A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986326 in Adult Participants With Discoid Lupus Erythematosus, Subacute Cutaneous Lupus Erythematosus, or Systemic Lupus Erythematosus
Status: Recruiting
Location: See all (27) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The purpose of this study is to evaluate safety, drug levels and drug effects on cells and organs of the body, after receiving multiple increasing doses of BMS-986326 via intravenous (IV) infusion or subcutaneous (SC) injection, in participants with different forms of lupus.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Having a diagnosis of Discoid Lupus Erythematosus (DLE), Subacute Cutaneous Lupus Erythematosus (SCLE), or Systemic Lupus Erythematosus (SLE).
• Participants with DLE or SCLE must have their diagnosis at least 3 months prior to screening and must be confirmed by biopsy (except if only the facial/head/neck region is affected) and must have some ongoing disease activity (based CLASI-A scoring).
• Participants with SLE must have a diagnosis of SLE at screening based on the 2019 EULAR/ACR Classification for SLE and have mild-moderate disease severity (based on a SLEDAI-2K score).
Locations
United States
California
Local Institution - 0048
COMPLETED
San Diego
Florida
Clinical Research of West Florida, Inc. (Clearwater)
RECRUITING
Clearwater
Clinical Research of West Florida
RECRUITING
Tampa
Georgia
North Georgia Rheumatology
WITHDRAWN
Lawrenceville
Kentucky
Skin Sciences
RECRUITING
Louisville
Nevada
Local Institution - 0062
COMPLETED
Las Vegas
New York
Columbia University Irving Medical Center
WITHDRAWN
New York
Pennsylvania
Altoona Center For Clinical Research
RECRUITING
Duncansville
Texas
Allen Arthritis
WITHDRAWN
Allen
Metroplex Clinical Research Center
WITHDRAWN
Dallas
Washington
Arthritis Northwest, PLLC
RECRUITING
Spokane
Other Locations
Argentina
Clinica Adventista Belgrano
RECRUITING
Caba
Hospital Universitario Austral
RECRUITING
Pilar
Bulgaria
Local Institution - 0072
ACTIVE_NOT_RECRUITING
Sofia
Germany
Charité Research Organisation
RECRUITING
Berlin
Städtisches Klinikum Dessau
RECRUITING
Dessau
Universitaetsklinikum Carl Gustav Carus Dresden
RECRUITING
Dresden
Mexico
Local Institution - 0077
WITHDRAWN
Chihuahua City
Local Institution - 0073
WITHDRAWN
Cuauhtémoc, Ciudad De México
Local Institution - 0068
WITHDRAWN
Mexico City
Netherlands
Local Institution - 0051
COMPLETED
Leiden
Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
RECRUITING
Poznan
Klinika Ambroziak Dermatologia
RECRUITING
Warsaw
Romania
ARENSIA Exploratory Medicine
RECRUITING
Bucharest
ARENSIA Exploratory Medicine
RECRUITING
Cluj-napoca
Spain
CHUAC-Complejo Hospitalario Universitario A Coruña
RECRUITING
A Coruña
Hospital Universitario Reina Sofia
RECRUITING
Córdoba
Contact Information
Primary
BMS Study Connect Contact Center www.BMSStudyConnect.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain the NCT# and Site #.