Colitis UlcerativePhase 2SPECIFI-UCNCT06867094
A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis
A Phase 2 study testing SAR441566 in people with Colitis Ulcerative, run by Sanofi at 117 sites in 24 countries.
Trial 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 UC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colitis Ulcerative
- What is being tested?
- SAR441566
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 117 sitesin 24 countries
- Study dates
- 28 Mar 2025to 12 Oct 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Male or female participants aged 18 to 75 years inclusive, at the time of signing the informed consent
- Participants who have clinical evidence of active UC for ≥3 months before screening and confirmed by endoscopy during the screening period
- 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
- Must have received prior treatment for UC (either "a" or "b" below or a combination of both "a" and "b"):
- 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
- 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
- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Participants with active CD, indeterminate colitis, ischemic colitis, microscopic colitis
- 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
- Participant with prior colectomy, ostomy or ileoanal pouch, or anticipated colectomy during their participation in the study
- Participants with fecal sample positive for ova or parasites, bacterial pathogens, or positive for Clostridium difficile B toxin in stools
- Participants with active tuberculosis (TB) or a history of incompletely treated active TB or latent TB infection per local guidelines
Show all 21Show fewer
- 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
- Participants with any other active, chronic or recurrent infection, including recurrent or disseminated herpes zoster or disseminated herpes simplex
- Participants with a known history of human immunodeficiency virus (HIV) infection or positive HIV-1 or HIV-2 serology at screening
- Participants presenting with active malignancies, lymphoproliferative disease, or recurrence of either, within the 5 years before screening
- 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.
- 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.
- 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
- 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
- Participants requiring or receiving any parental nutrition and/or exclusive enteral nutrition
- Participants who received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to screening
- Participants who received fecal microbial transplantation within 30 days prior to screening
- Participants who have ever been exposed to natalizumab (Tysabri®) or oral carotegrast methyl (Carogra®)
- Participants who received IV corticosteroids within 14 days prior to screening or during screening period
- Screening laboratory and other analyses show abnormal results.
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Trial locations and contacts
117 sites in 24 countries.
117 sites in 24 countries
United States19 sites
University of Michigan Health System - Ann Arbor- Site Number : 8400010
Ann Arbor, Michigan, 48109
Bristol Hospital- Site Number : 8400017
Bristol, Connecticut, 06010
Medical University Of South Carolina - MUSC Health Ashley River Tower - ART- Site Number : 8400008
Charleston, South Carolina, 29401
Novum Research- Site Number : 8400018
Clermont, Florida, 34711
GI Alliance - Glenview- Site Number : 8400005
Glenview, Illinois, 60026
Illinois Gastroenterology Group- Site Number : 8400004
Gurnee, Illinois, 60031
Gastro Health & Nutrition- Site Number : 8400007
Katy, Texas, 77494
Clinical Research of Osceola- Site Number : 8400012
Kissimmee, Florida, 34741
NexGen Research- Site Number : 8400020
Lima, Ohio, 45805
SI Research Associates- Site Number : 8400019
Lubbock, Texas, 79424
Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400002
Miami Lakes, Florida, 33016
Icahn School of Medicine at Mount Sinai- Site Number : 8400001
New York, New York, 10029
Queens Village Primary Medical Center- Site Number : 8400011
Queens Village, New York, 11428
University of Washington Medical Center- Site Number : 8400014
Seattle, Washington, 98195
Texas Digestive Disease Consultants - Southlake- Site Number : 8400015
Southlake, Texas, 76092
GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400003
Sun City, Arizona, 85351
Washington Gastroenterology - Tacoma- Site Number : 8400009
Tacoma, Washington, 98405
GCP Clinical Research- Site Number : 8400016
Tampa, Florida, 33609
Frontier Clinical Research - Uniontown- Site Number : 8400006
Uniontown, Pennsylvania, 15401
Japan14 sites
Investigational Site Number : 3920002
Bunkyo-Ku, Tokyo, 113-8510
Investigational Site Number : 3920012
Hiroshima, 734-8530
Investigational Site Number : 3920016
Kagoshima, 892-0843
Investigational Site Number : 3920005
Kashiwa, Chiba, 277-0871
Investigational Site Number : 3920011
Kodaira, Tokyo, 187-8510
Investigational Site Number : 3920006
Kofu, Yamanashi, 400-0027
Investigational Site Number : 3920014
Kure, Hiroshima, 737-0811
Investigational Site Number : 3920001
Niigata, 950-1104
Investigational Site Number : 3920010
Osaka, 530-0011
Investigational Site Number : 3920003
Sapporo, Hokkaido, 004-0041
Investigational Site Number : 3920007
Sapporo, Hokkaido, 065-0033
Investigational Site Number : 3920015
Tokyo, 108-8642
Investigational Site Number : 3920009
Yahaba, Iwate, 028-3695
Investigational Site Number : 3920013
Yokohama, Kanagawa, 220-0041
Italy10 sites
Investigational Site Number : 3800007
Alessandria, 15100
Investigational Site Number : 3800006
Genoa, Genova, 16132
Investigational Site Number : 3800002
Milan, Milano, 20132
Investigational Site Number : 3800008
Naples, Napoli, 80131
Investigational Site Number : 3800001
Padua, Padova, 35128
Investigational Site Number : 3800009
Palermo, 90127
Investigational Site Number : 3800004
Pisa, 56124
Investigational Site Number : 3800011
Rome, Roma, 00161
Investigational Site Number : 3800003
Rozzano, Milano, 20089
Investigational Site Number : 3800010
Turin, Torino, 10126
China9 sites
Investigational Site Number : 1560002
Guangzhou, 510655
Investigational Site Number : 1560001
Hangzhou, 310016
Investigational Site Number : 1560003
Huizhou, 516001
Investigational Site Number : 1560017
Huizhou, 516001
Investigational Site Number : 1560004
Jiazhuang, 050000
Investigational Site Number : 1560014
Linhai, 317000
Investigational Site Number : 1560008
Luoyang, 471003
Investigational Site Number : 1560005
Shanghai, 200120
Investigational Site Number : 1560011
Wuhan, 430014
India8 sites
Investigational Site Number : 3560005
Hyderabad, 500082
Investigational Site Number : 3560003
Jaipur, 302001
Investigational Site Number : 3560009
Jaipur, 302004
Investigational Site Number : 3560002
Kolkata, 700020
Investigational Site Number : 3560004
Ludhiana, 141002
Investigational Site Number : 3560007
Secunderabad, 500003
Investigational Site Number : 3560001
Surat, 395002
Investigational Site Number : 3560010
Visakhapatnam, 530040
Germany7 sites
Investigational Site Number : 2760005
Berlin, 10117
Investigational Site Number : 2760008
Berlin, 14050
Investigational Site Number : 2760010
Duisburg, 47055
Investigational Site Number : 2760009
Frankfurt, 60590
Investigational Site Number : 2760003
Hanover, 30625
Investigational Site Number : 2760011
Tübingen, 72076
Investigational Site Number : 2760006
Ulm, 89081
Argentina5 sites
Investigational Site Number : 0320003
Buenos Aires, 1006
Investigational Site Number : 0320002
Buenos Aires, 1023
Investigational Site Number : 0320001
Buenos Aires, 1061
Investigational Site Number : 0320005
Buenos Aires, 1125
Investigational Site Number : 0320004
San Miguel de Tucumán, Tucumán Province, 4000
Poland5 sites
Investigational Site Number : 6160008
Oświęcim, Lesser Poland Voivodeship, 32-600
Investigational Site Number : 6160002
Rzeszów, Podkarpackie Voivodeship, 35-055
Investigational Site Number : 6160004
Warsaw, Masovian Voivodeship, 03-580
Investigational Site Number : 6160001
Warsaw, Masovian Voivodeship, 04-501
Investigational Site Number : 6160005
Wroclaw, Lower Silesian Voivodeship, 53-034
South Africa5 sites
Investigational Site Number : 7100002
Cape Town, 7405
Investigational Site Number : 7100001
Cape Town, 7708
Investigational Site Number : 7100004
KwaDukuza, 4449
Investigational Site Number : 7100003
Pretoria, 0002
Investigational Site Number : 7100005
Pretoria, 0157
Canada4 sites
Investigational Site Number : 1240006
Ajax, Ontario, L1S 7K7
Investigational Site Number : 1240004
Kentville, Nova Scotia, B4N 0A3
Investigational Site Number : 1240001
Québec, Quebec, G1N 4V3
Investigational Site Number : 1240005
Richmond Hill, Ontario, L4C 9M7
Bulgaria3 sites
Investigational Site Number : 1000001
Burgas, 8000
Investigational Site Number : 1000003
Rousse, 7002
Investigational Site Number : 1000002
Sofia, 1612
Chile3 sites
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, 7500010
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, 8330034
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, 8331143
France3 sites
Investigational Site Number : 2500003
Nice, 06202
Investigational Site Number : 2500001
Toulouse, 31059
Investigational Site Number : 2500002
Vandœuvre-lès-Nancy, 54511
Georgia3 sites
Investigational Site Number : 2680002
Tbilisi, 0144
Investigational Site Number : 2680003
Tbilisi, 0160
Investigational Site Number : 2680001
Tbilisi, 0180
Greece3 sites
Investigational Site Number : 3000001
Athens, 106 76
Investigational Site Number : 3000003
Athens, 124 62
Investigational Site Number : 3000002
Heraklion, 711 10
Turkey (Türkiye)3 sites
Investigational Site Number : 7920002
Istanbul, 34899
Investigational Site Number : 7920003
Izmir, 35100
Investigational Site Number : 7920001
Mersin, 33070
Australia2 sites
Investigational Site Number : 0360003
Kurralta Park, South Australia, 5037
Investigational Site Number : 0360005
Richmond, Victoria, 3121
Austria2 sites
Investigational Site Number : 0400002
Salzburg, 5020
Investigational Site Number : 0400001
Vienna, 1090
Belgium2 sites
Investigational Site Number : 0560002
Ghent, 9000
Investigational Site Number : 0560001
Leuven, 3000
Brazil2 sites
Hospital de Clinicas de Porto Alegre- Site Number : 0760002
Porto Alegre, Rio Grande do Sul, 90035903
Hospital Ernesto Dornelles- Site Number : 0760003
Porto Alegre, Rio Grande do Sul, 90160-093
Czechia2 sites
Investigational Site Number : 2030001
Olomouc, 779 00
Investigational Site Number : 2030002
Ostrava, 710 00
About this study
Official title: 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 Ulcerative Colitis
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 UC. The primary objective of this study is to assess efficacy of different doses of SAR441566 on clinical remission in participants with moderate-to-severe ulcerative colitis.
This study will include a screening period of up to 28 days (+ 7 calendar days if needed) followed by the main study treatment period of 52 weeks which will be comprised of a double blind (DB) treatment period with 12 weeks of induction period followed by a maintenance period of 40 weeks and 2-week follow-up after end of treatment.
Read more
Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants (for participants not enrolling in the LTS study).
- The study duration will be up to 59 weeks.
- The treatment duration will be up to 52 weeks in the DB arm and up to 40 weeks in the OL arm.
- The number of visits will be 12 for the main study treatment period and 8 for the OL treatment period.
- Conditions
- Colitis Ulcerative
- Being tested
- SAR441566, SAR441566 matching Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR441566Drug
Pharmaceutical form: Tablet Route of administration: Oral
SAR441566 matching PlaceboDrug
Pharmaceutical form: Tablet Route of administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| SAR441566 dose regimen 1 | Experimental | Participants will receive SAR441566 dose regimen 1 Receives: Drug: SAR441566 |
| SAR441566 dose regimen 2 | Experimental | Participants will receive SAR441566 dose regimen 2 Receives: Drug: SAR441566 |
| SAR441566 dose regimen 3 | Experimental | Participants will receive SAR441566 dose regimen 3 Receives: Drug: SAR441566 |
| Placebo | Placebo comparator | Participants will receive SAR441566-matching placebo Receives: Drug: SAR441566 matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving clinical remission at Week 12 by modified Mayo Score (mMS)
Clinical remission by modified Mayo score (mMS) is defined as a mMS ≤2 with no subscore >1 (stool frequency [SF] of 0 or 1 with at least a 1-point decrease from baseline, rectal bleeding [RB] of 0 and modified Mayo Endoscopic Subscore [mMES] of 0 or 1 where 1 does not include friability).
Each component of the mMS (SF, RB, and mMES) is scored from 0 to 3. The total mMS ranges from 0 to 9 with higher scores indicating greater disease severity.
Measured: Week 12
Secondary outcomes (15)
Proportion of participants achieving clinical response at Week 12 by modified Mayo Score (mMS)
Clinical response by modified Mayo score (mMS) is defined as a decrease from baseline in the mMS of ≥2 points and an improvement of ≥30% from baseline plus a decrease in rectal bleeding (RB) subscore ≥1 or an absolute RB subscore ≤1.
Each component of the mMS (SF, RB, and mMES) is scored from 0 to 3. The total mMS ranges from 0 to 9 with higher scores indicating greater disease severity.
Measured: Week 12
Proportion of participants achieving clinical response at Week 12 by full Mayo score (MS)
Clinical response by full Mayo score (MS) is defined as a decrease from baseline in the MS of ≥3 points and an improvement of ≥30% from baseline plus a decrease in rectal bleeding (RB) subscore ≥1 or an absolute RB subscore ≤1.
The MS (also referred to as the full Mayo Score) is a composite index designed to measure ulcerative colitis (UC) disease activity and consists of 4 subscores: RB and SF, which are patient-reported subscores, Physician's global assessment (PGA), and endoscopic findings. Individual items are rated 0 to 3, giving the composite score a maximum of 12, with higher scores indicating greater disease severity.
Measured: Week 12
Proportion of participants achieving clinical remission at Week 12 by full Mayo score (MS)
Clinical remission by full Mayo score (MS) is defined as a MS ≤2 with no score >1.
Measured: Week 12
Proportion of participants achieving the combination of patient-reported outcome 2 (PRO2) remission and endoscopic remission at Week 12
Patient-reported outcome 2 (PRO2) remission is defined as PRO2 score ≤1 with rectal bleeding (RB) of 0, and endoscopic remission is defined as mMES of 0.
PRO2 score is defined as the sum of Mayo SF and RB subscores.
Measured: Week 12
Proportion of participants achieving endoscopic remission at Week 12
Endoscopic remission is defined as mMES of 0.
Measured: Week 12
Change from baseline in PRO2 from randomization to Week 12
PRO2 score is defined as the sum of the Mayo SF and RB subscores.
Measured: From Baseline to Week 12
Proportion of participants achieving endoscopic response at Week 12
Endoscopic response is defined as mMES decrease of at least 1 point.
Measured: Week 12
Proportion of participants achieving endoscopic improvement at Week 12
Endoscopic improvement is defined as mMES of 0 or 1 where 1 does not include friability.
Measured: Week 12
Proportion of participants achieving HEMI at Week 12
Histologic endoscopic mucosal improvement (HEMI) is defined by achievement of modified Mayo endoscopic improvement (mMES of 0 or 1 where 1 does not include friability) and histological improvement (original Geboes Score [OGS] ≤3.1).
Measured: Week 12
Plasma predose concentrations of SAR441566 at selected visits
Measured: Up to Week 52
Plasma postdose concentrations of SAR441566 at selected visits
Measured: Up to Week 52
Number of participants with any treatment-emergent adverse events (TEAEs) during induction and maintenance treatment period
Measured: Up to Week 52
Number of participants with any treatment-emergent adverse events (TEAEs) during open-label treatment period
Measured: From Week 12 to Week 52
Proportion achieving Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 12
Inflammatory Bowel Disease Questionnaire (IBDQ) remission is considered as an IBDQ-32 total score ≥170 points.
IBDQ is designed to capture the patient's experience of IBD on 4 domains of functioning and well-being: bowel and systemic symptoms and emotional and social function. The total IBDQ score ranges from 32 to 224 which indicates better quality of life.
Measured: Week 12
Proportion of participants achieving Inflammatory Bowel Disease Questionnaire (IBDQ) response at Week 12
Inflammatory Bowel Disease Questionnaire (IBDQ) response is defined as an increase from baseline in the total IBDQ score in the range of 16 to 32 points.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start28 Mar 2025
- Primary completion6 Aug 2026
- Study completion12 Oct 2026
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis UlcerativeStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867094
- Sponsor's protocol ID
- DRI17822
- Other IDs
- U1111-1308-9729, 2025-520705-12, 2025
- Acronym
- SPECIFI-UC
- Status last verified
- Oct 2026
- First submitted
- 4 Mar 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org