ACTIVE_NOT_RECRUITING

A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus

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Conditions

Systemic Lupus ErythematosusAutoimmune DiseasesImmune System DiseasesConnective Tissue DiseasesImmune-mediated DiseasesActive Systemic Lupus ErythematosusLupusSLEDeucravacitinibTyk2POETYKPOETYK SLE

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population.

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-2)

Quick Facts

Study Start:2023-01-12
Study Completion:2028-11-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05620407

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 0063
La Jolla, California, 92037
United States
Local Institution - 0241
La Mesa, California, 91942
United States
Local Institution - 0242
San Diego, California, 92128
United States
Local Institution - 0143
San Leandro, California, 94578
United States
Local Institution - 0147
Santa Monica, California, 90404
United States
Local Institution - 0213
Clearwater, Florida, 33765
United States
Local Institution - 0059
Jacksonville, Florida, 32256
United States
Local Institution - 0075
Margate, Florida, 33063
United States
Local Institution - 0007
Oakland Park, Florida, 33334
United States
Local Institution - 0239
Plant City, Florida, 33160
United States
Emory University School of Medicine- Grady Campus
Atlanta, Georgia, 30303
United States
Local Institution - 0137
Marietta, Georgia, 30060
United States
Local Institution - 0089
Orland Park, Illinois, 60467
United States
Local Institution - 0041
Skokie, Illinois, 60076
United States
Local Institution - 0231
New Orleans, Louisiana, 70112
United States
Local Institution - 0060
Boston, Massachusetts, 02114
United States
Local Institution - 0056
Boston, Massachusetts, 02215
United States
Local Institution - 0084
Worcester, Massachusetts, 01605
United States
Local Institution - 0152
Grand Blanc, Michigan, 48439
United States
Local Institution - 0072
Rochester, Minnesota, 55905
United States
Local Institution - 0216
Las Vegas, Nevada, 89102
United States
Local Institution - 0165
Paramus, New Jersey, 07652
United States
Local Institution - 0069
Brooklyn, New York, 11201
United States
Local Institution - 0217
Great Neck, New York, 11021
United States
Local Institution - 0150
New York, New York, 10021
United States
Local Institution - 0102
New York, New York, 10032
United States
Local Institution - 0145
Syracuse, New York, 13210
United States
Local Institution - 0178
Charlotte, North Carolina, 28210
United States
Local Institution - 0005
Cleveland, Ohio, 44106
United States
Local Institution - 0043
Oklahoma City, Oklahoma, 73104
United States
Local Institution - 0205
Pittsburgh, Pennsylvania, 15224
United States
Local Institution - 0081
Charleston, South Carolina, 29425
United States
Local Institution - 0225
Florence, South Carolina, 29501
United States
Local Institution - 0002
Jackson, Tennessee, 38305
United States
Local Institution - 0001
Colleyville, Texas, 76034
United States
Local Institution - 0164
El Paso, Texas, 79902
United States
Local Institution - 0169
Katy, Texas, 77494
United States
Local Institution - 0201
Temple, Texas, 76508
United States
Local Institution - 0133
Danville, Virginia, 24541
United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

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 Registration Dates

Study Start Date2023-01-12
Study Completion Date2028-11-13

Study Record Updates

Study Start Date2023-01-12
Study Completion Date2028-11-13

Terms related to this study

Keywords Provided by Researchers

  • Autoimmune Diseases
  • Immune System Diseases
  • Connective Tissue Diseases
  • Immune-mediated Diseases
  • Active Systemic Lupus Erythematosus
  • Lupus
  • SLE
  • Deucravacitinib
  • Tyk2
  • POETYK
  • POETYK SLE

Additional Relevant MeSH Terms

  • Systemic Lupus Erythematosus