RECRUITING

A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome

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 assess the safety and efficacy of two doses of Deucravacitinib in adult participants with Active Sjögren's Syndrome.

Official Title

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome (POETYK SjS-1)

Quick Facts

Study Start:2023-09-11
Study Completion:2028-11-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05946941

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
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 the NCT# and Site #.
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 0222
La Palma, California, 90623
United States
Local Institution - 0218
San Francisco, California, 94143
United States
Providence St. John's Health Center
Santa Monica, California, 90404
United States
Denver Arthritis Clinic
Denver, Colorado, 80230
United States
Clinical Research of West Florida, Inc
Clearwater, Florida, 33765
United States
Local Institution - 0223
Sarasota, Florida, 34239
United States
Augusta University
Augusta, Georgia, 30912
United States
Clinic of Robert Hozman/Clinical Investigation Specialists Inc.
Skokie, Illinois, 60076
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
Local Institution - 0123
Hopkinsville, Kentucky, 42240
United States
Ochsner Health Center - Baton Rouge
Baton Rouge, Louisiana, 70836
United States
Arthritis and Diabetes Clinic
Monroe, Louisiana, 71203
United States
Johns Hopkins Medicine - Jerome L. Greene Sjogrens Syndrome Center
Baltimore, Maryland, 21224-2746
United States
Tufts Medical Center
Boston, Massachusetts, 02111
United States
Saint Paul Rheumatology
Eagan, Minnesota, 55121
United States
Institute for Rheumatic & Autoimmune Diseases, Overlook Medical Center
Summit, New Jersey, 07901
United States
New Mexico Clinical Research Osteoporosis
Albuquerque, New Mexico, 87106
United States
NYU Langone Hospital - Long Island
Mineola, New York, 11501
United States
Local Institution - 0132
Corvallis, Oregon, 97330
United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
United States
West Tennessee Research Institute
Jackson, Tennessee, 38305
United States
Arthritis and Rheumatology Research Institute
Allen, Texas, 75013
United States
Trinity Universal Research Associates
Plano, Texas, 75024
United States
University of Washington Medical Center
Seattle, Washington, 98195
United States
Arthritis Northwest
Spokane, Washington, 99204
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 Date2023-09-11
Study Completion Date2028-11-16

Study Record Updates

Study Start Date2023-09-11
Study Completion Date2028-11-16

Terms related to this study

Keywords Provided by Researchers

  • Deucravacitinib
  • Sjogren's Syndrome
  • BMS-986165
  • POETYK
  • Sjogren Syndrome
  • Sjogren-Larson Syndrome
  • Gougerot-Sjogren
  • Gougerot Sjogren Syndrome
  • Sjogren
  • Sjogren's
  • Sjogren Disease
  • Sjogren's Disease

Additional Relevant MeSH Terms

  • Sjögren's Syndrome