Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BMS-986322 · 1 trial · 1 indication
PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. The PASI-75 response rate is defined as the percentage of participants with moderate-to-severe PsO achieving at least 75% reduction from baseline in PASI score. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Treatment related adverse events, serious adverse events and treatment related adverse events leading to treatment discontinuation are considered safety related events.
Mild TEAE: An event that is easily tolerated by the participant, causing minimal discomfort, and not interfering with everyday activities. Moderate TEAE:An event that causes sufficient discomfort and interferes with normal everyday activities. Severe TEAE: An event that prevents normal everyday activities. An AE that is assessed as severe should not be confused with an SAE. Severe is a category utilized for rating the intensity of an event, and both AEs and SAEs can be assessed as severe.
Number of participants with AE indicating clinical laboratory abnormality
Number of participants with clinically significant changes from baseline in ECG evaluations. ECG results for participants with any result outside of a pre-specified range and investigator identified abnormalities will be listed for the Safety Population. The following criteria will be used to determine ECG results that are outside of a pre-specified range: * PR (msec): Value \> 200 * QRS (msec): Value \> 120 * QT (msec): Value \> 500 or change from baseline \> 30 * QTcF (msec): Value \> 450 or change from baseline \> 30
Number of participants with clinically significant changes from baseline in vital signs evaluations. Vital signs for participants with any out-of-range result will be listed for the Safety Population. The following criteria will be used to determine vital sign results that are outside of a prespecified range, where changes from baseline are based on matched postural positions: * Heart Rate (bpm): Value \> 100 and change from baseline \> 30, or Value \< 55 and change from baseline \< -15 * Systolic blood pressure (mmHg): Value \> 140 and change from baseline \> 20, or Value \< 90 and change from baseline \< -20 * Diastolic blood pressure (mmHg): Value \> 90 and change from baseline \> 10, or Value \< 55 and change from baseline \< -10 * Respiration (breaths/min): Value \> 16 or change from baseline \> 10 * Temperature (°C): Value \> 38.3 or change from baseline \> 1.6
Number of participants with clinically significant changes from baseline in physical examination evaluations
| Arm | Type | Description |
|---|---|---|
| BMS-986322 Dose 1 | EXPERIMENTAL | - |
| BMS-986322 Dose 2 | EXPERIMENTAL | - |
| BMS-986322 Dose 3 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| BMS-986322 | DRUG | Specified dose on specified days |
| Placebo | OTHER | Specified dose on specified days |
Inclusion Criteria: * Diagnosis of plaque psoriasis (PsO) for ≥ 6 months * Body mass index 18 to 40 kg/m\^2 and total body weight \> 50 kg (110 lbs) * Deemed by Investigator to be eligible for phototherapy or systemic therapy * Psoriatic plaques must cover ≥ 10% of body surface area at baseline * P...
Top 12 of 13 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Johnson & Johnson | JNJ | 11 | PHASE3 | JNJ-77242113, Ustekinumab, Guselkumab |
| Bristol-Myers Squibb Company | BMY | 14 | PHASE3 | Deucravacitinib |
| AbbVie, Inc. | ABBV | 5 | PHASE3 | Risankizumab |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 3 | PHASE3 | Zasocitinib |
| Alumis Inc. | ALMS | 2 | PHASE3 | Envudeucitinib |
| Oruka Therapeutics, Inc. | ORKA | 4 | PHASE2 | ORKA-002, ORKA-001 |
| Can-Fite Biopharma Ltd | CANF | 1 | PHASE3 | Piclidenoson |
| Organon & Co. | OGN | 1 | PHASE3 | Tapinarof |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | Ponesimod |
| Novartis AG Sponsored ADR | NVS | 4 | - | Secukinumab |
| Bausch Health Companies Inc. | BHC | 2 | - | Brodalumab |
| Merck & Co., Inc. | MRK | 1 | PHASE1 | MK-8644 |
BMS-986322 is an investigational small molecule being studied for the treatment of moderate-to-severe psoriasis. It is not approved for any indication and remains in clinical development. Bristol-Myers Squibb evaluated it in a Phase 2 trial in adults with this chronic inflammatory skin condition.
BMS-986322 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company sponsored the Phase 2 clinical program evaluating the small molecule in moderate-to-severe psoriasis.
BMS-986322 is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA or any other regulatory agency for psoriasis or any other indication.
BMS-986322 has been evaluated in one Phase 2 clinical trial, NCT05730725, titled A Study to Evaluate Effectiveness and Safety of BMS-986322 in Participants With Moderate-to-Severe Psoriasis. The trial enrolled 109 adults across the United States, Australia, Canada, Japan, and the United Kingdom and has been completed.
The Phase 2 trial NCT05730725 was a randomized, double-blind, placebo-controlled study of BMS-986322 in 109 adults aged 18 years and older with moderate-to-severe psoriasis. It enrolled participants across five countries and has been completed.