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Evaluating SAR443122 for treating ulcerative colitis in adults

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

Phase 2 Interventional Sanofi · NCT05588843

This study is testing a new medication called SAR443122 to see if it can help adults with moderate to severe ulcerative colitis feel better.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment182 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorSanofi Industry-sponsored
Drugs / interventionsnatalizumab, methotrexate, prednisone
Locations95 sites (Lancaster, California and 94 other locations)
Trial IDNCT05588843 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 2 study designed to assess the efficacy and safety of SAR443122 in adults with moderate to severe ulcerative colitis (UC). Participants will be assigned to one of four parallel arms, receiving either SAR443122 at different doses or a placebo over a total duration of up to 58 weeks, which includes a 12-week induction phase followed by a 40-week maintenance phase. The study aims to determine the optimal dose for further clinical development based on various efficacy, safety, and pharmacokinetic parameters.

Who should consider this trial

Good fit: Ideal candidates include adults with active ulcerative colitis for at least three months who have not responded adequately to previous treatments.

Not a fit: Patients who have not been diagnosed with ulcerative colitis or those who have not failed previous treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients suffering from moderate to severe ulcerative colitis.

How similar studies have performed: Other studies have shown promise in treating ulcerative colitis with similar approaches, but the specific efficacy of SAR443122 is still being evaluated.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Where this trial is running

Lancaster, California and 94 other locations

+45 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Colitis Ulcerative
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.