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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Participants aged 18 through 75 years at the time of screening - 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:

- 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03817424
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Viela Bio
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jack Ratchford, MD
Principal Investigator Affiliation Viela Bio
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Poland, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, Dermatomyositis
Additional Details

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.

Arms & Interventions

Arms

Experimental: 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.

Experimental: 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.

Experimental: 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.

Placebo Comparator: Placebo

Participants will receive placebo matching to VIB7734 via injection q4w for a total of 3 doses on Days 1, 29, and 57.

Interventions

Drug: - VIB7734

Participants will receive VIB7734 via injection.

Drug: - Placebo

Participants will receive placebo matching to VIB7734 via injection.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Viela Bio Investigative Site, Anniston, Alabama

Status

Recruiting

Address

Viela Bio Investigative Site

Anniston, Alabama, 36201

Viela Bio Investigative Site, Birmingham, Alabama

Status

Not yet recruiting

Address

Viela Bio Investigative Site

Birmingham, Alabama, 35294

Viela Bio Investigative Site, Los Angeles, California

Status

Not yet recruiting

Address

Viela Bio Investigative Site

Los Angeles, California, 90022

Viela Bio Investigative Site, Upland, California

Status

Recruiting

Address

Viela Bio Investigative Site

Upland, California, 91786

Viela Bio Investigative Site, Danbury, Connecticut

Status

Recruiting

Address

Viela Bio Investigative Site

Danbury, Connecticut, 06810

Viela Bio Investigative Site, Fort Lauderdale, Florida

Status

Recruiting

Address

Viela Bio Investigative Site

Fort Lauderdale, Florida, 33309

Viela Bio Investigative Site, Hialeah, Florida

Status

Not yet recruiting

Address

Viela Bio Investigative Site

Hialeah, Florida, 33016

Viela Bio Investigative Site, Jacksonville, Florida

Status

Recruiting

Address

Viela Bio Investigative Site

Jacksonville, Florida, 32216

Viela Bio Investigative Site, Miami Lakes, Florida

Status

Not yet recruiting

Address

Viela Bio Investigative Site

Miami Lakes, Florida, 33014

Viela Bio Investigative Site, Saint Petersburg, Florida

Status

Not yet recruiting

Address

Viela Bio Investigative Site

Saint Petersburg, Florida, 33710

Viela Bio Investigative Site, Lawrenceville, Georgia

Status

Recruiting

Address

Viela Bio Investigative Site

Lawrenceville, Georgia, 30046

Viela Bio Investigative Site, Great Neck, New York

Status

Recruiting

Address

Viela Bio Investigative Site

Great Neck, New York, 11021

Viela Bio Investigative Site, Charlotte, North Carolina

Status

Recruiting

Address

Viela Bio Investigative Site

Charlotte, North Carolina, 28204

Viela Bio Investigative Site, Durham, North Carolina

Status

Recruiting

Address

Viela Bio Investigative Site

Durham, North Carolina, 27713

Viela Bio Investigative Site, Duncansville, Pennsylvania

Status

Recruiting

Address

Viela Bio Investigative Site

Duncansville, Pennsylvania, 16635

Viela Bio Investigative Site, Philadelphia, Pennsylvania

Status

Recruiting

Address

Viela Bio Investigative Site

Philadelphia, Pennsylvania, 19104

Viela Bio Investigative Site, Memphis, Tennessee

Status

Recruiting

Address

Viela Bio Investigative Site

Memphis, Tennessee, 38119

Viela Bio Investigative Site, Allen, Texas

Status

Not yet recruiting

Address

Viela Bio Investigative Site

Allen, Texas, 75013

Viela Bio Investigative Site, Mesquite, Texas

Status

Not yet recruiting

Address

Viela Bio Investigative Site

Mesquite, Texas, 75150

International Sites

Viela Bio Investigative Site, Białystok, Poland

Status

Recruiting

Address

Viela Bio Investigative Site

Białystok, ,

Viela Bio Investigative Site, Bydgoszcz, Poland

Status

Recruiting

Address

Viela Bio Investigative Site

Bydgoszcz, ,

Viela Bio Investigative Site, Kraków, Poland

Status

Recruiting

Address

Viela Bio Investigative Site

Kraków, ,

Viela Bio Investigative Site, Poznań, Poland

Status

Recruiting

Address

Viela Bio Investigative Site

Poznań, ,

Viela Bio Investigative Site, Rzeszów, Poland

Status

Recruiting

Address

Viela Bio Investigative Site

Rzeszów, ,

Viela Bio Investigative Site, Warsaw, Poland

Status

Recruiting

Address

Viela Bio Investigative Site

Warsaw, ,

Viela Bio Investigative Site, Wrocław, Poland

Status

Recruiting

Address

Viela Bio Investigative Site

Wrocław, ,

Viela Bio Investigative Site, Barcelona, Spain

Status

Recruiting

Address

Viela Bio Investigative Site

Barcelona, ,

Viela Bio Investigative Site, Bilbao, Spain

Status

Recruiting

Address

Viela Bio Investigative Site

Bilbao, ,

Viela Bio Investigative Site, Madrid, Spain

Status

Recruiting

Address

Viela Bio Investigative Site

Madrid, ,

Viela Bio Investigative Site, Sevilla, Spain

Status

Recruiting

Address

Viela Bio Investigative Site

Sevilla, ,