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

Completed · Phase 1 · Has a placebo group

Conditions studied: Dendritic Cell -Mediated Rheumatic Diseases

In brief

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.

Key facts

Study ID

NCT04948099

Run by

Amgen

People needed

73

Starts

2021-07-06

Expected to finish

2023-07-03

Last updated by the study team

2024-12-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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