A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus

Lupus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06013995
• Other study ID #: IM034-1000
• Secondary ID: 2022-503009-39
• Status: Recruiting
• Phase: Phase 1
• Start date: September 21, 2023
• Est. completion date: November 24, 2025

Study information

• Verified date: February 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 24, 2025
• Est. primary completion date: November 24, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus

Intervention

Drug:
• BMS-986326
Specified dose on specified days

Other:
• Placebo for BMS-986326
Specified dose on specified days

Locations

Country	Name	City	State
Argentina	Local Institution - 0075	Caba	Ciudad Autónoma De Buenos Aires
Argentina	Local Institution - 0070	Pilar	Buenos Aires
Bulgaria	Local Institution - 0072	Sofia	Sofia (stolitsa)
Germany	Local Institution - 0071	Dessau
Mexico	Local Institution - 0077	Chihuahua
Mexico	Local Institution - 0073	Cuauhtémoc, Ciudad De México	Distrito Federal
Mexico	Local Institution - 0068	Mexico City	Distrito Federal
Poland	Local Institution - 0074	Poznan	Wielkopolskie
Poland	Local Institution - 0069	Warszawa	Mazowieckie
Romania	Local Institution - 0065	Bucharest	Bucure?ti
Romania	Local Institution - 0064	Cluj-Napoca	Cluj
Spain	Local Institution - 0045	Cordoba
United States	Allen Arthritis	Allen	Texas
United States	Clinical Research of West Florida, Inc. (Clearwater)	Clearwater	Florida
United States	Metroplex Clinical Research Center	Dallas	Texas
United States	Altoona Center For Clinical Research	Duncansville	Pennsylvania
United States	IMA Clinical Research Las Vegas	Las Vegas	Nevada
United States	North Georgia Rheumatology	Lawrenceville	Georgia
United States	Columbia University Irving Medical Center	New York	New York
United States	TriWest Research Associates - La Mesa	San Diego	California
United States	Clinical Research of West Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Bulgaria,  Germany,  Mexico,  Poland,  Romania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events (AEs)		Up to 228 days
Primary	Number of participants with serious adverse events (SAEs)		Up to 228 days
Primary	Number of participants with clinical laboratory abnormalities		Up to 228 days
Primary	Number of participants with vital sign abnormalities		Up to 228 days
Primary	Number of participants with electrocardiogram (ECG) abnormalities		Up to 228 days
Primary	Number of participants with physical examination abnormalities		Up to 228 days
Secondary	Maximum observed serum concentration (Cmax)		Predose and post-dose up to Day 167
Secondary	Time of Cmax (Tmax)		Predose and post-dose up to Day 167
Secondary	Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])		Predose and post-dose up to Day 167
Secondary	Change from baseline in regulatory T cells (Treg) count to Day 144		Baseline up to Day 144
Secondary	Change from baseline in Treg-to-conventional t cells (Tconv) ratio		Baseline up to Day 144
Secondary	Number of participants with anti-drug antibodies		Baseline up to Day 167

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting