Lupus
Conditions
Keywords
Pharmacokinetics, BMS-986326, Cutaneous Lupus, discoid lupus erythematosus (DLE), subacute cutaneous lupus erythematosus (SCLE), Systemic lupus erythematosus (SLE)
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.
Interventions
OTHERPlacebo for BMS-986326
Specified dose on specified days
DRUGBMS-986326
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Countries
Argentina, Bulgaria, Germany, Netherlands, Poland, Romania, Spain, United States
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed