nodularis, etc.)
• Treatment with live (attenuated) vaccine in the past 4 weeks.

Sponsors & Collaborators

• Université de Sherbrooke: lead
• 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

Study Sites (5)

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

NOT YET RECRUITING

McGill University Health Centre

Montreal, Quebec, H4A 3S5, Canada

NOT YET RECRUITING

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

NOT YET RECRUITING

CIUSSS de l'Estrie- CHUS

Sherbrooke, Quebec, J1H 5H6, Canada

RECRUITING

Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blinded study assessing intervention versus placebo

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 30, 2025
• Study Start: January 29, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: March 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE

Locations

CA (3); GB (1); AU (1)