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A Study to Assess the Safety and Drug Levels of BMS-986256 in Participants With Active Cutaneous Lupus Erythematosus

  • Clinicaltrials.gov identifier

    NCT04493541

  • Recruitment Status

    Recruiting

  • First Posted

    July 30, 2020

  • Last update posted

    September 29, 2020

Study Description

Brief summary:

The purpose of this study is to assess the safety and drug levels of BMS-986256 in participants with cutaneous lupus erythematosus.

  • Condition or Disease:Lupus Erythematosus, Cutaneous
  • Intervention/Treatment: Drug: BMS-986256
    Other: BMS-986256 Placebo
  • Phase: Phase 1

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 24 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 Study to Assess the Safety and Pharmacokinetics of BMS-986256 in Participants With Active Cutaneous Lupus Erythematosus
  • Actual Study Start Date: August 2020
  • Estimated Primary Completion Date: January 2022
  • Estimated Study Completion Date: January 2022

Arms and interventions

Arm Intervention/treatment
Experimental: BMS-986256
Drug: BMS-986256
Specified Dose on Specified Days
Placebo Comparator: Placebo
Other: BMS-986256 Placebo
Specified Dose on Specified Days

Outcome Measures

  • Primary Outcome Measures: 1. Incidence of clinically significant changes in vital signs: Blood pressure [ Time Frame: Up to 20 weeks ]
  • 2. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 24 weeks ]
  • 3. Incidence of Adverse Events (AEs) [ Time Frame: Up to 20 weeks ]
  • 4. Number of laboratory test abnormalities: Hematology [ Time Frame: Up to 20 weeks ]
  • 5. Number of laboratory test abnormalities: Urinalysis [ Time Frame: Up to 20 weeks ]
  • 6. Number of laboratory test abnormalities: Clinical Chemistry [ Time Frame: Up to 20 weeks ]
  • 7. Incidence of clinically significant changes in physical examination findings [ Time Frame: Up to 20 weeks ]
  • 8. Incidence of clinically significant changes in vital signs: Body temperature [ Time Frame: Up to 20 weeks ]
  • 9. Incidence of clinically significant changes in vital signs: Respiratory rate [ Time Frame: Up to 20 weeks ]
  • 10. Incidence of clinically significant changes in vital signs: Heart rate [ Time Frame: Up to 20 weeks ]
  • 11. Incidence of clinically significant changes in Electrocardiogram (ECG) parameters [ Time Frame: Up to 20 weeks ]
  • Secondary Outcome Measures: 1. Maximum observed plasma concentration (Cmax) of BMS-986256 [ Time Frame: Up to 20 weeks ]
  • 2. Time to maximum concentration (Tmax) of BMS-986256 [ Time Frame: Up to 20 weeks ]
  • 3. Trough observed plasma concentration (Ctrough) of BMS-986256 [ Time Frame: Up to 20 weeks ]
  • 4. Area under the concentration-time curve over the dosing interval (AUC (TAU)) of BMS-986256 [ Time Frame: Up to 20 weeks ]
  • 5. Maximum observed plasma concentration (Cmax) of metabolite BMT-271199 [ Time Frame: Up to 20 weeks ]
  • 6. Time to maximum concentration (Tmax) of metabolite BMT-271199 [ Time Frame: Up to 20 weeks ]
  • 7. Trough observed plasma concentration (Ctrough) of metabolite BMT-271199 [ Time Frame: Up to 20 weeks ]
  • 8. Area under the concentration-time curve over the dosing interval (AUC (TAU)) of metabolite BMT-271199 [ Time Frame: Up to 20 weeks ]

Eligibility Criteria

  • Ages Eligible for Study: 18 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: Must have one of following diagnoses: i) Meet European League Against Rheumatoid (EULAR)/American College of Rheumatology 2019 Classification Criteria for systemic lupus erythematosus (SLE) ii) Biopsy-proven cutaneous lupus erythematosus (CLE) Active cutaneous lupus disease, defined as a modified Cutaneous Lupus Erythematosus Disease Area and Severity Index- Activity (mCLASI-A) score ≥ 6 Active cutaneous lupus skin lesion(s) amenable to biopsy Women and men must agree to follow specific methods of contraception, if applicable Exclusion Criteria: Diagnosis of discoid lupus erythematosus (DLE) or subacute cutaneous lupus erythematosus (SCLE) without SLE. Active severe or unstable neuropsychiatric SLE Active, severe Lupus Nephritis (LN) Any British Isles Lupus Assessment Group (BILAG) A or B, unless within the constitutional, musculoskeletal and/or mucocutaneous domains Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #

Locations

Germany
Local Institution
Berlin

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04493541 History of Changes
  • Other Study ID Numbers: IM026-027, 2019-004044-29
  • First Posted: July 30, 2020 Key Record Dates
  • Last Update Posted: September 29, 2020
  • Last Verified: September 2020
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Lupus Erythematosus, Systemic
    Lupus Erythematosus, Cutaneous
    Connective Tissue Diseases
    Autoimmune Diseases
    Immune System Diseases
    Skin Diseases