Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BMS-986166 · 2 trials · 2 indications
The Eczema Area and Severity Index (EASI) is a validated, composite scoring system assessed by the investigator based on the extent of each of the 4 body regions (head and neck, upper limbs, lower limbs, and trunk) affected with AD and the intensity of each of 4 key signs of AD (erythema, induration/papulation, excoriation, and lichenification) and is based on a 4-point scale of 0 (absent), 1 (mild), 2 (moderate), and 3 (severe). For each of the 4 body regions, the mean intensity of inflamed lesions for each of the 4 signs is recorded. Xerosis, scaling, urticaria, or post-inflammatory pigmentation changes are not included. The total EASI score ranges from 0 to 72. The lower the score the better.
measured by number of patients
measured by number of patients
measured by investigator
measured by investigator
measured by ECG
measured with external monitoring device
measured by serum chemistry, hematology, serology and urinalysis results
measured in degrees Celsius or Fahrenheit
measured by investigator
measured by investigator
measured by investigator
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| Treatment BMS-986166 Dose 1 | EXPERIMENTAL | - |
| Treatment BMS-986166 Dose 2 | EXPERIMENTAL | - |
| Treatment BMS-986166 Dose 3 | EXPERIMENTAL | - |
| Treatment Branebrutinib | EXPERIMENTAL | - |
| Dose Panel 1 | EXPERIMENTAL | BMS-986166 or Placebo matching BMS-986166 |
| Dose Panel 2 | EXPERIMENTAL | BMS-986166 or Placebo matching BMS-986166 |
| Dose Panel 3 | EXPERIMENTAL | BMS-986166 or Placebo matching BMS-986166 |
| Name | Type | Description |
|---|---|---|
| BMS-986166 | DRUG | Specified dose on specified days |
| Branebrutinib | DRUG | Specified dose on specified days |
| Placebo | OTHER | Specified dose on specified days |
| Placebo matching BMS-986166 | OTHER | Specified dose on specified days |
Inclusion Criteria: * Chronic atopic dermatitis (AD) diagnosed according to the Eichenfield modification of Hanifin's and Rajka's (E-HR) criteria at Screening * Disease duration of at least 24 months since diagnosis by any criteria * Documented history of inadequate control of AD by a stable regime...
BMS-986166 is an investigational small molecule being developed by Bristol-Myers Squibb for immune-mediated conditions. It has been studied in atopic dermatitis and ulcerative colitis. It is a Phase 2 asset and has not been approved for any indication.
BMS-986166 has been studied for the treatment of atopic dermatitis and ulcerative colitis. A Phase 2 trial evaluated it in adults with atopic dermatitis, and a Phase 1 study was conducted in healthy volunteers under a protocol listing ulcerative colitis. It remains investigational and is not approved for any use.
Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY, is the developer of BMS-986166. The company sponsored the clinical studies of the compound in atopic dermatitis and in healthy volunteers.
BMS-986166 is in Phase 2 development. A completed Phase 2 study, NCT05014438, evaluated BMS-986166 or branebrutinib in participants with atopic dermatitis. An earlier completed Phase 1 multiple-dose study, NCT03038711, assessed safety and tolerability in healthy volunteers. The drug is investigational and has not been approved.
BMS-986166 has been evaluated in two completed studies. NCT05014438 was a Phase 2 trial of BMS-986166 or branebrutinib in adults with atopic dermatitis, conducted in the United States, Australia, Austria, Canada, Germany, Poland, and Spain. NCT03038711 was a Phase 1 multiple-dose safety and tolerability study in 213 healthy volunteers in the United States.
BMS-986166 is not approved. It is an investigational small molecule in Phase 2 clinical development for atopic dermatitis and ulcerative colitis, and it has completed a Phase 2 trial in atopic dermatitis and a Phase 1 study in healthy volunteers.