NCT04493541

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2020

Typical duration for phase_1

Geographic Reach
1 country

1 active site

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

July 28, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2020

Completed
27 days until next milestone

Study Start

First participant enrolled

August 26, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2023

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

2.7 years

First QC Date

July 28, 2020

Last Update Submit

May 8, 2023

Conditions

Lupus Erythematosus, Cutaneous

Outcome Measures

Primary Outcomes (11)

  • Incidence of Serious Adverse Events (SAEs)

    Up to 24 weeks

  • Incidence of Adverse Events (AEs)

    Up to 20 weeks

  • Number of laboratory test abnormalities: Hematology

    Up to 20 weeks

  • Number of laboratory test abnormalities: Urinalysis

    Up to 20 weeks

  • Number of laboratory test abnormalities: Clinical Chemistry

    Up to 20 weeks

  • Incidence of clinically significant changes in physical examination findings

    Up to 20 weeks

  • Incidence of clinically significant changes in vital signs: Body temperature

    Up to 20 weeks

  • Incidence of clinically significant changes in vital signs: Respiratory rate

    Up to 20 weeks

  • Incidence of clinically significant changes in vital signs: Blood pressure

    Up to 20 weeks

  • Incidence of clinically significant changes in vital signs: Heart rate

    Up to 20 weeks

  • Incidence of clinically significant changes in Electrocardiogram (ECG) parameters

    Up to 20 weeks

Secondary Outcomes (8)

  • Maximum observed plasma concentration (Cmax) of BMS-986256

    Up to 20 weeks

  • Time to maximum concentration (Tmax) of BMS-986256

    Up to 20 weeks

  • Trough observed plasma concentration (Ctrough) of BMS-986256

    Up to 20 weeks

  • Area under the concentration-time curve over the dosing interval (AUC (TAU)) of BMS-986256

    Up to 20 weeks

  • Maximum observed plasma concentration (Cmax) of metabolite BMT-271199

    Up to 20 weeks

  • +3 more secondary outcomes

Study Arms (2)

BMS-986256

EXPERIMENTAL
Drug: BMS-986256

Placebo

PLACEBO COMPARATOR
Other: BMS-986256 Placebo

Interventions

BMS-986256DRUG

Specified Dose on Specified Days

BMS-986256
BMS-986256 PlaceboOTHER

Specified Dose on Specified Days

Placebo

Eligibility Criteria

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

You may qualify if:

  • a) 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) OR ii) Biopsy-proven acute cutaneous lupus erythematosus (ACLE), subacute cutaneous lupus erythematosus (SCLE), or discoid lupus erythematosus (DLE): Participants without a concurrent SLE diagnosis are eligible b) Active cutaneous lupus disease, defined as a modified Cutaneous Lupus Erythematosus Disease Area and Severity Index- Activity (mCLASI-A) score ≥ 6 c) Active cutaneous lupus skin lesion(s) amenable to biopsy
  • Women of childbearing potential (WOCBP) and men must agree to follow instructions for method(s) of contraception, if applicable

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution - 0001

Berlin, 10117, Germany

Location

Related Links

MeSH Terms

Conditions

Lupus Erythematosus, Cutaneous

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin 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

July 28, 2020

First Posted

July 30, 2020

Study Start

August 26, 2020

Primary Completion

April 21, 2023

Study Completion

April 21, 2023

Last Updated

May 9, 2023

Record last verified: 2023-05

Locations

DE(1)