Clinical trial NCT06637631: A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease.
Official title: A Phase 2, Multinational, Multicenter, Randomized, Doubleblind, Placebocontrolled, Dose-ranging Study to Evaluate the Efficacy and Safety of SAR441566 in Adults With Moderate to Severe Crohn's Disease.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Crohn's Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-10-15
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

This study will include a screening period of 4 weeks (+7 calendar days if needed), followed by the Main Study (MS) treatment period, lasting 52 weeks. The MS period include a Double-Blind (DB) treatment period with 12 weeks of induction followed by 40 weeks of maintenance. At the end of 52 weeks in the MS period, eligible participants from MS period will be offered a Double-Blind Maintenance Extension (DBME) period for up to 52 weeks.

Additionally, an Open Label (OL) period of up to 92 weeks will be offered to eligible participants. The combined duration of the DB maintenance and OL periods cannot exceed 92 weeks, while the sum of the DBME and OL periods may not exceed 52 weeks, depending on when participants switch.


Eligibility criteria: 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 local regulations regarding the methods of contraception for those participating in clinical studies. Women participants should not be pregnant or breastfeeding.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

1. Participants with active UC, indeterminate colitis or short bowel syndrome
2. Participants with CD isolated to the stomach, duodenum, jejunum, or peri anal region, without colonic or ileal involvement
3. Participants with following ongoing known complications of CD: fistula, abscess, symptomatic stricture/stenosis, fulminant colitis, toxic megacolon, recent bowel resection within 3 months of screening or history of \> 3 bowel resections
4. Participants with stool sample positive for infectious pathogens
5. Participants with active tuberculosis (TB) or a history of incompletely treated active or latent TB per local guidelines
6. Participants with Positive Hepatitis B surface antigen (HBsAg) or positive Hepatitis B core antibody (HBcAb); and/or positive Hepatitis C antibody (HCV) at the Screening Visit
7. Participants with any other active, chronic or recurrent infection, including recurrent or disseminated herpes zoster or disseminated herpes simplex
8. Participants with a known history of Human Immunodeficiency Virus (HIV) infection or positive HIV-1 or HIV-2 serology at screening
9. Participants presenting with active malignancies, lymphoproliferative disease, or recurrence of either, within the 5 years before screening
10. Participants with adenomatous colonic polyps or colonic mucosal dysplasia (low- or high grade) not excised or incompletely excised
11. Infection(s) requiring treatment with IV anti infectives within 30 days or oral/intramuscular anti-infectives within 14 days prior to the screening visit
12. Participants requiring or receiving any parental nutrition and/or exclusive enteral nutrition
13. Participants who received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to screening
14. Participants who received fecal microbial transplantation within 30 days prior to screening
15. Participants who have ever been exposed to natalizumab (Tysabri®) or oral carotegrast methyl (Carogra®)
16. Participants who received IV corticosteroids within 14 days prior to screening or during screening period
17. Participants who received therapeutic enema or suppository, other than required for colonoscopy within 14 days prior to screening or during screening
18. Screening laboratory and other analyses show abnormal results

Primary outcomes:
measure: Proportion of participants achieving endoscopic response
timeFrame: Week 12
Secondary outcomes:
measure: Proportion of participants achieving clinical remission based on Crohn's Disease Activity Index (CDAI)
timeFrame: Week 12
measure: Proportion of participants achieving Patient-Reported Outcome (PRO-2) remission
timeFrame: Week 12
measure: Proportion of participants achieving both clinical remission and endoscopic response
timeFrame: Week 12
measure: Proportion of participants achieving endoscopic remission based on centrally read SES-CD
timeFrame: From Baseline to Week 12
measure: Proportion of participants achieving CDAI clinical response
timeFrame: From Baseline to Week 12
measure: Proportion of participants achieving Inflammatory Bowel Disease Questionnaire (IBDQ) remission
timeFrame: Week 12
measure: Proportion of participants achieving IBDQ response
timeFrame: From baseline to Week 12
measure: Change from baseline in the IBDQ scores
timeFrame: From Baseline to week 12
measure: Plasma pre-dose concentrations of SAR441566 at selected visits
timeFrame: Up to week 104
measure: Plasma post-dose concentrations of SAR441566 at selected visits
timeFrame: Up to week 104
measure: Number of participants experiencing any TEAEs
timeFrame: Up to week 52
measure: Number of participants experiencing any TEAEs
timeFrame: From week 12 to week 104
Other outcomes:
Locations:
city: Bristol
country: United States
facility: Connecticut Clinical Research Institute- Site Number : 8400007
state: Connecticut
city: Kissimmee
country: United States
facility: Clinical Research of Osceola- Site Number : 8400013
state: Florida
city: Miami Lakes
country: United States
facility: Wellness Clinical Research - Miami Lakes- Site Number : 8400010
state: Florida
city: Glenview
country: United States
facility: GI Alliance - Glenview- Site Number : 8400015
state: Illinois
city: Gurnee
country: United States
facility: Illinois Gastroenterology Group- Site Number : 8400011
state: Illinois
city: Ann Arbor
country: United States
facility: University of Michigan Health System - Ann Arbor- Site Number : 8400017
state: Michigan
city: Flowood
country: United States
facility: GIA Alliance - Flowood - Site Number : 8400019
state: Mississippi
city: Las Vegas
country: United States
facility: Vector Clinical Trials- Site Number : 8400001
state: Nevada
city: New York
country: United States
facility: A1 Clinical Network- Site Number : 8400005
state: New York
city: Uniontown
country: United States
facility: Frontier Clinical Research - Uniontown- Site Number : 8400009
state: Pennsylvania
city: Katy
country: United States
facility: Vitality Digestive Institute Clinical Research- Site Number : 8400003
state: Texas
city: Southlake
country: United States
facility: Texas Digestive Disease Consultants - Southlake- Site Number : 8400002
state: Texas
city: Tacoma
country: United States
facility: Washington Gastroenterology - Tacoma- Site Number : 8400008
state: Washington
city: San Miguel de Tucumán
country: Argentina
facility: Investigational Site Number : 0320002
state: Tucumán
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320003
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320001
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320005
city: Sydney
country: Australia
facility: Investigational Site Number : 0360002
state: New South Wales
city: South Brisbane
country: Australia
facility: Investigational Site Number : 0360001
state: Queensland
city: Parkville
country: Australia
facility: Investigational Site Number : 0360003
state: Victoria
city: Salvador
country: Brazil
facility: Centro de Pesquisas da Clínica IBIS- Site Number : 0760001
state: Bahia
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento- Site Number : 0760006
state: Rio Grande Do Sul
city: Gorna Oryahovitsa
country: Bulgaria
facility: Investigational Site Number : 1000001
city: Calgary
country: Canada
facility: Investigational Site Number : 1240001
state: Alberta
city: Montreal
country: Canada
facility: Investigational Site Number : 1240003
state: Quebec
city: Québec City
country: Canada
facility: Investigational Site Number : 1240005
state: Quebec
city: Talcahuano
country: Chile
facility: Investigational Site Number : 1520004
state: Biobío
city: Santiago
country: Chile
facility: Investigational Site Number : 1520001
state: Reg Metropolitana De Santiago
city: Viña Del Mar
country: Chile
facility: Investigational Site Number : 1520002
state: Valparaíso
city: Santiago
country: Chile
facility: Investigational Site Number : 1520003
city: Changzhou
country: China
facility: Investigational Site Number : 1560008
city: Chongqing
country: China
facility: Investigational Site Number : 1560009
city: Fuzhou
country: China
facility: Investigational Site Number : 1560012
city: Guangzhou
country: China
facility: Investigational Site Number : 1560001
city: Guangzhou
country: China
facility: Investigational Site Number : 1560002
city: Hangzhou
country: China
facility: Investigational Site Number : 1560004
city: Hangzhou
country: China
facility: Investigational Site Number : 1560003
city: Hefei
country: China
facility: Investigational Site Number : 1560007
city: Nanchang
country: China
facility: Investigational Site Number : 1560011
city: Shanghai
country: China
facility: Investigational Site Number : 1560006
city: Shanghai
country: China
facility: Investigational Site Number : 1560005
city: Suzhou
country: China
facility: Investigational Site Number : 1560010
city: Osijek
country: Croatia
facility: Investigational Site Number : 1910004
city: Toulouse Cedex 9
country: France
facility: Investigational Site Number : 2500003
city: Vandoeuvre-les-nancy
country: France
facility: Investigational Site Number : 2500001
city: Tbilisi
country: Georgia
facility: Investigational Site Number : 2680002
city: Berlin
country: Germany
facility: Investigational Site Number : 2760004
city: Berlin
country: Germany
facility: Investigational Site Number : 2760002
city: Halle
country: Germany
facility: Investigational Site Number : 2760005
city: Roma
country: Italy
facility: Investigational Site Number : 3800008
state: Lazio
city: Milan
country: Italy
facility: Investigational Site Number : 3800009
state: Milano
city: Milan
country: Italy
facility: Investigational Site Number : 3800002
state: Milano
city: Rozzano
country: Italy
facility: Investigational Site Number : 3800004
state: Milano
city: Padua
country: Italy
facility: Investigational Site Number : 3800001
state: Padova
city: Rome
country: Italy
facility: Investigational Site Number : 3800006
state: Roma
city: Pisa
country: Italy
facility: Investigational Site Number : 3800005
city: Kashiwa
country: Japan
facility: Investigational Site Number : 3920004
state: Chiba
city: Sakura
country: Japan
facility: Investigational Site Number : 3920001
state: Chiba
city: Sapporo
country: Japan
facility: Investigational Site Number : 3920006
state: Hokkaido
city: Sapporo
country: Japan
facility: Investigational Site Number : 3920010
state: Hokkaido
city: Sapporo
country: Japan
facility: Investigational Site Number : 3920007
state: Hokkaido
city: Morioka
country: Japan
facility: Investigational Site Number : 3920008
state: Iwate
city: Takamatsu-shi
country: Japan
facility: Investigational Site Number : 3920019
state: Kagawa
city: Nagaoka
country: Japan
facility: Investigational Site Number : 3920020
state: Niigata
city: Osaka-shi
country: Japan
facility: Investigational Site Number : 3920002
state: Osaka
city: Bunkyo
country: Japan
facility: Investigational Site Number : 3920003
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Investigational Site Number : 3920011
state: Tokyo
city: Oita
country: Japan
facility: Investigational Site Number : 3920018
city: Wakayama
country: Japan
facility: Investigational Site Number : 3920012
city: Breda
country: Netherlands
facility: Investigational Site Number : 5280004
city: Nijmegen
country: Netherlands
facility: Investigational Site Number : 5280002
city: Tilburg
country: Netherlands
facility: Investigational Site Number : 5280001
city: Seville
country: Spain
facility: Investigational Site Number : 7240002
state: Sevilla
city: Akdeniz
country: Turkey
facility: Investigational Site Number : 7920001
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920003
city: Zonguldak
country: Turkey
facility: Investigational Site Number : 7920002
Study officials:
References: