Health TrialsbyHealthPanel

Withdrawal of Dupilumab in Severe Asthma

ConditionSevere Asthma
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse

About this trial

Asthma management has been revolutionised by the development of biological therapies. Dupilumab is an anti-interleukin4 receptor marketed in 2020 for severe asthmatic patients with 2 exacerbations or more within the last 12 months. Although data showed that safety and efficacy of dupilumab are sustained when treatment is extended up to 3 years, no study has emerged regarding dupilumab discontinuation. This study aims to demonstrate the non-inferiority regarding strategy failure at 24 months of stopping dupilumab (intervention group) compared with its continuation (control group) in controlled asthma patients receiving this drug for at least 3 years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients ≥ 18 years old

Treated with dupilumab for at least 36 months for severe asthma

Well controlled asthma defined by an Asthma Control Questionnaire score ≥ 18 and 0 or 1 exacerbation within the year prior to the inclusion visit

Disqualifiers

Patients who refuse to discontinue dupilumab, for any reason

Patients with Forced expiratory volume in one second ≤ 30% of predicted values

Patients treated by an oral corticosteroid dose ≥ 10 mg/day (in prednisone equivalent)

Patients who have to discontinue dupilumab for a reason other than controlled asthma, such as an adverse drug reaction, a planned or current pregnancy, or a planned switch to another biologic indicated in severe asthma

Trial design

Design model

Parallel

Treatments tested in this trial

  • Stopping dupilumab

    Drug

    Stopping dupilumab with no dose-reducing or interval of time-increasing strategy

Treatment groups

205 Participants
are divided into 2 treatment groups
Group A: Stopping dupilumabExperimental treatment 1 intervention
Group B: Dupilumab continuationNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Strategy failure

Proportion of patients with strategy failure defined as patients with an annualised number of asthma exacerbations ≥ 2 and/or dupilumab resume or switch to another biologic within 24 months following randomisation

Time frame
24 months

Secondary outcomes

1

Change in asthma control test score

Comparing the interventional group with the control group regarding the change in asthma control test score at 6, 12 and 24 months compared to baseline. The asthma control test score is a self-administered questionnaire consisting of 5 questions related to the frequency of asthma symptoms and the use of rescue treatments over the past 4 weeks. The score ranges from 5 (poorest control) to 25 (perfect control)

Time frame
6, 12 and 24 months
2

Resumption of dupilumab

Proportion of patients with resumption of dupilumab in the interventional group (stopping dupilumab) at 6, 12 and 24 months

Time frame
6, 12 and 24 months
3

Adverse events or serious adverse events

Proportion of patients with adverse events or serious adverse events in both groups

Time frame
24 months
4

Time to loss of control

Comparing the interventional group with the control group regarding the time between baseline to loss of control defined by a reduction of 5 points or more on asthma test control score

Time frame
24 months

Other outcomes

Sponsors and contacts

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

University Hospital, Toulouse

Lead sponsor

Source ClinicalTrials.gov
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