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NCT06637631RECRUITINGIRB Ready

A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease.

(SPECIFI-CD)

Sponsored by Sanofi

Quick Self-Assessment

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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 phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate to severe Crohn's Disease (CD). The primary objective of this study is to assess the efficacy of different doses of SAR441566 compared with placebo in participants with moderate to severe CD.

Who Can Participate

Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply: 1. Male or female participants aged 18 to 75 years at the time of signing the ICF 2. Confirmed diagnosis of CD for at least 3 months prior to Baseline 3. Confirmed diagnosis of moderate to severe CD as assessed by:
Crohn's Disease Activity Index (CDAI) score and the Simple Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader
stool frequency (SF), abdominal pain (AP) score 4. History of prior exposure to standard treatment (5-ASA, steroids, immunomodulators or antibiotics) or advanced therapies (biologics or small molecules), but having inadequate response to, loss or response to or intolerance to at least one of these therapies 5. On stable doses of standard treatments prior to screening (Oral 5-ASA compounds, Oral corticosteroids, AZA, 6-MP, or MTX ..) 6. Contraceptive use by men and women should be consistent with l

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

260 participants

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Age Range

18 Years - 75 Years

โšง

Gender

ALL

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Sponsor

Sanofi

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Sun City

Arizona

Location available
View Sun City location page
RECRUITING

Bristol

Connecticut

Location available
View Bristol location page
RECRUITING

Clermont

Florida

Location available
View Clermont location page
RECRUITING

Homestead

Florida

Location available
View Homestead location page
RECRUITING

Kissimmee

Florida

Location available
View Kissimmee location page
RECRUITING

Miami Lakes

Florida

Location available
View Miami Lakes location page
RECRUITING

Tampa

Florida

Location available
View Tampa location page
RECRUITING

Glenview

Illinois

Location available
View Glenview location page
RECRUITING

Gurnee

Illinois

Location available
View Gurnee location page

๐Ÿ“ And 9 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 Sun City?

Join others in Arizona exploring innovative treatment options through clinical research

Crohn's Disease Treatment Options in Sun City, Arizona

If you're searching for Crohn's Disease treatment in Sun City, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Sun City, Bristol, Clermont 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 Arizona
Now Enrolling
Up to 260 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: NCT06637631. 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.