A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis
ConditionColitis Ulcerative
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSanofi
About this trial
This is a Phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate-to-severe UC. The primary objective of this study is to assess efficacy of different doses of SAR441566 on clinical remission in participants with moderate-to-severe ulcerative colitis.
This study will include a screening period of up to 28 days (+ 7 calendar days if needed) followed by the main study treatment period of 52 weeks which will be comprised of a double blind (DB) treatment period with 12 weeks of induction period followed by a maintenance period of 40 weeks and 2-week follow-up after end of treatment.
Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants (for participants not enrolling in the LTS study).
* The study duration will be up to 59 weeks. * The treatment duration will be up to 52 weeks in the DB arm and up to 40 weeks in the OL arm. * The number of visits will be 12 for the main study treatment period and 8 for the OL treatment period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female participants aged 18 to 75 years inclusive, at the time of signing the informed consent
Participants who have clinical evidence of active UC for ≥3 months before screening and confirmed by endoscopy during the screening period
Active moderate-to-severe UC at screening as defined by a modified Mayo Score (mMS) of 5 to 9 (without the Physician global Assessment (PGA), with a minimum rectal bleeding (RB) subscore ≥1, a minimum stool frequency (SF) subscore ≥1, a mMES ≥2 confirmed by central reader, a minimum sum of all subscores of 5, and a disease extent >15 cm from the anal verge
History of no prior exposure to approved Advanced Therapy (AT), but having inadequate response to, loss of response to or intolerance to standard treatment with any of the following : 5-ASA, thiopurines (eg.6-MP, AZA), MTX, oral or intravenous (IV) corticosteroids or history of corticosteroid dependence (defined an inability to successfully taper corticosteroids without recurrence of UC) OR
Disqualifiers
Participants with active CD, indeterminate colitis, ischemic colitis, microscopic colitis
Participants with the following ongoing known complications of UC: fulminant colitis, toxic megacolon, or any other manifestation that might require bowel surgery while enrolled in the study
Participant with prior colectomy, ostomy or ileoanal pouch, or anticipated colectomy during their participation in the study
Participants with fecal sample positive for ova or parasites, bacterial pathogens, or positive for Clostridium difficile B toxin in stools
Trial design
Design model
Parallel
Treatments tested in this trial
SAR441566
DrugPharmaceutical form: Tablet Route of administration: Oral
SAR441566 matching Placebo
DrugPharmaceutical form: Tablet Route of administration: Oral
Treatment groups
204 Participants
are divided into 4 treatment groupsGroup A: SAR441566 dose regimen 1Experimental treatment 1 intervention
Group B: SAR441566 dose regimen 2Experimental treatment 1 intervention
Group C: SAR441566 dose regimen 3Experimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of participants achieving clinical remission at Week 12 by modified Mayo Score (mMS)
Clinical remission by modified Mayo score (mMS) is defined as a mMS ≤2 with no subscore \>1 (stool frequency \[SF\] of 0 or 1 with at least a 1-point decrease from baseline, rectal bleeding \[RB\] of 0 and modified Mayo Endoscopic Subscore \[mMES\] of 0 or 1 where 1 does not include friability). Each component of the mMS (SF, RB, and mMES) is scored from 0 to 3. The total mMS ranges from 0 to 9 with higher scores indicating greater disease severity.
Time frame
Week 12Secondary outcomes
1
Proportion of participants achieving clinical response at Week 12 by modified Mayo Score (mMS)
Clinical response by modified Mayo score (mMS) is defined as a decrease from baseline in the mMS of ≥2 points and an improvement of ≥30% from baseline plus a decrease in rectal bleeding (RB) subscore ≥1 or an absolute RB subscore ≤1. Each component of the mMS (SF, RB, and mMES) is scored from 0 to 3. The total mMS ranges from 0 to 9 with higher scores indicating greater disease severity.
Time frame
Week 122
Proportion of participants achieving clinical response at Week 12 by full Mayo score (MS)
Clinical response by full Mayo score (MS) is defined as a decrease from baseline in the MS of ≥3 points and an improvement of ≥30% from baseline plus a decrease in rectal bleeding (RB) subscore ≥1 or an absolute RB subscore ≤1. The MS (also referred to as the full Mayo Score) is a composite index designed to measure ulcerative colitis (UC) disease activity and consists of 4 subscores: RB and SF, which are patient-reported subscores, Physician's global assessment (PGA), and endoscopic findings. Individual items are rated 0 to 3, giving the composite score a maximum of 12, with higher scores indicating greater disease severity.
Time frame
Week 123
Proportion of participants achieving clinical remission at Week 12 by full Mayo score (MS)
Clinical remission by full Mayo score (MS) is defined as a MS ≤2 with no score \>1.
Time frame
Week 124
Proportion of participants achieving the combination of patient-reported outcome 2 (PRO2) remission and endoscopic remission at Week 12
Patient-reported outcome 2 (PRO2) remission is defined as PRO2 score ≤1 with rectal bleeding (RB) of 0, and endoscopic remission is defined as mMES of 0. PRO2 score is defined as the sum of Mayo SF and RB subscores.
Time frame
Week 12 Source ClinicalTrials.gov