Clinical trial NCT02780388: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Adult Onset Rheumatoid Arthritis
Keywords: MEDI4920, VIB4920, CD40L, RA, rheumatoid arthritis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2016-05-23
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

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

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
timeFrame: Day 1 through Day 169
measure: Number of Participants With Treatment-emergent AEs of Special Interests (AESIs)
timeFrame: Day 1 through Day 169
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of VIB4920
timeFrame: 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
measure: Time to Maximum Plasma Concentration (Tmax) of VIB4920
timeFrame: 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
measure: Area Under the Plasma Concentration Time Curve of the Dosing Interval (AUCtau) of VIB4920
timeFrame: 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
measure: Dose Normalized AUCtau of VIB4920
timeFrame: 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
measure: Area Under the Plasma Concentration Time Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of VIB4920
timeFrame: 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
measure: Systemic Clearance (CL) of VIB4920
timeFrame: 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
measure: Terminal Elimination Half-life (t½) of VIB4920
timeFrame: 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
measure: Volume of Distribution at Steady State (Vss) of VIB4920
timeFrame: 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
measure: Accumulation Ratio (AR) of VIB4920
timeFrame: 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
measure: Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to VIB4920
timeFrame: Pre-dose on Days 1, 29, 57, and 85; and on Days 141, and 169
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Research Site
state: Alabama
city: DeBary
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Miami Lakes
country: United States
facility: Research Site
state: Florida
city: South Miami
country: United States
facility: Research Site
state: Florida
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Duncansville
country: United States
facility: Research Site
state: Pennsylvania
city: Mesquite
country: United States
facility: Research Site
state: Texas
city: Bialystok
country: Poland
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
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.