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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04684654
• Other study ID #: IM039-004
• Secondary ID: 2019-003660-49U1
• Status: Terminated
• Phase: Phase 1
• Start date: February 16, 2021
• Est. completion date: July 25, 2023

Study information

• Verified date: August 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 118
• Est. completion date: July 25, 2023
• Est. primary completion date: July 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants
• Primary Sjögren's Syndrome
• Sjogren's Syndrome
• Syndrome

Intervention

Biological:
• BMS-986325
Specified dose on specified days

Other:
• Placebo for BMS-986325
Specified dose on specified days

Locations

Country	Name	City	State
Germany	Local Institution - 0001	Berlin
United States	Medvin Clinical Research - Metyas	Covina	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AEs)		Up to 137 days
Primary	Incidence of clinically significant changes in clinical laboratory results: Hematology tests		Up to 137 days
Primary	Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests		Up to 137 days
Primary	Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests		Up to 137 days
Primary	Incidence of clinically significant changes in vital signs: Body temperature		Up to 137 days
Primary	Incidence of clinically significant changes in vital signs: Respiratory rate		Up to 137 days
Primary	Incidence of clinically significant changes in vital signs: Blood pressure		Up to 137 days
Primary	Incidence of clinically significant changes in vital signs: Heart rate		Up to 137 days
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Incidence of clinically significant changes in physical examination findings		Up to 137 days
Primary	Incidence of clinically significant changes in inflammatory markers: C-reactive protein (CRP)		Up to 137 days
Primary	Incidence of clinically significant changes in inflammatory markers: Interferon-gamma (IFN-?)		Up to 137 days
Primary	Incidence of clinically significant changes in inflammatory markers: Interleukin-1 beta (IL-1ß)		Up to 137 days
Primary	Incidence of clinically significant changes in inflammatory markers: Interleukin-6 (IL-6)		Up to 137 days
Primary	Incidence of clinically significant changes in inflammatory markers: Interleukin-8 (IL-8)		Up to 137 days
Primary	Incidence of clinically significant changes in inflammatory markers: Tumor necrosis factor alpha (TNFa)		Up to 137 days
Secondary	Maximum observed plasma concentration (Cmax)		Up to 137 days
Secondary	Time of maximum observed plasma concentration (Tmax)		Up to 137 days
Secondary	Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))		Up to 137 days

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting