Adult Onset Rheumatoid Arthritis Clinical Trial
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
| Verified date | August 2019 |
| Source | Viela Bio |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 57 |
| Est. completion date | August 9, 2018 |
| Est. primary completion date | May 21, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Poland | Research Site | Bialystok | |
| Poland | Research Site | Bydgoszcz | |
| Poland | Research Site | Poznan | |
| Poland | Research Site | Warszawa | |
| United States | Research Site | Anniston | Alabama |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | DeBary | Florida |
| United States | Research Site | Duncansville | Pennsylvania |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Mesquite | Texas |
| United States | Research Site | Miami Lakes | Florida |
| United States | Research Site | South Miami | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Viela Bio |
United States, Poland,
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, Müller-Ladner U, Howe D, Ettinger R, Herbst R, Drappa J. A CD40L-targeting protein reduces a — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | Maximum Observed Plasma Concentration (Cmax) of VIB4920 | Maximum observed plasma concentration (Cmax) of VIB4920 is reported. | 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 | |
| Secondary | Time to Maximum Plasma Concentration (Tmax) of VIB4920 | Time to maximum plasma concentration (Tmax) of VIB4920 is reported. | 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 | |
| Secondary | 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 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 | |
| Secondary | 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). | 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 | |
| Secondary | 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. | 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 | |
| Secondary | Systemic Clearance (CL) of VIB4920 | Systemic clearance is a quantitative measure of the rate at which a drug substance is removed from the body. | 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 | |
| Secondary | 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. | 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 | |
| Secondary | Volume of Distribution at Steady State (Vss) of VIB4920 | Volume of distribution at steady state (Vss) of VIB4920 is reported. | 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 | |
| Secondary | Accumulation Ratio (AR) of VIB4920 | Accumulation ratio of VIB4920 is reported. Accumulation ratio was determined using AUCtau, Dose 7/AUCtau, Dose 1. | 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 | |
| Secondary | Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to VIB4920 | The number of participants with positive antibodies to VIB4920 are reported. | Pre-dose on Days 1, 29, 57, and 85; and on Days 141, and 169 |