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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-503009-39 | Other Identifier | EU CTR |
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The purpose of this study is to evaluate safety, drug levels and drug effects on cells and organs of the body, after receiving multiple increasing doses of BMS-986326 via intravenous (IV) infusion or subcutaneous (SC) injection, in participants with different forms of lupus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: BMS-986326 Dose 1 IV | Experimental |
| |
| Cohort B: BMS-986326 Dose 2 IV | Experimental |
| |
| Cohort C1: BMS-986326 Dose 3 IV | Experimental |
| |
| Cohort C2: BMS-986326 Dose 3 SC | Experimental |
| |
| Cohort D2: BMS-986326 Dose 4 SC | Experimental |
| |
| Cohort E2: BMS-986326 Dose 3 SC | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986326 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to 228 days | |
| Number of participants with serious adverse events (SAEs) | Up to 228 days | |
| Number of participants with clinical laboratory abnormalities | Up to 228 days | |
| Number of participants with vital sign abnormalities | Up to 228 days | |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to 228 days | |
| Number of participants with physical examination abnormalities | Up to 228 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed serum concentration (Cmax) | Predose and post-dose up to Day 167 | |
| Time of Cmax (Tmax) | Predose and post-dose up to Day 167 | |
| Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T]) |
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Inclusion Criteria:
Exclusion criteria:
Note: Other protocol-defined inclusion/exclusion criteria apply.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0048 | San Diego | California | 92108 | United States | ||
| Local Institution - 0055 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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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-trials-and-research.html
See Plan Description
See Plan Description
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| Placebo for BMS-986326 | Other | Specified dose on specified days |
|
| Predose and post-dose up to Day 167 |
| Serum PK parameters such as AUC(TAU) | Predose and post-dose up to Day 167 |
| Change from baseline in regulatory T cells (Treg) count to Day 144 | Baseline up to Day 144 |
| Change from baseline in Treg-to-conventional t cells (Tconv) ratio | Baseline up to Day 144 |
| Number of participants with anti-drug antibodies | Baseline up to Day 167 |
| Clearwater |
| Florida |
| 33765 |
| United States |
| Local Institution - 0029 | Tampa | Florida | 33606 | United States |
| Skin Sciences | Louisville | Kentucky | 40217 | United States |
| Local Institution - 0062 | Las Vegas | Nevada | 89102 | United States |
| Local Institution - 0005 | Duncansville | Pennsylvania | 16635 | United States |
| Arthritis Northwest, PLLC | Spokane | Washington | 99204 | United States |
| Local Institution - 0070 | Pilar | Buenos Aires | 1629 | Argentina |
| Local Institution - 0075 | CABA | Buenos Aires F.D. | 1430 | Argentina |
| Local Institution - 0072 | Sofia | 1618 | Bulgaria |
| Local Institution - 0044 | Berlin | 10117 | Germany |
| Local Institution - 0071 | Dessau | 06847 | Germany |
| Local Institution - 0047 | Dresden | 01307 | Germany |
| Local Institution - 0051 | Leiden | 2333 CL | Netherlands |
| Local Institution - 0074 | Poznan | 61-848 | Poland |
| Local Institution - 0069 | Warsaw | 02-953 | Poland |
| Local Institution - 0065 | Bucharest | Bucharest | 11658 | Romania |
| Local Institution - 0064 | Cluj-Napoca | Cluj | 400006 | Romania |
| Local Institution - 0046 | A Coruña | A Coruña [La Coruña] | 15006 | Spain |
| Local Institution - 0045 | Córdoba | Córdoba | 14004 | Spain |
| ID | Term |
|---|---|
| D008179 | Lupus Erythematosus, Discoid |
| D008178 | Lupus Erythematosus, Cutaneous |
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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