A Study of Single and Multiple Ascending Doses of VIB1116 in Rheumatic Diseases

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of VIB1116 in Conventional Dendritic Cell (cDC) and Plasmacytoid Dendritic Cell (pDC)-Mediated Rheumatic Diseases

A first-in-human study to evaluate the safety and tolerability of escalating, single and multiple ascending doses of VIB1116 in adult participants with rheumatic diseases.

Study Overview

• Status: Completed
• Conditions: Dendritic Cell -Mediated Rheumatic Diseases
• Intervention / Treatment: Drug: Placebo; Drug: VIB1116

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 1

Contacts and Locations

Study Locations

• Poland
  • Kujawsko-pomorskie
    • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-168
      • Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
  • Mazowieckie
    • Warsaw, Mazowieckie, Poland, 02-691
      • ARS RHEUMATICA Sp. z o.o. REUMATIKA-Centrum Reumatologii NZOZ
  • Wielkopolskie
    • Poznań, Wielkopolskie, Poland, 61-545
      • Klinika Reumatologii i Rehabilitacji Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im W. Degi
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Pinnacle Research Group
  • Florida
    • Clearwater, Florida, United States, 33765-2616
      • Clinical Research of W FL
    • Jacksonville, Florida, United States, 32216-4362
      • Jacksonville Clinical Research
  • Louisiana
    • Lake Charles, Louisiana, United States, 70605
      • Accurate Clinical Research
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635-8445
      • Altoona Clinical Research
  • Texas
    • Dallas, Texas, United States, 75231
      • Rheumatology Associates
    • Mesquite, Texas, United States, 75150-6919
      • SW Rheumatology Center
    • San Antonio, Texas, United States, 78229-3539
      • Clinical Trials of Texas, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female ≥ 18 years of age and ≤ 60 years of age and a body mass index (BMI) < 30 kg/m² or, in patients who have completed dosing with a vaccine against COVID-19 and are at least 1 month post the last dose, ≤ 65 years of age and BMI < 35 kg/m^2
• A diagnosis of one of a specified list of rheumatologic diseases at least 6 months prior to screening.
• Stable dosing (or no use) of glucocorticoid or disease-modifying antirheumatic drugs (DMARDs) used for treatment of rheumatologic disease for ≥ 28 days prior to randomization.
• Willing to practice study-required contraception.

Exclusion Criteria:

• Planning to change treatment for rheumatologic disorder within 4 months after randomization
• Known immunodeficiency disorder or history of splenectomy, organ or cell-based transplantation, total lymphoid irradiation or T-cell vaccination or transfusion in prior 6 months
• Treatment with prednisone or equivalent at a dose > 10 mg/day or intraarticular, intravenous or intramuscular steroids within 28 days prior to screening

• Treatment with any of the following medications within 28 days prior to screening (unless otherwise specified below) above the given doses:

  • Mycophenolate mofetil > 2 g/day
  • Methotrexate > 20 mg/week
  • Leflunomide > 20 mg/day within 6 months prior to screening or receipt of leflunomide in combination with any dose of methotrexate
  • Azathioprine > 2 mg/kg/day
  • Cyclosporine (except eye drops); tacrolimus (except topical), sirolimus, thalidomide, lenalidomide, 6-mercaptopurine, or voclosporin
  • Hydroxychloroquine > 400 mg/day
  • Chloroquine > 250 mg/day
  • Quinacrine > 100 mg/day
  • Sulfasalazine > 3 g/day, except that no more than 1 g/day is permitted if used in combination with methotrexate
  • Dapsone > 100 mg/day
  • Danazol > 800 mg/day
  • Any other nonbiologic immunosuppressive/immunomodulatory agent not already specified (eg, mizoribine, retinoids, adrenocorticotropic hormone analogs, dehydroepiandrosterone [DHEA]) within 2 weeks prior to screening.
  • Receipt of any biologic B cell-depleting therapy within 12 months or non-depleting B cell-directed therapy within 6 months
  • Receipt of abatacept, etanercept, or other biologic immunomodulatory agent or immunoglobulins within 3 months
  • Receipt of any other biologic disease modifying antirheumatic drug (bDMARD) not already specified, such as any targeted therapy (other than Janus kinase [JAK] inhibitor), or receipt of cyclophosphamide or chlorambucil within 6 months
  • Receipt of JAK inhibitors within 3 months
  • Receipt of anticoagulants other than anti-platelet drugs in prior 28 days
  • Active malignancy, history of malignancy within prior 10 years (limited exceptions) or known first degree relative with a hereditary cancer syndrome unless the patient is known to be free of the predisposing genetic mutation
  • Receipt of live vaccine or live therapeutic infectious agent within the 28 days prior to screening.
  • Pregnancy, lactation, or planning to become pregnant or donate/retrieve eggs before the end of study follow-up.
• Hepatitis B or C infection, HIV infection, evidence of active TB or being at high risk for TB
• History of any severe herpes virus infection (including any history of severe Epstein-Barr virus, cytomegalovirus disease, end-organ disease, disseminated herpes simplex, disseminated zoster, or ophthalmic zoster) or > 1 episode of herpes zoster in the 2 years prior to screening and/or any opportunistic infection in the prior 2 years
• Infection requiring parenteral antimicrobial therapy within 60 days of screening or any clinically significant active or suspected infection ( within 28 days prior to screening
• History of anaphylaxis to any human immunoglobulin therapy or monoclonal antibody.
• Blood tests at screening (performed in the central laboratory) that meet study requirements including but not limited to normal coagulation testing and glomerular filtration rate < 50 mL/min/1.73
• High risk for COVID-19 or for severe COVID-19

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VIB1116; Single dose of VIB1116, SC or IV administration. Multiple doses of VIB1116, SC administration.	Drug: VIB1116; VIB1116
Placebo Comparator: Placebo; Single dose of Placebo, SC or IV administration. Multiple doses of Placebo, SC administration.	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Treatment-emergent adverse events, treatment-emergent serious adverse events, and adverse events of special interest	Up to Day 141

Secondary Outcome Measures

Outcome Measure	Time Frame
Serum concentration of VIB1116 and noncompartmental PK parameters	Up to Day 141
Change from baseline in the blood levels of plasmacytoid dendritic cells	Up to Day 141
Percentage of Participants who are ADA (antidrug antibody) positive	Up to Day 141
Titer in ADA positive participants	Up to Day 141

Collaborators and Investigators

• Sponsor: Viela Bio (acquired by Horizon Therapeutics)
• Investigators: Study Director: Suzy Hammel, Horizon Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2021
• Primary Completion (Actual): July 3, 2023
• Study Completion (Actual): July 3, 2023

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: June 30, 2021
• First Posted (Actual): July 1, 2021

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Phase 1; Autoimmune disease; Rheumatic disease
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Rheumatic Diseases; Collagen Diseases
• Other Study ID Numbers: VIB1116.P1.S1

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