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

NCT04948099 | Completed Phase 1 FDA Drug

• 1 other identifier: VIB1116.P1.S1
• Study Type: interventional
• Target: 73
• Locations: 2 countries
• Sites: 11

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.

Conditions

Dendritic Cell -Mediated Rheumatic Diseases

Keywords

Autoimmune disease; Rheumatic disease; Phase 1

Outcome Measures

Primary Outcomes (1)

• Treatment-emergent adverse events, treatment-emergent serious adverse events, and adverse events of special interest

  Up to Day 141

Secondary Outcomes (4)

• 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

• Percentage of Participants who are ADA (antidrug antibody) positive

  Up to Day 141

• Titer in ADA positive participants

  Up to Day 141

Study Arms (2)

VIB1116

EXPERIMENTAL

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

Drug: VIB1116

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

VIB1116 DRUG

VIB1116

VIB1116

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Amgen: lead

Study Sites (11)

Pinnacle Research Group

Anniston, Alabama, 36207, United States

Location

Clinical Research of W FL

Clearwater, Florida, 33765-2616, United States

Location

Jacksonville Clinical Research

Jacksonville, Florida, 32216-4362, United States

Location

Accurate Clinical Research

Lake Charles, Louisiana, 70605, United States

Location

Altoona Clinical Research

Duncansville, Pennsylvania, 16635-8445, United States

Location

Rheumatology Associates

Dallas, Texas, 75231, United States

Location

SW Rheumatology Center

Mesquite, Texas, 75150-6919, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229-3539, United States

Location

Klinika Reumatologii i Rehabilitacji Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im W. Degi

Poznan, Greater Poland Voivodeship, 61-545, Poland

Location

Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland

Location

ARS RHEUMATICA Sp. z o.o. REUMATIKA-Centrum Reumatologii NZOZ

Warsaw, Masovian Voivodeship, 02-691, Poland

Location

MeSH Terms

Conditions

Autoimmune Diseases; Rheumatic Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: July 1, 2021
• Study Start: July 6, 2021
• Primary Completion: July 3, 2023
• Study Completion: July 3, 2023
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (3); US (8)