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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
187
Om Research - Lancaster - 15th Street West- Site Number : 8400014
Lancaster, California, United States
Agile Clinical Research Trials- Site Number : 8400024
Atlanta, Georgia, United States
Endeavor Health - Evanston Hospital- Site Number : 8400027
Evanston, Illinois, United States
BVL Research- Site Number : 8400015
Liberty, Missouri, United States
Vector Clinical Trials- Site Number : 8400004
Las Vegas, Nevada, United States
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.
Time frame: At Week 12
Proportion of participants who achieve endoscopic improvement at Week 12
Time frame: At Week 12
Proportion of participants who achieve clinical response at Week 12 by mMS
Time frame: At Week 12
Proportion of participants who achieve clinical remission at Week 12 by full Mayo Score (MS)
Time frame: At Week 12
Proportion of participants who achieve clinical response at Week 12 by MS.
Time frame: At Week 12
Change from baseline on patient-reported outcome 2 (PRO2) total score (Mayo stool frequency and rectal bleeding subscores) over time
Time frame: From baseline to Week 12
Proportion of participants who achieve histological improvement at Week 12
Time frame: At Week 12
Proportion of participants who achieve Histologic-endoscopic mucosal improvement (HEMI) at Week 12 defined by achievement of modified Mayo endoscopic improvement and histological improvement
Time frame: At Week 12
Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score at Week 12
Time frame: At Week 12
Change from baseline in bowel signs and symptoms assessed by Ulcerative Colitis Patient Reported Outcome Signs and Symptoms (UC-PRO/SS) at Week 12
Time frame: At Week 12
Change from baseline in abdominal signs and symptoms assessed by UC-PRO/SS at Week 12
Time frame: At Week 12
Pharmacokinetic parameters: maximum concentration [Cmax]
Time frame: Until Week 52
Pharmacokinetic parameters: time to Cmax [tmax]
Time frame: Until Week 52
Pharmacokinetic parameters: area under the curve over the dosing interval [AUC0-tau]
Time frame: Until Week 52
Pharmacokinetic parameters: elimination half-life [t1/2z]
Time frame: Until Week 52
Participants with any Treatment Emergent Adverse Events (TEAEs) during induction and maintenance treatment period
Time frame: Until Week 52
Participants with any TEAEs during open-label treatment period
Time frame: Up to Week 52
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Sanmora Bespoke Clinical Research Solutions- Site Number : 8400016
East Orange, New Jersey, United States
NY Scientific- Site Number : 8400013
Brooklyn, New York, United States
Pioneer Clinical Research - New York- Site Number : 8400017
New York, New York, United States
Gastro One - Walnut Run Road- Site Number : 8400002
Cordova, Tennessee, United States
Houston Methodist Hospital- Site Number : 8400023
Houston, Texas, United States
...and 96 more locations