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OpenTrials
Completed

NCT Number: NCT06013995

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

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.

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Key information

Conditions

Lupus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Cutaneous Lupus Erythematosus, Discoid Lupus Erythematosus, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0070, Pilar, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986326

Drug

Specified dose on specified days

Placebo for BMS-986326

Other

Specified dose on specified days

Primary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to 228 days

  2. Number of participants with serious adverse events (SAEs)

    Time frame: Up to 228 days

  3. Number of participants with clinical laboratory abnormalities

    Time frame: Up to 228 days

  4. Number of participants with vital sign abnormalities

    Time frame: Up to 228 days

  5. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to 228 days

  6. Number of participants with physical examination abnormalities

    Time frame: Up to 228 days

Secondary outcomes

  1. Maximum observed serum concentration (Cmax)

    Time frame: Predose and post-dose up to Day 167

  2. Time of Cmax (Tmax)

    Time frame: Predose and post-dose up to Day 167

  3. Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])

    Time frame: Predose and post-dose up to Day 167

  4. Serum PK parameters such as AUC(TAU)

    Time frame: Predose and post-dose up to Day 167

  5. Change from baseline in regulatory T cells (Treg) count to Day 144

    Time frame: Baseline up to Day 144

  6. Change from baseline in Treg-to-conventional t cells (Tconv) ratio

    Time frame: Baseline up to Day 144

  7. Number of participants with anti-drug antibodies

    Time frame: Baseline up to Day 167

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 28, 2023
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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