RECRUITING

A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

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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-1)

Quick Facts

Study Start:2023-01-12
Study Completion:2027-12-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05617677

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

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
855-907-3286
Clinical.Trials@bms.com
First line of the email MUST contain NCT # and Site #.
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
The University of Arizona Arthritis Center
Tucson, Arizona, 85724
United States
Kaiser Permanente
Fontana, California, 92335
United States
Private Practice - Dr. Chandrakant V. Mehta
Hemet, California, 92543
United States
Arthritis & Osteoporosis Medical Center - La Palma
La Palma, California, 90623
United States
UCLA Clinical & Translational Research Center (CTRC)
Los Angeles, California, 90095
United States
Private Practice - Dr. Hans Richard Barthel
Santa Barbara, California, 93108
United States
Denver Arthritis Clinic
Denver, Colorado, 80230
United States
Yale New Haven Hospital-Smilow Cancer Center
New Haven, Connecticut, 06510
United States
Rheumatology Assoc. Of South Florida
Boca Raton, Florida, 33486
United States
Nouvelle Clinical Research
Cutler Bay, Florida, 33189
United States
University of Florida College of Medicine
Gainesville, Florida, 32610
United States
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, 33136
United States
Omega Research Group - Orlando
Orlando, Florida, 32806
United States
West Broward Rheumatology Associates
Tamarac, Florida, 33321
United States
Genesis Clinical Research, LLC
Tampa, Florida, 33603
United States
Baycare Medical Group
Tampa, Florida, 33614
United States
Piedmont West
Atlanta, Georgia, 30318
United States
North Georgia Rheumatology
Lawrenceville, Georgia, 30046
United States
Local Institution - 0077
Schaumburg, Illinois, 60195
United States
Local Institution - 0108
Indianapolis, Indiana, 46202
United States
Lake Cumberland Rheumatology
New Albany, Indiana, 47150
United States
Local Institution - 0225
New Orleans, Louisiana, 70121
United States
Local Institution - 0006
Detroit, Michigan, 48202
United States
Saint Paul Rheumatology
Eagan, Minnesota, 55121
United States
Atlantic Health System Overlook Medical Center
Summit, New Jersey, 07901
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
The Feinstein Institute for Medical Research
Manhasset, New York, 11030
United States
NYU Langone Health
New York, New York, 10016
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
Carolinas HealthCare System SouthPark
Charlotte, North Carolina, 28211
United States
Local Institution - 0003
Memphis, Tennessee, 38119
United States
Arthritis and Rheumatology Research Institute
Allen, Texas, 75013
United States
UT Southwestern Medical Center
Dallas, Texas, 75390
United States
Local Institution - 0088
Fort Worth, Texas, 76177
United States
Local Institution - 0219
Lubbock, Texas, 79415
United States
Advanced Rheumatology of Houston - Woodlands
The Woodlands, Texas, 77382
United States
Carilion Clinic
Roanoke, Virginia, 24016
United States
Swedish Medical Center
Seattle, Washington, 98122
United States
University of Washington Medical Center - Montlake
Seattle, Washington, 98195
United States
Local Institution - 0063
Franklin, Wisconsin, 53132
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 Date2027-12-17

Study Record Updates

Study Start Date2023-01-12
Study Completion Date2027-12-17

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