Clinical trial NCT04684654: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Participants
Primary Sjögren's Syndrome
Keywords: Primary Sjögren's Syndrome
Healthy participants
BMS-986325
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2020-12-24
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 137 days
measure: Incidence of clinically significant changes in clinical laboratory results: Hematology tests
timeFrame: Up to 137 days
measure: Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
timeFrame: Up to 137 days
measure: Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
timeFrame: Up to 137 days
measure: Incidence of clinically significant changes in vital signs: Body temperature
timeFrame: Up to 137 days
measure: Incidence of clinically significant changes in vital signs: Respiratory rate
timeFrame: Up to 137 days
measure: Incidence of clinically significant changes in vital signs: Blood pressure
timeFrame: Up to 137 days
measure: Incidence of clinically significant changes in vital signs: Heart rate
timeFrame: Up to 137 days
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
timeFrame: Up to 137 days
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval
timeFrame: Up to 137 days
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
timeFrame: Up to 137 days
measure: Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval
timeFrame: Up to 137 days
measure: Incidence of clinically significant changes in physical examination findings
timeFrame: Up to 137 days
measure: Incidence of clinically significant changes in inflammatory markers: C-reactive protein (CRP)
timeFrame: Up to 137 days
measure: Incidence of clinically significant changes in inflammatory markers: Interferon-gamma (IFN-γ)
timeFrame: Up to 137 days
measure: Incidence of clinically significant changes in inflammatory markers: Interleukin-1 beta (IL-1β)
timeFrame: Up to 137 days
measure: Incidence of clinically significant changes in inflammatory markers: Interleukin-6 (IL-6)
timeFrame: Up to 137 days
measure: Incidence of clinically significant changes in inflammatory markers: Interleukin-8 (IL-8)
timeFrame: Up to 137 days
measure: Incidence of clinically significant changes in inflammatory markers: Tumor necrosis factor alpha (TNFα)
timeFrame: Up to 137 days
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 137 days
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to 137 days
measure: Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
timeFrame: Up to 137 days
Other outcomes:
Locations:
city: Covina
country: United States
facility: Medvin Clinical Research - Metyas
state: California
city: Berlin
country: Germany
facility: Local Institution - 0001
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: