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

Phase 1

Recruiting

• Conditions: Lupus
• Interventions: Drug: BMS-986326; Other: Placebo for BMS-986326

• Registration Number: NCT06013995
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-23
• Study First Submitted QC: 2023-08-23
• Study First Posted: 2023-08-28
• Study Start: 2023-09-21
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-23
• Primary Completion: 2025-11-24
• Study Completion: 2025-11-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort D2: BMS-986326 Dose 4 SC	Placebo for BMS-986326	-
Cohort E1: BMS-986326 Dose 3 IV	BMS-986326	-
Cohort A: BMS-986326 Dose 1 IV	BMS-986326	-
Cohort A: BMS-986326 Dose 1 IV	Placebo for BMS-986326	-
Cohort B: BMS-986326 Dose 2 IV	BMS-986326	-
Cohort B: BMS-986326 Dose 2 IV	Placebo for BMS-986326	-
Cohort C1: BMS-986326 Dose 3 IV	BMS-986326	-
Cohort C1: BMS-986326 Dose 3 IV	Placebo for BMS-986326	-
Cohort C2: BMS-986326 Dose 3 SC	BMS-986326	-
Cohort C2: BMS-986326 Dose 3 SC	Placebo for BMS-986326	-
Cohort D1: BMS-986326 Dose 4 IV	BMS-986326	-
Cohort D1: BMS-986326 Dose 4 IV	Placebo for BMS-986326	-
Cohort D2: BMS-986326 Dose 4 SC	BMS-986326	-
Cohort E1: BMS-986326 Dose 3 IV	Placebo for BMS-986326	-
Cohort E2: BMS-986326 Dose 3 SC	BMS-986326	-
Cohort E2: BMS-986326 Dose 3 SC	Placebo for BMS-986326	-

Primary Outcome Measures

Name	Time	Method
Number of participants with clinical laboratory abnormalities	Up to 228 days
Number of participants with adverse events (AEs)	Up to 228 days
Number of participants with serious adverse events (SAEs)	Up to 228 days
Number of participants with vital sign abnormalities	Up to 228 days
Number of participants with electrocardiogram (ECG) abnormalities	Up to 228 days
Number of participants with physical examination abnormalities	Up to 228 days

Secondary Outcome Measures

Name	Time	Method
Maximum observed serum concentration (Cmax)	Predose and post-dose up to Day 167
Change from baseline in regulatory T cells (Treg) count to Day 144	Baseline up to Day 144
Time of Cmax (Tmax)	Predose and post-dose up to Day 167
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
Change from baseline in Treg-to-conventional t cells (Tconv) ratio	Baseline up to Day 144
Number of participants with anti-drug antibodies	Baseline up to Day 167

Trial Locations

Locations (21)

North Georgia Rheumatology; 🇺🇸 Lawrenceville, Georgia, United States

Local Institution - 0077; 🇲🇽 Chihuahua, Mexico

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States

Local Institution - 0073; 🇲🇽 Cuauhtémoc, Ciudad De México, Distrito Federal, Mexico

TriWest Research Associates - La Mesa; 🇺🇸 San Diego, California, United States

Clinical Research of West Florida, Inc. (Clearwater); 🇺🇸 Clearwater, Florida, United States

Metroplex Clinical Research Center; 🇺🇸 Dallas, Texas, United States

IMA Clinical Research Las Vegas; 🇺🇸 Las Vegas, Nevada, United States

Clinical Research of West Florida; 🇺🇸 Tampa, Florida, United States

Altoona Center For Clinical Research; 🇺🇸 Duncansville, Pennsylvania, United States

Local Institution - 0070; 🇦🇷 Pilar, Buenos Aires, Argentina

Allen Arthritis; 🇺🇸 Allen, Texas, United States

Local Institution - 0071; 🇩🇪 Dessau, Germany

Local Institution - 0072; 🇧🇬 Sofia, Sofia (stolitsa), Bulgaria

Local Institution - 0068; 🇲🇽 Mexico City, Distrito Federal, Mexico

Local Institution - 0069; 🇵🇱 Warszawa, Mazowieckie, Poland

Local Institution - 0045; 🇪🇸 Cordoba, Spain

Local Institution - 0075; 🇦🇷 Caba, Ciudad Autónoma De Buenos Aires, Argentina

Local Institution - 0074; 🇵🇱 Poznan, Wielkopolskie, Poland

Local Institution - 0064; 🇷🇴 Cluj-Napoca, Cluj, Romania

Local Institution - 0065; 🇷🇴 Bucharest, București, Romania