A study to investigate efficacy and safety of SAR441566 in patients with ulcerative colitis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sanofi-Aventis Recherche & Developpement

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

24 Jun 2025 → ongoing

Decision date (initial)

2025-06-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Sanofi-Aventis Recherche & Developpement

External identifiers

EU CT number

2025-520705-12-00

WHO UTN

U1111-1308-9729

ClinicalTrials.gov

NCT06867094

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Pharmacodynamic, Dose response, Safety, Efficacy

To assess efficacy of different doses of SAR441566 on clinical remission in participants with moderate-to-severe Ulcerative Colitis (UC)

Secondary objectives 10

1. To assess the effect of different doses of SAR441566 on clinical response in participants with moderate-to-severe UC
2. To assess the effect of different doses of SAR441566 on clinical remission in participants with moderate-to-severe UC
3. To assess the effect of different doses of SAR441566 on patient-reported outcomes (PRO) remission and endoscopic remission
4. To assess the effect of different doses of SAR441566 on endoscopic remission in participants with moderate-to-severe UC
5. To assess the effect of different doses of SAR441566 on PRO/signs and symptoms of UC
6. To assess the effect of different doses of SAR441566 on endoscopic response or improvement in participants with moderate-to-severe UC
7. To assess efficacy of different doses of SAR441566 in participants with moderate-to-severe UC on histologic improvement (based on histologic endoscopic mucosal improvement [HEMI])
8. To assess pharmacokinetic (PK) of different doses of SAR441566 in participants with moderate-to-severe UC
9. To assess the safety and tolerability of different doses of SAR441566 in participants with moderate-to-severe UC
10. To assess the effect of different dose of SAR441566 on inflammatory bowel disease questionnaire (IBDQ) response and remission in participants with moderate-to-severe UC

Conditions and MedDRA coding

Colitis Ulcerative

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Male or female participants aged 18 to 75 years inclusive, at the time of signing the informed consent
2. Participants who have clinical evidence of active UC for ≥3 months before screening and confirmed by endoscopy during the screening period
3. Active moderate-to-severe UC at screening as defined by a modified Mayo Score (mMS) of 5 to 9 (without the Physician global Assessment (PGA), with a minimum rectal bleeding (RB) subscore ≥1, a minimum stool frequency (SF) subscore ≥1, a mMES ≥2 confirmed by central reader, a minimum sum of all subscores of 5, and a disease extent >15 cm from the anal verge
4. · Must have received prior treatment for UC (either “a” or “b” below or a combination of both “a” and “b”): a) History of no prior exposure to approved Advanced Therapy (AT), but having inadequate response to, loss of response to or intolerance to standard treatment with any of the following : 5-ASA, thiopurines (eg.6-MP, AZA), MTX, oral or intravenous (IV) corticosteroids or history of corticosteroid dependence (defined an inability to successfully taper corticosteroids without recurrence of UC) OR b) History of inadequate response to, loss of response to or intolerance to treatment with ≥1 approved AT such as a biologic agent (eg. TNF antagonists, anti-integrin other than natalizumab, anti-IL-12/23, anti-IL-23, or a small molecule (such as a JAKi or S1PRm) for UC
5. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion criteria 19

1. Participants with active CD, indeterminate colitis, ischemic colitis, microscopic colitis
2. If the participant has extensive colitis for ≥8 years or disease limited to left side of colon (ie, distal to splenic flexure) for >10 years, regardless of age, a colonoscopy within 1 year of the screening visit is required to survey for dysplasia. Participants with dysplasia or cancer identified on biopsies will be excluded.
3. Female participants who is pregnant, breastfeeding, or is considering becoming pregnant during the study or within 3 months after the last dose of study drug
4. Infection(s) requiring treatment with IV anti-infectives within 30 days prior to the screening visit or oral/intramuscular anti-infectives within 14 days prior to the screening visit
5. Participants requiring or receiving any parental nutrition and/or exclusive enteral nutrition
6. Participants who received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to screening
7. Participants who received fecal microbial transplantation within 30 days prior to screening
8. Participants who have ever been exposed to natalizumab (Tysabri®) or oral carotegrast methyl (Carogra®)
9. Participants who received IV corticosteroids within 14 days prior to screening or during screening period
10. Screening laboratory and other analyses show abnormal results
11. Participants with the following ongoing known complications of UC: fulminant colitis, toxic megacolon, or any other manifestation that might require bowel surgery while enrolled in the study
12. Participant with prior colectomy, ostomy or ileoanal pouch, or anticipated colectomy during their participation in the study
13. Participants with fecal sample positive for ova or parasites, bacterial pathogens, or positive for Clostridium difficile B toxin in stools
14. Participants with active tuberculosis (TB) or a history of incompletely treated active TB or latent TB infection per local guidelines
15. Participants with Positive Hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) and/or hepatitis C virus antibody (HCVAb) at the screening visit
16. Participants with any other active, chronic or recurrent infection, including recurrent or disseminated herpes zoster or disseminated herpes simplex
17. Participants with a known history of human immunodeficiency virus (HIV) infection or positive HIV-1 or HIV-2 serology at screening
18. Participants presenting with active malignancies, lymphoproliferative disease, or recurrence of either, within the 5 years before screening
19. History of gastro-intestinal dysplasia other than completely removed low grade dysplasia OR presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during endoscopy by the time of the screening visit

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of participants achieving clinical remission at Week 12 by modified Mayo Score (mMS)

Secondary endpoints 15

1. Proportion of participants achieving clinical response at Week 12 by modified Mayo Score (mMS)
2. Proportion of participants achieving clinical response at Week 12 by full Mayo score (MS)
3. Proportion of participants achieving clinical remission at Week 12 by full Mayo score (MS)
4. Proportion of participants achieving the combination of patient-reported outcome 2 (PRO2) remission and endoscopic remission at Week 12
5. Proportion of participants achieving endoscopic remission at Week 12
6. Change from baseline in PRO2 from randomization to Week 12
7. Proportion of participants achieving endoscopic response at Week 12
8. Proportion of participants achieving endoscopic improvement at Week 12
9. Proportion of participants achieving HEMI at Week 12
10. Plasma predose concentrations of SAR441566 at selected visits
11. Plasma postdose concentrations of SAR441566 at selected visits
12. Number of participants with any treatment-emergent adverse events (TEAEs) during induction and maintenance treatment period
13. Number of participants with any reatment-emergent adverse events (TEAEs) during open-label treatment period
14. Proportion achieving Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 12
15. Proportion of participants achieving Inflammatory Bowel Disease Questionnaire (IBDQ) response at Week 12

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sanofi-Aventis Recherche & Developpement

Sponsor organisation

Sanofi-Aventis Recherche & Developpement

Address

82 Avenue Raspail

City

Gentilly

Postcode

94250

Country

France

Scientific contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Sciences and Operations

Public contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Sciences and Operations

Third parties 13

Locations

12 EU/EEA countries · 48 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 156 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications