Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SAR441566 · 7 trials · 4 indications
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.
Endoscopic response is defined as ≥50% reduction from baseline in centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD). The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.
ACR20 response criteria is a dichotomous composite endpoint indicating the proportion of participants with at least 20 percent improvement in the number of tender and swollen joints, and in three out of the remaining five ACR core-set measures: patient pain (VAS, No pain to Severe Pain), Patient Global Assessment of disease activity (VAS, Very well to Very Poor), physician global assessment of disease activity (VAS, Very good to Very bad), physical functioning assessment (Health Assessment Questionnaire-Disability Index \[HAQ-DI\]), and acute phase reactants (ESR or CRP mg/dl; in this study CRP will be used). ACR response is scored as a percentage improvement, comparing disease activity at two discrete time points. ACR20 is ≥ 20% improvement.
PASI is linear combination of percent of surface area of skin that is affected and severity of erythema(E),induration(i),desquamation(D) over 4 body regions: head(h),trunk(t),upper extremities(u),lower extremities(l). The signs of severity, E, i and D of lesions are assessed using numeric scale for which scores are made independently for each of the areas; range:0 (complete lack of cutaneous involvement) to 4 (severest possible involvement). For each body area, percentage of considered body area covered by plaque psoriasis is translated into numerical value "Ax":0=no involvement,1=\<10% to 6=90 to 100% involvement. These scores are noted Ah, At, Au, and Al in formula below. The PASI score is calculated according to the following formula: PASI = 0.1(Eh+ih+Dh)Ah + 0.3(Et+it+Dt)At + 0.2(Eu+iu+Du)Au + 0.4(El+il+Dl)Al. PASI score range:0 (no disease) to 72 (maximal disease);higher scores: greater psoriasis severity. Percentage of participants with PASI75 at Week 12 is presented.
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -2 at 10 minutes post-irradiation to the corresponding MEDon-drug measured on Day 8 at 10 minutes post-irradiation. Condition 1 is Full range solar ultraviolet B/ultraviolet A (UVB/UVA) \[290 to 400 nm\] exposure.
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -2 at 1 hour post-irradiation to the corresponding MEDon-drug measured on Day 8 at 1 hour post-irradiation. Condition 1 is full range solar UVB/UVA \[290 to 400 nm\] exposure.
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -1 at 24 hours post-irradiation to the corresponding MEDon-drug measured on Day 9 at 24 hours post-irradiation. Condition 1 is a Full range solar UVB/UVA \[290 to 400 nm\] exposure.
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -2 at 10 minutes post-irradiation to the corresponding MEDon-drug measured on Day 8 at 10 minutes post-irradiation. Condition 2 is a UVA only \[320 to 400 nm\] exposure.
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -2 at 1 hour post-irradiation to the corresponding MEDon-drug measured on Day 8 at 1 hour post-irradiation. Condition 2 is a UVA only \[320 to 400 nm\] exposure.
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -1 at 24 hours post-irradiation to the corresponding MEDon-drug measured on Day 9 at 24 hours post-irradiation. Condition 2 is a UVA only \[320 to 400 nm\] exposure.
Maximum plasma concentration observed
Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time Tlast (AUClast)
Area under the plasma concentration versus time curve extrapolated to infinity (AUC)
Assessment of adverse events (AE) / treatment-emergent adverse events (TEAE) including SAE and AESI
| Arm | Type | Description |
|---|---|---|
| SAR441566 dose regimen 1 | EXPERIMENTAL | Participants will receive SAR441566 dose regimen 1 |
| SAR441566 dose regimen 2 | EXPERIMENTAL | Participants will receive SAR441566 dose regimen 2 |
| SAR441566 dose regimen 3 | EXPERIMENTAL | Participants will receive SAR441566 dose regimen 3 |
| Placebo | PLACEBO_COMPARATOR | Participants will receive SAR441566-matching placebo |
| SAR441566 dose 1 | EXPERIMENTAL | Participants will receive SAR441566 dose 1. |
| SAR441566 dose 2 | EXPERIMENTAL | Participants will receive SAR441566 dose 2. |
| SAR441566 dose 3 | EXPERIMENTAL | Participants will receive SAR441566 dose 3. |
| SAR441566 dose regimen A | EXPERIMENTAL | Participant will receive dose regimen A of SAR441566 for 12 weeks |
| SAR441566 dose regimen B | EXPERIMENTAL | Participant will receive dose regimen B of SAR441566 for 12 weeks |
| SAR441566 dose regimen C | EXPERIMENTAL | Participant will receive dose regimen C of SAR441566 for 12 weeks |
| SAR441566 dose regimen D | EXPERIMENTAL | Participant will receive dose regimen D of SAR441566 for 12 weeks |
| SAR441566 dose regimen E | EXPERIMENTAL | Participants received dose regimen E of SAR441566 |
| Part I SAR441566 Dose A | EXPERIMENTAL | Participants will receive repeated low dose of SAR441566 for 7.5 days |
| Part I SAR441566 Dose B | EXPERIMENTAL | Participants will receive repeated high dose of SAR441566 for 7.5 days |
| Part I Placebo | PLACEBO_COMPARATOR | Participants will receive repeated SAR441566 matching placebo tablets for 7.5 days |
| Part II Ciprofloxacin | ACTIVE_COMPARATOR | Participants will receive repeated ciprofloxacin 500 mg twice-daily (BID) for 5.5 days |
| SAR441566 | EXPERIMENTAL | Participants will receive single ascending doses of SAR441566 on day 1 of each 8-12-day cycle |
| Name | Type | Description |
|---|---|---|
| SAR441566 | DRUG | Pharmaceutical form: Tablet Route of administration: Oral |
| SAR441566 matching Placebo | DRUG | Pharmaceutical form: Tablet Route of administration: Oral |
| Placebo | DRUG | Tablet |
| Ciprofloxacin | DRUG | Tablet |
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * 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 befor...
SAR441566 is an investigational small molecule being developed for psoriasis, Crohn's disease, ulcerative colitis, and rheumatoid arthritis. It is currently in Phase 2 clinical development for these indications, with studies evaluating its safety and efficacy in patients with mild to moderate psoriasis, plaque psoriasis, and ulcerative colitis.
SAR441566 targets TNFR1, the tumor necrosis factor receptor 1. By modulating this receptor, the drug aims to interfere with TNF-mediated inflammatory signaling pathways that contribute to autoimmune and inflammatory conditions such as psoriasis, rheumatoid arthritis, and inflammatory bowel disease.
SAR441566 is developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the drug's safety and efficacy across multiple inflammatory and autoimmune indications.
SAR441566 is in Phase 2 clinical development. It has completed Phase 1 and Phase 2 trials in psoriasis and rheumatoid arthritis, and a Phase 2 trial in ulcerative colitis is currently recruiting participants. The drug is investigational and not yet approved by regulatory authorities.
SAR441566 has been studied in several clinical trials. Completed trials include NCT05453942 in mild to moderate psoriasis, NCT05844735 in rheumatoid arthritis, and NCT06073119 in plaque psoriasis. An ongoing Phase 2 trial, NCT06867094, is recruiting patients with ulcerative colitis across multiple countries.
SAR441566 is the primary identifier for this investigational drug. No alternative names have been associated with it in clinical trial registrations. It is consistently referred to as SAR441566 across all studies conducted by Sanofi.