NCT06013995CompletedPhase 1
A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus
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
Source: ClinicalTrials.gov · Last updated 26 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 45 (actual)
- First submitted
- 23 Aug 2023
- Start date
- 21 Sept 2023
- Primary completion date
- 14 Apr 2026
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Lupus (SLE)
- NCT number
- NCT06013995
- EU CT number
- 2022-503009-39-00
- EudraCT number
- 2022-503009-39
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 45
- From 21 Sept 2023 to the primary completion date, 14 Apr 2026
- 20 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Drug-induced CLE and drug-induced SLE.
Other
- SLE that is considered by the Investigator to be severe.
- Women who are pregnant or breastfeeding.
- Current use of \>10 mg prednisone (or equivalent) per day.
- Note: Other protocol-defined inclusion/exclusion criteria apply.
Who the study is looking for
- 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).
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Local Institution - 0075 Coordinator of this site? Confirm its status | CABA | Argentina | Unknown status |
| Local Institution - 0070 Coordinator of this site? Confirm its status | Pilar | Argentina | Unknown status |
| Multiprofile Hospital for Active Treatment Sveta Sofia Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| Charite Research Organisation GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Staedtisches Klinikum Dessau Coordinator of this site? Confirm its status | Dessau-Rosslau | Germany | Completed |
| Technische Universität Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Completed |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Completed |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Completed |
| Centre for Human Drug Research Coordinator of this site? Confirm its status | Leiden | Netherlands | Completed |
| Uniwersytecki Szpital Kliniczny w Poznaniu Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| Klinika Ambroziak Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Centrul Medical Monza S.R.L Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| Spitalul Clinic Judetean De Urgenta Cluj Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Completed |
| Local Institution - 0055 Coordinator of this site? Confirm its status | Clearwater | United States | Unknown status |
| Local Institution - 0005 Coordinator of this site? Confirm its status | Duncansville | United States | Unknown status |
| Local Institution - 0062 Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Skin Sciences Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Local Institution - 0048 Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Arthritis Northwest, PLLC Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| Local Institution - 0029 Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.