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NCT06456593RECRUITINGIRB Ready

Efficacy and Safety of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease

(ENHANCE-CD)

Sponsored by Abivax S.A.

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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 has 3 treatment phases, a 12-Week Induction Phase, a 40-Week Maintenance Phase, and a 48-Week Extension Phase. The objective is to evaluate the efficacy and safety of obefazimod compared to placebo as induction and maintenance therapy in subjects with moderately to severely active CD after inadequate response (no response, loss of response, or intolerance) to conventional therapies and/or advanced therapies.

Who Can Participate

Inclusion Criteria

Male or female (at birth) 18 to 75 years old and able to understand, sign, and date the written voluntary informed consent at the visit prior to any protocol-specified procedures 2. Able and willing to comply with study visits and procedures as per protocol. 3. Confirmed and documented diagnosis of CD based on endoscopy and histology reports. 4. Moderately to severely active CD as defined by 220 โ‰ค CDAI โ‰ค 450 and SES-CD โ‰ฅ 6 for ileo-colonic or colonic disease or SES-CD โ‰ฅ 4 for isolated ileal disease (per central reading). 5. Documented inadequate response (defined as lack of response or loss of response or intolerance) to at least one of the following treatments: corticosteroids (CS), immunosuppressants (IS), biologic or biosimilar therapies, or janus kinase (JAK) (note: failure to only 5-aminosalicylic acid \[5-ASA\] is not accepted) 6. Women of childbearing potential (WOCBP) and male subjects with WOCBP partner must agree to comply with contraception requiremen

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

212 participants

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Age Range

18 Years - 75 Years

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Gender

ALL

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Sponsor

Abivax S.A.

Study Locations

Choose your preferred location or select flexible during enrollment

NOT_YET_RECRUITING

Fairhope

Alabama

Location available
View Fairhope location page
NOT_YET_RECRUITING

Scottsdale

Arizona

Location available
View Scottsdale location page
RECRUITING

Sun City

Arizona

Location available
View Sun City location page
NOT_YET_RECRUITING

Irvine

California

Location available
View Irvine location page
RECRUITING

Murrieta

California

Location available
View Murrieta location page
RECRUITING

Colorado Springs

Colorado

Location available
View Colorado Springs location page
RECRUITING

Brandon

Florida

Location available
View Brandon location page
RECRUITING

Clearwater

Florida

Location available
View Clearwater location page
RECRUITING

Lakeland

Florida

Location available
View Lakeland location page

๐Ÿ“ And 34 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 Crohn's Disease Treatment in Fairhope?

Join others in Alabama exploring innovative treatment options through clinical research

Crohn's Disease Treatment Options in Fairhope, Alabama

If you're searching for Crohn's Disease treatment in Fairhope, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Fairhope, Scottsdale, Sun City 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 Crohn's Disease. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Alabama
Now Enrolling
Up to 212 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Crohn's Disease?

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 Crohn's Disease

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 Crohn's Disease 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: NCT06456593. 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.