Asthma Control study: Dupilumab Prefilled Syringe
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?
An investigational subcutaneous injection being studied for early asthma control in adults with moderate asthma. It is designed to block interleukin‑4 and interleukin‑13 signaling pathways to reduce airway inflammation.
Also referred to as Dupilumab.
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
- The study wants to see whether giving dupilumab early can lead to complete asthma control and prevent lung damage, compared to usual care.
- Who it's for
- Adults 18‑79 with moderate asthma who have had at least one steroid‑requiring attack in the past two years and high inflammation markers.
- What's involved
- Participants receive injections of dupilumab or a placebo every two weeks for one year, while continuing their normal asthma medicines. They visit the clinic every three months for breathing tests, questionnaires, and safety checks.
- Time commitment
- The study lasts one year, with clinic visits every three months.
- 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
- Participant must be 18-\<80 years of age at the time of signing the informed consent. Type of participant and disease characteristics
- 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)
- Peak flow variability of \>20% between two assessments
You likely can't join if
- 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...
- Contra-indication to study drug
See the full eligibility criteria
- Participant must be 18-\<80 years of age at the time of signing the informed consent. Type of participant and disease characteristics
- 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
- Peak flow variability of \>20% between two assessments
- 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.
- 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
- 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.
- 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
- 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 or fully resected Cervical Intraepithelial Neoplasia/dysplasia).
- 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
- Current helminth infection
The study team makes the final eligibility decision.
Where it is enrolling
- Nedlands, Western Australia, Australia
- Québec, Quebec, Canada
- Sherbrooke, Quebec, Canada
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
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, so 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, but 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?
This study is enrolling now at Nedlands, Western Australia, Australia; Québec, Quebec, Canada; Sherbrooke, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.