Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Deucravacitinib · 15 trials · 12 indications
MACE defined as non-fatal myocardial infarction \[MI\], nonfatal stroke, and cardiovascular death
The American College of Rheumatology (ACR) 20 is defined as 20% improvement over baseline in tender (68) and swollen (66) joint counts and a 20% improvement in 3 of the 5 remaining core data set measures: Participant Global Assessment of Disease Activity; Participant Global Assessment of Pain; Participant assessment of physical function; Physician Global Assessment of psoriatic arthritis; and Acute phase reactant value of high sensitivity C-reactive protein (hsCRP). Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 20% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication. The 95% CI is calculated using Clopper-Pearson exact method.
Part A
Part A
Part A
Part B
Part B
Long-term extension (LTE) Period
LTE Period
LTE Period
LTE Period
LTE Period
Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24
Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24
Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24
Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24
Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24
Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24
Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24
Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: * Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) * Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70
Number of participants experiencing AEs, SAEs, AEs leading to study discontinuation, and AEs of interest (AEIs). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. SAEs is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization; results significant disability; or is a congenital anomaly/birth defect. TEAEs are defined as AEs with an onset date on or after the first dose of study treatment up to 30 days after the last dose of study treatment in the study, or if a pre-existing condition worsens in severity or becomes serious after receiving the first dose of study treatment
Number of participants experiencing abnormalities in laboratory testing including chemistry, hematology, and renal.
Change from baseline in laboratory parameters including lipid profile, chemistry liver function, chemistry (other), and chemistry renal function
Changes from IM011077 study baseline in electrocardiogram (ECG) parameters - ECG mean heart rate
Changes from IM011077 study baseline in electrocardiogram (ECG) parameters
Changes from IM011077 study baseline in vital signs parameters - heart rate
Changes from IM011077 study baseline in vital signs parameters
| Arm | Type | Description |
|---|---|---|
| Administration of Deucravacitinib | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Arm A | EXPERIMENTAL | - |
| Arm B | ACTIVE_COMPARATOR | - |
| Deucravacitinib, Dose 1 | EXPERIMENTAL | - |
| Deucravacitinib, Dose 2 | EXPERIMENTAL | - |
| Placebo, followed by Deucravacitinib Dose 1 or Dose 2 | PLACEBO_COMPARATOR | - |
| Arm 1: Deucravacitinib | EXPERIMENTAL | - |
| Arm 2: Placebo | PLACEBO_COMPARATOR | - |
| Deucravacitinib | EXPERIMENTAL | - |
| Apremilast | OTHER | - |
| Active treatment deucravacitinib standard dose | EXPERIMENTAL | - |
| Active treatment deucravacitinib half-standard dose | EXPERIMENTAL | - |
| Central Centrifugal Cicatricial Alopecia | EXPERIMENTAL | Contains individuals diagnosed with Central Centrifugal Cicatricial Alopecia. |
| Frontal Fibrosing Alopecia | EXPERIMENTAL | Contains individuals diagnosed with Frontal Fibrosing Alopecia. |
| Active Treatment: Deucravacitinib Dose 1 | EXPERIMENTAL | - |
| Active Treatment: Deucravacitinib Dose 2 | EXPERIMENTAL | - |
| Long-Term Extension Rollover Study: Deucravacitinib | EXPERIMENTAL | - |
| BMS-986165 Formulation 1 | EXPERIMENTAL | - |
| BMS-986165 Formulation 2 | EXPERIMENTAL | - |
| BMS-986165 Formulation 2 + Fed | EXPERIMENTAL | - |
| BMS-986165 Formulation 2 + Famotidine | EXPERIMENTAL | - |
| Part A: Deucravacitinib | EXPERIMENTAL | - |
| Part B: Deucravacitinib | EXPERIMENTAL | - |
| Part A | EXPERIMENTAL | - |
| Part B | EXPERIMENTAL | - |
| Part C | EXPERIMENTAL | - |
| Part D | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Deucravacitinib | DRUG | Specified dose on specified days |
| Placebo | OTHER | Specified dose on specified days |
| Ustekinumab | DRUG | Specified dose on specified days |
| Apremilast | DRUG | Specified dose on specified days |
| Placebo matching deucravacitinib | OTHER | Specified dose on specified days |
| Famotidine | DRUG | Specified dose on specified days |
Inclusion Criteria * Participants must have stable plaque psoriasis for 6 months or more prior to Screening. * Participants must have moderate to severe psoriasis defined by:. i) Psoriasis Area and Severity Index (PASI) ≥ 12, at screening visit and Day 1. ii) Static Physician's Global Assessmen...