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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
7/01/2025

Titles & IDs
Public title
A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease.
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.
Secondary ID [1] 0 0
2024-512633-32-00
Secondary ID [2] 0 0
DRI18212
Universal Trial Number (UTN)
Trial acronym
SPECIFI-CD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants achieving endoscopic response
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Proportion of participants achieving clinical remission based on Crohn's Disease Activity Index (CDAI)
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Proportion of participants achieving Patient-Reported Outcome (PRO-2) remission
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
Proportion of participants achieving both clinical remission and endoscopic response
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
Proportion of participants achieving endoscopic remission based on centrally read SES-CD
Timepoint [4] 0 0
From Baseline to Week 12
Secondary outcome [5] 0 0
Proportion of participants achieving CDAI clinical response
Timepoint [5] 0 0
From Baseline to Week 12
Secondary outcome [6] 0 0
Proportion of participants achieving Inflammatory Bowel Disease Questionnaire (IBDQ) remission
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
Proportion of participants achieving IBDQ response
Timepoint [7] 0 0
From baseline to Week 12
Secondary outcome [8] 0 0
Change from baseline in the IBDQ scores
Timepoint [8] 0 0
From Baseline to week 12
Secondary outcome [9] 0 0
Plasma pre-dose concentrations of SAR441566 at selected visits
Timepoint [9] 0 0
Up to week 104
Secondary outcome [10] 0 0
Plasma post-dose concentrations of SAR441566 at selected visits
Timepoint [10] 0 0
Up to week 104
Secondary outcome [11] 0 0
Number of participants experiencing any TEAEs
Timepoint [11] 0 0
Up to week 52
Secondary outcome [12] 0 0
Number of participants experiencing any TEAEs
Timepoint [12] 0 0
From week 12 to week 104

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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/12/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
23/05/2029
Actual
Sample size
Target
260
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Investigational Site Number : 0360001 - South Brisbane
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Pennsylvania

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT06637631
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Transparency email recommended (Toll free for US & Canada)
Address 0 0
Country 0 0
Phone 0 0
800-633-1610
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06637631