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Comparing dupilumab with increased inhaled asthma medication for uncontrolled asthma

AIM4: Next Step - Asthma Uncontrolled With ICS in Medium Dose (GINA 4): Next Step; Efficacy of Dupilumab Added to Medium Dose ICS/LABA in Comparison to ICS Dose Escalation to High Dose ICS/LABA in Patients With Uncontrolled Asthma

Phase 4 Interventional Regeneron Pharmaceuticals · NCT06572228

This study is testing whether adding dupilumab to a medium dose of asthma medication helps people with uncontrolled asthma feel better compared to just increasing their current medication.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment250 (estimated)
Ages12 Years to 80 Years
SexAll
SponsorRegeneron Pharmaceuticals Industry-sponsored
Drugs / interventionsdupilumab
Locations84 sites (Bakersfield, California and 83 other locations)
Trial IDNCT06572228 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of dupilumab when added to a medium dose of inhaled corticosteroid and long-acting beta-agonist (ICS/LABA) compared to simply increasing the dose of ICS/LABA in patients with uncontrolled asthma. Participants must have been on a stable medium dose of ICS/LABA for at least three months and have a history of severe asthma exacerbations. The study will also assess the side effects associated with dupilumab. It is a Phase 4 clinical trial conducted in Canada and the United States, focusing on adolescent and adult patients.

Who should consider this trial

Good fit: Ideal candidates are adolescents and adults with a diagnosis of asthma for at least 12 months who are currently on a medium dose of ICS/LABA but still experience uncontrolled symptoms.

Not a fit: Patients who have well-controlled asthma or those not currently on a medium dose of ICS/LABA may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with uncontrolled asthma, potentially reducing symptoms and exacerbations.

How similar studies have performed: Other studies have shown promising results with dupilumab in asthma management, indicating that this approach may be effective.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

1. Diagnosis of asthma for ≥12 months, based on the Global Initiative for Asthma (GINA) 2023 guidance document
2. Existing treatment with medium dose ICS/LABA (\>250 to 500 μg/day of fluticasone propionate DPI or equivalent, per GINA 2023 guidance document) for at least 3 months with a stable dose ≥1 month prior to visit 1
3. Participants requiring a maximum of 3 controllers for their asthma will be considered eligible for this study
4. Pre-bronchodilator FEV1, as defined in the protocol
5. 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
6. Demonstrated adherence to medium dose ICS/LABA on at least 80% of days during the run-in period
7. ACQ-5 score ≥1.5 at screening (visit 1)
8. History of ≥1 severe exacerbation(s) in the previous year before visit 1, but not in the 30 days immediately preceding visit 1
9. Biomarker criteria: Baseline blood eosinophil count ≥300 cells/μL at visit 1 (\~90% of population), as defined in the protocol

Key Exclusion Criteria:

1. Diagnosis of chronic obstructive pulmonary disease (COPD) or other lung diseases which may impair lung function and interfere with treatment assessments
2. 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)
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
4. Weight is less than 30 kilograms
5. Current smoker or cessation of smoking within 6 months prior to visit 1 or previous smoker with a smoking history ≥10 pack-years
6. 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
7. 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 Inclusion/Exclusion criteria apply

Where this trial is running

Bakersfield, California and 83 other locations

+34 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions AsthmaUncontrolledSevere exacerbationsType 2 InflammationElevated blood eosinophilsIncreased Fractional exhaled Nitric OxideAtopy and elevated Immunoglobulin E
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.