Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023-504848-34 | EudraCT Number | ||
| U1111-1282-3606 | Registry Identifier | WHO |
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The purpose of this study is to evaluate clinical effectiveness and safety of BMS-986322 in participants with moderate-to-severe psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986322 Dose 1 | Experimental |
| |
| BMS-986322 Dose 2 | Experimental |
| |
| BMS-986322 Dose 3 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986322 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achiving PASI-75 at Week 12 | 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. | 12 Weeks |
| Number of Participants With Safety Related Events | Treatment related adverse events, serious adverse events and treatment related adverse events leading to treatment discontinuation are considered safety related events. | approximately 85 days |
| Number of Participants With TEAE by Worst Intensity | 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. | approximately 5 months |
| Number of Participants With AE Indicating Clinical Laboratory Abnormality | Number of participants with AE indicating clinical laboratory abnormality | approximately 5 months |
| Number of Participants With Clinically Significant Changes From Baseline in ECG Evaluations. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achiving sPGA Score of 0 or 1 at Week 12 | The static Physician's Global Assessment(sPGA) The sPGA is used to assess a participant's psoriasis lesions at a specific time point. Lesions are graded based on three characteristics: Erythema (E) Induration (I) Scaling (S) Each is scored individually, and the average of the three scores, rounded to the nearest whole number, determines the final sPGA score. 0 = No evidence 1= Minimal 2 = Mild 3 = Moderate 4 = Severe. The lower the score the better. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0006 | Birmingham | Alabama | 35205-5021 | United States | ||
| Local Institution - 0012 |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
Not provided
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trialsand research/disclosurecommitment.html
See Plan Description
See Plan Description
109 Participants Enrolled and Treated
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo |
| FG001 | Treatment 1 | BMS-986322 16mg |
| FG002 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 29, 2023 |
Not provided
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| Placebo | Other | Specified dose on specified days |
|
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:
| approximately 5 months |
| Number of Participants With Clinically Significant Changes From Baseline in Vital Signs Evaluations | 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:
| approximately 5 months |
| Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Evaluations | Number of participants with clinically significant changes from baseline in physical examination evaluations | approximately 5 months |
| 12 Weeks |
| Percentage of Participants Achiving PASI-50 at Week 12 | 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-50 response rate is defined as the percentage of participants with moderate-to-severe PsO achieving at least 50% 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. | 12 Weeks |
| Percentage of Participants Achiving PASI-90 at Week 12 | 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-90 response rate is defined as the percentage of participants with moderate-to-severe PsO achieving at least 90% 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. | 12 Weeks |
| Percentage of Participants Achiving PASI-100 at Week 12 | 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-100 response rate is defined as the percentage of participants with moderate-to-severe PsO achieving at least 100% 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. | 12 Weeks |
| Change of PASI-75 Scores Overtime | 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. | From start of treatment (Week 1) to Week 2, 4, 8 and 12 |
| Change of PASI-90 Scores Overtime | 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-90 response rate is defined as the percentage of participants with moderate-to-severe PsO achieving at least 90% 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. | From start of treatment (Week 1) to Week 2, 4, 8 and 12 |
| Change of PASI-100 Scores Overtime | 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-100 response rate is defined as the percentage of participants with moderate-to-severe PsO achieving at least 100% 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. | From start of treatment (Week 1) to Week 2, 4, 8 and 12 |
| Change of PASI-50 Scores Overtime | 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-50 response rate is defined as the percentage of participants with moderate-to-severe PsO achieving at least 50% 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. | From start of treatment (Week 1) to Week 2, 4, 8 and 12 |
| Mean Change Frome Baseline of PASI Scores Overtime | 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. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment. | From start of treatment (Week 1) to Week 2, 4, 8, and 12 |
| Ctrough Measurements Overtime | trough observed plasma concentration | From start of treatment (Week 1) to Week 2, 4, 8 and 12 |
| Cmax at Day 15 | maximum observed concentration | At Day 15 post first dose |
| Tmax at Day 15 | time to maximum observed concentration | At Day 15 post first dose |
| AUC(Tau) at Day 15 | area under the plasma concentration-time curve over the dosing interval | At Day 15 post first dose |
| Encino |
| California |
| 91436 |
| United States |
| Local Institution - 0005 | Fountain Valley | California | 92708-3701 | United States |
| Local Institution - 0002 | Fremont | California | 94538 | United States |
| Local Institution - 0001 | Los Angeles | California | 90045-3606 | United States |
| Local Institution - 0016 | Los Angeles | California | 90056 | United States |
| Local Institution - 0003 | Santa Ana | California | 92701-2201 | United States |
| Local Institution - 0013 | Coral Gables | Florida | 33134-5736 | United States |
| Local Institution - 0056 | Skokie | Illinois | 60077-1049 | United States |
| Local Institution - 0044 | Clarksville | Indiana | 47129-2201 | United States |
| Local Institution - 0057 | Leawood | Kansas | 66211 | United States |
| Local Institution - 0004 | Beverly | Massachusetts | 01915-1672 | United States |
| Local Institution - 0060 | Lee's Summit | Missouri | 64064 | United States |
| Local Institution - 0007 | Portsmouth | New Hampshire | 03801 | United States |
| Local Institution - 0055 | Durham | North Carolina | 27713-8507 | United States |
| Local Institution - 0008 | Cleveland | Ohio | 44106-1716 | United States |
| Local Institution - 0058 | Rapid City | South Dakota | 57702-9208 | United States |
| Local Institution - 0059 | Dallas | Texas | 75230-5808 | United States |
| Local Institution - 0011 | Webster | Texas | 77598 | United States |
| Local Institution - 0024 | Brisbane | Queensland | 4102 | Australia |
| Local Institution - 0019 | Carlton | Victoria | 3053 | Australia |
| Local Institution - 0045 | Pascoe Vale South | Victoria | 3044 | Australia |
| Local Institution - 0062 | St. John's | Newfoundland and Labrador | A1E 1V4 | Canada |
| Local Institution - 0034 | Barrie | Ontario | L4M 7G1 | Canada |
| Local Institution - 0020 | Hamilton | Ontario | L8L 3C3 | Canada |
| Local Institution - 0041 | London | Ontario | N6A 2C2 | Canada |
| Local Institution - 0030 | Toronto | Ontario | M2N 3A6 | Canada |
| Local Institution - 0049 | Sapporo | Hokkaido | 064-0807 | Japan |
| Local Institution - 0023 | tabashi City | Tokyo | 1738606 | Japan |
| Local Institution - 0051 | Fukuoka | 814-0180 | Japan |
| Local Institution - 0042 | Itabashi-Ku | 173-8610 | Japan |
| Local Institution - 0026 | Nagoya | 467-8602 | Japan |
| Local Institution - 0027 | Tsu | 514-8507 | Japan |
| Local Institution - 0050 | Hinckley | LEC | LE10 2SE | United Kingdom |
| Local Institution - 0046 | Leytonstone | E11 1NR | United Kingdom |
| Treatment 2 |
BMS-986322 32mg |
| FG003 | Treatment 3 | BMS-986322 64mg |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo |
| BG001 | Treatment 1 | BMS-986322 16mg |
| BG002 | Treatment 2 | BMS-986322 32mg |
| BG003 | Treatment 3 | BMS-986322 64mg |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achiving PASI-75 at Week 12 | 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. | Full Analysis Set | Posted | Number | 95% Confidence Interval | Percentage | 12 Weeks |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Safety Related Events | Treatment related adverse events, serious adverse events and treatment related adverse events leading to treatment discontinuation are considered safety related events. | All Treated Participants | Posted | Count of Participants | Participants | approximately 85 days |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With TEAE by Worst Intensity | 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. | All Treated Participants | Posted | Count of Participants | Participants | approximately 5 months |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With AE Indicating Clinical Laboratory Abnormality | Number of participants with AE indicating clinical laboratory abnormality | All Treated Participants | Posted | Count of Participants | Participants | approximately 5 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achiving sPGA Score of 0 or 1 at Week 12 | The static Physician's Global Assessment(sPGA) The sPGA is used to assess a participant's psoriasis lesions at a specific time point. Lesions are graded based on three characteristics: Erythema (E) Induration (I) Scaling (S) Each is scored individually, and the average of the three scores, rounded to the nearest whole number, determines the final sPGA score. 0 = No evidence 1= Minimal 2 = Mild 3 = Moderate 4 = Severe. The lower the score the better. | Full Analysis Set | Posted | Number | 95% Confidence Interval | Percentage | 12 Weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achiving PASI-50 at Week 12 | 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-50 response rate is defined as the percentage of participants with moderate-to-severe PsO achieving at least 50% 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. | Full Analysis Set | Posted | Number | 95% Confidence Interval | Percentage of Participants | 12 Weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achiving PASI-90 at Week 12 | 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-90 response rate is defined as the percentage of participants with moderate-to-severe PsO achieving at least 90% 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. | Full Analysis Set | Posted | Number | 95% Confidence Interval | Percentage of Participants | 12 Weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achiving PASI-100 at Week 12 | 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-100 response rate is defined as the percentage of participants with moderate-to-severe PsO achieving at least 100% 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. | Full Analysis Set | Posted | Number | 95% Confidence Interval | Percentage of Participants | 12 Weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change of PASI-75 Scores Overtime | 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. | Full Analysis Set | Posted | Number | 95% Confidence Interval | Percentage of Participants | From start of treatment (Week 1) to Week 2, 4, 8 and 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change of PASI-90 Scores Overtime | 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-90 response rate is defined as the percentage of participants with moderate-to-severe PsO achieving at least 90% 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. | Full Analysis Set | Posted | Number | 95% Confidence Interval | Percentage of Participants | From start of treatment (Week 1) to Week 2, 4, 8 and 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change of PASI-100 Scores Overtime | 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-100 response rate is defined as the percentage of participants with moderate-to-severe PsO achieving at least 100% 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. | Full Analysis Set | Posted | Number | 95% Confidence Interval | Percentage of Participants | From start of treatment (Week 1) to Week 2, 4, 8 and 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change of PASI-50 Scores Overtime | 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-50 response rate is defined as the percentage of participants with moderate-to-severe PsO achieving at least 50% 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. | Full Analysis Set | Posted | Number | 95% Confidence Interval | Percentage of Participants | From start of treatment (Week 1) to Week 2, 4, 8 and 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change Frome Baseline of PASI Scores Overtime | 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. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment. | Full Analysis Set | Posted | Mean | Standard Deviation | PASI Score on a Scale | From start of treatment (Week 1) to Week 2, 4, 8, and 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Ctrough Measurements Overtime | trough observed plasma concentration | All participants who were treated with BMS-986322 and with PK measurements | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | From start of treatment (Week 1) to Week 2, 4, 8 and 12 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Cmax at Day 15 | maximum observed concentration | All participants who were treated with BMS-986322 and with Cmax measurements | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | At Day 15 post first dose |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Tmax at Day 15 | time to maximum observed concentration | All participants who were treated with BMS-986322 and with Tmax measurements | Posted | Median | Full Range | hours | At Day 15 post first dose |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | AUC(Tau) at Day 15 | area under the plasma concentration-time curve over the dosing interval | All participants who were treated with BMS-986322 and with AUC(Tau) measurements | Posted | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | At Day 15 post first dose |
|
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Significant Changes From Baseline in ECG Evaluations. | 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:
| Safety Population | Posted | Count of Participants | Participants | approximately 5 months |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Significant Changes From Baseline in Vital Signs Evaluations | 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:
| Safety Population | Posted | Count of Participants | Participants | approximately 5 months |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Evaluations | Number of participants with clinically significant changes from baseline in physical examination evaluations | All Treated Participants | Posted | Count of Participants | Participants | approximately 5 months |
|
|
Adverse Events, Serious Adverse Events:,All-Cause mortality (From randomization to end of study treatment): Approximately 85 Days
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo | 0 | 28 | 1 | 28 | 7 | 28 |
| EG001 | Treatment 1 | BMS-986322 16 mg | 0 | 27 | 1 | 27 | 7 | 27 |
| EG002 | Treatment 2 | BMS-986322 32 mg | 0 | 27 | 0 | 27 | 10 | 27 |
| EG003 | Treatment 3 | BMS-986322 64 mg | 0 | 27 | 0 | 27 | 11 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticulitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please Email | Clinical.Trials@bms.com |
| Aug 6, 2025 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
BMS-986322 64mg
|
|
BMS-986322 64mg
|
|
BMS-986322 64mg
|
|
BMS-986322 64mg
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG003 | Treatment 3 | BMS-986322 64mg |
|
|
|
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