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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 studied for cutaneous lupus erythematosus, ulcerative colitis, and coronavirus infection. It is being developed by Sanofi and is currently in Phase 2 clinical trials for these conditions.
SAR443122 is a small molecule therapeutic developed by Sanofi. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being evaluated for its effects on the immune system in conditions including cutaneous lupus erythematosus and ulcerative colitis.
SAR443122 is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical trials to evaluate the drug's safety and efficacy in multiple indications.
SAR443122 is currently in Phase 2 clinical development. It has completed a Phase 1 trial in severe COVID-19 and a Phase 2 proof-of-concept study in cutaneous lupus erythematosus. An additional Phase 2 dose-finding study in ulcerative colitis is active but not recruiting participants.
SAR443122 has been studied in three clinical trials: NCT04469621, a Phase 1 trial in severe COVID-19; NCT04781816, a Phase 2 proof-of-concept study in cutaneous lupus erythematosus; and NCT05588843, a Phase 2 dose-finding study in ulcerative colitis. All trials are randomized, double-blind, and placebo-controlled.
SAR443122 is not known to have alternative names. It is a distinct investigational compound developed by Sanofi, and no other names for this drug have been identified in clinical trial registrations.