NCT06013995

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2023

Typical duration for phase_1

Geographic Reach
8 countries

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
24 days until next milestone

Study Start

First participant enrolled

September 21, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2026

Completed
Last Updated

May 26, 2026

Status Verified

May 1, 2026

Enrollment Period

2.6 years

First QC Date

August 23, 2023

Last Update Submit

May 22, 2026

Conditions

Lupus

Keywords

PharmacokineticsBMS-986326Cutaneous Lupusdiscoid lupus erythematosus (DLE)subacute cutaneous lupus erythematosus (SCLE)Systemic lupus erythematosus (SLE)

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (7)

  • 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

  • Serum PK parameters such as AUC(TAU)

    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

  • +2 more secondary outcomes

Study Arms (6)

Cohort A: BMS-986326 Dose 1 IV

EXPERIMENTAL
Drug: BMS-986326Other: Placebo for BMS-986326

Cohort B: BMS-986326 Dose 2 IV

EXPERIMENTAL
Drug: BMS-986326Other: Placebo for BMS-986326

Cohort C1: BMS-986326 Dose 3 IV

EXPERIMENTAL
Drug: BMS-986326Other: Placebo for BMS-986326

Cohort C2: BMS-986326 Dose 3 SC

EXPERIMENTAL
Drug: BMS-986326Other: Placebo for BMS-986326

Cohort D2: BMS-986326 Dose 4 SC

EXPERIMENTAL
Drug: BMS-986326Other: Placebo for BMS-986326

Cohort E2: BMS-986326 Dose 3 SC

EXPERIMENTAL
Drug: BMS-986326Other: Placebo for BMS-986326

Interventions

BMS-986326DRUG

Specified dose on specified days

Cohort A: BMS-986326 Dose 1 IVCohort B: BMS-986326 Dose 2 IVCohort C1: BMS-986326 Dose 3 IVCohort C2: BMS-986326 Dose 3 SCCohort D2: BMS-986326 Dose 4 SCCohort E2: BMS-986326 Dose 3 SC
Placebo for BMS-986326OTHER

Specified dose on specified days

Cohort A: BMS-986326 Dose 1 IVCohort B: BMS-986326 Dose 2 IVCohort C1: BMS-986326 Dose 3 IVCohort C2: BMS-986326 Dose 3 SCCohort D2: BMS-986326 Dose 4 SCCohort E2: BMS-986326 Dose 3 SC

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Local Institution - 0048

San Diego, California, 92108, United States

Location

Local Institution - 0055

Clearwater, Florida, 33765, United States

Location

Local Institution - 0029

Tampa, Florida, 33606, United States

Location

Skin Sciences

Louisville, Kentucky, 40217, United States

Location

Local Institution - 0062

Las Vegas, Nevada, 89102, United States

Location

Local Institution - 0005

Duncansville, Pennsylvania, 16635, United States

Location

Arthritis Northwest, PLLC

Spokane, Washington, 99204, United States

Location

Local Institution - 0070

Pilar, Buenos Aires, 1629, Argentina

Location

Local Institution - 0075

CABA, Buenos Aires F.D., 1430, Argentina

Location

Local Institution - 0072

Sofia, 1618, Bulgaria

Location

Local Institution - 0044

Berlin, 10117, Germany

Location

Local Institution - 0071

Dessau, 06847, Germany

Location

Local Institution - 0047

Dresden, 01307, Germany

Location

Local Institution - 0051

Leiden, 2333 CL, Netherlands

Location

Local Institution - 0074

Poznan, 61-848, Poland

Location

Local Institution - 0069

Warsaw, 02-953, Poland

Location

Local Institution - 0065

Bucharest, Bucharest, 11658, Romania

Location

Local Institution - 0064

Cluj-Napoca, Cluj, 400006, Romania

Location

Local Institution - 0046

A Coruña, A Coruña [La Coruña], 15006, Spain

Location

Local Institution - 0045

Córdoba, Córdoba, 14004, Spain

Location

Related Links

MeSH Terms

Conditions

Lupus Erythematosus, DiscoidLupus Erythematosus, CutaneousLupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2023

First Posted

August 28, 2023

Study Start

September 21, 2023

Primary Completion

April 14, 2026

Study Completion

April 14, 2026

Last Updated

May 26, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
See Plan Description
Access Criteria
See Plan Description
More information

Locations

PL(2)AR(2)BU(1)NL(1)RO(2)US(7)DE(3)ES(2)