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New treatment option for Asthma Control
Official title A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
ClinicalTrials.gov ID: NCT07309614
What this study is testing
What is Dupilumab Prefilled Syringe?
Dupilumab Prefilled Syringe is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for asthma control.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 24 months
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 79
You may be able to join 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
You likely can't join 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...
- 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...
- Presence of significant and uncorrectable inhaler technique deficiencies, as assessed by the research team during inhaler technique evaluation at...
See the full eligibility criteria
- 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...
- 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...
- Presence of one (or more) of the following additional risk factors for asthma attacks32 at screening or baseline: (i) uncontrolled asthma symptoms indicated by ACQ5 score of ≥ 1.5; (ii) impaired lung function indicated...
- Female participants a. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: i. Is a woman of nonchildbearing potential (WONCBP)...
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 4.2
- 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.
- Prohibited medication
The study team makes the final eligibility decision.
Where it's taking place
- Nedlands, Western Australia, Australia
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
- Sherbrooke, Quebec, Canada
- Oxford, Oxfordshire, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nedlands, Western Australia, Australia; Montreal, Quebec, Canada; Québec, Quebec, Canada; Sherbrooke, Quebec, Canada; Oxford, Oxfordshire, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.