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NCT06790121RECRUITINGIRB Ready

A Study to Investigate the Efficacy and Safety of Subcutaneous Lunsekimig (SAR443765) Compared With Placebo in Adult Participants With Moderate-to-severe Atopic Dermatitis

Sponsored by Sanofi

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 144 participants interested
1% interest

Express Your Interest Today

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 is a parallel, Phase 2b, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of lunsekimig monotherapy in adult participants (aged 18 to 80 years, inclusive) with moderate-to-severe atopic dermatitis (AD).

Who Can Participate

Inclusion Criteria

Participants must be 18 to 80 years of age, inclusive, at the time of signing the informed consent.
Diagnosis of Atopic Dermatitis (AD) as defined by the American Academy of Dermatology (AAD) clinical guidelines (2023) for 1 year or longer at baseline (Day 1)
Documented history within 6 months prior to Screening Visit, of either inadequate response or inadvisability of topical treatments
Eczema Area and Severity Index (EASI) score of 16 or higher (range, 0 to 72) at baseline (Day 1)
Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score of 3 or 4 at baseline visit (Day 1) (on the 0 to 4 vIGA-AD scale, a vIGA-AD score of 3 and 4 represents moderate and severe, respectively).
AD involvement of 10% or more of Body Surface Are (BSA) at baseline (Day 1)
Weekly average of daily Peak Pruritis-Numerical Rating (PP-NRS) score of โ‰ฅ4 at baseline (Day 1)
Must have applied a stable dose of topical bland emollient (simple moisturizer

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

๐Ÿ‘ฅ

Target Enrollment

144 participants

๐ŸŽ‚

Age Range

18 Years - 80 Years

โšง

Gender

ALL

๐Ÿข

Sponsor

Sanofi

Study Locations

Choose your preferred location or select flexible during enrollment

Unknown

Encino

California

Location available
View Encino location page
Unknown

Sacramento

California

Location available
View Sacramento location page
Unknown

Thousand Oaks

California

Location available
View Thousand Oaks location page
Unknown

Boca Raton

Florida

Location available
View Boca Raton location page
Unknown

Coral Gables

Florida

Location available
View Coral Gables location page
Unknown

Evans

Georgia

Location available
View Evans location page
Unknown

Boise

Idaho

Location available
View Boise location page
Unknown

New Albany

Indiana

Location available
View New Albany location page
Unknown

Plainfield

Indiana

Location available
View Plainfield location page

๐Ÿ“ And 14 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 Atopic Dermatitis Treatment in Encino?

Join others in California exploring innovative treatment options through clinical research

Atopic Dermatitis Treatment Options in Encino, California

If you're searching for Atopic Dermatitis treatment in Encino, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Encino, Thousand Oaks, Boca Raton 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 Atopic Dermatitis. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 144 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Atopic Dermatitis?

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 Atopic Dermatitis

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 Atopic Dermatitis 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: NCT06790121. 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.