Multiple Sclerosis Clinical Trial

A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren’s Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis

Summary

The purpose of this study is to evaluate the safety and tolerability of escalating, multiple subcutaneous (SC) doses of VIB7734 in participants with Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis.

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Full Description

This study will have 3 periods: screening, treatment period, and extended follow-up. The screening period is 28 days. A total of 32 participants will be enrolled in 3 cohorts with 8 participants in Cohort 1, and 12 participants each in Cohorts 2 and 3. In Cohort 1, participants will be randomized in a 3:1 ratio to receive VIB7734 or matching placebo by injection every 4 weeks (q4w) for a total of 3 doses on Days 1, 29, and 57. In Cohorts 2 and 3, participants diagnosed with lupus only will be randomized in a 2:1 ratio to receive VIB7734 or matching placebo by injection q4w for 3 doses on Days 1, 29, and 57. Participants will be followed until at least Day 141. After the Day 141 visit, participants will exit the study if participants meets adequate plasmacytoid dendritic cells (pDCs). If an adequate pDC level does not meet at Day 141 visit, the participant will continue the follow-up for pDC repletion until they meet the protocol defined adequate pDC level or Day 337 visit has been reached.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participants aged 18 through 75 years at the time of screening

Participants with at least one of the following diagnoses:

Systemic Lupus Erythematosus
Cutaneous lupus erythematosus, including acute CLE, subacute CLE, and discoid lupus erythematosus
Sjogren's syndrome (for Cohort 1 only)
Systemic sclerosis (for Cohort 1 only)
Probable or definite polymyositis (for Cohort 1 only)
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:

Severe manifestations of the diseases under study that could impact the participant safety
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

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

31

Study ID:

NCT03817424

Recruitment Status:

Completed

Sponsor:

Viela Bio

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There are 19 Locations for this study

See Locations Near You

Viela Bio Investigative Site
Anniston Alabama, 36201, United States
Viela Bio Investigative Site
Birmingham Alabama, 35294, United States
Viela Bio Investigative Site
Los Angeles California, 90022, United States
Viela Bio Investigative Site
Upland California, 91786, United States
Viela Bio Investigative Site
Danbury Connecticut, 06810, United States
Viela Bio Investigative Site
Fort Lauderdale Florida, 33309, United States
Viela Bio Investigative Site
Hialeah Florida, 33016, United States
Viela Bio Investigative Site
Jacksonville Florida, 32216, United States
Viela Bio Investigative Site
Miami Lakes Florida, 33014, United States
Viela Bio Investigative Site
Saint Petersburg Florida, 33710, United States
Viela Bio Investigative Site
Lawrenceville Georgia, 30046, United States
Viela Bio Investigative Site
Great Neck New York, 11021, United States
Viela Bio Investigative Site
Charlotte North Carolina, 28204, United States
Viela Bio Investigative Site
Durham North Carolina, 27713, United States
Viela Bio Investigative Site
Duncansville Pennsylvania, 16635, United States
Viela Bio Investigative Site
Philadelphia Pennsylvania, 19104, United States
Viela Bio Investigative Site
Memphis Tennessee, 38119, United States
Viela Bio Investigative Site
Allen Texas, 75013, United States
Viela Bio Investigative Site
Mesquite Texas, 75150, United States
Viela Bio Investigative Site
Białystok , , Poland
Viela Bio Investigative Site
Bydgoszcz , , Poland
Viela Bio Investigative Site
Kraków , , Poland
Viela Bio Investigative Site
Poznań , , Poland
Viela Bio Investigative Site
Rzeszów , , Poland
Viela Bio Investigative Site
Warsaw , , Poland
Viela Bio Investigative Site
Wrocław , , Poland
Viela Bio Investigative Site
Barcelona , , Spain
Viela Bio Investigative Site
Bilbao , , Spain
Viela Bio Investigative Site
Madrid , , Spain
Viela Bio Investigative Site
Sevilla , , Spain

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 1

Estimated Enrollment:

31

Study ID:

NCT03817424

Recruitment Status:

Completed

Sponsor:


Viela Bio

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