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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 1

Conditions: Healthy Participants; Primary Sjögren's Syndrome

Treatments: Other: Placebo for BMS-986325; Biological: BMS-986325

Study type: Interventional

Funder types: Industry

Identifiers

NCT04684654

IM039-004

2019-003660-49 (EudraCT Number)

U1111-1241-6583 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 118 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts 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). 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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118 participants in 6 patient groups, including a placebo group

Part A (SAD)

Experimental group

Description:

Single Ascending Dose (SAD)

Treatment:

Biological: BMS-986325

Part A (SAD) Placebo

Placebo Comparator group

Treatment:

Other: Placebo for BMS-986325

Part B (MAD)

Experimental group

Description:

Multiple Ascending Dose (MAD)

Treatment:

Biological: BMS-986325

Part B (MAD) Placebo

Placebo Comparator group

Treatment:

Other: Placebo for BMS-986325

Part C (pSS)

Experimental group

Description:

Primary Sjögren's Syndrome (pSS)

Treatment:

Biological: BMS-986325

Part C (pSS) Placebo

Placebo Comparator group

Treatment:

Other: Placebo for BMS-986325