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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04948099
Recruitment Status : Recruiting
First Posted : July 1, 2021
Last Update Posted : May 23, 2022
Sponsor:
Information provided by (Responsible Party):
Viela Bio (acquired by Horizon Therapeutics)

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dendritic Cell -Mediated Rheumatic Diseases Drug: VIB1116 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 6, 2021
Estimated Primary Completion Date : May 15, 2023
Estimated Study Completion Date : May 15, 2023

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




Primary Outcome Measures :
  1. Treatment-emergent adverse events, treatment-emergent serious adverse events, and adverse events of special interest [ Time Frame: Up to Day 141 ]

Secondary Outcome Measures :
  1. Serum concentration of VIB1116 and noncompartmental PK parameters [ Time Frame: Up to Day 141 ]
  2. Change from baseline in the blood levels of plasmacytoid dendritic cells [ Time Frame: Up to Day 141 ]
  3. Percentage of Participants who are ADA (antidrug antibody) positive [ Time Frame: Up to Day 141 ]
  4. Titer in ADA positive participants [ Time Frame: Up to Day 141 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04948099


Contacts
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Contact: Horizon Therapeutics 1-866-479-6742 clinicaltrials@horizontherapeutics.com

Locations
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United States, Alabama
Pinnacle Research Group Recruiting
Anniston, Alabama, United States, 36207
Contact: Ruby Fields       rfields@pinnacletrials.com   
Principal Investigator: Vishala Chindalore, MD         
U of Alabama Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35233
Contact: Thomas Frazier    205-975-9564    thomasfrazier@uabmc.edu   
Principal Investigator: Walter Chatham, MD         
United States, Florida
Clinical Research of W FL Recruiting
Clearwater, Florida, United States, 33765-2616
Contact: Maartje Brucculeri, MSc    727-466-0078 ext 223    mbrucculeri@crwf.com   
Principal Investigator: Robert Levin, MD         
Jacksonville Clinical Research Recruiting
Jacksonville, Florida, United States, 32216-4362
Contact: Richard Smith, RN    904-732-9254    rsmith@encoredocs.com   
Principal Investigator: Steven Mathews, MD         
United States, Pennsylvania
Altoona Clinical Research Recruiting
Duncansville, Pennsylvania, United States, 16635-8445
Contact: Brenda Earnest    814-693-0300 ext 202    brendaearnest@altoonaresearch.com   
Principal Investigator: Alan Kivitz, MD         
United States, Texas
SW Rheumatology Center Recruiting
Mesquite, Texas, United States, 75150-6919
Contact: Guadalupe Cindo    972-288-2600 ext 106    gcindo@swrr.net   
Principal Investigator: Atul Singhal, MD         
Clinical Trials of Texas, Inc. Recruiting
San Antonio, Texas, United States, 78229-3539
Contact: Maristelle Co    210-949-0122    mco@cttexas.com   
Principal Investigator: Pendleton Wickersham, MD         
Poland
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy Recruiting
Bydgoszcz, Kujawsko-pomorskie, Poland, 85-168
Contact: Krzysztof Kowalik       kpmk@vp.pl   
Principal Investigator: Rafal Wojciechowski, MD         
ARS RHEUMATICA Sp. z o.o. REUMATIKA-Centrum Reumatologii NZOZ Recruiting
Warsaw, Mazowieckie, Poland, 02-691
Contact: Jerzy Dabrowski       j.dabrowski.reumatika@gmail.com   
Principal Investigator: Paula Sliwinska-Stanczyk, MD, PhD         
MTZ Clinical Research Sp z o o Recruiting
Warszawa, Mazowieckie, Poland, 02-106
Contact: Justyna Mokrzynska       justyna.mokrzynska@mtz-clinical.pl   
Principal Investigator: Anna Olak-Popko, MD         
Klinika Reumatologii i Rehabilitacji Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im W. Degi Recruiting
Poznań, Wielkopolskie, Poland, 61-545
Contact: Magdalena Richter       mag.richt@gmail.com   
Principal Investigator: Wlodzimierz Samborski, MD         
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Tadeusza Sokolowskiego Pomorskiego UM w Szczecinie Withdrawn
Szczecin, Zachodniopomorskie, Poland, 71-252
Sponsors and Collaborators
Viela Bio (acquired by Horizon Therapeutics)
Investigators
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Study Director: Suzy Hammel Horizon Therapeutics
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Responsible Party: Viela Bio (acquired by Horizon Therapeutics)
ClinicalTrials.gov Identifier: NCT04948099    
Other Study ID Numbers: VIB1116.P1.S1
First Posted: July 1, 2021    Key Record Dates
Last Update Posted: May 23, 2022
Last Verified: May 2022
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
Keywords provided by Viela Bio (acquired by Horizon Therapeutics):
Autoimmune disease
Rheumatic disease
Phase 1
Additional relevant MeSH terms:
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Rheumatic Diseases
Collagen Diseases
Musculoskeletal Diseases
Connective Tissue Diseases