DUPILUMAB for Severe asthma

Inclusion criteria

• {"criterion_text":"- Adult patients ≥ 18 years old"}
• {"criterion_text":"- Patients treated with dupilumab, prescribed by a pneumologist, for at least 36 months for severe asthma"}
• {"criterion_text":"- Well controlled asthma defined by an ACT score ≥ 18 and 0 or 1 exacerbation within the year prior to randomization"}
• {"criterion_text":"- Affiliated person or beneficiary of a social security scheme"}
• {"criterion_text":"- Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research)"}
• {"criterion_text":"- Effective contraception for women of childbearing age"}

Exclusion criteria

• {"criterion_text":"- Patients who refuse to discontinue dupilumab, for any reason"}
• {"criterion_text":"- Alcohol and/or drug misuse as determined by the investigator"}
• {"criterion_text":"- Pregnancy or breastfeeding"}
• {"criterion_text":"- Patient unwilling to sign the informed consent form"}
• {"criterion_text":"- Patient placed under juridical protection"}
• {"criterion_text":"- Patients with FEV1 ≤ 30% of predicted values"}
• {"criterion_text":"- Patients treated by an oral corticosteroid dose ≥ 10 mg/day (in prednisolone equivalent)"}
• {"criterion_text":"- Patients who have to discontinue dupilumab for a reason other than controlled asthma, such as an adverse drug reaction, a planned or current pregnancy, a medical condition requiring the discontinuation of dupilumab (e.g. in a context of the occurrence of helminthiasis), a planned or current vaccination with live and/or live- attenuated vaccine, or a planned switch to another biologic indicated in severe asthma"}
• {"criterion_text":"- Patients who have to continue dupilumab for the treatment of comorbidities apart from nasal polyposis"}
• {"criterion_text":"- Active smoking"}
• {"criterion_text":"- Patients whose compliance to asthma treatment is considered poor or doubtful by the investigator"}
• {"criterion_text":"- Patients participating in another interventional research study"}
• {"criterion_text":"- Patients with any condition that would prevent participation in the study and completion of the study procedures, including language limitation"}

Primary endpoints

• {"endpoint_text":"- The proportion of patients with strategy failure defined as patients with an annualised number of asthma exacerbations ≥ 2 and/or resumption of dupilumab or switch to another biologic within 24 months following randomisation","definition_or_measurement_approach":"Proportion of patients meeting strategy failure criteria within 24 months post-randomisation. Strategy failure defined as annualised asthma exacerbations ≥ 2 and/or resumption of dupilumab or switch to another biologic; measured over 24 months following randomisation."}

Secondary endpoints

• {"endpoint_text":"- To compare stopping dupilumab with its continuation regarding: a) the change in the asthma control test (ACT) score at 6, 12 and 24 months compared to baseline b) the time between baseline to loss of control defined with a reduction of 5 points or more on ACT score (compared to baseline) c) the time between baseline to the first exacerbation d) the number of exacerbations within 24 months e) the proportion of patients with ≥ 1 exacerbation and ≥ 1 severe exacerbation at 6, 12 and 24 months","definition_or_measurement_approach":"ACT score change at specified timepoints vs baseline; time-to-event analyses for loss of control (≥5 point ACT decrease) and time to first exacerbation; count of exacerbations within 24 months; proportions with ≥1 exacerbation and severe exacerbation at 6, 12, 24 months."}
• {"endpoint_text":"- The proportion of patients with resumption of dupilumab in the interventional group (stopping dupilumab) at 6, 12 and 24 months","definition_or_measurement_approach":"Proportion of patients in the stopping (interventional) arm who restart dupilumab at each timepoint (6, 12, 24 months)."}
• {"endpoint_text":"- The proportion of patients with AE or SAE in both groups","definition_or_measurement_approach":"Proportion of participants reporting adverse events (AEs) or serious adverse events (SAEs) in each arm during study follow-up (up to 24 months)."}

Other endpoints

• {"endpoint_text":"- Exploratory objectives are: 1/ to identify baseline factors associated to asthma loss of control at 6, 12 and 24 months for all included patients 2/ to identify biomarkers associated to asthma loss of control over the 24 months in a subset of patients included in high inclusion potential centres (≥ 10 patients) who will provide supplementary samples at baseline, 6, 12 and 24 months. Asthma loss of control is defined by either a/ number of annualised asthma exacerbations ≥ 2 or b/ resumption of dupilumab or switch to another biologic or c/ a decrease in the ACT score (at least 5 points), at 6, 12 and 24 months.","definition_or_measurement_approach":"Identify baseline predictors of loss of control at 6/12/24 months; biomarker associations assessed in subset providing additional samples at baseline, 6, 12, 24 months. Loss of control defined as annualised exacerbations ≥2, resumption of dupilumab or switch to another biologic, or ACT decrease ≥5 points."}

France

Earliest CTIS Part Ii Submission Date

08-11-2024

Latest Decision Or Authorization Date

11-02-2026

Processing Time Days

460

Number Of Sites

31

Number Of Participants

205

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Toulouse

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France