Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06637631
Registration number
NCT06637631
Ethics application status
Date submitted
10/10/2024
Date registered
15/10/2024
Date last updated
8/07/2025
Titles & IDs
Public title
A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease.
Query!
Scientific 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.
Query!
Secondary ID [1]
0
0
2024-512633-32-00
Query!
Secondary ID [2]
0
0
DRI18212
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
SPECIFI-CD
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease
0
0
Query!
Condition category
Condition code
Oral and Gastrointestinal
0
0
0
0
Query!
Inflammatory bowel disease
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Oral and Gastrointestinal
0
0
0
0
Query!
Crohn's disease
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - SAR441566
Treatment: Drugs - SAR441566 matching Placebo
Experimental: SAR441566 dose 1 - Participants will receive SAR441566 dose 1.
Experimental: SAR441566 dose 2 - Participants will receive SAR441566 dose 2.
Experimental: SAR441566 dose 3 - Participants will receive SAR441566 dose 3.
Placebo comparator: Placebo - Participants will receive SAR441566 matching placebo.
Treatment: Drugs: SAR441566
Pharmaceutical form: Tablet Route of administration: Oral
Treatment: Drugs: SAR441566 matching Placebo
Pharmaceutical form: Tablet Route of administration: Oral
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Proportion of participants achieving endoscopic response
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Week 12
Query!
Secondary outcome [1]
0
0
Proportion of participants achieving clinical remission based on Crohn's Disease Activity Index (CDAI)
Query!
Assessment method [1]
0
0
CDAI clinical remission is defined as CDAI score \<150. CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease.
Query!
Timepoint [1]
0
0
Week 12
Query!
Secondary outcome [2]
0
0
Proportion of participants achieving Patient-Reported Outcome (PRO-2) remission
Query!
Assessment method [2]
0
0
PRO 2 remission is defined as the unweighted CDAI component of daily abdominal pain (AP) score =1, and the unweighted CDAI component of daily average stool frequency (SF) score =3 (ie, AP =1 and SF =3 and no worsening from baseline).
Query!
Timepoint [2]
0
0
Week 12
Query!
Secondary outcome [3]
0
0
Proportion of participants achieving both clinical remission and endoscopic response
Query!
Assessment method [3]
0
0
Clinical remission and endoscopic response based on CDAI \<150 and =50% reduction from baseline in centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD)
Query!
Timepoint [3]
0
0
Week 12
Query!
Secondary outcome [4]
0
0
Proportion of participants achieving endoscopic remission based on centrally read SES-CD
Query!
Assessment method [4]
0
0
Endoscopic remission is defined as a centrally read SES-CD =4 points (SES-CD =2 points for isolated ileal disease) and a SES-CD decrease from baseline =2 points with no SES-CD sub score \>1 point
Query!
Timepoint [4]
0
0
From Baseline to Week 12
Query!
Secondary outcome [5]
0
0
Proportion of participants achieving CDAI clinical response
Query!
Assessment method [5]
0
0
CDAI clinical response is defined as a CDAI reduction from baseline =100 points.
Query!
Timepoint [5]
0
0
From Baseline to Week 12
Query!
Secondary outcome [6]
0
0
Proportion of participants achieving Inflammatory Bowel Disease Questionnaire (IBDQ) remission
Query!
Assessment method [6]
0
0
IBDQ remission is defined as IBDQ total score =170 points. The Inflammatory Bowel Disease Questionnaire (IBDQ) is used to assess health-related quality of life (HRQoL) in patients with inflammatory bowel disease. It consists of 32 questions evaluating bowel and systemic symptoms, as well as emotional and social functions. Each question is answered on a scale from 1 (worst) to 7 (best). The total score ranges from 32 to 224 with higher scores indicating better health-related quality of life.
Query!
Timepoint [6]
0
0
Week 12
Query!
Secondary outcome [7]
0
0
Proportion of participants achieving IBDQ response
Query!
Assessment method [7]
0
0
IBDQ response defined as an improvement of IBDQ scores by 27 points or more at Week 12 compared with baseline
Query!
Timepoint [7]
0
0
From baseline to Week 12
Query!
Secondary outcome [8]
0
0
Change from baseline in the IBDQ scores
Query!
Assessment method [8]
0
0
The total IBDQ score ranges from 32 to 224 which indicates better quality of life. A positive change from Baseline indicates improvement.
Query!
Timepoint [8]
0
0
From Baseline to week 12
Query!
Secondary outcome [9]
0
0
Plasma pre-dose concentrations of SAR441566 at selected visits
Query!
Assessment method [9]
0
0
Query!
Timepoint [9]
0
0
Up to week 104
Query!
Secondary outcome [10]
0
0
Plasma post-dose concentrations of SAR441566 at selected visits
Query!
Assessment method [10]
0
0
Query!
Timepoint [10]
0
0
Up to week 104
Query!
Secondary outcome [11]
0
0
Number of participants experiencing any TEAEs
Query!
Assessment method [11]
0
0
Any TEAEs, including any serious opportunistic infections, psoriasiform skin lesions or other immune mediated phenomena during double-blind (DB) induction and maintenance treatment period
Query!
Timepoint [11]
0
0
Up to week 52
Query!
Secondary outcome [12]
0
0
Number of participants experiencing any TEAEs
Query!
Assessment method [12]
0
0
Any TEAEs, including any serious opportunistic infections, psoriasiform skin lesions or other immune mediated phenomena during double-blind maintenance extension and open-label treatment periods
Query!
Timepoint [12]
0
0
From week 12 to week 104
Query!
Eligibility
Key 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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
10/12/2024
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
23/05/2029
Query!
Actual
Query!
Sample size
Target
260
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
Investigational Site Number : 0360002 - Sydney
Query!
Recruitment hospital [2]
0
0
Investigational Site Number : 0360001 - South Brisbane
Query!
Recruitment hospital [3]
0
0
Investigational Site Number : 0360003 - Parkville
Query!
Recruitment postcode(s) [1]
0
0
2139 - Sydney
Query!
Recruitment postcode(s) [2]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [3]
0
0
3050 - Parkville
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Connecticut
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Illinois
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Michigan
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Mississippi
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Nevada
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
New York
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
North Carolina
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Pennsylvania
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Texas
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Washington
Query!
Country [13]
0
0
Argentina
Query!
State/province [13]
0
0
Tucumán
Query!
Country [14]
0
0
Argentina
Query!
State/province [14]
0
0
Buenos Aires
Query!
Country [15]
0
0
Brazil
Query!
State/province [15]
0
0
Bahia
Query!
Country [16]
0
0
Brazil
Query!
State/province [16]
0
0
Rio Grande Do Sul
Query!
Country [17]
0
0
Bulgaria
Query!
State/province [17]
0
0
Gorna Oryahovitsa
Query!
Country [18]
0
0
Canada
Query!
State/province [18]
0
0
Alberta
Query!
Country [19]
0
0
Canada
Query!
State/province [19]
0
0
Quebec
Query!
Country [20]
0
0
Chile
Query!
State/province [20]
0
0
BiobÃo
Query!
Country [21]
0
0
Chile
Query!
State/province [21]
0
0
Reg Metropolitana De Santiago
Query!
Country [22]
0
0
Chile
Query!
State/province [22]
0
0
ValparaÃso
Query!
Country [23]
0
0
Chile
Query!
State/province [23]
0
0
Santiago
Query!
Country [24]
0
0
China
Query!
State/province [24]
0
0
Changzhou
Query!
Country [25]
0
0
China
Query!
State/province [25]
0
0
Chongqing
Query!
Country [26]
0
0
China
Query!
State/province [26]
0
0
Fuzhou
Query!
Country [27]
0
0
China
Query!
State/province [27]
0
0
Guangzhou
Query!
Country [28]
0
0
China
Query!
State/province [28]
0
0
Hangzhou
Query!
Country [29]
0
0
China
Query!
State/province [29]
0
0
Hefei
Query!
Country [30]
0
0
China
Query!
State/province [30]
0
0
Nanchang
Query!
Country [31]
0
0
China
Query!
State/province [31]
0
0
Shanghai
Query!
Country [32]
0
0
China
Query!
State/province [32]
0
0
Suzhou
Query!
Country [33]
0
0
Croatia
Query!
State/province [33]
0
0
Osijek
Query!
Country [34]
0
0
Czechia
Query!
State/province [34]
0
0
Olomouc
Query!
Country [35]
0
0
France
Query!
State/province [35]
0
0
Montpellier
Query!
Country [36]
0
0
France
Query!
State/province [36]
0
0
Nice
Query!
Country [37]
0
0
France
Query!
State/province [37]
0
0
Toulouse Cedex 9
Query!
Country [38]
0
0
France
Query!
State/province [38]
0
0
Vandoeuvre-les-nancy
Query!
Country [39]
0
0
Georgia
Query!
State/province [39]
0
0
Kutaisi
Query!
Country [40]
0
0
Georgia
Query!
State/province [40]
0
0
Tbilisi
Query!
Country [41]
0
0
Germany
Query!
State/province [41]
0
0
Berlin
Query!
Country [42]
0
0
Germany
Query!
State/province [42]
0
0
Halle
Query!
Country [43]
0
0
Italy
Query!
State/province [43]
0
0
Lazio
Query!
Country [44]
0
0
Italy
Query!
State/province [44]
0
0
Milano
Query!
Country [45]
0
0
Italy
Query!
State/province [45]
0
0
Padova
Query!
Country [46]
0
0
Italy
Query!
State/province [46]
0
0
Roma
Query!
Country [47]
0
0
Italy
Query!
State/province [47]
0
0
Pisa
Query!
Country [48]
0
0
Japan
Query!
State/province [48]
0
0
Chiba
Query!
Country [49]
0
0
Japan
Query!
State/province [49]
0
0
Hokkaido
Query!
Country [50]
0
0
Japan
Query!
State/province [50]
0
0
Iwate
Query!
Country [51]
0
0
Japan
Query!
State/province [51]
0
0
Kagawa
Query!
Country [52]
0
0
Japan
Query!
State/province [52]
0
0
Niigata
Query!
Country [53]
0
0
Japan
Query!
State/province [53]
0
0
Osaka
Query!
Country [54]
0
0
Japan
Query!
State/province [54]
0
0
Tokyo
Query!
Country [55]
0
0
Japan
Query!
State/province [55]
0
0
Oita
Query!
Country [56]
0
0
Japan
Query!
State/province [56]
0
0
Wakayama
Query!
Country [57]
0
0
Korea, Republic of
Query!
State/province [57]
0
0
Busan-gwangyeoksi
Query!
Country [58]
0
0
Korea, Republic of
Query!
State/province [58]
0
0
Daejeon-gwangyeoksi
Query!
Country [59]
0
0
Mauritius
Query!
State/province [59]
0
0
Quatre Bornes
Query!
Country [60]
0
0
Netherlands
Query!
State/province [60]
0
0
Breda
Query!
Country [61]
0
0
Netherlands
Query!
State/province [61]
0
0
Nijmegen
Query!
Country [62]
0
0
Netherlands
Query!
State/province [62]
0
0
Tilburg
Query!
Country [63]
0
0
Netherlands
Query!
State/province [63]
0
0
Utrecht
Query!
Country [64]
0
0
Spain
Query!
State/province [64]
0
0
Sevilla
Query!
Country [65]
0
0
Turkey
Query!
State/province [65]
0
0
Istanbul
Query!
Country [66]
0
0
Turkey
Query!
State/province [66]
0
0
Mersin
Query!
Country [67]
0
0
Turkey
Query!
State/province [67]
0
0
Zonguldak
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Sanofi
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT06637631
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Trial Transparency email recommended (Toll free for US & Canada)
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
800-633-1610
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06637631
Download to PDF