- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04684654
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Phone Number: 855-907-3286
- Email: Clinical.Trials@bms.com
Study Contact Backup
- Name: First line of the email MUST contain NCT # and Site #.
Study Locations
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Berlin, Germany, 10117
- Local Institution - 0001
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California
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Covina, California, United States, 91722
- Medvin Clinical Research - Metyas
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part A (SAD)
Single Ascending Dose (SAD)
|
Specified dose on specified days
|
Placebo Comparator: Part A (SAD) Placebo
|
Specified dose on specified days
|
Experimental: Part B (MAD)
Multiple Ascending Dose (MAD)
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Specified dose on specified days
|
Placebo Comparator: Part B (MAD) Placebo
|
Specified dose on specified days
|
Experimental: Part C (pSS)
Primary Sjögren's Syndrome (pSS)
|
Specified dose on specified days
|
Placebo Comparator: Part C (pSS) Placebo
|
Specified dose on specified days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Adverse Events (AEs)
Time Frame: Up to 137 days
|
Up to 137 days
|
|
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time Frame: Up to 137 days
|
Up to 137 days
|
|
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time Frame: Up to 137 days
|
Up to 137 days
|
|
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time Frame: Up to 137 days
|
Up to 137 days
|
|
Incidence of clinically significant changes in vital signs: Body temperature
Time Frame: Up to 137 days
|
Up to 137 days
|
|
Incidence of clinically significant changes in vital signs: Respiratory rate
Time Frame: Up to 137 days
|
Up to 137 days
|
|
Incidence of clinically significant changes in vital signs: Blood pressure
Time Frame: Up to 137 days
|
Up to 137 days
|
|
Incidence of clinically significant changes in vital signs: Heart rate
Time Frame: Up to 137 days
|
Up to 137 days
|
|
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
Time Frame: Up to 137 days
|
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
Time Frame: Up to 137 days
|
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
Time Frame: Up to 137 days
|
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
Time Frame: Up to 137 days
|
QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)
|
Up to 137 days
|
Incidence of clinically significant changes in physical examination findings
Time Frame: Up to 137 days
|
Up to 137 days
|
|
Incidence of clinically significant changes in inflammatory markers: C-reactive protein (CRP)
Time Frame: Up to 137 days
|
Up to 137 days
|
|
Incidence of clinically significant changes in inflammatory markers: Interferon-gamma (IFN-γ)
Time Frame: Up to 137 days
|
Up to 137 days
|
|
Incidence of clinically significant changes in inflammatory markers: Interleukin-1 beta (IL-1β)
Time Frame: Up to 137 days
|
Up to 137 days
|
|
Incidence of clinically significant changes in inflammatory markers: Interleukin-6 (IL-6)
Time Frame: Up to 137 days
|
Up to 137 days
|
|
Incidence of clinically significant changes in inflammatory markers: Interleukin-8 (IL-8)
Time Frame: Up to 137 days
|
Up to 137 days
|
|
Incidence of clinically significant changes in inflammatory markers: Tumor necrosis factor alpha (TNFα)
Time Frame: Up to 137 days
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Up to 137 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum observed plasma concentration (Cmax)
Time Frame: Up to 137 days
|
Up to 137 days
|
Time of maximum observed plasma concentration (Tmax)
Time Frame: Up to 137 days
|
Up to 137 days
|
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
|
Up to 137 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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