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

Primary Purpose

Adult Onset Rheumatoid Arthritis

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
VIB4920
Placebo
Sponsored by
Viela Bio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Onset Rheumatoid Arthritis focused on measuring MEDI4920, VIB4920, CD40L, RA, rheumatoid arthritis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo

VIB4920 75 mg

VIB4920 500 mg

VIB4920 1000 mg

VIB4920 1500 mg

Arm Description

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.

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

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

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) of VIB4920
Maximum observed plasma concentration (Cmax) of VIB4920 is reported.
Time to Maximum Plasma Concentration (Tmax) of VIB4920
Time to maximum plasma concentration (Tmax) of VIB4920 is reported.
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 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).
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.
Systemic Clearance (CL) of VIB4920
Systemic clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
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.
Volume of Distribution at Steady State (Vss) of VIB4920
Volume of distribution at steady state (Vss) of VIB4920 is reported.
Accumulation Ratio (AR) of VIB4920
Accumulation ratio of VIB4920 is reported. Accumulation ratio was determined using AUCtau, Dose 7/AUCtau, Dose 1.
Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to VIB4920
The number of participants with positive antibodies to VIB4920 are reported.

Full Information

First Posted
May 3, 2016
Last Updated
August 12, 2019
Sponsor
Viela Bio
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1. Study Identification

Unique Protocol Identification Number
NCT02780388
Brief Title
A Phase 1b Study of MEDI4920 in Participants With Adult-onset Rheumatoid Arthritis
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 12, 2016 (Actual)
Primary Completion Date
May 21, 2018 (Actual)
Study Completion Date
August 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Viela Bio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Onset Rheumatoid Arthritis
Keywords
MEDI4920, VIB4920, CD40L, RA, rheumatoid arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
VIB4920 75 mg
Arm Type
Experimental
Arm Description
Participants will receive a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks.
Arm Title
VIB4920 500 mg
Arm Type
Experimental
Arm Description
Participants will receive a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks.
Arm Title
VIB4920 1000 mg
Arm Type
Experimental
Arm Description
Participants will receive a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks.
Arm Title
VIB4920 1500 mg
Arm Type
Experimental
Arm Description
Participants will receive a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks.
Intervention Type
Drug
Intervention Name(s)
VIB4920
Other Intervention Name(s)
MEDI4920
Intervention Description
Participants will receive a single IV dose of VIB4920 Q2W from Day 1 up to 12 weeks.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Participants will receive a single IV dose of placebo matched to VIB4920 Q2W from Day 1 up to 12 weeks.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Description
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.
Time Frame
Day 1 through Day 169
Title
Number of Participants With Treatment-emergent AEs of Special Interests (AESIs)
Description
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.
Time Frame
Day 1 through Day 169
Secondary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax) of VIB4920
Description
Maximum observed plasma concentration (Cmax) of VIB4920 is reported.
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
Title
Time to Maximum Plasma Concentration (Tmax) of VIB4920
Description
Time to maximum plasma concentration (Tmax) of VIB4920 is reported.
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
Title
Area Under the Plasma Concentration Time Curve of the Dosing Interval (AUCtau) of VIB4920
Description
Area under the plasma concentration time curve of the dosing interval (AUCtau) of VIB4920 is reported.
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
Title
Dose Normalized AUCtau of VIB4920
Description
Dose normalized AUCtau of VIB4920 is reported. Dose normalized AUCtau is calculated by dividing AUCtau by the dose of administered VIB4920 (in mg).
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
Title
Area Under the Plasma Concentration Time Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of VIB4920
Description
Area under the plasma concentration time curve from time zero to extrapolated infinite time (AUC0-inf) of VIB4920 is reported.
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
Title
Systemic Clearance (CL) of VIB4920
Description
Systemic clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
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
Title
Terminal Elimination Half-life (t½) of VIB4920
Description
Terminal elimination half-life (t½) is the time required for half of the drug to be eliminated from the plasma.
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
Title
Volume of Distribution at Steady State (Vss) of VIB4920
Description
Volume of distribution at steady state (Vss) of VIB4920 is reported.
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
Title
Accumulation Ratio (AR) of VIB4920
Description
Accumulation ratio of VIB4920 is reported. Accumulation ratio was determined using AUCtau, Dose 7/AUCtau, Dose 1.
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
Title
Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to VIB4920
Description
The number of participants with positive antibodies to VIB4920 are reported.
Time Frame
Pre-dose on Days 1, 29, 57, and 85; and on Days 141, and 169

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Research Site
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Research Site
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Research Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Research Site
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Research Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Research Site
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Research Site
City
Bialystok
ZIP/Postal Code
15-897
Country
Poland
Facility Name
Research Site
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
60-856
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-106
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
31019027
Citation
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.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/31019027?report=abstract
Description
Related Info

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

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