NCT04684654

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2021

Typical duration for phase_1

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 24, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

February 16, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2023

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

2.4 years

First QC Date

December 22, 2020

Last Update Submit

August 22, 2023

Conditions

Healthy ParticipantsPrimary Sjögren's Syndrome

Keywords

Primary Sjögren's SyndromeHealthy participantsBMS-986325

Outcome Measures

Primary Outcomes (19)

  • Incidence of Adverse Events (AEs)

    Up to 137 days

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

    Up to 137 days

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

    Up to 137 days

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

    Up to 137 days

  • Incidence of clinically significant changes in vital signs: Body temperature

    Up to 137 days

  • Incidence of clinically significant changes in vital signs: Respiratory rate

    Up to 137 days

  • Incidence of clinically significant changes in vital signs: Blood pressure

    Up to 137 days

  • Incidence of clinically significant changes in vital signs: Heart rate

    Up to 137 days

  • 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

  • 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

  • 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

  • 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

  • Incidence of clinically significant changes in physical examination findings

    Up to 137 days

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

    Up to 137 days

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

    Up to 137 days

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

    Up to 137 days

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

    Up to 137 days

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

    Up to 137 days

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

    Up to 137 days

Secondary Outcomes (3)

  • Maximum observed plasma concentration (Cmax)

    Up to 137 days

  • Time of maximum observed plasma concentration (Tmax)

    Up to 137 days

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

    Up to 137 days

Study Arms (6)

Part A (SAD)

EXPERIMENTAL

Single Ascending Dose (SAD)

Biological: BMS-986325

Part A (SAD) Placebo

PLACEBO COMPARATOR
Other: Placebo for BMS-986325

Part B (MAD)

EXPERIMENTAL

Multiple Ascending Dose (MAD)

Biological: BMS-986325

Part B (MAD) Placebo

PLACEBO COMPARATOR
Other: Placebo for BMS-986325

Part C (pSS)

EXPERIMENTAL

Primary Sjögren's Syndrome (pSS)

Biological: BMS-986325

Part C (pSS) Placebo

PLACEBO COMPARATOR
Other: Placebo for BMS-986325

Interventions

BMS-986325BIOLOGICAL

Specified dose on specified days

Part A (SAD)Part B (MAD)Part C (pSS)
Placebo for BMS-986325OTHER

Specified dose on specified days

Part A (SAD) PlaceboPart B (MAD) PlaceboPart C (pSS) Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Medvin Clinical Research - Metyas

Covina, California, 91722, United States

Location

Local Institution - 0001

Berlin, 10117, Germany

Location

Related Links

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2020

First Posted

December 24, 2020

Study Start

February 16, 2021

Primary Completion

July 25, 2023

Study Completion

July 25, 2023

Last Updated

August 23, 2023

Record last verified: 2023-08

Locations

US(1)DE(1)