Phase 1
Completed N=57
A Phase 1b Study of MEDI4920 in Participants With Adult-onset Rheumatoid Arthritis
Adult Onset Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT02780388 ↗
Enrolled (actual)
57
Serious AEs
1.8%
Results posted
Sep 2019
Primary outcomePrimary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) — 13; 3; 7; 6 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) |
13; 3; 7; 6; 10; 0 | — |
| PRIMARY Number of Participants With Treatment-emergent AEs of Special Interests (AESIs) |
0; 0; 0; 0; 1; 0 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of VIB4920 |
20.6; 158; 392; 360; 24.4; 157 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) of VIB4920 |
0.02; 0.04; 0.06; 0.06; 0.02; 0.04 | — |
| SECONDARY Area Under the Plasma Concentration Time Curve of the Dosing Interval (AUCtau) of VIB4920 |
122; 669; 2150; 2360; 262; 1430 | — |
| SECONDARY Dose Normalized AUCtau of VIB4920 |
1.62; 1.34; 2.15; 1.58; 3.49; 2.87 | — |
| SECONDARY Area Under the Plasma Concentration Time Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of VIB4920 |
163; 824; 2660; 3480 | — |
| SECONDARY Systemic Clearance (CL) of VIB4920 |
489; 654; 405; 457; 449; 536 | — |
| SECONDARY Terminal Elimination Half-life (t½) of VIB4920 |
6.25; 5.61; 6.12; 8.70; 7.82; 9.58 | — |
| SECONDARY Volume of Distribution at Steady State (Vss) of VIB4920 |
4230; 5040; 3510; 5380; 5060; 5600 | — |
| SECONDARY Accumulation Ratio (AR) of VIB4920 |
1.51; 1.51; 1.20; 1.76 | — |
| SECONDARY Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to VIB4920 |
3; 3; 1; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT02780388). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.