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

NCT06958536 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: DRI18450U1111-1306-75102024-517016-30-00
• Study Type: interventional
• Target: 99
• Locations: 12 countries
• Sites: 66

Brief Summary

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

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Percentage of participants who achieve endoscopic response at Week 16

  Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) \>50% from baseline (or a decrease of at least 2 points for subjects with a baseline score of 4 or more and isolated ileal disease) based on central reading. 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. 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.

  From Baseline to Week 16

Secondary Outcomes (18)

• Percentage of participants who achieve clinical remission based on Crohn's Disease Activity Index (CDAI) at Week 16

  At Week 16

• Percentage of participants who achieve PRO-2 (Patient Reported Outcome) clinical remission at Week 16

  At Week 16

• Percentage of participants who achieve endoscopic remission based on centrally read SES-CD at Week 16

  At Week 16

• Percentage of participants who achieve both clinical remission based on CDAI score and endoscopic response based on SES- CD at Week 16

  At Week 16

• Percentage of participants who achieve CDAI clinical response at Week 16

  At Week 16

Study Arms (3)

SAR442970 Dose Regimen A

EXPERIMENTAL

Participants will receive SAR442970 dose regimen A

Drug: SAR442970

SAR442970 Dose Regimen B

EXPERIMENTAL

Participants will receive SAR442970 dose regimen B

Drug: SAR442970

Placebo

PLACEBO COMPARATOR

Participants will receive placebo

Drug: Placebo

Interventions

SAR442970 DRUG

Route of Administration: Subcutaneous

SAR442970 Dose Regimen A; SAR442970 Dose Regimen B

Placebo DRUG

Route of Administration: Subcutaneous

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Crohn's Disease (CD) for at least 3 months prior to screening
• Confirmed diagnosis of moderate-to-severe CD
• History of prior exposure to standard treatment (5-Amino Salicylates (5-ASAs), steroids, immunomodulators or antibiotics) or advanced therapies (ATs) (biologics or small molecules), but having inadequate response to, loss or response to or intolerance to at least one of these therapies
• On stable doses of standard treatments prior to screening (Oral 5-ASA compounds, Oral corticosteroids, Azathioprine (AZA), 6-Mercaptopurine (6-MP), or Methotrexate (MTX), or Antibiotics, etc.)
• Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

You may not qualify if:

• Participants with active Ulcerative Colitis (UC), indeterminate colitis, adenomatous colonic polyps not excised, colonic mucosal dysplasia (low- or high-grade dysplasia) or short bowel syndrome
• Participants with CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement
• Participants with following ongoing known complications of CD:
• Any manifestation that might require bowel surgery while enrolled in the study
• Participant with ostomy or ileoanal pouch
• Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short bowel syndrome
• Participant with surgical bowel resection within the past three months prior to screening, or a history of \>3 bowel resections
• History of any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the study
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (66)

Investigational Site Number: 8400024

Tucson, Arizona, 85724, United States

RECRUITING

Investigational Site Number: 8400005

Escondido, California, 92025, United States

RECRUITING

Investigational Site Number: 8400001

Lancaster, California, 93534, United States

RECRUITING

Investigational Site Number: 8400017

Kissimmee, Florida, 34741, United States

RECRUITING

Investigational Site Number: 8400015

Lighthouse PT, Florida, 33064, United States

RECRUITING

Investigational Site Number 8400028

Miami, Florida, 33134, United States

RECRUITING

Investigational Site Number: 8400012

Miami, Florida, 33136, United States

RECRUITING

Investigational Site Number: 8400007

Orlando, Florida, 32804, United States

RECRUITING

Investigational Site Number: 8400011

Palmetto Bay, Florida, 33176, United States

RECRUITING

Investigational Site Number: 8400019

Marietta, Georgia, 30060, United States

RECRUITING

Investigational Site Number: 8400025

Iowa City, Iowa, 52242, United States

RECRUITING

Investigational Site Number: 8400006

Kansas City, Kansas, 66160, United States

RECRUITING

Investigational Site Number: 8400022

Boston, Massachusetts, 02115, United States

RECRUITING

Investigational Site Number: 8400008

Wyoming, Michigan, 49519, United States

RECRUITING

Investigational Site Number: 8400013

St Louis, Missouri, 63110, United States

RECRUITING

Investigational Site Number: 8400003

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Investigational Site Number: 8400009

Harrisburg, Pennsylvania, 17110, United States

RECRUITING

Investigational Site Number: 8400002

Fredericksburg, Texas, 78229, United States

RECRUITING

Investigational Site Number: 8400016

Ogden, Utah, 84405, United States

RECRUITING

Investigational Site Number: 8400027

Richmond, Virginia, 23249, United States

RECRUITING

Investigational Site Number: 0360002

Brisbane, Queensland, 4101, Australia

RECRUITING

Investigational Site Number: 0360004

Kurralta Park, South Australia, 5037, Australia

RECRUITING

Investigational Site Number: 0360001

Footscray, 3011, Australia

RECRUITING

Investigational Site Number: 0560001

Leuven, B-3000, Belgium

RECRUITING

Investigative Site: 1560003

Changsha, 410011, China

RECRUITING

Investigational Site Number: 1560008

Changsha, 410013, China

RECRUITING

Investigative Site: 1560005

Changzhou, 213003, China

RECRUITING

Investigational Site Number: 1560001

Guangzhou, 510655, China

RECRUITING

Investigational Site Number: 1560006

Hangzhou, 310009, China

RECRUITING

Investigative Site: 1560004

Nanchang, 330006, China

RECRUITING

Investigative Site: 1560002

Shanghai, 200092, China

RECRUITING

Investigational Site Number: 1560007

Shenyang, 110004, China

RECRUITING

Investigational Site Number: 2030002

Brno, JM, 61500, Czechia

RECRUITING

Investigational Site Number: 2030003

Hradec Králové, 50012, Czechia

RECRUITING

Investigational Site Number: 2030005

Slaný, 274 01, Czechia

RECRUITING

Investigational Site Number: 2500001

Montpellier, 34090, France

RECRUITING

Investigational Site Number: 2500003

Nice, 6000, France

RECRUITING

Investigational Site Number: 2500002

Toulouse, 31059, France

RECRUITING

Investigational Site Number: 2760002

Minden, Northwest, 32423, Germany

RECRUITING

Investigational Site Number: 2760003

Jena, 07747, Germany

RECRUITING

Investigational Site Number: 2760004

Kiel, 24105, Germany

RECRUITING

Investigational Site Number: 2760001

Ulm, 89081, Germany

RECRUITING

Investigational Site Number: 3920007

Kashiwa, Chiba, 277-0871, Japan

RECRUITING

Investigational Site Number: 3920005

Ōita, Oita Prefecture, 870-0033, Japan

RECRUITING

Investigational Site Number: 3920006

Hamamatsu, Shizuoka, 432-8061, Japan

RECRUITING

Investigational Site Number: 3920004

Bunkyō City, 113-8519, Japan

RECRUITING

Investigational Site Number: 3920003

Hamamatsu, 431-3192, Japan

RECRUITING

Investigational Site Number: 3920009

Hirosaki, 036-8545, Japan

RECRUITING

Investigational Site Number: 3920001

Morioka, 020-8505, Japan

RECRUITING

Investigational Site Number: 3920002

Nishinomiya, 663-8501, Japan

RECRUITING

Investigational Site Number: 6160002

Wroclaw, Lower Silesian Voivodeship, 53-149, Poland

RECRUITING

Investigational Site Number: 6160001

Krakow, 31-501, Poland

RECRUITING

Investigational Site Number: 6160005

Lublin, 20-582, Poland

RECRUITING

Investigational Site Number: 6160006

Sopot, 81-756, Poland

RECRUITING

Investigational Site Number: 6160008

Warsaw, 00-189, Poland

RECRUITING

Investigational Site Number: 6160003

Warsaw, 01-783, Poland

RECRUITING

Investigational Site Number: 6160004

Wroclaw, 54-206, Poland

RECRUITING

Investigational Site Number: 7100003

Johannesburg, 1619, South Africa

RECRUITING

Investigational Site Number: 7240002

Madrid, 28003, Spain

RECRUITING

Investigational Site Number: 7240001

Madrid, 28046, Spain

RECRUITING

Investigational Site Number: 7240003

Seville, 41009, Spain

RECRUITING

Investigational Site Number: 8260007

Bury, BL9 7TD, United Kingdom

RECRUITING

Investigational Site Number: 8260004

Cambridge, CB2 0QQ, United Kingdom

RECRUITING

Investigational Site Number: 8260005

London, E11 1NR, United Kingdom

RECRUITING

Investigational Site Number: 8260002

London, HA8 0AD, United Kingdom

RECRUITING

Investigational Site Number: 8260001

London, SE1 7EH, United Kingdom

RECRUITING

Related Links

• DRI18450 Plain Language Results Summary

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

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

CONTACT

800-633-1610; contact-us@sanofi.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 6, 2025
• Study Start: June 3, 2025
• Primary Completion (Estimated): December 17, 2026
• Study Completion (Estimated): October 17, 2029
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

GB (5); FR (3); ES (3); AU (3); PL (7); DE (4); CN (8); US (20); CZ (3); JP (8); BE (1); ZA (1)