Healthy ParticipantsPhase 1NCT04684654
BMS-986325 in Healthy Participants and Participants With Primary Sjögren's Syndrome
A Phase 1 study testing BMS-986325 in people with Healthy Participants and Primary Sjögren's Syndrome, run by Bristol-Myers Squibb at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Primary Sjögren's Syndrome
- What is being tested?
- BMS-986325
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 16 Feb 2021to 25 Jul 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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 locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Medvin Clinical Research - Metyas
Covina, California, 91722
About this study
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
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.
- Conditions
- Healthy Participants, Primary Sjögren's Syndrome
- Being tested
- BMS-986325, Placebo for BMS-986325
- Keywords
- Primary Sjögren's Syndrome, Healthy participants, BMS-986325
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986325Biological
Specified dose on specified days
Placebo for BMS-986325Other
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part A (SAD) | Experimental | Single Ascending Dose (SAD) Receives: Biological: BMS-986325 |
| Part A (SAD) Placebo | Placebo comparator | Not described Receives: Other: Placebo for BMS-986325 |
| Part B (MAD) | Experimental | Multiple Ascending Dose (MAD) Receives: Biological: BMS-986325 |
| Part B (MAD) Placebo | Placebo comparator | Not described Receives: Other: Placebo for BMS-986325 |
| Part C (pSS) | Experimental | Primary Sjögren's Syndrome (pSS) Receives: Biological: BMS-986325 |
| Part C (pSS) Placebo | Placebo comparator | Not described Receives: Other: Placebo for BMS-986325 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
Measured: Up to 137 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Measured: Up to 137 days
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Measured: Up to 137 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Measured: Up to 137 days
Incidence of clinically significant changes in vital signs: Body temperature
Measured: Up to 137 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Measured: Up to 137 days
Incidence of clinically significant changes in vital signs: Blood pressure
Measured: Up to 137 days
Incidence of clinically significant changes in vital signs: Heart rate
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: Up to 137 days
Incidence of clinically significant changes in physical examination findings
Measured: Up to 137 days
Incidence of clinically significant changes in inflammatory markers: C-reactive protein (CRP)
Measured: Up to 137 days
Incidence of clinically significant changes in inflammatory markers: Interferon-gamma (IFN-γ)
Measured: Up to 137 days
Incidence of clinically significant changes in inflammatory markers: Interleukin-1 beta (IL-1β)
Measured: Up to 137 days
Incidence of clinically significant changes in inflammatory markers: Interleukin-6 (IL-6)
Measured: Up to 137 days
Incidence of clinically significant changes in inflammatory markers: Interleukin-8 (IL-8)
Measured: Up to 137 days
Incidence of clinically significant changes in inflammatory markers: Tumor necrosis factor alpha (TNFα)
Measured: Up to 137 days
Secondary outcomes (3)
Maximum observed plasma concentration (Cmax)
Measured: Up to 137 days
Time of maximum observed plasma concentration (Tmax)
Measured: Up to 137 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
Measured: Up to 137 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start16 Feb 2021
- Primary completion25 Jul 2023
- Study completion25 Jul 2023
Why it stopped: Insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684654
- Sponsor's protocol ID
- IM039-004
- Other IDs
- 2019-003660-49, U1111-1241-6583, 2019
- Status last verified
- Aug 2023
- First submitted
- 22 Dec 2020
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04684654
- Acronym / sponsor ID
- IM039-004
- Conditions
- Healthy Participants, Primary Sjögren's Syndrome
- Keywords
- Primary Sjögren's Syndrome, Healthy participants, BMS-986325
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part A (SAD) | Experimental | Biological: BMS-986325Single Ascending Dose (SAD) |
| Part A (SAD) Placebo | Placebo comparator | Other: Placebo for BMS-986325 |
| Part B (MAD) | Experimental | Biological: BMS-986325Multiple Ascending Dose (MAD) |
| Part B (MAD) Placebo | Placebo comparator | Other: Placebo for BMS-986325 |
| Part C (pSS) | Experimental | Biological: BMS-986325Primary Sjögren's Syndrome (pSS) |
| Part C (pSS) Placebo | Placebo comparator | Other: Placebo for BMS-986325 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986325Specified dose on specified days | Biological | Part A (SAD), Part B (MAD), Part C (pSS) |
| Placebo for BMS-986325Specified dose on specified days | Other | Part A (SAD) Placebo, Part B (MAD) Placebo, Part C (pSS) Placebo |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: Up to 137 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time frame: Up to 137 days
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time frame: Up to 137 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time frame: Up to 137 days
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Up to 137 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Time frame: Up to 137 days
Incidence of clinically significant changes in vital signs: Blood pressure
Time frame: Up to 137 days
Incidence of clinically significant changes in vital signs: Heart rate
Time frame: 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
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
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
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)
Incidence of clinically significant changes in physical examination findings
Time frame: Up to 137 days
Incidence of clinically significant changes in inflammatory markers: C-reactive protein (CRP)
Time frame: Up to 137 days
Incidence of clinically significant changes in inflammatory markers: Interferon-gamma (IFN-γ)
Time frame: Up to 137 days
Incidence of clinically significant changes in inflammatory markers: Interleukin-1 beta (IL-1β)
Time frame: Up to 137 days
Incidence of clinically significant changes in inflammatory markers: Interleukin-6 (IL-6)
Time frame: Up to 137 days
Incidence of clinically significant changes in inflammatory markers: Interleukin-8 (IL-8)
Time frame: Up to 137 days
Incidence of clinically significant changes in inflammatory markers: Tumor necrosis factor alpha (TNFα)
Time frame: Up to 137 days
3 secondary outcomes
Maximum observed plasma concentration (Cmax)
Time frame: Up to 137 days
Time of maximum observed plasma concentration (Tmax)
Time frame: 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
Results and safety
The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986325 in people with Healthy Participants and Primary Sjögren's Syndrome, run by Bristol-Myers Squibb at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) (time frame: Up to 137 days). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.