A Study to Evaluate BMS-986511 in Adults With Major Depressive Disorder

September 3, 2026 updated by: Bristol-Myers Squibb

A Phase 2, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Monotherapy, Multicenter Study to Evaluate the Efficacy and Safety of BMS-986511 in Two Sequential Parts in Participants With Major Depressive Disorder

A Study to Evaluate BMS-986511 in Adults with Major Depressive Disorder

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • 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

  • 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

  • Czechia
      • Kladno, Czechia, 27201
        • Local Institution - 0005
        • Contact:
          • Site 0005
      • Klecany, Czechia, 25067
        • Local Institution - 0081
        • Contact:
          • Site 0081
      • Pilsen, Czechia, 31200
        • Local Institution - 0028
        • Contact:
          • Site 0028
    • Czech Republic
      • Prague, Czech Republic, Czechia, 10000
        • Local Institution - 0080
        • Contact:
          • Site 0080
    • Praha 6
      • Prague, Praha 6, Czechia, 16000
        • Local Institution - 0111
        • Contact:
          • Site 0111
    • Praha 8
      • Prague, Praha 8, Czechia, 18600
        • Local Institution - 0032
        • Contact:
          • Site 0032
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Local Institution - 0144
        • Contact:
          • Site 0144
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Local Institution - 0038
        • Contact:
          • Site 0038
      • Rogers, Arkansas, United States, 72758
        • Local Institution - 0047
        • Contact:
          • Site 0047
    • California
      • Garden Grove, California, United States, 92845
        • Local Institution - 0046
        • Contact:
          • Site 0046
      • Glendale, California, United States, 91206
        • Local Institution - 0042
        • Contact:
          • Site 0042
      • Lemon Grove, California, United States, 91945
        • Local Institution - 0071
        • Contact:
          • Site 0071
      • Oakland, California, United States, 94607
        • Local Institution - 0079
        • Contact:
          • Site 0079
      • Upland, California, United States, 91786
        • Local Institution - 0050
        • Contact:
          • Site 0050
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Local Institution - 0007
        • Contact:
          • Site 0007
      • Orlando, Florida, United States, 32801
        • Local Institution - 0024
        • Contact:
          • Site 0024
    • Georgia
      • Atlanta, Georgia, United States, 30331
        • Local Institution - 0140
        • Contact:
          • Site 0140
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • Local Institution - 0044
        • Contact:
          • Site 0044
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Local Institution - 0075
        • Contact:
          • Site 0075
    • New York
      • Cedarhurst, New York, United States, 11516
        • Local Institution - 0041
        • Contact:
          • Site 0041
      • Mount Kisco, New York, United States, 10549
        • Local Institution - 0069
        • Contact:
          • Site 0069
      • Staten Island, New York, United States, 10312
        • Local Institution - 0121
        • Contact:
          • Site 0121
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Local Institution - 0083
      • Columbus, Ohio, United States, 43210
        • Local Institution - 0086
        • Contact:
          • Site 0086
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • Local Institution - 0027
        • Contact:
          • Site 0027
    • Texas
      • Dallas, Texas, United States, 75231
        • Local Institution - 0016
        • Contact:
          • Site 0016
    • Washington
      • Everett, Washington, United States, 98201
        • Local Institution - 0003
        • Contact:
          • Site 0003

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants must meet the MDD diagnosis per DSM-5 criteria confirmed by structured interview.
  • Participant must have current moderate to severe MDE confirmed by clinical assessment and validated scale.
  • Participant must have current MDE duration >12 weeks at screening.
  • Outpatient participants able to comply with study procedures.
  • Participant require medication washout completed before baseline.
  • Participant must have BMI within protocol range.
  • Participants must meet reproductive safety requirements.

Exclusion Criteria:

  • Participants must not have other primary psychiatric disorders or a history of treatment-resistant depression during the current episode.
  • Participants must not have recent history of active suicidal ideation or attempt within the past year.
  • Participants must not have prior lifetime treatment with electroconvulsive therapy, ketamine/esketamine, deep brain stimulation, or transcranial magnetic stimulation.
  • Participants must not have recent history of alcohol/substance abuse or use of cannabis.
  • Participants must not have significant ECG abnormalities, or poorly controlled diabetes.
  • 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: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Placebo
Drug: Placebo
Specified dose on specified days
Experimental: BMS-986511: Dose A
Drug: BMS-986511
Specified dose on specified days
Other Names:
  • Evifacotrep
Experimental: BMS-986511: Dose B
Drug: BMS-986511
Specified dose on specified days
Other Names:
  • Evifacotrep

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change from baseline in Hamilton Depression Rating Scale -17 Item (HDRS-17) total score
Time Frame: Up to Day 57
Up to Day 57

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Treatment Emergent Adverse Events (AEs)
Time Frame: Up to 71 days
Up to 71 days
Number of Participants with Serious Adverse Events (SAEs)
Time Frame: Up to 71 days
Up to 71 days
Number of Participants with AEs Leading to Treatment Discontinuation
Time Frame: Up to 71 days
Up to 71 days
Number of Participants with AEs Leading to Death
Time Frame: Up to Day 71
Up to Day 71

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

Investigators

  • 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 (Estimated)

October 30, 2026

Primary Completion (Estimated)

November 6, 2028

Study Completion (Estimated)

November 6, 2028

Study Registration Dates

First Submitted

August 14, 2026

First Submitted That Met QC Criteria

August 14, 2026

First Posted (Actual)

August 19, 2026

Study Record Updates

Last Update Posted (Actual)

September 4, 2026

Last Update Submitted That Met QC Criteria

September 3, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN013-0002
  • 2026-526617-28 (Other Identifier: EU CTR)
  • U1111-1339-3799 (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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