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
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.
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
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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