Multiple Sclerosis (MS)Phase 1NCT05064436
A Study to Evaluate the Safety, Tolerability, Kinetics, Biodistribution and Repeatability of 11C-BMS-986196 After Intravenous (IV) Administration in Healthy Participants and After Repeat IV Administration in Participants With Multiple Sclerosis
A Phase 1 study testing 11C-BMS-986196 in people with Multiple Sclerosis (MS), run by Bristol-Myers Squibb at 2 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, kinetics, biodistribution and central nervous system signal of 11C-BMS-986196 after intravenous (IV) administration in healthy participants and after repeat IV administration in participants with multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis (MS)
- What is being tested?
- 11C-BMS-986196
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Dec 2021to 18 Dec 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- For Parts A \& B:
- Body mass index (BMI) of 18 to 34 kg/m2, inclusive, and total body weight ≥ 50 kg
- Documentation of normal Allen's test result at Screening and on PET scanning days in the arm that will be used for arterial line placement
- For Part A only:
- Healthy male and female participants without clinically significant deviation from normal in medical history, physical examination (PE), electrocardiograms (ECGs), and clinical laboratory determinations
- For Part B only:
- Male or female participant diagnosed with MS according to the 2017 revisions of the McDonald diagnostic criteria
- Expanded Disability Status Scale (EDSS) score between 0 to 6.5, inclusive, at Screening
Who cannot join
- For Parts A \& B:
- Benign MS defined as a baseline EDSS of 2.0 with MS diagnosis ≥ 10 years prior to Day 1. Spinal MS without clinical or radiological evidence of brain lesions. Any other combination of clinical and radiological data suggestive of an absence of inflammatory brain lesions.
- Any major surgery within 4 weeks of study treatment administration and/or any minor surgery within 2 weeks of tracer administration
- For Part A only:
- Any significant acute or chronic medical illness
- For Part B only:
Show all 9Show fewer
- Any significant acute or chronic medical illness (other than MS) posing a risk to the participant's safety or negatively affecting the ability to detect CNS PET signal
- MS relapse within 14 days prior to Day 1. Participants with a MS relapse within 30 days prior to Day 1 must agree to have their second PET scan scheduled on Day 1 or Day 2
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Phase 1, Open-label, Multi-part Study to Evaluate the Safety, Tolerability, Kinetics, Biodistribution, and CNS Signal of the Positron Emission Tomography Ligand 11C-BMS-986196 in Healthy Participants After Intravenous Administration and to Evaluate the Safety, Tolerability, Kinetics, and CNS Signal Repeatability of 11C-BMS-986196 After Repeat Intravenous Administration in Participants With Multiple Sclerosis
The purpose of this study is to evaluate the safety, tolerability, kinetics, biodistribution and central nervous system signal of 11C-BMS-986196 after intravenous (IV) administration in healthy participants and after repeat IV administration in participants with multiple sclerosis.
- Conditions
- Multiple Sclerosis (MS)
- Being tested
- 11C-BMS-986196
- Keywords
- Multiple Sclerosis (MS), Healthy Participants, 11C-BMS-986196, PET tracer
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
11C-BMS-986196Drug
Also called BMS-986196
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part A - Healthy Participants | Experimental | Not described Receives: Drug: 11C-BMS-986196 |
| Part B - Participants with MS | Experimental | Not described Receives: Drug: 11C-BMS-986196 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events Based on Severity.
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment.
Measured: From first visit up to 9 days post
Number of Participants With Clinically Significant Changes in Electrocardiograms.
Number of participants with clinically significant changes in electrocardiograms.
Measured: From first visit up to 9 days post
Number of Participants With Clinically Significant Changes in Vital Signs.
Number of participants with clinically significant changes in vital signs.
Measured: From first visit up to 9 days post
Number of Participants With Clinically Significant Changes in Laboratory Values.
Number of participants with clinically significant changes in laboratory values.
Measured: From first visit up to 9 days post
Number of Participants With Clinically Significant Changes in Phsyical Examinations.
Number of participants with clinically significant changes in phsyical examinations.
Measured: From first visit up to 9 days post
Number of Participants With Clinically Significant Changes in C-SSRS.
Number of participants with clinically significant changes in C-SSRS.
Columbia-Suicide Severity Rating Scale (C-SSRS).
The entire Columbia Suicide Severity Rating Scale (C-SSRS) will be administered, but the investigators will use its' Suicidal Ideation Intensity scale (0-25 score range summed from five items, with higher scores indicating more severe suicidal ideation) as the primary outcome.
Data Not Collected
Measured: Data Not Collected
Radiation Dosimetry Calculated From PET-CT Images in Healthy Participants
Measurement and assessment of radiation exposure and absorption of ionizing radiation in body tissue.
The Organ Level Internal Dose Assessment (OLINDA) 2.0 software package (Hermes Medical Solutions) was used to estimate the organ and whole-body radiation absorbed doses. OLINDA uses Medical Internal Radiation Dose (MIRD) methodology (Stabin, Sparks, and Crowe 2005). The NURBs ICRP-89 adult male (73 kg) model was used to calculate the referent s-factors (Valentin and Streffer 2002). Tissue weighting factors defined in (ICRP Publication 103, 2007) were used to calculate the whole body effective dose (ED). All other MIRD assumptions about the homogeneity of source organ distribution were employed.
Measured: 2 hours
Image Acquisition Window After Tracer Administration
Period of time required to collect the imaging data during a scan.
Participants received a bolus intravenous administration of up to 370 MBq of 11CBMS- 986196. Immediately following the 11C-BMS-986196 administration, dynamic PET emission data were acquired for 90 minutes in a single bed position focused on the cranium.
For PET acquisitions, a low dose CT scan was performed before administration of the radiotracer, to enable correction for attenuation of emitted radiation.
Measured: 90 Mins
Percentage of Participants With Test Repeatablity Based on SUV.
Standardized uptake value (SUV) is Semi-quantitative measurement of tracer uptake in body tissue defined as ratio of radioactivity per unit volume of a region of interest to the radioactivity per unit volume of the whole body.
Test-retest repeatability based on standardized uptake value (SUV) of CNS PET images in participants with MS: The test-retest repeatability will be based on a quantitative analysis of cranial PET images and will be evaluated for the Response-Evaluable 3 population. The test-retest repeatability (%), which is defined based upon the absolute value of the difference between test and retest values normalized by their mean:
Test-Retest difference = RT-T Test-retest repeatability (%) = 100%-2×|(RT-T)/(RT+T)|×100%
with T being the calculated value for the parameter measured at Visit 1 (test, T) and RT being the calculated value for the same parameter measured at Visit 2 (retest, RT).
Measured: 2 hours
Percentage of Participants With Test Repeatablity Based on VT.
Volume of Distribution (VT) is the ratio of the radioligand concentration in a region of interest to the radioligand concentration in plasma at equilibrium.
Test-retest repeatability based on VT of CNS PET images in participants with MS: The test-retest repeatability will be based on a quantitative analysis of cranial PET images and will be evaluated for the Response-Evaluable 3 population. The test-retest repeatability (%), which is defined based upon the absolute value of the difference between test and retest values normalized by their mean:
Test-Retest difference = RT-T Test-retest repeatability (%) = 100%-2×|(RT-T)/(RT+T)|×100%
with T being the calculated value for the parameter measured at Visit 1 (test, T) and RT being the calculated value for the same parameter measured at Visit 2 (retest, RT).
Measured: 2 Hours
Percentage of Free Brain BTK Relative to Baseline
Percentage of free brain Burtons Tyrosine Kinase (BTK) relative to baseline
Measured: Data Not Collected
Mean Standardized Uptake Value (SUV) in the Brain
Standardized uptake value (SUV) is Semi-quantitative measurement of tracer uptake in body tissue defined as ratio of radioactivity per unit volume of a region of interest to the radioactivity per unit volume of the whole body.
Measured: On visits 1 (Day 1) and vist 2 (2hrs to 6 days after visit 1 tracer administration)
Mean Volume of Distribution (VT) in the Brain
Volume of Distribution (VT) is the ratio of the radioligand concentration in a region of interest to the radioligand concentration in plasma at equilibrium.
Measured: On visits 1 (Day 1) and vist 2 (2hrs to 6 days after visit 1 tracer administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start10 Dec 2021
- Primary completion18 Dec 2023
- Study completion18 Dec 2023
Why it stopped: Business objectives have changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple Sclerosis (MS)Studies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT05064436
- Sponsor's protocol ID
- IM038-010
- Other IDs
- 2021-001986-19
- Status last verified
- Apr 2025
- First submitted
- 22 Sep 2021
- Last updated
- 24 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Multi-part Study to Evaluate the Safety, Tolerability, Kinetics, Biodistribution, and CNS Signal of the Positron Emission Tomography Ligand 11C-BMS-986196 in Healthy Participants After Intravenous Administration and to Evaluate the Safety, Tolerability, Kinetics, and CNS Signal Repeatability of 11C-BMS-986196 After Repeat Intravenous Administration in Participants With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05064436
- Acronym / sponsor ID
- IM038-010
- Conditions
- Multiple Sclerosis (MS)
- Keywords
- Multiple Sclerosis (MS), Healthy Participants, 11C-BMS-986196, PET tracer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business objectives have changed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 1 Oct 2021 (actual)
- Results
- Posted 24 Apr 2025
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, kinetics, biodistribution and central nervous system signal of 11C-BMS-986196 after intravenous (IV) administration in healthy participants and after repeat IV administration in participants with multiple sclerosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A - Healthy Participants | Experimental | Drug: 11C-BMS-986196 |
| Part B - Participants with MS | Experimental | Drug: 11C-BMS-986196 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Body mass index (BMI) of 18 to 34 kg/m2, inclusive, and total body weight ≥ 50 kg
- Documentation of normal Allen's test result at Screening and on PET scanning days in the arm that will be used for arterial line placement
- Healthy male and female participants without clinically significant deviation from normal in medical history, physical examination (PE), electrocardiograms (ECGs), and clinical laboratory determinations
- Male or female participant diagnosed with MS according to the 2017 revisions of the McDonald diagnostic criteria
- Expanded Disability Status Scale (EDSS) score between 0 to 6.5, inclusive, at Screening
Key exclusion criteria (9 listed)
- Benign MS defined as a baseline EDSS of 2.0 with MS diagnosis ≥ 10 years prior to Day 1. Spinal MS without clinical or radiological evidence of brain lesions. Any other combination of clinical and radiological data suggestive of an absence of inflammatory brain lesions.
- Any major surgery within 4 weeks of study treatment administration and/or any minor surgery within 2 weeks of tracer administration
- Any significant acute or chronic medical illness
- Any significant acute or chronic medical illness (other than MS) posing a risk to the participant's safety or negatively affecting the ability to detect CNS PET signal
- MS relapse within 14 days prior to Day 1. Participants with a MS relapse within 30 days prior to Day 1 must agree to have their second PET scan scheduled on Day 1 or Day 2
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 |
|---|---|---|
| 11C-BMS-986196Also: BMS-986196Specified dose on specified days | Drug | Part A - Healthy Participants, Part B - Participants with MS |
Primary outcome
Number of Participants With Adverse Events Based on Severity.
Time frame: From first visit up to 9 days post
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment.
Number of Participants With Clinically Significant Changes in Electrocardiograms.
Time frame: From first visit up to 9 days post
Number of participants with clinically significant changes in electrocardiograms.
Number of Participants With Clinically Significant Changes in Vital Signs.
Time frame: From first visit up to 9 days post
Number of participants with clinically significant changes in vital signs.
Number of Participants With Clinically Significant Changes in Laboratory Values.
Time frame: From first visit up to 9 days post
Number of participants with clinically significant changes in laboratory values.
Number of Participants With Clinically Significant Changes in Phsyical Examinations.
Time frame: From first visit up to 9 days post
Number of participants with clinically significant changes in phsyical examinations.
Number of Participants With Clinically Significant Changes in C-SSRS.
Time frame: Data Not Collected
Number of participants with clinically significant changes in C-SSRS. Columbia-Suicide Severity Rating Scale (C-SSRS). The entire Columbia Suicide Severity Rating Scale (C-SSRS) will be administered, but the investigators will use its' Suicidal Ideation Intensity scale (0-25 score range summed from five items, with higher scores indicating more severe suicidal ideation) as the primary outcome. Data Not Collected
Radiation Dosimetry Calculated From PET-CT Images in Healthy Participants
Time frame: 2 hours
Measurement and assessment of radiation exposure and absorption of ionizing radiation in body tissue. The Organ Level Internal Dose Assessment (OLINDA) 2.0 software package (Hermes Medical Solutions) was used to estimate the organ and whole-body radiation absorbed doses. OLINDA uses Medical Internal Radiation Dose (MIRD) methodology (Stabin, Sparks, and Crowe 2005). The NURBs ICRP-89 adult male (73 kg) model was used to calculate the referent s-factors (Valentin and Streffer 2002). Tissue weighting factors defined in (ICRP Publication 103, 2007) were used to calculate the whole body effective dose (ED). All other MIRD assumptions about the homogeneity of source organ distribution were employed.
Image Acquisition Window After Tracer Administration
Time frame: 90 Mins
Period of time required to collect the imaging data during a scan. Participants received a bolus intravenous administration of up to 370 MBq of 11CBMS- 986196. Immediately following the 11C-BMS-986196 administration, dynamic PET emission data were acquired for 90 minutes in a single bed position focused on the cranium. For PET acquisitions, a low dose CT scan was performed before administration of the radiotracer, to enable correction for attenuation of emitted radiation.
Percentage of Participants With Test Repeatablity Based on SUV.
Time frame: 2 hours
Standardized uptake value (SUV) is Semi-quantitative measurement of tracer uptake in body tissue defined as ratio of radioactivity per unit volume of a region of interest to the radioactivity per unit volume of the whole body. Test-retest repeatability based on standardized uptake value (SUV) of CNS PET images in participants with MS: The test-retest repeatability will be based on a quantitative analysis of cranial PET images and will be evaluated for the Response-Evaluable 3 population. The test-retest repeatability (%), which is defined based upon the absolute value of the difference between test and retest values normalized by their mean: Test-Retest difference = RT-T Test-retest repeatability (%) = 100%-2×|(RT-T)/(RT+T)|×100% with T being the calculated value for the parameter measured at Visit 1 (test, T) and RT being the calculated value for the same parameter measured at Visit 2 (retest, RT).
Percentage of Participants With Test Repeatablity Based on VT.
Time frame: 2 Hours
Volume of Distribution (VT) is the ratio of the radioligand concentration in a region of interest to the radioligand concentration in plasma at equilibrium. Test-retest repeatability based on VT of CNS PET images in participants with MS: The test-retest repeatability will be based on a quantitative analysis of cranial PET images and will be evaluated for the Response-Evaluable 3 population. The test-retest repeatability (%), which is defined based upon the absolute value of the difference between test and retest values normalized by their mean: Test-Retest difference = RT-T Test-retest repeatability (%) = 100%-2×|(RT-T)/(RT+T)|×100% with T being the calculated value for the parameter measured at Visit 1 (test, T) and RT being the calculated value for the same parameter measured at Visit 2 (retest, RT).
Percentage of Free Brain BTK Relative to Baseline
Time frame: Data Not Collected
Percentage of free brain Burtons Tyrosine Kinase (BTK) relative to baseline
Mean Standardized Uptake Value (SUV) in the Brain
Time frame: On visits 1 (Day 1) and vist 2 (2hrs to 6 days after visit 1 tracer administration)
Standardized uptake value (SUV) is Semi-quantitative measurement of tracer uptake in body tissue defined as ratio of radioactivity per unit volume of a region of interest to the radioactivity per unit volume of the whole body.
Mean Volume of Distribution (VT) in the Brain
Time frame: On visits 1 (Day 1) and vist 2 (2hrs to 6 days after visit 1 tracer administration)
Volume of Distribution (VT) is the ratio of the radioligand concentration in a region of interest to the radioligand concentration in plasma at equilibrium.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 11C-BMS-986196 in people with Multiple Sclerosis (MS), 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 8 inclusion and 9 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 24 Apr 2025. 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, United Kingdom. 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. 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?
Yes. Results are posted in the registry (first posted 24 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Adverse Events Based on Severity. (time frame: From first visit up to 9 days post). The study lists 13 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 24 Apr 2025.