AzTrials
AzTrials

Colitis UlcerativePhase 2RESOLUTENCT05588843

Dose-finding Study of SAR443122 in Adult Participants With Ulcerative Colitis

A Phase 2 study testing SAR443122 in people with Colitis Ulcerative, run by Sanofi at 106 sites in 19 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a randomized, double-blind, placebo controlled, dose-ranging Phase 2 study. The primary objective is to evaluate the efficacy and safety of SAR443122 compared to placebo in participants 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?
SAR443122
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
187 participants
Where
106 sitesin 19 countries
Study dates
25 Nov 2022to 2 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 who have clinical evidence of active Ulcerative Colitis [UC] for ≥3 months before screening as confirmed by endoscopy during the screening period.
  • Participants must have a minimum disease extent of 15 centimeters from the anal verge.
  • Participants are inadequate or non-responders, have shown loss of response, or are intolerant to at least 1 of following approved treatments: amino-salicylate, corticosteroids, immunosuppressants or biologics other than natalizumab (Tysabri®) or small molecules.
  • Participants on corticosteroids must be on a stable dose ≥2 weeks prior to screening and during screening period.
  • Participants on methotrexate, azathioprine or 6- mercaptopurine must be on treatment for at least 8 weeks prior to screening; and on a stable dose ≥4 weeks prior to screening and during screening period.
  • Participants on oral 5-aminosalicylates, mesalamine or sulfasalazine must be on a stable dose for ≥4 weeks prior to screening and during screening period.
  • Participants on advanced therapies must have 1) last administration at least 5 half-lives prior to randomization, or 2) undetectable level of the biologic in their blood prior to randomization.
  • 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.

Who cannot join

  • Participants with Crohn's Disease (CD).
  • Participants with diagnosis of indeterminate colitis or microscopic colitis.
  • Participants with stool sample positive for culture for aerobic pathogens or C difficile.
  • Participants with prior colectomy or anticipated colectomy during their participation in the study.
  • Participants with presence of ileal pouch or ostomy.
  • Participants with fulminant disease or toxic megacolon.
Show all 37Show fewer
  • Participants with colonic dysplasia except for adenoma.
  • Participants with intestinal failure or short bowel syndrome requiring Total Parenteral Nutrition (TPN).
  • Participants with history of recurrent or recent serious infection that has not resolved within 4 weeks prior to randomization.
  • Participants presenting with active malignancies or recurrence of malignancy within the 5 years before screening.
  • Participants with a history or presence of another significant illness that according to the investigator's judgment would adversely affect the subject's ability to participate in this study.
  • Participants presenting with fever (≥38°C) or persistent chronic or active recurring infection within 4 weeks prior to the Screening Visit requiring treatment with antibiotics, antivirals, or any history of frequent recurrent infections deemed unacceptable per investigator's judgment.
  • Participants who were administered any live (attenuated) vaccine within 3 months prior to the randomization Visit.
  • Participants with a history of recurrent herpes zoster.
  • Participants with uncontrolled diabetes, defined as HbA1c ≥9.0% at the Screening Visit.
  • Participants with active tuberculosis (TB) or non-tuberculous mycobacterial infection, or a history of incompletely treated active or latent TB per local guidelines will be excluded from the study unless it is documented by a specialist that the participant has been adequately treated and can now start treatment with the RIPK1 kinase inhibitor.
  • Participants presenting with opportunistic infections within six months prior to screening or while receiving anti-TNF treatment in the last 6 months.
  • Participants undergoing hemodialysis or peritoneal dialysis.
  • Participants with a known history of Human Immunodeficiency Virus (HIV) infection or positive HIV serology at screening.
  • 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. Participants that were treated for HCV and clear the virus documented by HCV RNA by PCR below the limit of quantification can be eligible.
  • Positive COVID-19 test, suspected COVID-19 infection or known exposure to COVID-19 during the screening period.
  • History of COVID-19 infection within 4 weeks prior to Screening; history of mechanical ventilation or extracorporeal membrane oxygenation (ECMO) due to COVID-19 infection within 3 months prior to Screening or with residual significant complications from COVID-19 making it unsafe for the participant to enter this study.
  • Participants presenting alcohol or drug dependency within the 2 years prior to the Screening Visit.
  • Participants with unexplained, uncontrolled, or untreated thyroid disease or unexplained abnormal serum prolactin levels at screening.
  • Participants under cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide or tacrolimus treatment within 4 weeks prior to screening.
  • Participants with previous exposure to natalizumab (Tysabri®).
  • Participants with previous exposure to RIPK1 inhibitor.
  • Participants under antidiarrheals within 2 weeks prior to screening and during screening period.
  • Participants under prednisone >25 mg/day (or equivalent).
  • Participants under budesonide >9 mg/day.
  • Participants who received intravenous corticosteroids or cytapheresis therapy within 2 weeks prior to screening or during screening.
  • Participants who were rectally administered topical 5-aminosalicylate or corticosteroids within 4 weeks prior to screening.
  • Participants who received therapeutic enema or suppository, other than required for colonoscopy or flexible sigmoidoscopy within 4 weeks prior to screening or during screening.
  • Participants who received antibiotics for UC or gastrointestinal infection within 4 weeks prior to screening.
  • Participants who have taken other investigational medications within 2 months or 5 half--lives, (whichever is longer) prior to screening.
  • Presence of significant laboratory findings at the Screening Visit.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

106 sites in 19 countries.

106 sites in 19 countries

United States14 sites

  • Agile Clinical Research Trials- Site Number : 8400024

    Atlanta, Georgia, 30328

  • NY Scientific- Site Number : 8400013

    Brooklyn, New York, 11235

  • Gastro One - Walnut Run Road- Site Number : 8400002

    Cordova, Tennessee, 38018

  • Sanmora Bespoke Clinical Research Solutions- Site Number : 8400016

    East Orange, New Jersey, 07018

  • Endeavor Health - Evanston Hospital- Site Number : 8400027

    Evanston, Illinois, 60201

  • Houston Methodist Hospital- Site Number : 8400023

    Houston, Texas, 77030

  • 1960 Family Practice- Site Number : 8400019

    Houston, Texas, 77090

  • Om Research - Lancaster - 15th Street West- Site Number : 8400014

    Lancaster, California, 93534

  • Vector Clinical Trials- Site Number : 8400004

    Las Vegas, Nevada, 89128

  • BVL Research- Site Number : 8400015

    Liberty, Missouri, 64068

  • GI Alliance - Mansfield- Site Number : 8400010

    Mansfield, Texas, 76063

  • Pioneer Clinical Research - New York- Site Number : 8400017

    New York, New York, 10016

  • Richmond VA Medical Center- Site Number : 8400022

    Richmond, Virginia, 23249

  • Integrity Research - Sugar Land- Site Number : 8400026

    Sugar Land, Texas, 77478

Other trials in United States

India12 sites

  • Investigational Site Number : 3560003

    Gūrgaon, 122002

  • Investigational Site Number : 3560009

    Jaipur, 302001

  • Investigational Site Number : 3560001

    Jaipur, 302007

  • Investigational Site Number : 3560005

    Kochi, 682017

  • Investigational Site Number : 3560004

    Ludhiana, 141010

  • Investigational Site Number : 3560013

    New Delhi, 110029

  • Investigational Site Number : 3560007

    Pune, 411001

  • Investigational Site Number : 3560008

    Rajkot, 360005

  • Investigational Site Number : 3560012

    Secunderabad, 500003

  • Investigational Site Number : 3560010

    Surat, 395002

  • Investigational Site Number : 3560011

    Surat, 395009

  • Investigational Site Number : 3560006

    Thiruvananthapuram, 695011

Other trials in India

Poland10 sites

  • Investigational Site Number : 6160006

    Gdynia, Pomeranian Voivodeship, 81-384

  • Investigational Site Number : 6160009

    Katowice, Silesian Voivodeship, 40-748

  • Investigational Site Number : 6160016

    Katowice, 40-600

  • Investigational Site Number : 6160015

    Krakow, 31-156

  • Investigational Site Number : 6160010

    Łęczna, Lublin Voivodeship, 21-010

  • Investigational Site Number : 6160011

    Tychy, Silesian Voivodeship, 43-100

  • Investigational Site Number : 6160002

    Warsaw, Masovian Voivodeship, 02-507

  • Investigational Site Number : 6160017

    Warsaw, Masovian Voivodeship, 02-786

  • Investigational Site Number : 6160018

    Włocławek, Kuyavian-Pomeranian Voivodeship, 87-800

  • Investigational Site Number : 6160004

    Wroclaw, Lower Silesian Voivodeship, 50-162

Other trials in Poland

Italy8 sites

  • Investigational Site Number : 3800008

    Bolzano, Bolzano / Bozen, 39100

  • Investigational Site Number : 3800004

    Catanzaro, 88100

  • Investigational Site Number : 3800007

    Milan, Milano, 20097

  • Investigational Site Number : 3800003

    Milan, 20132

  • Investigational Site Number : 3800006

    Palermo, 90146

  • Investigational Site Number : 3800001

    Pavia, 27100

  • Investigational Site Number : 3800002

    Rome, Roma, 00168

  • Investigational Site Number : 3800005

    Rozzano, Milano, 20089

Other trials in Italy

Argentina7 sites

  • Investigational Site Number : 0320002

    Buenos Aires, 1128

  • Investigational Site Number : 0320006

    CABA, Buenos Aires, C1023AAB

  • Investigational Site Number : 0320004

    Córdoba, 5000

  • Investigational Site Number : 0320005

    Córdoba, 5000

  • Investigational Site Number : 0320003

    Rosario, Santa Fe Province, 2002

  • Investigational Site Number : 0320007

    Salta, 4400

  • Investigational Site Number : 0320001

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

China7 sites

  • Investigational Site Number : 1560001

    Guangzhou, 510655

  • Investigational Site Number : 1560004

    Hangzhou, 310016

  • Investigational Site Number : 1560003

    Hefei, 230022

  • Investigational Site Number : 1560006

    Nanchang, 330006

  • Investigational Site Number : 1560007

    Nanjing, 210008

  • Investigational Site Number : 1560005

    Shanghai, 200025

  • Investigational Site Number : 1560002

    Shenyang, 110004

Other trials in China

Japan7 sites

  • Investigational Site Number : 3920007

    Chūō, Tokyo, 104-0061

  • Investigational Site Number : 3920002

    Fukushima, 720-0825

  • Investigational Site Number : 3920005

    Hamamatsu, Shizuoka, 432-8061

  • Investigational Site Number : 3920011

    Nagaoka, Niigata, 940-2108

  • Investigational Site Number : 3920001

    Ōita, 870-0823

  • Investigational Site Number : 3920003

    Osaka, 540-0006

  • Investigational Site Number : 3920006

    Saitama, 330-8553

Other trials in Japan

Chile5 sites

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 7500010

  • Investigational Site Number : 1520005

    Santiago, Reg Metropolitana de Santiago, 7620001

  • Investigational Site Number : 1520006

    Santiago, Reg Metropolitana de Santiago, 8380456

  • Investigational Site Number : 1520004

    Talcahuano, Biobio, 2687000

  • Investigational Site Number : 1520007

    Viña del Mar, Valparaiso, 2540364

Other trials in Chile

Germany5 sites

  • Investigational Site Number : 6420001

    Düsseldorf, 40225

  • Investigational Site Number : 2760003

    Fulda, 36043

  • Investigational Site Number : 2760001

    Kiel, 24105

  • Investigational Site Number : 2760008

    Ludwigshafen, 67067

  • Investigational Site Number : 2760006

    Ulm, 89081

Other trials in Germany

Mexico5 sites

  • Investigational Site Number : 4840001

    Chihuahua City, 31000

  • Investigational Site Number : 4840003

    Chihuahua City, 31203

  • Investigational Site Number : 4840002

    Durango, 34000

  • Investigational Site Number : 4840005

    Mérida, Yucatán, 97070

  • Investigational Site Number : 4840006

    Tlalnepantla, 54055

Other trials in Mexico

Czechia4 sites

  • Investigational Site Number : 2030007

    České Budějovice, 370 01

  • Investigational Site Number : 2030001

    Hradec Králové, 500 12

  • Investigational Site Number : 2030002

    Klatovy, 339 01

  • Investigational Site Number : 2030003

    Prague, 190 00

Other trials in Czechia

France4 sites

  • Investigational Site Number : 2500007

    Marseille, 13915

  • Investigational Site Number : 2500008

    Nantes, 44314

  • Investigational Site Number : 2500006

    Neuilly-sur-Seine, 92200

  • Investigational Site Number : 2500001

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Georgia4 sites

  • Investigational Site Number : 2680003

    Batumi, 6000

  • Investigational Site Number : 2680005

    Kutaisi, 4600

  • Investigational Site Number : 2680002

    Tbilisi, 0160

  • Investigational Site Number : 2680004

    Tbilisi, 0186

Other trials in Georgia

Hungary4 sites

  • Investigational Site Number : 3480001

    Békéscsaba, 5600

  • Investigational Site Number : 3480005

    Budapest, 1062

  • Investigational Site Number : 3480002

    Budapest, 1085

  • Investigational Site Number : 3480006

    Gyöngyös, 3200

Other trials in Hungary

Slovakia3 sites

  • Investigational Site Number : 7030003

    Banská Bystrica, 975 17

  • Investigational Site Number : 7030002

    Košice, 040 13

  • Investigational Site Number : 7030001

    Nitra, 949 01

Other trials in Slovakia

United Kingdom3 sites

  • Investigational Site Number : 8260002

    Cambridge, Cambridgeshire, CB2 2QQ

  • Investigational Site Number : 8260006

    London, London, City of, SE1 9RT

  • Investigational Site Number : 8260003

    Warrington, WA5 1LZ

Other trials in United Kingdom

Netherlands2 sites

  • Investigational Site Number : 5280001

    Amsterdam, 1081 HV

  • Investigational Site Number : 5280002

    Nijmegen, 6525 GA

Other trials in Netherlands

Romania1 site

  • Investigational Site Number : 6420002

    Cluj-Napoca, 400006

Other trials in Romania

Spain1 site

  • Investigational Site Number : 7240006

    Barcelona, Barcelona [Barcelona], 08022

Other trials in Spain

About this study

Official title: A Randomized, Double-blind, Placebo Controlled, Dose-finding Study to Assess the Efficacy and Safety of SAR443122 in Adult Patients With Moderate to Severe Ulcerative Colitis

This is a randomized, double-blind, placebo controlled, dose-ranging Phase 2 study. The primary objective is to evaluate the efficacy and safety of SAR443122 compared to placebo in participants with moderate to severe UC. Dose selection for further clinical development will be based on the multiple efficacy, safety and PK parameters.

The study consists of 4 parallel arms (3 dose groups of SAR443122 vs placebo) to assess the efficacy and safety of SAR443122 in participants with moderate to severe UC. All participants will receive a total of 52 weeks (a 12-week induction treatment phase and a 40-week maintenance phase) of study treatment, except if treatment should be discontinued per investigator's assessment.

Read more

At the end of the first 12 weeks of induction treatment, all participants in clinical response or remission will be offered study treatment up to 40 weeks and will continue with the same blinded treatment that was assigned. Participants who do not achieve clinical response or remission at the end of the initial 12 weeks induction treatment will roll over in an open-label treatment arm and will be treated with SAR443122 at the highest tested dose.

In addition, participants from the maintenance treatment that lose clinical efficacy at any time up to V10/Week 40 (Week 28 of maintenance) will be offered to roll over in the open-label treatment arm with SAR443122 at the highest dose.

Read the detailed description

Total study duration per participant will be up to 58 weeks, including a screening period of up to 4 weeks, a treatment period up to 52 weeks and a post-treatment follow-up period of 2 weeks.

Being tested
SAR443122, 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.

  • SAR443122Drug

    oral capsule

  • PlaceboDrug

    oral capsule

Study groups in NCT05588843
Study groupRoleWhat they receive
SAR443122 level 1ExperimentalDose level 1
Receives: Drug: SAR443122
SAR443122 level 2ExperimentalDose level 2
Receives: Drug: SAR443122
SAR443122 level 3ExperimentalDose level 3
Receives: Drug: SAR443122
PlaceboPlacebo comparatorMatching Placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    The Mayo score (full MS) is a composite instrument that consists of patient reported stool frequency and rectal bleeding, endoscopy-derived measures and physician-reported assessment (PGA). The modified Mayo score is calculated omitting PGA. And an endoscopy score of 1 with no friability.

    Measured: At Week 12

Secondary outcomes (16)

  1. Proportion of participants who achieve endoscopic improvement at Week 12

    Measured: At Week 12

  2. Proportion of participants who achieve clinical response at Week 12 by mMS

    Measured: At Week 12

  3. Proportion of participants who achieve clinical remission at Week 12 by full Mayo Score (MS)

    Measured: At Week 12

  4. Proportion of participants who achieve clinical response at Week 12 by MS.

    Measured: At Week 12

  5. Change from baseline on patient-reported outcome 2 (PRO2) total score (Mayo stool frequency and rectal bleeding subscores) over time

    Measured: From baseline to Week 12

  6. Proportion of participants who achieve histological improvement at Week 12

    Measured: At Week 12

  7. Proportion of participants who achieve Histologic-endoscopic mucosal improvement (HEMI) at Week 12 defined by achievement of modified Mayo endoscopic improvement and histological improvement

    Measured: At Week 12

  8. Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score at Week 12

    Measured: At Week 12

  9. Change from baseline in bowel signs and symptoms assessed by Ulcerative Colitis Patient Reported Outcome Signs and Symptoms (UC-PRO/SS) at Week 12

    Measured: At Week 12

  10. Change from baseline in abdominal signs and symptoms assessed by UC-PRO/SS at Week 12

    Measured: At Week 12

  11. Pharmacokinetic parameters: maximum concentration [Cmax]

    Measured: Until Week 52

  12. Pharmacokinetic parameters: time to Cmax [tmax]

    Measured: Until Week 52

  13. Pharmacokinetic parameters: area under the curve over the dosing interval [AUC0-tau]

    Measured: Until Week 52

  14. Pharmacokinetic parameters: elimination half-life [t1/2z]

    Measured: Until Week 52

  15. Participants with any Treatment Emergent Adverse Events (TEAEs) during induction and maintenance treatment period

    Measured: Until Week 52

  16. Participants with any TEAEs during open-label treatment period

    Measured: Up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2022
  2. Study start25 Nov 2022
  3. Primary completion10 Feb 2026
  4. Study completion2 Dec 2026 (estimated)

Resources

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
187 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05588843
Sponsor's protocol ID
DRI16804
Other IDs
U1111-1269-6212, 2022-500290-14
Acronym
RESOLUTE
Status last verified
Apr 2026
First submitted
17 Oct 2022
Last updated
27 Apr 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SAR443122 in people with Colitis Ulcerative, run by Sanofi at 106 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in United States, India, Poland, Italy, Argentina and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants who achieve clinical remission at Week 12 by modified Mayo Score (mMS) (time frame: At Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05588843.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in