BMS-986325 in Healthy Participants and Participants With Primary Sjögren's Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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A Double-Blind, Placebo-Controlled, Randomized, Single and Multiple Dose Study on the Safety, Pharmacokinetics, and Exploratory Pharmacodynamics of Subcutaneous and Intravenous BMS-986325 Administration in Healthy Participants and Participants With Primary Sjögren's Syndrome

Conditions
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Healthy Participants, Primary Sjögren's Syndrome

Intervention / Treatment
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* Biological: BMS-986325
* Other: Placebo for BMS-986325


Participation Criteria
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Eligibility Criteria
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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/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A (SAD)<br>Single Ascending Dose (SAD) | Biological: BMS-986325<br>* Specified dose on specified days<br>|
| Placebo Comparator: Part A (SAD) Placebo<br> | Other: Placebo for BMS-986325<br>* Specified dose on specified days<br>|
| Experimental: Part B (MAD)<br>Multiple Ascending Dose (MAD) | Biological: BMS-986325<br>* Specified dose on specified days<br>|
| Placebo Comparator: Part B (MAD) Placebo<br> | Other: Placebo for BMS-986325<br>* Specified dose on specified days<br>|
| Experimental: Part C (pSS)<br>Primary Sjögren's Syndrome (pSS) | Biological: BMS-986325<br>* Specified dose on specified days<br>|
| Placebo Comparator: Part C (pSS) Placebo<br> | Other: Placebo for BMS-986325<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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)) |  | Up to 137 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Sjögren's Syndrome, Healthy participants, BMS-986325