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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-003660-49 | EudraCT Number | ||
| U1111-1241-6583 | Other Identifier | WHO |
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Insufficient enrollment
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The purpose of this study is to evaluate the safety, tolerability, drug levels, and drug effects of BMS-986325 in healthy participants and participants with primary Sjögren's syndrome. The results will guide the future clinical development with BMS-986325.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A (SAD) | Experimental | Single Ascending Dose (SAD) |
|
| Part A (SAD) Placebo | Placebo Comparator |
| |
| Part B (MAD) | Experimental | Multiple Ascending Dose (MAD) |
|
| Part B (MAD) Placebo | Placebo Comparator |
| |
| Part C (pSS) | Experimental | Primary Sjögren's Syndrome (pSS) |
|
| Part C (pSS) Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986325 | Biological | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Up to 137 days | |
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests | Up to 137 days | |
| Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests | Up to 137 days | |
| Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests | Up to 137 days | |
| Incidence of clinically significant changes in vital signs: Body temperature | Up to 137 days | |
| Incidence of clinically significant changes in vital signs: Respiratory rate | Up to 137 days | |
| Incidence of clinically significant changes in vital signs: Blood pressure | Up to 137 days | |
| Incidence of clinically significant changes in vital signs: Heart rate | Up to 137 days | |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval | PR interval: The time from the onset of the P wave to the start of the QRS complex | Up to 137 days |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Up to 137 days | |
| Time of maximum observed plasma concentration (Tmax) | Up to 137 days | |
| Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) |
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Inclusion Criteria:
Healthy Participants (Part A and Part B)
Participants with Sjögren's Syndrome (Part C)
Exclusion Criteria:
Healthy Participants (Part A and Part B) - Any significant acute or chronic medical illness
Healthy Participants (Part A and Part B) and Participants with Primary Sjögren's Syndrome (pSS) (Part C)
- Any major surgery within 4 weeks prior to study drug administration, or any surgery planned during the course of the study
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 |
|---|---|---|---|---|---|---|
| Medvin Clinical Research - Metyas | Covina | California | 91722 | United States | ||
| Local Institution - 0001 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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| Placebo for BMS-986325 | Other | Specified dose on specified days |
|
QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization |
| Up to 137 days |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval | QT interval: Measured from the beginning of the QRS complex to the end of the T wave | Up to 137 days |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval | QTcF interval: Corrected QT interval using Fridericia's formula (QTcF) | Up to 137 days |
| Incidence of clinically significant changes in physical examination findings | Up to 137 days |
| Incidence of clinically significant changes in inflammatory markers: C-reactive protein (CRP) | Up to 137 days |
| Incidence of clinically significant changes in inflammatory markers: Interferon-gamma (IFN-γ) | Up to 137 days |
| Incidence of clinically significant changes in inflammatory markers: Interleukin-1 beta (IL-1β) | Up to 137 days |
| Incidence of clinically significant changes in inflammatory markers: Interleukin-6 (IL-6) | Up to 137 days |
| Incidence of clinically significant changes in inflammatory markers: Interleukin-8 (IL-8) | Up to 137 days |
| Incidence of clinically significant changes in inflammatory markers: Tumor necrosis factor alpha (TNFα) | Up to 137 days |
| Up to 137 days |
| Berlin |
| 10117 |
| Germany |