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

Primary Purpose

Healthy Participants, Primary Sjögren's Syndrome

Status

Terminated

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

BMS-986325

Placebo for BMS-986325

About this trial

This is an interventional treatment trial for Healthy Participants focused on measuring Primary Sjögren's Syndrome, Healthy participants, BMS-986325

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)
Seropositive for anti-Sjögren's syndrome antigen A antibody
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
Any major surgery within 4 weeks prior to study drug administration, or any surgery planned during the course of the study

Participants with Sjögren's Syndrome (Part C)

Systemic immune-mediated disease other than pSS, such as rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), mixed connective tissue disease, or systemic sclerosis, that can better explain the majority of the symptoms (ie, secondary Sjögren's syndrome)
Recent (within 6 months before Day 1) drug or alcohol abuse as defined by the 'Diagnostic Criteria for Drug and Alcohol Abuse' in the Diagnostic and Statistical Manual 5 (DSM 5) or corresponding local regulations

Other protocol-defined inclusion/exclusion criteria apply

Sites / Locations

Medvin Clinical Research - Metyas
Local Institution - 0001

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Part A (SAD)

Part A (SAD) Placebo

Part B (MAD)

Part B (MAD) Placebo

Part C (pSS)

Part C (pSS) Placebo

Arm Description

Single Ascending Dose (SAD)

Multiple Ascending Dose (MAD)

Primary Sjögren's Syndrome (pSS)

Outcomes

Primary Outcome Measures

Incidence of Adverse Events (AEs)

Incidence of clinically significant changes in clinical laboratory results: Hematology tests

Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests

Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests

Incidence of clinically significant changes in vital signs: Body temperature

Incidence of clinically significant changes in vital signs: Respiratory rate

Incidence of clinically significant changes in vital signs: Blood pressure

Incidence of clinically significant changes in vital signs: Heart rate

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

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

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

Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval

QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)

Incidence of clinically significant changes in physical examination findings

Incidence of clinically significant changes in inflammatory markers: C-reactive protein (CRP)

Incidence of clinically significant changes in inflammatory markers: Interferon-gamma (IFN-γ)

Incidence of clinically significant changes in inflammatory markers: Interleukin-1 beta (IL-1β)

Incidence of clinically significant changes in inflammatory markers: Interleukin-6 (IL-6)

Incidence of clinically significant changes in inflammatory markers: Interleukin-8 (IL-8)

Incidence of clinically significant changes in inflammatory markers: Tumor necrosis factor alpha (TNFα)

Secondary Outcome Measures

Maximum observed plasma concentration (Cmax)

Time of maximum observed plasma concentration (Tmax)

Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))

Full Information

NCT ID

NCT04684654

First Posted

December 22, 2020

Last Updated

August 22, 2023

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT04684654

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Terminated

Why Stopped

Insufficient enrollment

Study Start Date

February 16, 2021 (Actual)

Primary Completion Date

July 25, 2023 (Actual)

Study Completion Date

July 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy Participants, Primary Sjögren's Syndrome

Keywords

Primary Sjögren's Syndrome, Healthy participants, BMS-986325

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

118 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part A (SAD)

Arm Type

Experimental

Arm Description

Single Ascending Dose (SAD)

Arm Title

Part A (SAD) Placebo

Arm Type

Placebo Comparator

Arm Title

Part B (MAD)

Arm Type

Experimental

Arm Description

Multiple Ascending Dose (MAD)

Arm Title

Part B (MAD) Placebo

Arm Type

Placebo Comparator

Arm Title

Part C (pSS)

Arm Type

Experimental

Arm Description

Primary Sjögren's Syndrome (pSS)

Arm Title

Part C (pSS) Placebo

Arm Type

Placebo Comparator

Intervention Type

Biological

Intervention Name(s)

BMS-986325

Intervention Description

Specified dose on specified days

Intervention Type

Other

Intervention Name(s)

Placebo for BMS-986325

Intervention Description

Specified dose on specified days

Primary Outcome Measure Information:

Title

Incidence of Adverse Events (AEs)

Time Frame

Up to 137 days

Title

Incidence of clinically significant changes in clinical laboratory results: Hematology tests

Time Frame

Up to 137 days

Title

Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests

Time Frame

Up to 137 days

Title

Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests

Time Frame

Up to 137 days

Title

Incidence of clinically significant changes in vital signs: Body temperature

Time Frame

Up to 137 days

Title

Incidence of clinically significant changes in vital signs: Respiratory rate

Time Frame

Up to 137 days

Title

Incidence of clinically significant changes in vital signs: Blood pressure

Time Frame

Up to 137 days

Title

Incidence of clinically significant changes in vital signs: Heart rate

Time Frame

Up to 137 days

Title

Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval

Description

PR interval: The time from the onset of the P wave to the start of the QRS complex

Time Frame

Up to 137 days

Title

Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval

Description

QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization

Time Frame

Up to 137 days

Title

Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval

Description

QT interval: Measured from the beginning of the QRS complex to the end of the T wave

Time Frame

Up to 137 days

Title

Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval

Description

QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)

Time Frame

Up to 137 days

Title

Incidence of clinically significant changes in physical examination findings

Time Frame

Up to 137 days

Title

Incidence of clinically significant changes in inflammatory markers: C-reactive protein (CRP)

Time Frame

Up to 137 days

Title

Incidence of clinically significant changes in inflammatory markers: Interferon-gamma (IFN-γ)

Time Frame

Up to 137 days

Title

Incidence of clinically significant changes in inflammatory markers: Interleukin-1 beta (IL-1β)

Time Frame

Up to 137 days

Title

Incidence of clinically significant changes in inflammatory markers: Interleukin-6 (IL-6)

Time Frame

Up to 137 days

Title

Incidence of clinically significant changes in inflammatory markers: Interleukin-8 (IL-8)

Time Frame

Up to 137 days

Title

Incidence of clinically significant changes in inflammatory markers: Tumor necrosis factor alpha (TNFα)

Time Frame

Up to 137 days

Secondary Outcome Measure Information:

Title

Maximum observed plasma concentration (Cmax)

Time Frame

Up to 137 days

Title

Time of maximum observed plasma concentration (Tmax)

Time Frame

Up to 137 days

Title

Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))

Time Frame

Up to 137 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Medvin Clinical Research - Metyas

City

Covina

State/Province

California

ZIP/Postal Code

91722

Country

United States

Facility Name

Local Institution - 0001

City

Berlin

ZIP/Postal Code

10117

Country

Germany

12. IPD Sharing Statement

Links:

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Description

BMS Clinical Trial Information

URL

https://www.bmsstudyconnect.com/s/US/English/USenHome

Description

BMS Clinical Trial Patient Recruiting

Learn more about this trial

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

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