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NCT06572228RECRUITINGIRB Ready

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

(AIM4:Next Step)

Sponsored by Regeneron Pharmaceuticals

Quick Self-Assessment

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Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

This study is researching a drug called dupilumab. The study is focused on patients who have uncontrolled asthma. Asthma is a condition where the airways narrow and swell, making it difficult to breathe. Uncontrolled asthma means that patients are still having frequent symptoms while taking their current asthma medication.

Who Can Participate

Inclusion Criteria

Diagnosis of asthma for โ‰ฅ12 months, based on the Global Initiative for Asthma (GINA) 2023 guidance document 2. Existing treatment with medium dose ICS/LABA (\>250 to 500 ฮผg/day of fluticasone propionate DPI or equivalent, per GINA 2023 guidance document) for at least 3 months with a stable dose โ‰ฅ1 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 ฮผg albuterol/salbutamol at screening OR a documented history of โ‰ฅ20% 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 โ‰ฅ1.5 at screening (visit 1) 8. History of โ‰ฅ1 severe exacerbation(s) in the previous year before visit 1, but not in the 30 days immediately preceding visit 1

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

250 participants

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Age Range

12 Years - 80 Years

โšง

Gender

ALL

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Sponsor

Regeneron Pharmaceuticals

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Bakersfield

California

Location available
View Bakersfield location page
RECRUITING

La Jolla

California

Location available
View La Jolla location page
RECRUITING

Lancaster

California

Location available
View Lancaster location page
RECRUITING

Long Beach

California

Location available
View Long Beach location page
RECRUITING

Newport Beach

California

Location available
View Newport Beach location page
RECRUITING

Orange

California

Location available
View Orange location page
WITHDRAWN

Redondo Beach

California

Location available
View Redondo Beach location page
RECRUITING

Santa Monica

California

Location available
View Santa Monica location page
RECRUITING

Stockton

California

Location available
View Stockton location page

๐Ÿ“ And 46 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Uncontrolled Asthma Treatment in Bakersfield?

Join others in California exploring innovative treatment options through clinical research

Uncontrolled Asthma Treatment Options in Bakersfield, California

If you're searching for Uncontrolled Asthma treatment in Bakersfield, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Bakersfield, La Jolla, Lancaster and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Uncontrolled Asthma. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 250 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Uncontrolled Asthma?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Uncontrolled Asthma

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Uncontrolled Asthma Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06572228. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.