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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03817424
Recruitment Status : Completed
First Posted : January 25, 2019
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
Viela Bio

Tracking Information
First Submitted Date  ICMJE January 22, 2019
First Posted Date  ICMJE January 25, 2019
Last Update Posted Date August 13, 2020
Actual Study Start Date  ICMJE December 13, 2018
Actual Primary Completion Date July 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2019)
  • Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) [ Time Frame: Day 1 up to Day 337 ]
  • Number of Participants With Adverse Events of Special Interest (AESIs) [ Time Frame: Day 1 up to Day 337 ]
  • Number of Participants With Laboratory Abnormalities Reported as TEAEs [ Time Frame: Day 1 up to Day 337 ]
  • Number of Participants With Vital Sign Abnormalities Reported as TEAEs [ Time Frame: Day 1 up to Day 337 ]
  • Number of Participants With 12-Lead Electrocardiogram Abnormalities Reported as TEAEs [ Time Frame: Day 1 up to Day 337 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2019)
  • Maximum Observed Serum Concentration (Cmax) of VIB7734 Maximum Observed Serum Concentration (Cmax) of VIB7734 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: Day 1 up to Day 253 ]
  • Blood Levels of pDCs [ Time Frame: Day 1 up to Day 337 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Systemic Lupus Erythematosus
  • Cutaneous Lupus Erythematosus
  • Sjogren's Syndrome
  • Systemic Sclerosis
  • Polymyositis
  • Dermatomyositis
Intervention  ICMJE
  • Drug: VIB7734
    Participants will receive VIB7734 via injection.
    Other Name: MEDI7734
  • Drug: Placebo
    Participants will receive placebo matching to VIB7734 via injection.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: VIB7734
  • 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.
    Intervention: Drug: VIB7734
  • 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.
    Intervention: Drug: VIB7734
  • 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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 11, 2020)
31
Original Estimated Enrollment  ICMJE
 (submitted: January 22, 2019)
32
Actual Study Completion Date  ICMJE July 20, 2020
Actual Primary Completion Date July 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03817424
Other Study ID Numbers  ICMJE VIB7734.P1b.S1
2018-003767-60 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Viela Bio
Study Sponsor  ICMJE Viela Bio
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jack Ratchford, MD Viela Bio
PRS Account Viela Bio
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP