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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004044-29 | EudraCT Number |
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The purpose of this study is to assess the safety and drug levels of BMS-986256 in participants with cutaneous lupus erythematosus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986256 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986256 | Drug | Specified Dose on Specified Days |
| |
| BMS-986256 Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Serious Adverse Events (SAEs) | Up to 24 weeks | |
| Incidence of Adverse Events (AEs) | Up to 20 weeks | |
| Number of laboratory test abnormalities: Hematology | Up to 20 weeks | |
| Number of laboratory test abnormalities: Urinalysis | Up to 20 weeks | |
| Number of laboratory test abnormalities: Clinical Chemistry | Up to 20 weeks | |
| Incidence of clinically significant changes in physical examination findings | Up to 20 weeks | |
| Incidence of clinically significant changes in vital signs: Body temperature | Up to 20 weeks | |
| Incidence of clinically significant changes in vital signs: Respiratory rate | Up to 20 weeks | |
| Incidence of clinically significant changes in vital signs: Blood pressure | Up to 20 weeks | |
| Incidence of clinically significant changes in vital signs: Heart rate | Up to 20 weeks | |
| Incidence of clinically significant changes in Electrocardiogram (ECG) parameters |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of BMS-986256 | Up to 20 weeks | |
| Time to maximum concentration (Tmax) of BMS-986256 | Up to 20 weeks | |
| Trough observed plasma concentration (Ctrough) of BMS-986256 |
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Inclusion Criteria:
a) Must have one of following diagnoses: i) Meet European League Against Rheumatoid (EULAR)/American College of Rheumatology 2019 Classification Criteria for systemic lupus erythematosus (SLE) OR ii) Biopsy-proven acute cutaneous lupus erythematosus (ACLE), subacute cutaneous lupus erythematosus (SCLE), or discoid lupus erythematosus (DLE): Participants without a concurrent SLE diagnosis are eligible b) Active cutaneous lupus disease, defined as a modified Cutaneous Lupus Erythematosus Disease Area and Severity Index- Activity (mCLASI-A) score ≥ 6 c) Active cutaneous lupus skin lesion(s) amenable to biopsy
• Women of childbearing potential (WOCBP) and men must agree to follow instructions for method(s) of contraception, if applicable
Exclusion Criteria:
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 - 0001 | Berlin | 10117 | Germany |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| FDA Safety Alerts and Recalls |
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| ID | Term |
|---|---|
| D008178 | Lupus Erythematosus, Cutaneous |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| Other |
Specified Dose on Specified Days |
|
| Up to 20 weeks |
| Up to 20 weeks |
| Area under the concentration-time curve over the dosing interval (AUC (TAU)) of BMS-986256 | Up to 20 weeks |
| Maximum observed plasma concentration (Cmax) of metabolite BMT-271199 | Up to 20 weeks |
| Time to maximum concentration (Tmax) of metabolite BMT-271199 | Up to 20 weeks |
| Trough observed plasma concentration (Ctrough) of metabolite BMT-271199 | Up to 20 weeks |
| Area under the concentration-time curve over the dosing interval (AUC (TAU)) of metabolite BMT-271199 | Up to 20 weeks |