NCT02780388

Brief Summary

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2016

Typical duration for phase_1

Geographic Reach
2 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

May 12, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 23, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 21, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 16, 2019

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

2 years

First QC Date

May 3, 2016

Results QC Date

August 12, 2019

Last Update Submit

December 10, 2024

Conditions

Adult Onset Rheumatoid Arthritis

Keywords

MEDI4920, VIB4920, CD40L, RA, rheumatoid arthritis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (10)

  • Maximum Observed Plasma Concentration (Cmax) of VIB4920

    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

    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

    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 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

    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

  • +5 more secondary outcomes

Study Arms (5)

Placebo

PLACEBO COMPARATOR

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

VIB4920 75 mg

EXPERIMENTAL

Participants will receive a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.

Drug: VIB4920

VIB4920 500 mg

EXPERIMENTAL

Participants will receive a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.

Drug: VIB4920

VIB4920 1000 mg

EXPERIMENTAL

Participants will receive a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.

Drug: VIB4920

VIB4920 1500 mg

EXPERIMENTAL

Participants will receive a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.

Drug: VIB4920

Interventions

VIB4920DRUG

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

Also known as: MEDI4920
VIB4920 1000 mgVIB4920 1500 mgVIB4920 500 mgVIB4920 75 mg
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult-onset rheumatoid arthritis
  • swollen and tender joints

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Research Site

Anniston, Alabama, 36207, United States

Location

Research Site

DeBary, Florida, 32713, United States

Location

Research Site

Jacksonville, Florida, 32216, United States

Location

Research Site

Miami Lakes, Florida, 33014, United States

Location

Research Site

South Miami, Florida, 33143, United States

Location

Research Site

Cincinnati, Ohio, 45242, United States

Location

Research Site

Duncansville, Pennsylvania, 16635, United States

Location

Research Site

Mesquite, Texas, 75150, United States

Location

Research Site

Bialystok, 15-897, Poland

Location

Research Site

Bydgoszcz, 85-168, Poland

Location

Research Site

Poznan, 60-856, Poland

Location

Research Site

Warsaw, 02-106, Poland

Location

Related Publications (1)

  • 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.

    PMID: 31019027RESULT

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Viela Bio Clinical Operations
Organization
Viela Bio
ClinicalTrials@VielaBio.com
+1 240-558-0038

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

May 3, 2016

First Posted

May 23, 2016

Study Start

May 12, 2016

Primary Completion

May 21, 2018

Study Completion

August 9, 2018

Last Updated

December 27, 2024

Results First Posted

September 16, 2019

Record last verified: 2024-12

Locations

PL(4)US(8)