Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BMS-986322 · 6 trials · 3 indications
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 | - |
| Administration of BMS-986322 | EXPERIMENTAL | - |
| Part 1: Rosuvastatin + BMS-986322 | EXPERIMENTAL | - |
| Part 2: Metformin + BMS-986322 + Glucose | EXPERIMENTAL | - |
| Part 3: Methotrexate + BMS-986322 + Leucovorin | EXPERIMENTAL | - |
| BMS-986322 and Loestrin | EXPERIMENTAL | Loestrin, then progress to combination |
| Cohort J1 | EXPERIMENTAL | - |
| Cohort J2 | EXPERIMENTAL | - |
| Cohort J3 | EXPERIMENTAL | - |
| Part A: BMS-986322 | EXPERIMENTAL | - |
| Part B: BMS-986322 Placebo | EXPERIMENTAL | - |
| Part C: BMS-986322 with famotidine | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BMS-986322 | DRUG | Specified dose on specified days |
| Placebo | OTHER | Specified dose on specified days |
| Rosuvastatin | DRUG | Specified dose on specified days |
| Metformin | DRUG | Specified dose on specified days |
| Glucose | DIETARY_SUPPLEMENT | Specified dose on specified days |
| Methotrexate | DRUG | Specified dose on specified days |
| Leucovorin | DRUG | Specified dose on specified days |
| Loestrin | DRUG | Specified dose on specified days |
| Placebo for BMS-986322 | OTHER | Specified dose on specified days |
| BMS-986322 Placebo | OTHER | Specified Dose on Specified Days |
| famotidine | DRUG | 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...
BMS-986322 is an investigational small molecule being studied for the treatment of moderate-to-severe psoriasis. It has also been evaluated in clinical trials involving healthy participants to assess its drug levels, effects, safety, and interactions. The drug is not approved and remains in clinical development.
BMS-986322 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company has sponsored multiple clinical trials of the drug, including studies in healthy participants and in patients with moderate-to-severe psoriasis.
BMS-986322 is in Phase 1 and Phase 2 clinical development. It has completed Phase 1 trials in healthy participants and a Phase 2 trial in participants with moderate-to-severe psoriasis. The drug is investigational and has not been approved by regulatory authorities.
BMS-986322 has completed four clinical trials. These include NCT04175925 and NCT05579574 in healthy participants, NCT05730725 in participants with moderate-to-severe psoriasis, and NCT06088264 in healthy adult male participants. All trials are completed, with a total enrollment of 313 participants.
BMS-986322 is the primary name used for this investigational drug in clinical trials. No alternative names have been reported in the available clinical trial information. It is a small molecule being studied for psoriasis and in healthy volunteer studies.