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CompletedNCT02780388Updated Dec 27, 2024Results posted

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

A Phase 1 interventional study of VIB4920 and Placebo in Adult Onset Rheumatoid Arthritis, sponsored by Amgen. Completed at 12 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-12-27.

Sponsored by Amgen · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
57
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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).

Read the detailed description

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

02

Conditions studied

  • Adult Onset Rheumatoid Arthritis

Keywords

  • MEDI4920, VIB4920, CD40L, RA, rheumatoid arthritis
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.

This study's enrollment of 57 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • adult-onset rheumatoid arthritis
  • swollen and tender joints

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
57 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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

  • 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

Interventions

  • DrugVIB4920

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

    Also known as: MEDI4920

  • OtherPlacebo

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Day 1 through Day 169

  2. 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.

    Time frame: Day 1 through Day 169

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of VIB4920

    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

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

    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

  3. 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.

    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

  4. 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).

    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

  5. 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.

    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

  6. Systemic Clearance (CL) of VIB4920

    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

  7. 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.

    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

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

    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

  9. Accumulation Ratio (AR) of VIB4920

    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

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

    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

07

Results

Posted Sep 16, 2019

Participant flow

The study was conducted from 12 May 2016 to 09 Aug 2018 in Poland and the United States of America.

Participant flow — Overall Study
MilestonePlaceboVIB4920 75 mgVIB4920 500 mgVIB4920 1000 mgVIB4920 1500 mg
Started158101212
Completed146101212
Not completed12000
Withdrew: Lost to follow-up01000
Withdrew: Withdrawal by subject11000

Outcome measures

PrimaryNumber 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.

Time frame:
Day 1 through Day 169
Reported as:
Count of participants · Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
ParticipantsPlaceboVIB4920 75 mgVIB4920 500 mgVIB4920 1000 mgVIB4920 1500 mg
TEAEs1337610
TESAEs00001
PrimaryNumber 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.

Time frame:
Day 1 through Day 169
Reported as:
Count of participants · Participants
Number of Participants With Treatment-emergent AEs of Special Interests (AESIs)
ParticipantsPlaceboVIB4920 75 mgVIB4920 500 mgVIB4920 1000 mgVIB4920 1500 mg
Encephalitis00001
Herpes simplex00001
Oral herpes00010
SecondaryMaximum Observed Plasma Concentration (Cmax) of VIB4920

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
Reported as:
Mean · µg/mL
Maximum Observed Plasma Concentration (Cmax) of VIB4920
µg/mLVIB4920 75 mgVIB4920 500 mgVIB4920 1000 mgVIB4920 1500 mg
Dose 120.6 ± 5.26158 ± 95.4392 ± 84.4360 ± 83.8
Dose 724.4 ± 3.72157 ± 40.7423 ± 114627 ± 159
SecondaryTime to Maximum Plasma Concentration (Tmax) of VIB4920

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
Reported as:
Median · Days
Time to Maximum Plasma Concentration (Tmax) of VIB4920
DaysVIB4920 75 mgVIB4920 500 mgVIB4920 1000 mgVIB4920 1500 mg
Dose 10.02 (0.02 to 1.00)0.04 (0.04 to 0.04)0.06 (0.06 to 1.00)0.06 (0.06 to 0.06)
Dose 70.02 (0.02 to 0.02)0.04 (0.04 to 0.04)0.06 (0.06 to 0.06)0.06 (0.06 to 0.06)
SecondaryArea 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.

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
Reported as:
Mean · µg*day/mL
Area Under the Plasma Concentration Time Curve of the Dosing Interval (AUCtau) of VIB4920
µg*day/mLVIB4920 75 mgVIB4920 500 mgVIB4920 1000 mgVIB4920 1500 mg
Dose 1122 ± 25.5669 ± 1642150 ± 4962360 ± 466
Dose 7262 ± 94.71430 ± 4663760 ± 13705850 ± 1530
SecondaryDose 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).

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
Reported as:
Mean · µg*day/mL/mg
Dose Normalized AUCtau of VIB4920
µg*day/mL/mgVIB4920 75 mgVIB4920 500 mgVIB4920 1000 mgVIB4920 1500 mg
Dose 11.62 ± 0.3411.34 ± 0.3282.15 ± 0.4961.58 ± 0.311
Dose 73.49 ± 1.262.87 ± 0.9313.76 ± 1.373.90 ± 1.02
SecondaryArea 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.

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
Reported as:
Mean · µg*day/mL
Area Under the Plasma Concentration Time Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of VIB4920
µg*day/mLVIB4920 75 mgVIB4920 500 mgVIB4920 1000 mgVIB4920 1500 mg
Area Under the Plasma Concentration Time Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of VIB4920163 ± 42.7824 ± 2282660 ± 7443480 ± 842
SecondarySystemic Clearance (CL) of VIB4920

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
Reported as:
Mean · mL/day
Systemic Clearance (CL) of VIB4920
mL/dayVIB4920 75 mgVIB4920 500 mgVIB4920 1000 mgVIB4920 1500 mg
Dose 1489 ± 135654 ± 203405 ± 120457 ± 120
Dose 7449 ± 129536 ± 152421 ± 107381 ± 94.8
SecondaryTerminal 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.

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
Reported as:
Mean · Days
Terminal Elimination Half-life (t½) of VIB4920
DaysVIB4920 75 mgVIB4920 500 mgVIB4920 1000 mgVIB4920 1500 mg
Dose 16.25 ± 1.265.61 ± 0.8916.12 ± 0.7258.70 ± 2.61
Dose 77.82 ± 1.509.58 ± 1.579.72 ± 1.329.58 ± 1.37
SecondaryVolume of Distribution at Steady State (Vss) of VIB4920

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
Reported as:
Mean · mL
Volume of Distribution at Steady State (Vss) of VIB4920
mLVIB4920 75 mgVIB4920 500 mgVIB4920 1000 mgVIB4920 1500 mg
Dose 14230 ± 5955040 ± 12203510 ± 8445380 ± 1210
Dose 75060 ± 9805600 ± 10104620 ± 10604100 ± 905
SecondaryAccumulation Ratio (AR) of VIB4920

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
Reported as:
Mean · Ratio
Accumulation Ratio (AR) of VIB4920
RatioVIB4920 75 mgVIB4920 500 mgVIB4920 1000 mgVIB4920 1500 mg
Accumulation Ratio (AR) of VIB49201.51 ± 0.2651.51 ± 0.2871.20 ± 0.2511.76 ± 0.305
SecondaryNumber of Participants With Positive Anti-Drug Antibodies (ADA) Titer to VIB4920

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
Reported as:
Count of participants · Participants
Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to VIB4920
ParticipantsVIB4920 75 mgVIB4920 500 mgVIB4920 1000 mgVIB4920 1500 mg
Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to VIB49203310

Adverse events

Collected over Day 1 through Day 169. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/15 (0%)0/15 (0%)13/15 (86.7%)
VIB4920 75 mg0/8 (0%)0/8 (0%)3/8 (37.5%)
VIB4920 500 mg0/10 (0%)0/10 (0%)7/10 (70%)
VIB4920 1000 mg0/12 (0%)0/12 (0%)6/12 (50%)
VIB4920 1500 mg0/12 (0%)1/12 (8.3%)10/12 (83.3%)
Most frequent serious events
Most frequent serious events
EventPlaceboVIB4920 75 mgVIB4920 500 mgVIB4920 1000 mgVIB4920 1500 mg
EncephalitisInfections and infestations0/150/80/100/121/12
Most frequent other events
Showing 10 of 81
Most frequent other events
EventPlaceboVIB4920 75 mgVIB4920 500 mgVIB4920 1000 mgVIB4920 1500 mg
Upper respiratory tract infectionInfections and infestations4/150/81/102/120/12
DiarrhoeaGastrointestinal disorders1/152/81/100/120/12
HyperhidrosisSkin and subcutaneous tissue disorders0/150/80/100/123/12
Urinary tract infectionInfections and infestations0/150/80/100/123/12
NasopharyngitisInfections and infestations1/150/82/100/120/12
DizzinessNervous system disorders0/150/82/100/120/12
Alanine aminotransferase increasedInvestigations0/150/80/101/122/12
LeukopeniaBlood and lymphatic system disorders0/150/80/100/122/12
Acute sinusitisInfections and infestations2/150/80/100/121/12
FatigueGeneral disorders2/150/80/101/120/12

Baseline characteristics

Intent-to treat population included all randomized and treated participants, grouped according to assigned treatment.

Age, Continuous
Age, Continuous(years)PlaceboVIB4920 75 mgVIB4920 500 mgVIB4920 1000 mgVIB4920 1500 mgTotal
Mean58.3 ± 8.057.9 ± 7.453.7 ± 9.852.1 ± 11.550.9 ± 8.654.6 ± 9.4
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboVIB4920 75 mgVIB4920 500 mgVIB4920 1000 mgVIB4920 1500 mgTotal
Female1466101046
Male1242211
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboVIB4920 75 mgVIB4920 500 mgVIB4920 1000 mgVIB4920 1500 mgTotal
Hispanic or Latino321107
Not Hispanic or Latino1269111250
Unknown or Not Reported000000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboVIB4920 75 mgVIB4920 500 mgVIB4920 1000 mgVIB4920 1500 mgTotal
American Indian or Alaska Native000000
Asian000000
Native Hawaiian or Other Pacific Islander000000
Black or African American201205
White1389101252
More than one race000000
Unknown or Not Reported000000
08

Study locations

12 sites
  • Research Site
    Anniston, Alabama 36207, United States
  • Research Site
    DeBary, Florida 32713, United States
  • Research Site
    Jacksonville, Florida 32216, United States
  • Research Site
    Miami Lakes, Florida 33014, United States
  • Research Site
    South Miami, Florida 33143, United States
  • Research Site
    Cincinnati, Ohio 45242, United States
  • Research Site
    Duncansville, Pennsylvania 16635, United States
  • Research Site
    Mesquite, Texas 75150, United States
  • Research Site
    Bialystok, 15-897, Poland
  • Research Site
    Bydgoszcz, 85-168, Poland
  • Research Site
    Poznan, 60-856, Poland
  • Research Site
    Warszawa, 02-106, Poland
09

References and documents

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. PubMed 31019027 ↗

Related links

Study documents

  • Study protocol · Sep 29, 2017
  • Statistical analysis plan · May 27, 2016

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02780388
Lead sponsor
Amgen
Responsible party
Sponsor
First posted
May 23, 2016
Start date
May 12, 2016
Primary completion
May 21, 2018
Completion
Aug 9, 2018
Results posted
Sep 16, 2019
Last update
Dec 27, 2024

Study contacts

MD
study director · Amgen

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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