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

NCT ID: NCT04948099

Last Updated: 2024-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-06
• Study Completion Date: 2023-07-03

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.

Detailed Description

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

Conditions

Dendritic Cell -Mediated Rheumatic Diseases

Keywords

Autoimmune disease; Rheumatic disease; Phase 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

VIB1116

Single dose of VIB1116, SC or IV administration.

Multiple doses of VIB1116, SC administration.

Group Type: EXPERIMENTAL

VIB1116

Intervention Type: DRUG

VIB1116

Placebo

Single dose of Placebo, SC or IV administration.

Multiple doses of Placebo, SC administration.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

VIB1116

VIB1116

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Pinnacle Research Group

Anniston, Alabama, United States

Clinical Research of W FL

Clearwater, Florida, United States

Jacksonville Clinical Research

Jacksonville, Florida, United States

Accurate Clinical Research

Lake Charles, Louisiana, United States

Altoona Clinical Research

Duncansville, Pennsylvania, United States

Rheumatology Associates

Dallas, Texas, United States

SW Rheumatology Center

Mesquite, Texas, United States

Clinical Trials of Texas, Inc.

San Antonio, Texas, United States

Klinika Reumatologii i Rehabilitacji Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im W. Degi

Poznan, Greater Poland Voivodeship, Poland

Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

ARS RHEUMATICA Sp. z o.o. REUMATIKA-Centrum Reumatologii NZOZ

Warsaw, Masovian Voivodeship, Poland

Countries

United States; Poland

Other Identifiers

VIB1116.P1.S1

Identifier Type: -

Identifier Source: org_study_id