A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis
NCT ID: NCT03817424
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
31 participants
INTERVENTIONAL
2018-12-13
2020-07-20
Brief Summary
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Detailed Description
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Study acquired from Horizon in 2024. Originally Viela Bio was the sponsor.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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Cohort 1: VIB7734 Dose 1
Participants will receive VIB7734 Dose 1 via injection q4w for a total of 3 doses on Days 1, 29, and 57.
VIB7734
Participants will receive VIB7734 via injection.
Cohort 2: VIB7734 Dose 2
Participants will receive VIB7734 Dose 2 via injection q4w for a total of 3 doses on Days 1, 29, and 57.
VIB7734
Participants will receive VIB7734 via injection.
Cohort 3: VIB7734 Dose 3
Participants will receive VIB7734 Dose 3 via injection q4w for a total of 3 doses on Days 1, 29, and 57.
VIB7734
Participants will receive VIB7734 via injection.
Placebo
Participants will receive placebo matching to VIB7734 via injection q4w for a total of 3 doses on Days 1, 29, and 57.
Placebo
Participants will receive placebo matching to VIB7734 via injection.
Interventions
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VIB7734
Participants will receive VIB7734 via injection.
Placebo
Participants will receive placebo matching to VIB7734 via injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants with at least one of the following diagnoses:
1. Systemic Lupus Erythematosus
2. Cutaneous lupus erythematosus, including acute CLE, subacute CLE, and discoid lupus erythematosus
3. Sjogren's syndrome (for Cohort 1 only)
4. Systemic sclerosis (for Cohort 1 only)
5. Probable or definite polymyositis (for Cohort 1 only)
6. Probable or definite dermatomyositis (for Cohort 1 only)
* For Cohorts 2 and 3 only: Participants with CLASI activity score greater than or equal to (\>=) 8 at both Visits 1 (screening) and 2 (baseline)
* For Cohorts 2 and 3 only: a skin lesion amenable to punch skin biopsy and willingness of the participant to undergo skin biopsy at two time points
* For Cohorts 2 and 3 only: photographs of skin lesions must be submitted for review to confirm the diagnosis of SLE or CLE with active skin lesions confirmation of the diagnosis by the central reviewer must be received prior to randomization
* Females of childbearing potential and nonsterilized males who are ready to use protocol defined contraception methods
Exclusion Criteria
* Known history of a primary immunodeficiency or an underlying condition such as known human immunodeficiency virus (HIV) infection, a positive result for HIV infection, splenectomy, or any underlying condition that predisposes the participant to infection
* At screening, have adequate central laboratory test results: aspartate transaminase greater than (\>) 2.5 x upper limit of normal (ULN); alanine transaminase \>2.5 x ULN; total bilirubin 1.5 x ULN; total immunoglobulin \< 500 gram/decilitre; neutrophil count less than (\<) 1,000/μL; platelet count \< 85,000/μL; haemoglobin \< 10 g/dL; glycosylated haemoglobin \> 8 percent (%); total lymphocyte count \< 300 cells/mm\^3; glomerular filtration rate \< 50 mL/min/1.73 m\^2; plasmacytoid dendritic cells (pDC) level \< 0.02% of peripheral blood mononuclear cells (PBMCs)
* Positive test for chronic hepatitis B infection at screening and for hepatitis C virus antibody
* History of or active tuberculosis (TB), or a positive QuantiFERON®-TB Gold test at screening; a primary immunodeficiency or an underlying condition such as known human immunodeficiency virus (HIV) infection, a positive result for HIV infection per central laboratory; cancer; clinically significant cardiac disease
* Herpes zoster infection within 3 months before randomization and/or any severe herpes virus family infection at any time prior to randomization
* Any acute illness or evidence of clinically significant active infection, such as fever \>= 38.0 degrees Celsius (\>= 100.5 degrees Fahrenheit) at screening (Visit 1) or Day 1 (Visit 2)
* Cohorts 2 and 3 only: use of Group 1 (super-high potency) or Group 2 (high potency) topical corticosteroids
* Receipt of a live-attenuated vaccine within 4 weeks prior to Day 1
* Cohorts 2 and 3 only: have received changing doses of mycophenolate mofetil, methotrexate, leflunomide, azathioprine, or non-steroidal topical immunosuppressants within 28 days before study Day 1 or changing doses of oral or topical corticosteroids within 14 days before study Day 1
18 Years
75 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Viela Bio Investigative Site
Anniston, Alabama, United States
Viela Bio Investigative Site
Birmingham, Alabama, United States
Viela Bio Investigative Site
Los Angeles, California, United States
Viela Bio Investigative Site
Upland, California, United States
Viela Bio Investigative Site
Danbury, Connecticut, United States
Viela Bio Investigative Site
Fort Lauderdale, Florida, United States
Viela Bio Investigative Site
Hialeah, Florida, United States
Viela Bio Investigative Site
Jacksonville, Florida, United States
Viela Bio Investigative Site
Miami Lakes, Florida, United States
Viela Bio Investigative Site
St. Petersburg, Florida, United States
Viela Bio Investigative Site
Lawrenceville, Georgia, United States
Viela Bio Investigative Site
Great Neck, New York, United States
Viela Bio Investigative Site
Charlotte, North Carolina, United States
Viela Bio Investigative Site
Durham, North Carolina, United States
Viela Bio Investigative Site
Duncansville, Pennsylvania, United States
Viela Bio Investigative Site
Philadelphia, Pennsylvania, United States
Viela Bio Investigative Site
Memphis, Tennessee, United States
Viela Bio Investigative Site
Allen, Texas, United States
Viela Bio Investigative Site
Mesquite, Texas, United States
Viela Bio Investigative Site
Bialystok, , Poland
Viela Bio Investigative Site
Bydgoszcz, , Poland
Viela Bio Investigative Site
Krakow, , Poland
Viela Bio Investigative Site
Poznan, , Poland
Viela Bio Investigative Site
Rzeszów, , Poland
Viela Bio Investigative Site
Warsaw, , Poland
Viela Bio Investigative Site
Wroclaw, , Poland
Viela Bio Investigative Site
Barcelona, , Spain
Viela Bio Investigative Site
Bilbao, , Spain
Viela Bio Investigative Site
Madrid, , Spain
Viela Bio Investigative Site
Seville, , Spain
Countries
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Other Identifiers
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2018-003767-60
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
VIB7734.P1b.S1
Identifier Type: -
Identifier Source: org_study_id