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

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.

Study Overview

• Status: Completed
• Conditions: Systemic Lupus Erythematosus; Systemic Sclerosis; Dermatomyositis; Polymyositis; Sjogren's Syndrome; Cutaneous Lupus Erythematosus
• Intervention / Treatment: Drug: VIB7734; Drug: Placebo

Detailed 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.

Study acquired from Horizon in 2024. Originally Viela Bio was the sponsor.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: VIB7734; Participants will receive VIB7734 via injection.; Other Names: MEDI7734
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.	Drug: VIB7734; Participants will receive VIB7734 via injection.; Other Names: MEDI7734
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.	Drug: VIB7734; Participants will receive VIB7734 via injection.; Other Names: MEDI7734
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.	Drug: Placebo; Participants will receive placebo matching to VIB7734 via injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Change from Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score (Cohorts 2 and 3)	Day 1 up to Day 253
Blood Levels of pDCs	Day 1 up to Day 337

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2018
• Primary Completion (Actual): July 20, 2020
• Study Completion (Actual): July 20, 2020

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: January 22, 2019
• First Posted (Actual): January 25, 2019

Study Record Updates

• Last Update Posted (Actual): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Nervous System Diseases; Muscular Diseases; Pathologic Processes; Neuromuscular Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Disease; Eye Diseases; Skin Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Myositis; Lupus Erythematosus, Systemic; Syndrome; Sclerosis; Sjogren's Syndrome; Scleroderma, Systemic; Scleroderma, Diffuse; Dermatomyositis; Polymyositis; Lupus Erythematosus, Cutaneous
• Other Study ID Numbers: VIB7734.P1b.S1; 2018-003767-60 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No