Efficacy of Dupilumab Added to Medium Dose Inhaled Corticosteroid/Long-acting Beta-agonist (ICS/LABA) in Comparison to ICS Dose Escalation to High Dose ICS/LABA in Adolescent and Adult Patients with Uncontrolled Asthma

Phase 4

Recruiting

• Conditions: Asthma

• Registration Number: 2023-510458-18-00
• Lead Sponsor: Regeneron Pharmaceuticals Inc.

Brief Summary

To evaluate the efficacy of dupilumab added to medium dose ICS/LABA in reducing severe asthma exacerbations in comparison to ICS dose escalation to high dose ICS-LABA in participants with uncontrolled asthma

Detailed Description

This study is a Phase 3b in Canada Minors will not be enrolled in Denmark

Study Timeline

• Study First Submitted: 2024-08-23
• Study First Submitted QC: 2024-08-23
• Study Start: 2024-08-26
• Study First Posted: 2024-08-27
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-11
• Last Update Posted: 2025-07-14
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Not specified
• Target Recruitment: 62

Inclusion Criteria

Participants must be 12 to 80 years of age inclusive at the time of signing the informed consent/assent form with a physician diagnosis of asthma for ≥12 months, based on the Global Initiative for Asthma (GINA) 2023 guidance document

Note: Other protocol-defined Inclusion criteria apply

Existing treatment with medium dose ICS/LABA (>250 to 500 μg/day of fluticasone propionate DPI (dry powder inhaler) or equivalent, per GINA 2023 guidance document) for at least 3 months with a stable dose ≥1 month prior to visit 1

Participants requiring a maximum of 3 controllers for their asthma will be considered eligible for this study

Pre-bronchodilator FEV1, as defined in the protocol

Reversibility of at least 12% and 200 mL in FEV1 after the administration of 200 to 400 μg albuterol/salbutamol at screening OR a documented history of ≥20% reduction in the FEV1, as defined in the protocol

Demonstrated adherence to medium dose ICS/LABA on at least 80% of days during the run-in period

ACQ-5 score ≥1.5 at screening (visit 1)

History of ≥1 severe exacerbation(s) in the previous year before visit 1, but not in the 30 days immediately preceding visit 1

Biomarker criteria: Baseline blood eosinophil count ≥300 cells/μL at visit 1 (~90% of population), as defined in the protocol

Exclusion Criteria

Diagnosis of chronic obstructive pulmonary disease (COPD) or other lung diseases which may impair lung function and interfere with treatment assessments

Clinical evidence of lung disease(s) other than asthma or imaging (Chest X-ray, computed tomography [CT], magnetic resonance imaging [MRI]) with significant findings within 12 months of visit 1 and up to and including the baseline visit (visit 3)

A participant who experiences a severe asthma exacerbation at any time from 1 month prior to the screening visit (visit 1) up to and including the baseline visit (visit 3), as defined in the protocol

Weight is less than 30 kilograms

Current smoker or cessation of smoking within 6 months prior to visit 1 or previous smoker with a smoking history ≥10 pack-years

Severe concomitant illness(es) that, in the Investigator’s judgment, would adversely affect the participant’s participation in the study, as defined in the protocol

Participants cannot be on systemic corticosteroids at any time from 1 month prior to the screening visit (visit 1) through the duration of the run-in period

Note: Other protocol-defined Exclusion criteria apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Annualized severe asthma exacerbation rate		Annualized severe asthma exacerbation rate

Secondary Outcome Measures

Name	Time	Method
Change in pre-bronchodilator Forced Expiratory Volume in the first second (FEV1)		Change in pre-bronchodilator Forced Expiratory Volume in the first second (FEV1)
Annualized cumulative dose of systemic corticosteroid exposure to treat severe asthma exacerbations		Annualized cumulative dose of systemic corticosteroid exposure to treat severe asthma exacerbations
Change in Asthma Control Questionnaire (ACQ-5)		Change in Asthma Control Questionnaire (ACQ-5)
Proportion of participants achieving ACQ-5 <1.5		Proportion of participants achieving ACQ-5 <1.5
Change in pre-bronchodilator FEV1		Change in pre-bronchodilator FEV1
Change in percent of predicted FEV1		Change in percent of predicted FEV1
Change in peak expiratory flow (PEF)		Change in peak expiratory flow (PEF)
Change in forced vital capacity (FVC)		Change in forced vital capacity (FVC)
Change in forced expiratory flow (FEF) 25-75%		Change in forced expiratory flow (FEF) 25-75%
Change in FEV1:FVC ratio		Change in FEV1:FVC ratio
Change in post-bronchodilator FEV1		Change in post-bronchodilator FEV1
Time to first severe exacerbation event		Time to first severe exacerbation event
Proportion of participants achieving a 0.5-point improvement minimal clinically important difference (MCID) in ACQ-5		Proportion of participants achieving a 0.5-point improvement minimal clinically important difference (MCID) in ACQ-5
Incidence of Treatment-emergent adverse events (TEAEs)		Incidence of Treatment-emergent adverse events (TEAEs)

Trial Locations

Locations (80)

Kern Research, Inc; 🇺🇸 Bakersfield, California, United States

Modena Allergy & Asthma, Inc.; 🇺🇸 La Jolla, California, United States

Antelope Valley Clinical Trials; 🇺🇸 Lancaster, California, United States

Ark Clinical Research - Long Beach; 🇺🇸 Long Beach, California, United States

Newport Native Md, Inc.; 🇺🇸 Newport Beach, California, United States

Riviera Allergy Medical Center; 🇺🇸 Redondo Beach, California, United States

Raffi Tachdjian MD inc; 🇺🇸 Santa Monica, California, United States

Bensch Clinical Research; 🇺🇸 Stockton, California, United States

Integrated Research of Inland, Inc.; 🇺🇸 Upland, California, United States

Allianz Research Institute; 🇺🇸 Westminster, California, United States

Scroll for more (70 remaining)