Dendritic Cell -Mediated Rheumatic Diseases
Conditions
Keywords
Autoimmune disease, Rheumatic disease, Phase 1
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.
Interventions
DRUGVIB1116
VIB1116
DRUGPlacebo
Placebo
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment-emergent adverse events, treatment-emergent serious adverse events, and adverse events of special interest | Up to Day 141 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants who are ADA (antidrug antibody) positive | Up to Day 141 |
| Titer in ADA positive participants | Up to Day 141 |
| 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 |
Countries
Poland, United States
Outcome results
None listed