A Study of Single Ascending Doses of VIB1116 in Rheumatic Diseases

• Status: Recruiting
• Trial end date: 2022-12-15
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Viela Bio

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 final 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 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):

• 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 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