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

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

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).

Study Overview

• Status: Completed
• Conditions: Adult Onset Rheumatoid Arthritis
• Intervention / Treatment: Other: Placebo; Drug: VIB4920

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 1

Contacts and Locations

Study Locations

• Poland
  • Bialystok, Poland, 15-897
    • Research Site
  • Bydgoszcz, Poland, 85-168
    • Research Site
  • Poznan, Poland, 60-856
    • Research Site
  • Warszawa, Poland, 02-106
    • Research Site
• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
      • Research Site
  • Florida
    • DeBary, Florida, United States, 32713
      • Research Site
    • Jacksonville, Florida, United States, 32216
      • Research Site
    • Miami Lakes, Florida, United States, 33014
      • Research Site
    • South Miami, Florida, United States, 33143
      • Research Site
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Research Site
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Research Site
  • Texas
    • Mesquite, Texas, United States, 75150
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants will receive a single intravascular (IV) dose of placebo matched to VIB4920 (formerly MEDI4920) once every 2 weeks (Q2W) from Day 1 up to 12 weeks.	Other: Placebo; Participants will receive a single IV dose of placebo matched to VIB4920 Q2W from Day 1 up to 12 weeks.
Experimental: VIB4920 75 mg; Participants will receive a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.	Drug: VIB4920; Participants will receive a single IV dose of VIB4920 Q2W from Day 1 up to 12 weeks.; Other Names: MEDI4920
Experimental: VIB4920 500 mg; Participants will receive a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.	Drug: VIB4920; Participants will receive a single IV dose of VIB4920 Q2W from Day 1 up to 12 weeks.; Other Names: MEDI4920
Experimental: VIB4920 1000 mg; Participants will receive a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.	Drug: VIB4920; Participants will receive a single IV dose of VIB4920 Q2W from Day 1 up to 12 weeks.; Other Names: MEDI4920
Experimental: VIB4920 1500 mg; Participants will receive a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.	Drug: VIB4920; Participants will receive a single IV dose of VIB4920 Q2W from Day 1 up to 12 weeks.; Other Names: MEDI4920

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)	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.	Day 1 through Day 169
Number of Participants With Treatment-emergent AEs of Special Interests (AESIs)	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.	Day 1 through Day 169

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) of VIB4920	Maximum observed plasma concentration (Cmax) of VIB4920 is reported.	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	Time to maximum plasma concentration (Tmax) of VIB4920 is reported.	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	Area under the plasma concentration time curve of the dosing interval (AUCtau) of VIB4920 is reported.	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	Dose normalized AUCtau of VIB4920 is reported. Dose normalized AUCtau is calculated by dividing AUCtau by the dose of administered VIB4920 (in mg).	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 From Time Zero to Extrapolated Infinite Time (AUC0-inf) of VIB4920	Area under the plasma concentration time curve from time zero to extrapolated infinite time (AUC0-inf) of VIB4920 is reported.	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
Systemic Clearance (CL) of VIB4920	Systemic clearance is a quantitative measure of the rate at which a drug substance is removed from the body.	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) of VIB4920	Terminal elimination half-life (t½) is the time required for half of the drug to be eliminated from the plasma.	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	Volume of distribution at steady state (Vss) of VIB4920 is reported.	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 (AR) of VIB4920	Accumulation ratio of VIB4920 is reported. Accumulation ratio was determined using AUCtau, Dose 7/AUCtau, Dose 1.	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
Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to VIB4920	The number of participants with positive antibodies to VIB4920 are reported.	Pre-dose on Days 1, 29, 57, and 85; and on Days 141, and 169

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

General Publications

• Karnell JL, Albulescu M, Drabic S, Wang L, Moate R, Baca M, Oganesyan V, Gunsior M, Thisted T, Yan L, Li J, Xiong X, Eck SC, de Los Reyes M, Yusuf I, Streicher K, Muller-Ladner U, Howe D, Ettinger R, Herbst R, Drappa J. A CD40L-targeting protein reduces autoantibodies and improves disease activity in patients with autoimmunity. Sci Transl Med. 2019 Apr 24;11(489):eaar6584. doi: 10.1126/scitranslmed.aar6584.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2016
• Primary Completion (Actual): May 21, 2018
• Study Completion (Actual): August 9, 2018

Study Registration Dates

• First Submitted: May 3, 2016
• First Submitted That Met QC Criteria: May 20, 2016
• First Posted (Estimated): May 23, 2016

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: MEDI4920, VIB4920, CD40L, RA, rheumatoid arthritis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: D5100C00002; 2015-005318-30 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No