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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06013995

Collaborator

(none)

Enrollment

Locations

Arms

23.1

Anticipated Duration (Months)

5.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lupus	Drug: BMS-986326 Other: Placebo for BMS-986326	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 15, 2023

Anticipated Primary Completion Date :

Aug 18, 2025

Anticipated Study Completion Date :

Aug 18, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort A: BMS-986326 Dose 1 IV	Drug: BMS-986326 Specified dose on specified days Other: Placebo for BMS-986326 Specified dose on specified days
Experimental: Cohort B: BMS-986326 Dose 2 IV	Drug: BMS-986326 Specified dose on specified days Other: Placebo for BMS-986326 Specified dose on specified days
Experimental: Cohort C1: BMS-986326 Dose 3 IV	Drug: BMS-986326 Specified dose on specified days Other: Placebo for BMS-986326 Specified dose on specified days
Experimental: Cohort C2: BMS-986326 Dose 3 SC	Drug: BMS-986326 Specified dose on specified days Other: Placebo for BMS-986326 Specified dose on specified days
Experimental: Cohort D1: BMS-986326 Dose 4 IV	Drug: BMS-986326 Specified dose on specified days Other: Placebo for BMS-986326 Specified dose on specified days
Experimental: Cohort D2: BMS-986326 Dose 4 SC	Drug: BMS-986326 Specified dose on specified days Other: Placebo for BMS-986326 Specified dose on specified days
Experimental: Cohort E1: BMS-986326 Dose 3 IV	Drug: BMS-986326 Specified dose on specified days Other: Placebo for BMS-986326 Specified dose on specified days
Experimental: Cohort E2: BMS-986326 Dose 3 SC	Drug: BMS-986326 Specified dose on specified days Other: Placebo for BMS-986326 Specified dose on specified days

Outcome Measures

Primary Outcome Measures

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 clinical laboratory abnormalities [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

Maximum observed serum concentration (Cmax) [Predose and post-dose up to Day 167]
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 regulatory T cells (Treg) count to Day 144 [Baseline up to Day 144]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research of West Florida	Tampa	Florida	United States	33606
2	North Georgia Rheumatology	Lawrenceville	Georgia	United States	30046
3	IMA Clinical Research Las Vegas	Las Vegas	Nevada	United States	89102
4	Allen Arthritis	Allen	Texas	United States	75013
5	Metroplex Clinical Research Center	Dallas	Texas	United States	75231
6	Local Institution - 0071	Dessau		Germany	06847
7	Local Institution - 0073	Cuauhtémoc, Ciudad De México	Distrito Federal	Mexico	06100
8	Local Institution - 0068	Mexico City	Distrito Federal	Mexico	07760
9	Local Institution - 0069	Warszawa	Mazowieckie	Poland	02-953
10	Local Institution - 0065	Bucharest	București	Romania	11658
11	Local Institution - 0064	Cluj-Napoca	Cluj	Romania	400006