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

  • STATUS
    Recruiting
  • End date
    Apr 9, 2026
  • participants needed
    182
  • sponsor
    Sanofi
Updated on 27 January 2023
corticosteroids
remission
methotrexate
endoscopy
mercaptopurine
azathioprine
sulfasalazine
mesalamine
aminosalicylates

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. 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.

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.

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.

Details
Condition Colitis Ulcerative
Treatment Placebo, SAR443122
Clinical Study IdentifierNCT05588843
SponsorSanofi
Last Modified on27 January 2023

Eligibility

Yes No Not Sure

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 and within no more than 10 days prior to randomization
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®)
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 biologics must have been administered 1) at least 5 half-lives prior to randomization, or 2) participant must have an 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
Participants with stool sample positive for culture for aerobic pathogens
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 malignancies except history of basal cell carcinoma or in-situ cervical carcinoma
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 requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the Screening Visit, or history of frequent recurrent infections 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 screening test suspected of 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
Participants under cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide or tacrolimus treatment within 4 weeks prior to screening
Participants with previous exposure to natalizumab (Tysabri®), JAK (Janus kinase) inhibitors or S1P receptor modulator
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 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
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