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

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

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.

Study Overview

• Status: Terminated
• Conditions: Healthy Participants; Primary Sjögren's Syndrome
• Intervention / Treatment: Biological: BMS-986325; Other: Placebo for BMS-986325

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Local Institution - 0001
• United States
  • California
    • Covina, California, United States, 91722
      • Medvin Clinical Research - Metyas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2021
• Primary Completion (Actual): July 25, 2023
• Study Completion (Actual): July 25, 2023

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 24, 2020

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Healthy participants; Primary Sjögren's Syndrome; BMS-986325
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Syndrome; Sjogren's Syndrome
• Other Study ID Numbers: IM039-004; 2019-003660-49 (EudraCT Number); U1111-1241-6583 (Other Identifier: WHO)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes