Healthy Participants, Primary Sjögren's Syndrome
Conditions
Keywords
Primary Sjögren's Syndrome, Healthy participants, BMS-986325
Brief summary
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.
Interventions
BIOLOGICALBMS-986325
Specified dose on specified days
OTHERPlacebo for BMS-986325
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy Participants (Part A and Part B) * Healthy male and female participants as determined by no clinically significant deviation from normal in medical history, physical examination (PE), electrocardiograms (ECGs), and clinical laboratory determinations * Males and Females, ages 18, or local age of majority, to 50 years, inclusive at screening * Body mass index (BMI):18.0 to 30.0 kg/m2, weight: ≥ 50 kg at screening * Must be fully vaccinated against SARS-CoV-2 Participants with Sjögren's Syndrome (Part C) * Sjögren's syndrome in the absence of another immune-mediated disease or rheumatologic condition based on the 2016 American College of Rheumatology-European League Against Rheumatism (EULAR) Classification Criteria for primary Sjögren's syndrome (pSS). Historical diagnosis as pSS documented in medical records, using the 2016 ACR/EULAR criteria, is also acceptable * Seropositive for anti-Sjögren's syndrome antigen A antibody (anti-SSA). Previous anti-SSA are also acceptable, and results should be documented in the Case Report Form (CRF) as past medical history * Males and females, ages 18, or local age of majority, to 75 years, inclusive at screening * Body mass index (BMI): 18.0 to 35.0 kg/m2; weight ≥ 50 kg at screening * Must be fully vaccinated against SARS-CoV-2 according to local regulations
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of clinically significant changes in inflammatory markers: Tumor necrosis factor alpha (TNFα) | 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 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 | Up to 137 days | PR interval: The time from the onset of the P wave to the start of the QRS complex |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval | Up to 137 days | QRS interval: A combination of the Q wave, R wave and S wave, the QRS complex represents ventricular depolarization |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval | Up to 137 days | QT interval: Measured from the beginning of the QRS complex to the end of the T wave |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval | Up to 137 days | QTcF interval: Corrected QT interval using Fridericia's formula (QTcF) |
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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)) | Up to 137 days |
| Maximum observed plasma concentration (Cmax) | Up to 137 days |
Countries
Germany, United States
Outcome results
None listed