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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02780388
Recruitment Status : Completed
First Posted : May 23, 2016
Results First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Viela Bio

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).

Condition or disease Intervention/treatment Phase
Adult Onset Rheumatoid Arthritis Drug: VIB4920 Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : May 12, 2016
Actual Primary Completion Date : May 21, 2018
Actual Study Completion Date : August 9, 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: MEDI4920




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02780388


Locations
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United States, Alabama
Research Site
Anniston, Alabama, United States, 36207
United States, Florida
Research Site
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
United States, Ohio
Research Site
Cincinnati, Ohio, United States, 45242
United States, Pennsylvania
Research Site
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Research Site
Mesquite, Texas, United States, 75150
Poland
Research Site
Bialystok, Poland, 15-897
Research Site
Bydgoszcz, Poland, 85-168
Research Site
Poznan, Poland, 60-856
Research Site
Warszawa, Poland, 02-106
Sponsors and Collaborators
Viela Bio
  Study Documents (Full-Text)

Documents provided by Viela Bio:
Study Protocol  [PDF] September 29, 2017
Statistical Analysis Plan  [PDF] May 27, 2016

Additional Information:
Publications of Results:
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Responsible Party: Viela Bio
ClinicalTrials.gov Identifier: NCT02780388    
Other Study ID Numbers: D5100C00002
2015-005318-30 ( EudraCT Number )
First Posted: May 23, 2016    Key Record Dates
Results First Posted: September 16, 2019
Last Update Posted: September 16, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Viela Bio:
MEDI4920, VIB4920, CD40L, RA, rheumatoid arthritis
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases