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



Status:Recruiting
Conditions:Lupus, Skin and Soft Tissue Infections, Neurology, Nephrology, Dermatology, Dermatology, Rheumatology
Therapuetic Areas:Dermatology / Plastic Surgery, Immunology / Infectious Diseases, Nephrology / Urology, Neurology, Rheumatology
Healthy:No
Age Range:18 - 75
Updated:1/27/2019
Start Date:December 13, 2018
End Date:September 2019
Contact:Jack Ratchford, MD
Email:RatchfordJ@vielabio.com
Phone:240-558-0038

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A Phase 1 Randomized, Placebo-Controlled, Blinded, Multiple Ascending Dose Study to Evaluate VIB7734 in Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis

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.

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.

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
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