Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease

August 31, 2026 updated by: Celgene

A Phase 2, Randomized, Double-blind, Three-Arm, Placebo-controlled, Multicenter Study Assessing the Efficacy, Safety and Tolerability of Orally Administered BMS-986368, a FAAH/MAGL Inhibitor, for the Treatment of Agitation in Participants With Alzheimer's Disease (BALANCE-AAD-1)

This is a study to evaluate the efficacy, safety, and tolerability of BMS-986368, a FAAH/MAGL inhibitor, for the treatment of agitation in participants with Alzheimer's Disease.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1405BOA
        • Not yet recruiting
        • Local Institution - 0069
        • Contact:
          • Site 0069
      • Córdoba, Argentina, 5004
        • Not yet recruiting
        • Local Institution - 0075
        • Contact:
          • Site 0075
      • Mendoza, Argentina, 5500
        • Not yet recruiting
        • Local Institution - 0072
        • Contact:
          • Site 0072
      • Santiago del Estero, Argentina, 4200
        • Not yet recruiting
        • Local Institution - 0073
        • Contact:
          • Site 0073
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1060AAE
        • Not yet recruiting
        • Local Institution - 0068
        • Contact:
          • Site 0068
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Not yet recruiting
        • Local Institution - 0071
        • Contact:
          • Site 0071
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, X5147
        • Not yet recruiting
        • Local Institution - 0074
        • Contact:
          • Site 0074
  • Australia
      • Darlinghurst, Australia, 2010
        • Not yet recruiting
        • Local Institution - 0077
        • Contact:
          • Site 0077
    • New South Wales
      • Macquarie Park, New South Wales, Australia, 2113
        • Not yet recruiting
        • Local Institution - 0076
        • Contact:
          • Site 0076
    • South Australia
      • Daw Park, South Australia, Australia, 5041
        • Not yet recruiting
        • Local Institution - 0090
        • Contact:
          • Site 0090
    • Victoria
      • Wangaratta, Victoria, Australia, 3677
        • Not yet recruiting
        • Local Institution - 0079
        • Contact:
          • Site 0079
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Not yet recruiting
        • Local Institution - 0078
        • Contact:
          • Site 0078
  • China
    • Anhui
      • Hefei, Anhui, China, 230022
        • Not yet recruiting
        • Local Institution - 0084
        • Contact:
          • Site 0084
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Not yet recruiting
        • Local Institution - 0092
        • Contact:
          • Site 0092
    • HUB
      • Wuhan, HUB, China, 430060
        • Not yet recruiting
        • Local Institution - 0093
        • Contact:
          • Site 0093
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Not yet recruiting
        • Local Institution - 0085
        • Contact:
          • Site 0085
    • Shanghai Municipality
      • Shanghai Shi, Shanghai Municipality, China, 200030
        • Not yet recruiting
        • Local Institution - 0082
        • Contact:
          • Site 0082
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Not yet recruiting
        • Local Institution - 0083
        • Contact:
          • Site 0083
  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Not yet recruiting
        • Local Institution - 0046
        • Contact:
          • Site 0046
      • Huntsville, Alabama, United States, 35801
        • Recruiting
        • University of Alabama - Huntsville Regional Medical Campus
        • Contact:
          • Tiffany Schwasinger-Schmidt, Site 0036
          • Phone Number: 256-551-4512
    • Arizona
      • Phoenix, Arizona, United States, 85028
        • Completed
        • Local Institution - 0048
      • Scottsdale, Arizona, United States, 85260
        • Not yet recruiting
        • Local Institution - 0040
        • Contact:
          • Site 0040
    • California
      • Anaheim, California, United States, 92805
        • Not yet recruiting
        • Local Institution - 0017
        • Contact:
          • Site 0017
      • Chino, California, United States, 91710
        • Recruiting
        • Inland Psychiatric Medical Group.
        • Contact:
          • Nandita Puchakayala, Site 0037
          • Phone Number: 909-488-9116
      • La Jolla, California, United States, 92037
        • Recruiting
        • Kaizen Brain Center
        • Contact:
          • MOHAMMED AHMED, Site 0018
          • Phone Number: 214-893-0542
      • La Jolla, California, United States, 92037
        • Recruiting
        • University of California San Diego - La Jolla
        • Contact:
          • Gabriel Leger, Site 0052
          • Phone Number: 858-246-1303
      • Lakewood, California, United States, 90805
        • Recruiting
        • Shreenath Clinical Service - Lakewood
        • Contact:
          • ERIC TATE, Site 0050
          • Phone Number: 714-717-6039
      • Sherman Oaks, California, United States, 91403
        • Completed
        • Local Institution - 0043
      • West Covina, California, United States, 91790
        • Recruiting
        • Next Level Clinical Trials
        • Contact:
          • Austina Cho, Site 0057
          • Phone Number: 714-999-6688
      • West Hills, California, United States, 91307
        • Completed
        • Local Institution - 0028
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus
        • Contact:
          • Samantha Holden, Site 0066
          • Phone Number: 303-724-2046
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20057
        • Recruiting
        • Georgetown University
        • Contact:
          • Brigid Reynolds, Site 0067
          • Phone Number: 202-687-3350
      • Washington D.C., District of Columbia, United States, 20060
        • Withdrawn
        • Local Institution - 0053
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Recruiting
        • Arrow Clinical Trials
        • Contact:
          • David Billmeier, Site 0003
          • Phone Number: 386-278-8000
      • Maitland, Florida, United States, 32751
        • Recruiting
        • ClinCloud
        • Contact:
          • Rosemary Laird, Site 0013
          • Phone Number: 717-357-1569
      • Maitland, Florida, United States, 32751
        • Not yet recruiting
        • Local Institution - 0007
        • Contact:
          • Site 0007
      • Miami, Florida, United States, 33125
        • Withdrawn
        • Local Institution - 0022
      • Miami, Florida, United States, 33166
        • Completed
        • Local Institution - 0010
      • Tampa, Florida, United States, 33607
        • Not yet recruiting
        • Local Institution - 0001
        • Contact:
          • Site 0001
      • Tampa, Florida, United States, 33612
        • Not yet recruiting
        • Local Institution - 0080
        • Contact:
          • Site 0080
      • The Villages, Florida, United States, 32162
        • Recruiting
        • Charter Research - Lady Lake
        • Contact:
          • Jeffrey Norton, Site 0039
          • Phone Number: 352-775-1000
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Completed
        • Local Institution - 0026
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • CenExel iResearch, LLC
        • Contact:
          • Kimball Johnson, Site 0035
          • Phone Number: 404-537-1281
      • Savannah, Georgia, United States, 31405
        • Recruiting
        • CenExel iResearch, LLC
        • Contact:
          • Yael Elfassy, Site 0015
          • Phone Number: 912-744-0800
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Completed
        • Local Institution - 0004
    • Illinois
      • Elgin, Illinois, United States, 60123
        • Withdrawn
        • Local Institution - 0086
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Not yet recruiting
        • Local Institution - 0011
        • Contact:
          • Site 0011
    • Massachusetts
      • Foxborough, Massachusetts, United States, 02035
        • Recruiting
        • K2 Medical Research
        • Contact:
          • john stoukides, Site 0025
          • Phone Number: 401-435-8950
      • South Dartmouth, Massachusetts, United States, 02747
        • Not yet recruiting
        • Local Institution - 0051
        • Contact:
          • Site 0051
    • Michigan
      • Sterling Heights, Michigan, United States, 48312
        • Not yet recruiting
        • Local Institution - 0088
        • Contact:
          • Site 0088
    • Montana
      • Missoula, Montana, United States, 59804
        • Recruiting
        • Boeson Research
        • Contact:
          • Lisa Koehl, Site 0061
          • Phone Number: 406-543-9700
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Recruiting
        • Be Well Clinical Studies - Omaha
        • Contact:
          • John Puente, Site 0062
          • Phone Number: 402-937-9293
    • Nevada
      • Las Vegas, Nevada, United States, 89121
        • Completed
        • Local Institution - 0041
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • Not yet recruiting
        • Local Institution - 0059
        • Contact:
          • Site 0059
      • Toms River, New Jersey, United States, 08755
        • Not yet recruiting
        • Local Institution - 0081
        • Contact:
          • Site 0081
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • University at Buffalo - UBMD Neurology
        • Contact:
          • Kinga Szigeti, Site 0034
          • Phone Number: 281-630-2316
      • Manhasset, New York, United States, 11030
        • Recruiting
        • The Feinstein Institute for Medical Research
        • Contact:
          • Jeremy Koppel, Site 0049
          • Phone Number: 516-562-3492
      • New Windsor, New York, United States, 12553
        • Recruiting
        • Mid Hudson Medical Research
        • Contact:
          • Sashi Makam, Site 0044
          • Phone Number: 845-674-9398
      • Staten Island, New York, United States, 10309
        • Completed
        • Local Institution - 0064
      • Syracuse, New York, United States, 13210
        • Recruiting
        • Research Central LLC (DBA Ichor Research)
        • Contact:
          • Karl Hafner, Site 0021
          • Phone Number: 315-529-0766
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Recruiting
        • New Hope Clinical Research
        • Contact:
          • Kurian Abraham, Site 0016
          • Phone Number: 980-209-9784
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • UNC Health REX Hospital
        • Contact:
          • Sandeep Vaishnavi, Site 0063
          • Phone Number: 919-784-1092
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
          • Kasia Rothenberg, Site 0023
          • Phone Number: 216-403-6847
      • Columbus, Ohio, United States, 43221
        • Not yet recruiting
        • Local Institution - 0087
        • Contact:
          • Site 0087
    • Oklahoma
      • Ardmore, Oklahoma, United States, 73401
        • Not yet recruiting
        • Local Institution - 0089
        • Contact:
          • Site 0089
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University - Vickie & Jack Farber Institute for Neuroscience
        • Contact:
          • James Ellison, Site 0058
          • Phone Number: 215-503-2823
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Not yet recruiting
        • Local Institution - 0031
        • Contact:
          • Site 0031
      • Cordova, Tennessee, United States, 38018
        • Recruiting
        • Neurology Clinic, P.C.
        • Contact:
          • Thomas Arnold, Site 0019
          • Phone Number: 901-866-9252
      • Nashville, Tennessee, United States, 37212
        • Recruiting
        • Vanderbilt University Medical Center- Village
        • Contact:
          • Joshua Smith, Site 0033
          • Phone Number: 601-594-0792
    • Texas
      • Austin, Texas, United States, 78626
        • Recruiting
        • Pinnacle Clinical Research
        • Contact:
          • Rohit Puskoor, Site 0060
          • Phone Number: 817-602-5188
      • Cypress, Texas, United States, 77065
        • Recruiting
        • Horizon Clinical Research Center - Houston
        • Contact:
          • Harpaul Gill, Site 0042
          • Phone Number: 949-491-0710
      • El Paso, Texas, United States, 79912
        • Recruiting
        • ANESC Research
        • Contact:
          • Aamr Herekar, Site 0045
          • Phone Number: 505-903-1715
      • Flower Mound, Texas, United States, 75028
        • Completed
        • Local Institution - 0024
      • Houston, Texas, United States, 77030
        • Withdrawn
        • Local Institution - 0020
      • Plano, Texas, United States, 75093
        • Recruiting
        • Stryde Research - Plano
        • Contact:
          • Peter Brokish, Site 0065
          • Phone Number: 214-407-8640
      • Richardson, Texas, United States, 75082
        • Not yet recruiting
        • Local Institution - 0091
        • Contact:
          • Site 0091
      • Round Rock, Texas, United States, 78681
        • Recruiting
        • Be Well Clinical Studies
        • Contact:
          • Mark Carlson, Site 0038
          • Phone Number: 000-000-0000
    • Utah
      • Provo, Utah, United States, 84604
        • Recruiting
        • Boeson Research - Provo
        • Contact:
          • Jason Andersen, Site 0027
          • Phone Number: 385-392-2200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Participants with a diagnosis of Alzheimer's disease with biomarker confirmation meeting the 2024 Revised criteria for diagnosis and staging of AD: Alzheimer's Association Workgroup.
  • The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) definition of agitation.
  • History of agitation with onset at least four weeks prior to Screening.
  • MMSE-1 score ≤24.
  • NPI-NH agitation/aggression sub-score ≥ 4.
  • Stable living environment for at least 6 weeks prior to Screening. Participants are eligible if they are in nursing homes, assisted living facilities, or living at home and have an identified study partner (caregiver).
  • Capable of self-locomotion (alone or with the aid of an assistive device); wheelchairs and other mobility aids are acceptable.

Exclusion Criteria

  • Clinically significant delusions/hallucinations requiring hospitalization.
  • History of bipolar disorder, schizophrenia, or schizoaffective disorder.
  • History of major depressive episode with psychotic features during the 12 months prior to Screening.
  • History of delirium within 30 days of Screening.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Specified dose on specified days
Experimental: BMS-986368 Dose 1
Drug: BMS-986368
Specified dose on specified days
Other Names:
  • CC-97489
Experimental: BMS-986368 Dose 2
Drug: BMS-986368
Specified dose on specified days
Other Names:
  • CC-97489

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Cohen-Mansfield Agitation Inventory (CMAI) total score from baseline
Time Frame: Up to Week 8
The CMAI is a scale administered by qualified rater based on caregiver's input on 29 items that assess the frequency of manifestations of agitated behaviors in older adults. Each item is rated on a 7-point scale: 1 = "never", 2 = "less than once a week", 3 = "once or twice a week", 4 = "several times a week", 5 = "once or twice a day", 6 = "several times a day" and 7 = "several times per hour." Ratings pertain to the period of time over the previous 2 weeks preceding administration of the CMAI. CMAI total scores range from 29 to 203.
Up to Week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in Clinical Global Impression-Severity (CGI-S)
Time Frame: Up to Week 8
Up to Week 8
CMAI sub-score change in Aggressive Behaviors
Time Frame: Up to Week 8
Up to Week 8
CMAI sub-score change in Physically Non-aggressive Behaviors
Time Frame: Up to Week 8
Up to Week 8
CMAI sub-score change in Verbally Agitated Behaviors
Time Frame: Up to Week 8
Up to Week 8
Change in Neuropsychiatric Inventory Nursing Home Version (NPI-NH) Total Score
Time Frame: Up to Week 8
Up to Week 8
Change in NPI-NH Agitation/Aggression Domain Score
Time Frame: Up to Week 8
Up to Week 8
Change in NPI-NH Occupational Disruptiveness for Agitation/aggression Domain
Time Frame: Up to Week 8
Up to Week 8
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to Day 28 After Last Dose
Up to Day 28 After Last Dose
Number of Participants with Serious Adverse Events (SAEs)
Time Frame: Up to Day 28 After Last Dose
Up to Day 28 After Last Dose
Number of Participants with Adverse Events (AEs)
Time Frame: Up to Day 28 After Last Dose
Up to Day 28 After Last Dose
Number of Participants with Clinically Significant Laboratory Abnormalities
Time Frame: Up to 28 Days After Last Dose
Up to 28 Days After Last Dose
Change in Suicidal Ideation Assessed by Sheehan-Suicidality Tracking Scale (S-STS)
Time Frame: Up to Day 28 After Last Dose
Up to Day 28 After Last Dose
Change in Behaviour Assessed by Sheehan-Suicidality Tracking Scale (S-STS)
Time Frame: Up to Day 28 After Last Dose
Up to Day 28 After Last Dose
Abuse Potential Assessed by the Cannabis Withdrawal Scale (CWS)
Time Frame: Up to Day 21 After Last Dose
Up to Day 21 After Last Dose
Withdrawal Symptoms Assessed by the Cannabis Withdrawal Scale (CWS)
Time Frame: Up to Day 21 After Last Dose
Up to Day 21 After Last Dose
Plasma Concentrations of BMS-986368
Time Frame: Up to Week 14
Up to Week 14
Change in CMAI-International Psychogeriatric Association (CMAI-IPA) Total Score
Time Frame: Up to Week 8
Up to Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Celgene

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 9, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 26, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 7, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IM045-P06
  • U1111-1313-8997 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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