Clinical trial NCT06013995: A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Lupus
Keywords: Pharmacokinetics
BMS-986326
Cutaneous Lupus
discoid lupus erythematosus (DLE)
subacute cutaneous lupus erythematosus (SCLE)
Systemic lupus erythematosus (SLE)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-08-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

* 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).

Exclusion criteria:

* SLE that is considered by the Investigator to be severe.
* Drug-induced CLE and drug-induced SLE.
* Women who are pregnant or breastfeeding.
* Current use of \>10 mg prednisone (or equivalent) per day.

Note: Other protocol-defined inclusion/exclusion criteria apply.

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 228 days
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to 228 days
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 228 days
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 228 days
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 228 days
measure: Number of participants with physical examination abnormalities
timeFrame: Up to 228 days
Secondary outcomes:
measure: Maximum observed serum concentration (Cmax)
timeFrame: Predose and post-dose up to Day 167
measure: Time of Cmax (Tmax)
timeFrame: Predose and post-dose up to Day 167
measure: Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
timeFrame: Predose and post-dose up to Day 167
measure: Change from baseline in regulatory T cells (Treg) count to Day 144
timeFrame: Baseline up to Day 144
measure: Change from baseline in Treg-to-conventional t cells (Tconv) ratio
timeFrame: Baseline up to Day 144
measure: Number of participants with anti-drug antibodies
timeFrame: Baseline up to Day 167
Other outcomes:
Locations:
city: San Diego
country: United States
facility: TriWest Research Associates - La Mesa
state: California
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc. (Clearwater)
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Lawrenceville
country: United States
facility: North Georgia Rheumatology
state: Georgia
city: Las Vegas
country: United States
facility: IMA Clinical Research Las Vegas
state: Nevada
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Duncansville
country: United States
facility: Altoona Center For Clinical Research
state: Pennsylvania
city: Allen
country: United States
facility: Allen Arthritis
state: Texas
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Pilar
country: Argentina
facility: Local Institution - 0070
state: Buenos Aires
city: Caba
country: Argentina
facility: Local Institution - 0075
state: Ciudad Autónoma De Buenos Aires
city: Sofia
country: Bulgaria
facility: Local Institution - 0072
state: Sofia (stolitsa)
city: Berlin
country: Germany
facility: Charité Research Organisation
city: Dessau
country: Germany
facility: Local Institution - 0071
city: Cuauhtémoc, Ciudad De México
country: Mexico
facility: Local Institution - 0073
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Local Institution - 0068
state: Distrito Federal
city: Chihuahua
country: Mexico
facility: Local Institution - 0077
city: Warszawa
country: Poland
facility: Local Institution - 0069
state: Mazowieckie
city: Poznan
country: Poland
facility: Local Institution - 0074
state: Wielkopolskie
city: Bucharest
country: Romania
facility: ARENSIA Exploratory Medicine
state: București
city: Cluj-Napoca
country: Romania
facility: ARENSIA Exploratory Medicine
state: Cluj
city: Cordoba
country: Spain
facility: Local Institution - 0045
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: