Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus

December 19, 2023 updated by: Bristol-Myers Squibb

A Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Systemic Lupus Erythematosus

The main objective of the trial is to characterize the long-term safety and tolerability of BMS-986165 in subjects with Systemic Lupus Erythematosus (SLE).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

261

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 Locations

  • Argentina
      • Caba, Argentina, 1111
        • Local Institution - 0100
      • Cordoba, Argentina, X5004FHP
        • Local Institution - 0122
      • Mendoza, Argentina, 5500
        • Local Institution - 0095
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1430
        • Clinica Adventista Belgrano
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1046
        • Local Institution - 0125
    • Santa FE
      • Rosario, Santa FE, Argentina, 2000
        • Local Institution - 0098
    • Tucuman
      • San Miguel De Tucum, Tucuman, Argentina, T4000AXL
        • Centro Medico Privado de Reumatologia
  • Brazil
      • Sao Paulo, Brazil, 01228-200
        • Local Institution - 0105
    • Bahia
      • Salvador, Bahia, Brazil, 40150150
        • Local Institution - 0116
    • Goias
      • Goiߡ, Goias, Brazil, 74110-120
        • Local Institution - 0118
    • Minas Gerais
      • Juiz de Fora, Minas Gerais, Brazil, 36010-570
        • Local Institution - 0106
    • Parana
      • Curitiba, Parana, Brazil, 80030-110
        • Local Institution - 0120
    • RIO Grande DO SUL
      • Porto Alegre, RIO Grande DO SUL, Brazil, 90480-000
        • Local Institution - 0107
    • SAO Paulo
      • Sao Bernardo do Campo, SAO Paulo, Brazil, 09715-090
        • Local Institution - 0111
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Local Institution - 0136
  • Colombia
      • Barranquilla, Colombia
        • Local Institution - 0108
      • Bogot, Colombia, 110221
        • Local Institution - 0101
      • Chia, Colombia, 250001
        • Local Institution - 0103
      • Zipaquira, Colombia, 250252
        • Local Institution - 0096
  • Hungary
      • Debrecen, Hungary, 4032
        • Local Institution - 0039
      • Gyula, Hungary, 5700
        • Local Institution - 0038
      • Szeged, Hungary, 6725
        • Local Institution - 0045
  • Japan
      • Tokyo, Japan, 162-8655
        • Local Institution - 0066
      • Tokyo, Japan, 173-8610
        • Local Institution - 0093
      • Tokyo, Japan, 113-8431
        • Local Institution - 0078
    • Chiba
      • Chiba-shi, Chiba, Japan, 260-8712
        • National Hospital Organization Chibahigashi National Hospital
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan, 807-8556
        • Local Institution - 0092
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital
      • Sapporo-Shi, Hokkaido, Japan, 060-8604
        • Sapporo City General Hospital
    • Miyagi
      • Sendai, Miyagi, Japan, 9808574
        • Local Institution - 0063
    • Tochigi
      • Shimotsuke-city, Tochigi, Japan, 329-0498
        • Local Institution - 0069
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-8560
        • Local Institution - 0065
  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Local Institution
      • Suwon, Korea, Republic of, 16499
        • Local Institution - 0053
  • Mexico
      • San Luis Potosi, Mexico, 78213
        • Local Institution - 0082
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 06760
        • Local Institution - 0087
    • Guanajuato
      • Leon, Guanajuato, Mexico, 37000
        • Local Institution - 0080
      • Leon, Guanajuato, Mexico, 37160
        • Centro de Investigacion Farmacologica del Bajio
    • Jalisco
      • Zapopan, Jalisco, Mexico, 45070
        • Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
    • Nuevo LEON
      • Monterrey, Nuevo LEON, Mexico, 64000
        • Accelerium Clinical Research
  • Poland
      • Bydgoszcz, Poland, 85-168
        • Local Institution - 0025
      • Koscian, Poland, 64-000
        • Local Institution - 0015
      • Krak, Poland, 31-637
        • Local Institution - 0018
      • Krakow, Poland, 30-363
        • Local Institution - 0014
      • Krakow, Poland, 31-011
        • Centrum Nowoczesnych Terapii Dobry Lekarz Spolka z ograniczona odpowiedzialnoscia
      • Lublin, Poland, 20-607
        • Local Institution - 0016
      • Poznan, Poland, 60-218
        • Local Institution - 0024
      • Sosnowiec, Poland, 41-200
        • Local Institution - 0029
      • Warsaw, Poland, 02-172
        • Local Institution - 0019
      • Warszawa, Poland, 02-691
        • Local Institution - 0022
      • Wroclaw, Poland, 50-363
        • Local Institution - 0010
      • Wroclaw, Poland, 52-416
        • Local Institution - 0023
  • Romania
      • Brasov, Romania, 500283
        • Local Institution - 0033
      • Galati, Romania, 800578
        • Local Institution - 0004
      • Ramnicu Valcea, Romania, 240277
        • Local Institution - 0002
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620043
        • Local Institution - 0061
      • Kemerovo, Russian Federation, 650066
        • Local Institution - 0056
      • Novosibirsk, Russian Federation, 630099
        • Local Institution - 0072
      • Orenburg, Russian Federation, 460018
        • Local Institution - 0057
      • Saint - Petersburg, Russian Federation, 191045
        • Local Institution - 0062
      • Smolensk, Russian Federation, 214025
        • Local Institution - 0070
      • St. Petersburg, Russian Federation, 197341
        • Local Institution - 0058
      • Vladimir, Russian Federation, 600005
        • Local Institution - 0055
      • Yaroslavl, Russian Federation, 150023
        • Local Institution - 0068
      • Yaroslavl, Russian Federation, 150030
        • Local Institution - 0060
  • Spain
      • Malaga, Spain, 29010
        • Hospital Regional Universitario de Malaga Hospital General
      • Sabadell, Spain, 08208
        • Local Institution - 0138
      • Sevilla, Spain, 41014
        • Local Institution - 0124
  • Taiwan
      • Taichung, Taiwan, 40201
        • Local Institution - 0052
      • Taipei, Taiwan, 10002
        • Local Institution - 0051
      • Taipei, Taiwan, 110
        • Local Institution - 0137
      • Taipei City, Taiwan, 10630
        • Local Institution
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233-1913
        • Local Institution - 0077
    • California
      • El Cajon, California, United States, 92020
        • Local Institution - 0030
      • Torrance, California, United States, 90502
        • Local Institution - 0049
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Local Institution - 0074
    • Florida
      • Aventura, Florida, United States, 33180
        • Local Institution - 0115
      • Brandon, Florida, United States, 33511
        • Local Institution - 0044
      • Gainesville, Florida, United States, 32603
        • Local Institution - 0140
      • Orlando, Florida, United States, 32835
        • Local Institution - 0133
      • Ormond Beach, Florida, United States, 32174-1139
        • Local Institution - 0032
      • Tampa, Florida, United States, 33613
        • Local Institution - 0048
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Local Institution - 0094
      • Lawrenceville, Georgia, United States, 30046
        • Local Institution - 0050
    • New York
      • Brooklyn, New York, United States, 11201
        • Local Institution - 0123
      • New York, New York, United States, 10016
        • Local Institution - 0131
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7280
        • Local Institution - 0071
      • Charlotte, North Carolina, United States, 28204
        • Local Institution - 0031
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Local Institution - 0064
    • Pennsylvania
      • Wyomissing, Pennsylvania, United States, 19610
        • Local Institution - 0035
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Local Institution - 0121
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Local Institution - 0001
    • Texas
      • Austin, Texas, United States, 78745
        • Tekton Research - Austin
      • Austin, Texas, United States, 78731-3146
        • Local Institution - 0041
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Houston, Texas, United States, 77084
        • Local Institution - 0037
      • Mesquite, Texas, United States, 75150
        • Local Institution - 0046

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Completion of SLE Study (NCT03252587) through the protocol-required treatment period, and currently receiving blinded study drug. Note: If a subject is not receiving blinded study drug due to exceptional circumstances (eg, missed investigational product [IP] due to COVID-19 pandemic, delays in study approval, etc), the subject may be allowed to enroll with approval from the BMS Clinical Trial Physician or designee.

Exclusion Criteria:

  • Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this study, would interfere with the interpretation of subject safety or study results, or considered unsuitable by the investigator for any other reason
  • Evidence of active tuberculosis (TB)

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BMS-986165 Dose 1
Drug: BMS-986165
Specified dose on specified days
Other Names:
  • Deucravacitinib
Experimental: BMS-986165 Dose 2
Drug: BMS-986165
Specified dose on specified days
Other Names:
  • Deucravacitinib
Experimental: BMS-986165 Dose 3
Drug: BMS-986165
Specified dose on specified days
Other Names:
  • Deucravacitinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with Adverse Events (AEs)
Time Frame: Up to 30 days after last treatment dose (approximately 178 weeks)
Up to 30 days after last treatment dose (approximately 178 weeks)
Number of participants with Serious Adverse Events (SAEs)
Time Frame: Up to 30 days after last treatment dose (approximately 178 weeks)
Up to 30 days after last treatment dose (approximately 178 weeks)
Number of participants with AEs leading to discontinuation
Time Frame: Up to 30 days after last treatment dose (approximately 178 weeks)
Up to 30 days after last treatment dose (approximately 178 weeks)
Number of participants with abnormal change from baseline in laboratory measurements over time
Time Frame: Up to 30 days after last treatment dose (approximately 178 weeks)
Up to 30 days after last treatment dose (approximately 178 weeks)
Number of participants with abnormal change from baseline in vital signs over time
Time Frame: Up to 30 days after last treatment dose (approximately 178 weeks)
Up to 30 days after last treatment dose (approximately 178 weeks)

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 (Actual)

March 26, 2019

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

March 27, 2019

First Submitted That Met QC Criteria

April 16, 2019

First Posted (Actual)

April 18, 2019

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM011-074
  • 2018-003471-35 (EudraCT Number)

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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