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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

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ClinicalTrials.gov Identifier: NCT03817424
Recruitment Status : Recruiting
First Posted : January 25, 2019
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Viela Bio

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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Cutaneous Lupus Erythematosus Sjogren's Syndrome Systemic Sclerosis Polymyositis Dermatomyositis Drug: VIB7734 Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 13, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019


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 Name: 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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) [ Time Frame: Day 1 up to Day 337 ]
  2. Number of Participants With Adverse Events of Special Interest (AESIs) [ Time Frame: Day 1 up to Day 337 ]
  3. Number of Participants With Laboratory Abnormalities Reported as TEAEs [ Time Frame: Day 1 up to Day 337 ]
  4. Number of Participants With Vital Sign Abnormalities Reported as TEAEs [ Time Frame: Day 1 up to Day 337 ]
  5. Number of Participants With 12-Lead Electrocardiogram Abnormalities Reported as TEAEs [ Time Frame: Day 1 up to Day 337 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. Number of Participants With Positive Anti-Drug Antibodies of VIB7734 [ Time Frame: Day 1 up to Day 309 ]
  6. 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 ]
  7. Blood Levels of pDCs [ Time Frame: Day 1 up to Day 337 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03817424


Contacts
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Contact: Jack Ratchford, MD 240-558-0038 RatchfordJ@vielabio.com

Locations
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United States, Alabama
Pinnacle Research Group, LLC Recruiting
Anniston, Alabama, United States, 36207
Sponsors and Collaborators
Viela Bio
Investigators
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Study Director: Jack Ratchford, MD Viela Bio

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Responsible Party: Viela Bio
ClinicalTrials.gov Identifier: NCT03817424     History of Changes
Other Study ID Numbers: VIB7734.P1b.S1
2018-003767-60 ( EudraCT Number )
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Scleroderma, Systemic
Lupus Erythematosus, Cutaneous
Syndrome
Sclerosis
Scleroderma, Diffuse
Sjogren's Syndrome
Dermatomyositis
Polymyositis
Disease
Pathologic Processes
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