Clinical trial NCT04948099: A Study of Single and Multiple Ascending Doses of VIB1116 in Rheumatic Diseases
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of VIB1116 in Conventional Dendritic Cell (cDC) and Plasmacytoid Dendritic Cell (pDC)-Mediated Rheumatic Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dendritic Cell -Mediated Rheumatic Diseases
Keywords: Autoimmune disease
Rheumatic disease
Phase 1
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2021-07-01
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Treatment-emergent adverse events, treatment-emergent serious adverse events, and adverse events of special interest
timeFrame: Up to Day 141
Secondary outcomes:
measure: Serum concentration of VIB1116 and noncompartmental PK parameters
timeFrame: Up to Day 141
measure: Change from baseline in the blood levels of plasmacytoid dendritic cells
timeFrame: Up to Day 141
measure: Percentage of Participants who are ADA (antidrug antibody) positive
timeFrame: Up to Day 141
measure: Titer in ADA positive participants
timeFrame: Up to Day 141
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group
state: Alabama
city: Clearwater
country: United States
facility: Clinical Research of W FL
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Clinical Research
state: Florida
city: Lake Charles
country: United States
facility: Accurate Clinical Research
state: Louisiana
city: Duncansville
country: United States
facility: Altoona Clinical Research
state: Pennsylvania
city: Dallas
country: United States
facility: Rheumatology Associates
state: Texas
city: Mesquite
country: United States
facility: SW Rheumatology Center
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
state: Kujawsko-pomorskie
city: Warsaw
country: Poland
facility: ARS RHEUMATICA Sp. z o.o. REUMATIKA-Centrum Reumatologii NZOZ
state: Mazowieckie
city: Poznań
country: Poland
facility: Klinika Reumatologii i Rehabilitacji Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im W. Degi
state: Wielkopolskie
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: