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

Amgen

Status and phase: Completed; Phase 1

Conditions: Dendritic Cell -Mediated Rheumatic Diseases

Treatments: Drug: VIB1116; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04948099

VIB1116.P1.S1

Details and patient eligibility

About

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.

Full description

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

Enrollment: 73 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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73 participants in 2 patient groups, including a placebo group

VIB1116

Experimental group

Description:

Single dose of VIB1116, SC or IV administration. Multiple doses of VIB1116, SC administration.

Treatment:

Drug: VIB1116

Placebo

Placebo Comparator group

Description:

Single dose of Placebo, SC or IV administration. Multiple doses of Placebo, SC administration.

Treatment:

Drug: Placebo