Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06958536

A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease

Led by Sanofi · Updated on 2026-03-27

99

Participants Needed

66

Research Sites

228 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a phase 2b, randomized, double-blind, 3-arm study for the treatment of Crohn's disease. The primary objective of this study is to assess the efficacy of different doses of SAR442970 compared with placebo in participants with moderate to severe Crohn's disease. The total study duration is up to 168 weeks, with a treatment period of up to 158 weeks including an open-label (OL) long-term extension (LTE) period of up to 104 weeks for eligible participants.

CONDITIONS

Official Title

A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Crohn's Disease for at least 3 months prior to screening
  • Confirmed moderate-to-severe Crohn's Disease
  • History of prior exposure to standard treatments or advanced therapies with inadequate response, loss of response, or intolerance to at least one
  • On stable doses of standard treatments prior to screening
  • Contraceptive use consistent with local regulations for clinical study participants
Not Eligible

You will not qualify if you...

  • Active Ulcerative Colitis, indeterminate colitis, adenomatous colonic polyps not removed, colonic mucosal dysplasia, or short bowel syndrome
  • Crohn's Disease isolated to stomach, duodenum, jejunum, or perianal region without colonic or ileal involvement
  • Ongoing complications requiring bowel surgery during study
  • Presence of ostomy or ileoanal pouch
  • Conditions interfering with drug absorption, including short bowel syndrome
  • Surgical bowel resection within 3 months before screening or history of more than 3 bowel resections
  • Any other condition that may pose risk according to the Investigator's opinion

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 66 locations

1

Investigational Site Number: 8400024

Tucson, Arizona, United States, 85724

Actively Recruiting

2

Investigational Site Number: 8400005

Escondido, California, United States, 92025

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3

Investigational Site Number: 8400001

Lancaster, California, United States, 93534

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4

Investigational Site Number: 8400017

Kissimmee, Florida, United States, 34741

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5

Investigational Site Number: 8400015

Lighthouse PT, Florida, United States, 33064

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6

Investigational Site Number 8400028

Miami, Florida, United States, 33134

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7

Investigational Site Number: 8400012

Miami, Florida, United States, 33136

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8

Investigational Site Number: 8400007

Orlando, Florida, United States, 32804

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9

Investigational Site Number: 8400011

Palmetto Bay, Florida, United States, 33176

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10

Investigational Site Number: 8400019

Marietta, Georgia, United States, 30060

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11

Investigational Site Number: 8400025

Iowa City, Iowa, United States, 52242

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12

Investigational Site Number: 8400006

Kansas City, Kansas, United States, 66160

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13

Investigational Site Number: 8400022

Boston, Massachusetts, United States, 02115

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14

Investigational Site Number: 8400008

Wyoming, Michigan, United States, 49519

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15

Investigational Site Number: 8400013

St Louis, Missouri, United States, 63110

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16

Investigational Site Number: 8400003

Chapel Hill, North Carolina, United States, 27599

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17

Investigational Site Number: 8400009

Harrisburg, Pennsylvania, United States, 17110

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18

Investigational Site Number: 8400002

Fredericksburg, Texas, United States, 78229

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19

Investigational Site Number: 8400016

Ogden, Utah, United States, 84405

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20

Investigational Site Number: 8400027

Richmond, Virginia, United States, 23249

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21

Investigational Site Number: 0360002

Brisbane, Queensland, Australia, 4101

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22

Investigational Site Number: 0360004

Kurralta Park, South Australia, Australia, 5037

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23

Investigational Site Number: 0360001

Footscray, Australia, 3011

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24

Investigational Site Number: 0560001

Leuven, Belgium, B-3000

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25

Investigative Site: 1560003

Changsha, China, 410011

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26

Investigational Site Number: 1560008

Changsha, China, 410013

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27

Investigative Site: 1560005

Changzhou, China, 213003

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28

Investigational Site Number: 1560001

Guangzhou, China, 510655

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29

Investigational Site Number: 1560006

Hangzhou, China, 310009

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30

Investigative Site: 1560004

Nanchang, China, 330006

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31

Investigative Site: 1560002

Shanghai, China, 200092

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32

Investigational Site Number: 1560007

Shenyang, China, 110004

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33

Investigational Site Number: 2030002

Brno, JM, Czechia, 61500

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34

Investigational Site Number: 2030003

Hradec Králové, Czechia, 50012

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35

Investigational Site Number: 2030005

Slaný, Czechia, 274 01

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36

Investigational Site Number: 2500001

Montpellier, France, 34090

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37

Investigational Site Number: 2500003

Nice, France, 6000

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38

Investigational Site Number: 2500002

Toulouse, France, 31059

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39

Investigational Site Number: 2760002

Minden, Northwest, Germany, 32423

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40

Investigational Site Number: 2760003

Jena, Germany, 07747

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41

Investigational Site Number: 2760004

Kiel, Germany, 24105

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42

Investigational Site Number: 2760001

Ulm, Germany, 89081

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43

Investigational Site Number: 3920007

Kashiwa, Chiba, Japan, 277-0871

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44

Investigational Site Number: 3920005

Ōita, Oita Prefecture, Japan, 870-0033

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45

Investigational Site Number: 3920006

Hamamatsu, Shizuoka, Japan, 432-8061

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46

Investigational Site Number: 3920004

Bunkyō City, Japan, 113-8519

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47

Investigational Site Number: 3920003

Hamamatsu, Japan, 431-3192

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48

Investigational Site Number: 3920009

Hirosaki, Japan, 036-8545

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49

Investigational Site Number: 3920001

Morioka, Japan, 020-8505

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50

Investigational Site Number: 3920002

Nishinomiya, Japan, 663-8501

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51

Investigational Site Number: 6160002

Wroclaw, Lower Silesian Voivodeship, Poland, 53-149

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52

Investigational Site Number: 6160001

Krakow, Poland, 31-501

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53

Investigational Site Number: 6160005

Lublin, Poland, 20-582

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54

Investigational Site Number: 6160006

Sopot, Poland, 81-756

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55

Investigational Site Number: 6160008

Warsaw, Poland, 00-189

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56

Investigational Site Number: 6160003

Warsaw, Poland, 01-783

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57

Investigational Site Number: 6160004

Wroclaw, Poland, 54-206

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58

Investigational Site Number: 7100003

Johannesburg, South Africa, 1619

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59

Investigational Site Number: 7240002

Madrid, Spain, 28003

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60

Investigational Site Number: 7240001

Madrid, Spain, 28046

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61

Investigational Site Number: 7240003

Seville, Spain, 41009

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62

Investigational Site Number: 8260007

Bury, United Kingdom, BL9 7TD

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63

Investigational Site Number: 8260004

Cambridge, United Kingdom, CB2 0QQ

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64

Investigational Site Number: 8260005

London, United Kingdom, E11 1NR

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65

Investigational Site Number: 8260002

London, United Kingdom, HA8 0AD

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66

Investigational Site Number: 8260001

London, United Kingdom, SE1 7EH

Actively Recruiting

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Research Team

T

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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