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SAR443122 · 3 trials · 3 indications
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.
The CLASI is a clinician rated scale designed to assess the disease activity and damage in CLE in adults. It is composed of 56 items covering 2 dimensions: the disease activity (CLASI-A) and the disease damage (CLASI-D). CLASI-A disease activity covers the domains: erythema, scale/hypertrophy, recent hair loss/alopecia, and mucous membrane lesions. CLASI-A sub-score ranges for 0 to 70, where 0-9 indicates mild disease, 10-20 indicates moderate disease, and 21-70 indicates severe disease. Higher score indicates a more severe skin disease. Baseline was defined as the Day 1 assessment value.
Relative change from baseline in CRP level on Day 7
| Arm | Type | Description |
|---|---|---|
| SAR443122 level 1 | EXPERIMENTAL | Dose level 1 |
| SAR443122 level 2 | EXPERIMENTAL | Dose level 2 |
| SAR443122 level 3 | EXPERIMENTAL | Dose level 3 |
| Placebo | PLACEBO_COMPARATOR | Matching Placebo |
| SAR443122 | EXPERIMENTAL | SAR443122 for 12 weeks |
| Name | Type | Description |
|---|---|---|
| SAR443122 | DRUG | oral capsule |
| Placebo | DRUG | oral capsule |
Inclusion Criteria: * Participants who have clinical evidence of active Ulcerative Colitis \[UC\] for ≥3 months before screening as confirmed by endoscopy during the screening period. * Participants must have a minimum disease extent of 15 centimeters from the anal verge. * Participants are inadequ...
SAR443122 is an investigational small molecule being developed for ulcerative colitis, coronavirus infection, and cutaneous lupus erythematosus. It is currently in Phase 2 clinical development for ulcerative colitis and has completed Phase 1 and Phase 2 trials for the other two conditions.
SAR443122 is being developed by Sanofi, a multinational pharmaceutical company traded on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the drug's safety and efficacy across multiple indications.
SAR443122 is in Phase 2 clinical development. It has completed a Phase 1 trial for coronavirus infection and a Phase 2 proof-of-concept study for cutaneous lupus erythematosus. A Phase 2 dose-finding study for ulcerative colitis is currently active but not recruiting participants.
SAR443122 has been studied in three clinical trials: NCT04469621, a completed Phase 1 trial in severe COVID-19; NCT04781816, a completed Phase 2 proof-of-concept study in cutaneous lupus erythematosus; and NCT05588843, an active Phase 2 dose-finding study in ulcerative colitis.
SAR443122 is not FDA approved. It is an investigational drug still in clinical development. The most advanced trial is a Phase 2 study in ulcerative colitis, which is active but not recruiting, indicating the drug has not yet completed the clinical development process required for regulatory approval.
Yes, SAR443122 is being tested for ulcerative colitis in a Phase 2 dose-finding study with the identifier NCT05588843. This trial is active but not recruiting and has enrolled 187 participants across multiple countries including the United States, Japan, and several European nations.