NCT06637631 · Sanofi
A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease.
(SPECIFI-CD)
What this study is about
This is a phase 2, multinational, conducted at multiple hospitals, randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment, dose-ranging study to evaluate the effectiveness and safety of SAR441566 in adults with moderate to severe Crohn's Disease (CD).
View original scientific description
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.
Interventions
DRUG
SAR441566
Pharmaceutical form: Tablet Route of administration: Oral
DRUG
SAR441566 matching Placebo
Pharmaceutical form: Tablet Route of administration: Oral
Primary outcome measures
Proportion of participants achieving endoscopic response
Time frame: Week 12
Endoscopic response is defined as ≥50% reduction from baseline in centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD). The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Sun City, Arizona
- Bristol, Connecticut
- Clermont, Florida
- Homestead, Florida
- Kissimmee, Florida
- Miami Lakes, Florida
- Tampa, Florida
- Glenview, Illinois
- Gurnee, Illinois
- Ann Arbor, Michigan
- Flowood, Mississippi
- Las Vegas, Nevada
And 7 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
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.
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.
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.
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.
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.
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.
Data: ClinicalTrials.gov · synced Jun 12, 2026 · Source of record for eligibility and locations