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

NCT03817424 | Completed Phase 1 FDA Drug

• 2 other identifiers: VIB7734.P1b.S12018-003767-60
• Study Type: interventional
• Target: 31
• Locations: 3 countries
• Sites: 30

Brief 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.

Conditions

Systemic Lupus Erythematosus; Cutaneous Lupus Erythematosus; Sjogren's Syndrome; Systemic Sclerosis; Polymyositis; Dermatomyositis

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

  Day 1 up to Day 337

• Number of Participants With Adverse Events of Special Interest (AESIs)

  Day 1 up to Day 337

• Number of Participants With Laboratory Abnormalities Reported as TEAEs

  Day 1 up to Day 337

• Number of Participants With Vital Sign Abnormalities Reported as TEAEs

  Day 1 up to Day 337

• Number of Participants With 12-Lead Electrocardiogram Abnormalities Reported as TEAEs

  Day 1 up to Day 337

Secondary Outcomes (7)

• Maximum Observed Serum Concentration (Cmax) of VIB7734 Maximum Observed Serum Concentration (Cmax) of VIB7734

  Days 1 (pre-dose), 8, 15, 29 (pre-dose), 36, 43, 57 (pre-dose), 64, 71, 85, 113, 141, 169, 197, 225, and 253

• Area Under the Concentration-time Curve (AUC) of VIB7734

  Days 1 (pre-dose), 8, 15, 29 (pre-dose), 36, 43, 57 (pre-dose), 64, 71, 85, 113, 141, 169, 197, 225, and 253

• Systemic Clearance (CL) of VIB7734

  Days 1 (pre-dose), 8, 15, 29 (pre-dose), 36, 43, 57 (pre-dose), 64, 71, 85, 113, 141, 169, 197, 225, and 253

• Terminal Half-life (t1/2) of VIB7734

  Days 1 (pre-dose), 8, 15, 29 (pre-dose), 36, 43, 57 (pre-dose), 64, 71, 85, 113, 141, 169, 197, 225, and 253

• Number of Participants With Positive Anti-Drug Antibodies of VIB7734

  Day 1 up to Day 309

Study Arms (4)

Cohort 1: VIB7734 Dose 1

EXPERIMENTAL

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

Drug: VIB7734

Cohort 2: VIB7734 Dose 2

EXPERIMENTAL

Participants will receive VIB7734 Dose 2 via injection q4w for a total of 3 doses on Days 1, 29, and 57.

Drug: VIB7734

Cohort 3: VIB7734 Dose 3

EXPERIMENTAL

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

Drug: VIB7734

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

VIB7734 DRUG

Participants will receive VIB7734 via injection.

Also known as: MEDI7734

Cohort 1: VIB7734 Dose 1; Cohort 2: VIB7734 Dose 2; Cohort 3: VIB7734 Dose 3

Placebo DRUG

Participants will receive placebo matching to VIB7734 via injection.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (30)

Viela Bio Investigative Site

Anniston, Alabama, 36201, United States

Location

Viela Bio Investigative Site

Birmingham, Alabama, 35294, United States

Location

Viela Bio Investigative Site

Los Angeles, California, 90022, United States

Location

Viela Bio Investigative Site

Upland, California, 91786, United States

Location

Viela Bio Investigative Site

Danbury, Connecticut, 06810, United States

Location

Viela Bio Investigative Site

Fort Lauderdale, Florida, 33309, United States

Location

Viela Bio Investigative Site

Hialeah, Florida, 33016, United States

Location

Viela Bio Investigative Site

Jacksonville, Florida, 32216, United States

Location

Viela Bio Investigative Site

Miami Lakes, Florida, 33014, United States

Location

Viela Bio Investigative Site

St. Petersburg, Florida, 33710, United States

Location

Viela Bio Investigative Site

Lawrenceville, Georgia, 30046, United States

Location

Viela Bio Investigative Site

Great Neck, New York, 11021, United States

Location

Viela Bio Investigative Site

Charlotte, North Carolina, 28204, United States

Location

Viela Bio Investigative Site

Durham, North Carolina, 27713, United States

Location

Viela Bio Investigative Site

Duncansville, Pennsylvania, 16635, United States

Location

Viela Bio Investigative Site

Philadelphia, Pennsylvania, 19104, United States

Location

Viela Bio Investigative Site

Memphis, Tennessee, 38119, United States

Location

Viela Bio Investigative Site

Allen, Texas, 75013, United States

Location

Viela Bio Investigative Site

Mesquite, Texas, 75150, United States

Location

Viela Bio Investigative Site

Bialystok, Poland

Location

Viela Bio Investigative Site

Bydgoszcz, Poland

Location

Viela Bio Investigative Site

Krakow, Poland

Location

Viela Bio Investigative Site

Poznan, Poland

Location

Viela Bio Investigative Site

Rzeszów, Poland

Location

Viela Bio Investigative Site

Warsaw, Poland

Location

Viela Bio Investigative Site

Wroclaw, Poland

Location

Viela Bio Investigative Site

Barcelona, Spain

Location

Viela Bio Investigative Site

Bilbao, Spain

Location

Viela Bio Investigative Site

Madrid, Spain

Location

Viela Bio Investigative Site

Seville, Spain

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Lupus Erythematosus, Cutaneous; Sjogren's Syndrome; Scleroderma, Systemic; Polymyositis; Dermatomyositis

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Myositis; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 25, 2019
• Study Start: December 13, 2018
• Primary Completion: July 20, 2020
• Study Completion: July 20, 2020
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4); PL (7); US (19)