ACTIVE_NOT_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:2028-11-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_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

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 0012
Birmingham, Alabama, 35205
United States
Local Institution - 0229
Phoenix, Arizona, 85006
United States
Local Institution - 0193
Tucson, Arizona, 85724
United States
Kaiser Permanente
Fontana, California, 92335
United States
Local Institution - 0247
La Mesa, California, 91942
United States
Local Institution - 0090
La Palma, California, 90623
United States
Local Institution - 0124
Los Angeles, California, 90095
United States
Local Institution - 0248
Sacramento, California, 95817
United States
Local Institution - 0253
San Diego, California, 92128
United States
Local Institution - 0128
Santa Barbara, California, 93108
United States
Local Institution - 0099
Denver, Colorado, 80230
United States
Local Institution - 0054
New Haven, Connecticut, 06510
United States
Local Institution - 0249
Coral Springs, Florida, 33065
United States
Local Institution - 0010
Gainesville, Florida, 32610
United States
Local Institution - 0087
Miami, Florida, 33136
United States
Local Institution - 0007
Orlando, Florida, 32806
United States
Local Institution - 0242
Plantation, Florida, 33317
United States
Local Institution - 0002
Tamarac, Florida, 33321
United States
Local Institution - 0165
Tampa, Florida, 33614
United States
Local Institution - 0204
Atlanta, Georgia, 30318
United States
Local Institution - 0228
Lawrenceville, Georgia, 30044
United States
Local Institution - 0147
Lawrenceville, Georgia, 30046
United States
Local Institution - 0227
Morton Grove, Illinois, 60053
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
Local Institution - 0179
Eagan, Minnesota, 55121
United States
Local Institution - 0177
Summit, New Jersey, 07901
United States
Local Institution - 0180
Manhasset, New York, 11030
United States
Local Institution - 0085
New York, New York, 10016
United States
Local Institution - 0098
Rochester, New York, 14642
United States
Local Institution - 0159
The Bronx, New York, 10467
United States
Local Institution - 0245
Charlotte, North Carolina, 28207
United States
Local Institution - 0155
Charlotte, North Carolina, 28211
United States
Local Institution - 0246
Summerville, South Carolina, 29486
United States
Local Institution - 0003
Memphis, Tennessee, 38119
United States
Local Institution - 0064
Allen, Texas, 75013
United States
Local Institution - 0065
Dallas, Texas, 75390
United States
Local Institution - 0088
Fort Worth, Texas, 76177
United States
Local Institution - 0250
Houston, Texas, 77090
United States
Local Institution - 0219
Lubbock, Texas, 79415
United States
Local Institution - 0005
The Woodlands, Texas, 77382
United States
Local Institution - 0009
Roanoke, Virginia, 24016
United States
Local Institution - 0011
Seattle, Washington, 98122
United States
Local Institution - 0139
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 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