An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma

Sanofi

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Dupilumab; Drug: Levosalbutamol/levalbuterol; Drug: Salbutamol/albuterol; Drug: ICS/LABA therapy; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01854047

DRI12544

2013-000856-16 (EudraCT Number)

U1111-1138-3962 (Other Identifier)

Details and patient eligibility

About

Primary Objective:

To evaluate the efficacy of different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma.

Secondary Objective:

To evaluate different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma, with regard to:

• Safety and tolerability
• Dupilumab systemic exposure and anti-drug antibodies

Full description

Total duration per participant of approximately 43 weeks including a screening period (14-21 days), a randomized treatment period (24 weeks), and a post-treatment period (16 weeks).

Enrollment: 776 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Participants with a physician diagnosis of moderate to severe, uncontrolled asthma for >=12 months, based on the Global Initiative for Asthma (GINA) 2009 Guidelines and:

• Existing treatment with moderate or high-dose inhaled corticosteroid / long-acting beta-2 agonist
• Forced expiratory volume (FEV1) 40 to 80% of predicted normal
• Asthma Control Questionnaire, 5-question version (ACQ-5) score >=1.5
• Reversibility of at least 12% and 200 mL in forced expiratory volume (FEV1)
• Had experienced, within prior year: hospitalization, emergency or urgent care visit or systemic corticosteroid treatment for worsening asthma

Exclusion criteria

• Participants <18 years
• Chronic obstructive pulmonary disease (COPD) or other lung diseases (eg, emphysema, idiopathic pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis) which impaired pulmonary function tests
• Chest X-ray within 12 months of screening visit or at screening visit with clinically significant findings of lung disease(s) other than asthma
• Current smoker or cessation of smoking within 6 months prior to Visit 1
• Previous smoker with a smoking history >10 pack-years

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

776 participants in 5 patient groups, including a placebo group

Dupilumab 300 mg q2w

Experimental group

Description:

2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable inhaled corticosteroid/ long-acting beta-agonist (ICS/LABA) therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.

Treatment:

Drug: Salbutamol/albuterol

Drug: ICS/LABA therapy

Drug: Levosalbutamol/levalbuterol

Drug: Dupilumab

Dupilumab 200 mg q2w

Experimental group

Description:

2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.

Treatment:

Drug: Salbutamol/albuterol

Drug: ICS/LABA therapy

Drug: Levosalbutamol/levalbuterol

Drug: Dupilumab

Dupilumab 300 mg q4w

Experimental group

Description:

2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.

Treatment:

Drug: placebo

Drug: Salbutamol/albuterol

Drug: ICS/LABA therapy

Drug: Levosalbutamol/levalbuterol

Drug: Dupilumab

Dupilumab 200 mg q4w

Experimental group

Description:

2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.

Treatment:

Drug: placebo

Drug: Salbutamol/albuterol

Drug: ICS/LABA therapy

Drug: Levosalbutamol/levalbuterol

Drug: Dupilumab

Placebo q2w

Placebo Comparator group

Description:

2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.

Treatment:

Drug: placebo

Drug: Salbutamol/albuterol

Drug: ICS/LABA therapy

Drug: Levosalbutamol/levalbuterol