Skip to main content
OpenTrials
Completed

NCT Number: NCT02780388

A Phase 1b Study of MEDI4920 in Participants With Adult-onset Rheumatoid Arthritis

The purpose of this study is to determine whether VIB4920 (formerly MEDI4920) is safe and well tolerated in participants with adult-onset rheumatoid arthritis (RA).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adult Onset Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Bialystok, Poland

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult-onset rheumatoid arthritis
  • swollen and tender joints

Exclusion criteria

  • venous thromboembolism or arterial thrombosis
  • pregnant or breastfeeding
  • positive hepatitis B, hepatitis C, and human immunodeficiency virus infection
  • active or untreated latent tuberculosis

Treatment and study plan

VIB4920

Drug

Participants will receive a single IV dose of VIB4920 Q2W from Day 1 up to 12 weeks.

Other names: MEDI4920

Placebo

Other

Participants will receive a single IV dose of placebo matched to VIB4920 Q2W from Day 1 up to 12 weeks.

Primary outcomes

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

    Time frame: Day 1 through Day 169

    An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.

  2. Number of Participants With Treatment-emergent AEs of Special Interests (AESIs)

    Time frame: Day 1 through Day 169

    An AESI (serious or non-serious) is one of scientific and medical interest specific to understanding of study drug and may have required close monitoring, collection of additional information by investigator and rapid communication by investigator to the sponsor.

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of VIB4920

    Time frame: Dose 1: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; Dose 7: Pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169

    Maximum observed plasma concentration (Cmax) of VIB4920 is reported.

  2. Time to Maximum Plasma Concentration (Tmax) of VIB4920

    Time frame: Dose 1: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; Dose 7: Pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169

    Time to maximum plasma concentration (Tmax) of VIB4920 is reported.

  3. Area Under the Plasma Concentration Time Curve of the Dosing Interval (AUCtau) of VIB4920

    Time frame: Dose 1: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; Dose 7: Pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169

    Area under the plasma concentration time curve of the dosing interval (AUCtau) of VIB4920 is reported.

  4. Dose Normalized AUCtau of VIB4920

    Time frame: Dose 1: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; Dose 7: Pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169

    Dose normalized AUCtau of VIB4920 is reported. Dose normalized AUCtau is calculated by dividing AUCtau by the dose of administered VIB4920 (in mg).

  5. Area Under the Plasma Concentration Time Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of VIB4920

    Time frame: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169

    Area under the plasma concentration time curve from time zero to extrapolated infinite time (AUC0-inf) of VIB4920 is reported.

  6. Systemic Clearance (CL) of VIB4920

    Time frame: Dose 1: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; Dose 7: Pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169

    Systemic clearance is a quantitative measure of the rate at which a drug substance is removed from the body.

  7. Terminal Elimination Half-life (t½) of VIB4920

    Time frame: Dose 1: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; Dose 7: Pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169

    Terminal elimination half-life (t½) is the time required for half of the drug to be eliminated from the plasma.

  8. Volume of Distribution at Steady State (Vss) of VIB4920

    Time frame: Dose 1: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; Dose 7: Pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169

    Volume of distribution at steady state (Vss) of VIB4920 is reported.

  9. Accumulation Ratio (AR) of VIB4920

    Time frame: Dose 1: Post-dose (end of infusion) on Day 1, pre-dose on Day 15; Dose 7: Pre- and post-dose (end of infusion) on Day 85; and on Days 92, 99, 113, 141, and 169

    Accumulation ratio of VIB4920 is reported. Accumulation ratio was determined using AUCtau, Dose 7/AUCtau, Dose 1.

  10. Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to VIB4920

    Time frame: Pre-dose on Days 1, 29, 57, and 85; and on Days 141, and 169

    The number of participants with positive antibodies to VIB4920 are reported.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Phase 1b Randomized, Double-blind, Placebo-controlled Multiple-ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, Pharmacodynamics, and Clinical Response of MEDI4920 in Subjects With Adult-onset Rheumatoid Arthritis

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 23, 2016
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.