Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06073093 | A Study to Evaluate SAR441566 Efficacy and Safety in Adults With Rheumatoid Arthritis | PHASE2 | COMPLETED | 264 | — | — | Nov 7, 2023 | Jul 2, 2025 | Jul 11, 2025 | 102 | United States, Argentina +17 |
| NCT05844735 | A Randomized Placebo- and Active Comparator-controlled Study to Evaluate the Photosafety of SAR441566 | PHASE1 | COMPLETED | 60 | — | — | May 22, 2023 | Oct 23, 2023 | Sep 16, 2025 | 1 | United States |
| NCT05858788 | A Single Ascending Dose Study to Characterize the Pharmacokinetics, Safety, and Tolerability of SAR441566 in Healthy Adult Japanese Male Participants. | PHASE1 | COMPLETED | 10 | — | — | May 15, 2023 | Jul 17, 2023 | Sep 18, 2025 | 1 | United States |
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.
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)
| Arm | Type | Description |
|---|---|---|
| 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 |
| Placebo | PLACEBO_COMPARATOR | Participant will receive SAR441566-matching placebo for 12 weeks |
| 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 | Tablet |
| Placebo | DRUG | Tablet |
| Ciprofloxacin | DRUG | Tablet |
Inclusion Criteria: * Diagnosis of adult-onset RA classified by ACR/EULAR 2010 revised classification criteria for RA of at least 3 months duration, with the onset of signs and symptoms of RA of at least 6 months duration * Moderate-to-severely active RA, defined as: * persistently active diseas...