ACTIVE_NOT_RECRUITING

A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

Talk to us

Conditions

Systemic Lupus ErythematosusBMS-986256SLEConnective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesAfimetoran

Quick Navigation

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, safety and tolerability of Afimetoran in participants with active Systemic Lupus Erythematosus (SLE). The extension period will provide additional long-term safety and efficacy data and enable those participants initially randomized to placebo to receive treatment with Afimetoran.

Official Title

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Afimetoran in Participants With Active Systemic Lupus Erythematosus

Quick Facts

Study Start:2021-10-11
Study Completion:2029-04-22
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04895696

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 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosed ≥ 12 weeks before the screening visit and qualify as having SLE according to the SLE International Collaborating Clinics (SLICC) Classification Criteria at the screening visit
  2. * Test positive, as determined by the central laboratory, for at least one of the following lupus related autoantibodies at the time of screening: antinuclear antibody ≥ 1:80, anti-double-stranded deoxyribonucleic acid (dsDNA) antibody, or anti-Smith antibody.
  3. * Have a total Hybrid Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score ≥ 6 points and clinical Hybrid SLEDAI score ≥ 4 points with joint involvement and/or rash
  1. * Active severe lupus nephritis (LN) as assessed by the investigator
  2. * Active or unstable neuropsychiatric lupus manifestations defined by the Hybrid SLEDAI
  3. * Diagnosis of Mixed Connective Tissue Disease for which the predominant diagnosis is not SLE
  4. * Antiphospholipid Syndrome

Contacts and Locations

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 0100
Birmingham, Alabama, 35205
United States
Local Institution - 0123
Huntington Beach, California, 92648
United States
Local Institution - 0170
La Jolla, California, 92037
United States
Local Institution - 0159
La Palma, California, 90623
United States
Local Institution - 0172
San Diego, California, 92128
United States
Local Institution - 0164
Woodland Hills, California, 91364
United States
Local Institution - 0121
Clearwater, Florida, 33765
United States
Local Institution - 0167
Kissimmee, Florida, 34741
United States
Local Institution - 0122
Orlando, Florida, 32808
United States
Local Institution - 0173
Ormond Beach, Florida, 32174
United States
Local Institution - 0154
Plantation, Florida, 33324
United States
Local Institution - 0137
South Miami, Florida, 33143
United States
Local Institution - 0155
Tamarac, Florida, 33321
United States
Local Institution - 0160
Atlanta, Georgia, 30318
United States
Local Institution - 0205
Suwanee, Georgia, 30024
United States
Local Institution - 0146
Orland Park, Illinois, 60467
United States
Local Institution - 0187
Hopkinsville, Kentucky, 42240
United States
Local Institution - 0171
Baton Rouge, Louisiana, 70836
United States
Local Institution - 0134
Wheaton, Maryland, 20902
United States
Local Institution - 0070
Eagan, Minnesota, 55121
United States
Local Institution - 0124
Saint Louis, Missouri, 63110
United States
Local Institution - 0165
Saint Louis, Missouri, 63141
United States
Local Institution - 0091
Las Vegas, Nevada, 89128
United States
Local Institution - 0219
West Long Branch, New Jersey, 07764
United States
Local Institution - 0132
Bronx, New York, 10461
United States
Local Institution - 0140
Manhasset, New York, 11030
United States
Local Institution - 0203
Charlotte, North Carolina, 28204
United States
Local Institution - 0103
Charlotte, North Carolina, 28211
United States
Local Institution - 0151
Columbus, Ohio, 43203
United States
Local Institution - 0042
Middleburg Heights, Ohio, 44130
United States
Local Institution - 0152
Allen, Texas, 75013
United States
Local Institution - 0197
Allen, Texas, 75013
United States
Local Institution - 0136
Amarillo, Texas, 79124
United States
Local Institution - 0029
Mesquite, Texas, 75150
United States
Local Institution - 0163
San Antonio, Texas, 78215
United States
Local Institution - 0223
Bellevue, Washington, 98004
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 Date2021-10-11
Study Completion Date2029-04-22

Study Record Updates

Study Start Date2021-10-11
Study Completion Date2029-04-22

Terms related to this study

Keywords Provided by Researchers

  • BMS-986256
  • Systemic Lupus Erythematosus
  • SLE
  • Connective Tissue Diseases
  • Autoimmune Diseases
  • Immune System Diseases
  • Afimetoran

Additional Relevant MeSH Terms

  • Systemic Lupus Erythematosus