Efficacy and Safety Study of Dupilumab in Patients With Persistent Asthma

Sanofi

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Dupilumab SAR231893; Drug: Asthma Controller Therapies (include prednisone/prednisolone); Drug: Placebo; Drug: Asthma Reliever Therapies

Study type: Interventional

Funder types: Industry

Identifiers

NCT03782532

2022-002375-11 (EudraCT Number)

U1111-1175-0772 (Other Identifier)

EFC13995

Details and patient eligibility

About

Primary Objective:

To evaluate the efficacy of dupilumab in patients with persistent asthma

Secondary Objectives:

• To evaluate the safety and tolerability of dupilumab
• To evaluate the effect of dupilumab on improving patient reported outcomes including health related quality of life
• To evaluate dupilumab systemic exposure and immunogenicity

Full description

The total duration of study per patient is approximately 40 weeks, including 3 to 5 weeks of screening period, 24 weeks of treatment period and 12 weeks of post-treatment period.

Enrollment: 486 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria :

• Adults and adolescent patients (≥12 years of age) with a physician diagnosis of asthma for ≥12 months, based on the Global Initiative for Asthma 2017 Guidelines and the following criteria:
• Patients requiring a third controller for their asthma will be considered eligible for this study, and it should also be used for at least 3 months with a stable dose ≥1 month prior to the screening visit (Visit 1).
• Patients requiring maintenance oral corticosteroids (OCS) with a stable dose ≤10 mg/day prednisone or equivalent will be allowed; OCS should be used for at least 3 months with a stable dose ≥1 month prior to the screening visit (Visit 1).
• Pre-bronchodilator FEV1 ≤ 80% of predicted normal for adults and ≤90% of predicted normal for adolescents at the screening visit and the randomization visit (Visits 1 and 2), prior to randomization.
• Asthma Control Questionnaire 5-question version (ACQ-5) score ≥1.5 at the screening visit and the randomization visit (Visits 1 and 2), prior to randomization.
• For patients not requiring maintenance OCS, screening blood eosinophil count ≥150 cells/μL or Fractional Exhaled Nitric Oxide (FENO) ≥25 parts per billion (ppb); for patients requiring maintenance OCS, there is no minimum requirement for blood eosinophil count and FENO level.

Exclusion criteria:

• Patients <12 years of age or the minimum legal age for adolescents in the country of the investigative site, whichever is higher (for those countries where local regulations permit enrollment of adults only, patient recruitment will be restricted to those who are ≥18 years of age).
• Weight is less than 30 kg at the screening visit (Visit 1) or the randomization visit (Visit 2).
• Chronic obstructive pulmonary disease or other lung diseases (eg, idiopathic pulmonary fibrosis) which may impair lung function.
• A patient who experiences a severe asthma exacerbation (defined as deterioration of asthma that results in emergency treatment, hospitalization due to asthma, treatment with systemic steroids, or treatment with systemic steroid at least twice the previous dose for patients on OCS maintenance) at any time from 1 month prior to the screening visit (Visit 1) up to and including the randomization visit (Visit 2).
• Evidence of lung disease(s) other than asthma, either clinical or imaging evidence (eg, chest X-ray, computed tomography, and magnetic resonance imaging) within 3 months prior to the screening visit (Visit 1) as per local standard of care.
• Current smoker or cessation of smoking within 6 months prior to the screening visit (Visit 1).
• Previous smoker with a smoking history >10 pack-years.
• Comorbid disease that might interfere with the evaluation of investigational medicinal product (IMP).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

486 participants in 2 patient groups, including a placebo group

Dupilumab

Experimental group

Description:

For patients without oral corticosteroids (OCS) maintenance therapy, dose 1 of dupilumab administered once in 2 weeks (q2w) with loading dose of dupilumab, two times dose 1; for patients on OCS maintenance therapy, the dose will be dupilumab dose 2 q2w with loading dose 2 times dose 2

Treatment:

Drug: Dupilumab SAR231893

Drug: Asthma Controller Therapies (include prednisone/prednisolone)

Drug: Asthma Reliever Therapies

Placebo for dupilumab

Placebo Comparator group

Description:

For patients without OCS maintenance therapy, the patients will take placebo matching to dupilumab dose 1 q2w with loading dose; for patients on OCS maintenance therapy, the patients will take placebo matching to dupilumab dose 2 q2w with loading dose

Treatment:

Drug: Placebo

Drug: Asthma Controller Therapies (include prednisone/prednisolone)

Drug: Asthma Reliever Therapies