Observational Study of VIB4920 to Evaluate the Duration of Clinical and Pharmacodynamic Efficacy of VIB4920

An Observational, Follow-on Study to the MEDI4920 (D5100C00002) Study to Evaluate the Duration of Clinical and Pharmacodynamic Efficacy of 12 weeks of Treatment with VIB4920 in Subjects with Moderate to Severe Rheumatoid Arthritis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002351-42-PL

Enrollment

Registered

2019-11-22

Start date

2020-01-13

Completion date

Unknown

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis MedDRA version: 20.0 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000004870

Interventions

Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants are eligible to be included in this study only if all of the following criteria apply: 1. Have successfully completed the 12-week treatment period and the follow-up period of the MEDI4920 D5100C00002 study and received treatment with 1000 mg or 1500 mg of VIB4920 at sites 2002456 and 2002205 in Poland. 2. Are willing and able to provide written informed consent and any locally required authorisation (e.g., European Union [EU] Data Privacy Directive in the EU) prior to undergoing any protocol-related procedures. 3. Are willing and able to comply with the protocol and complete all study assessments. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 17 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to estimate the duration of clinical efficacy of 12 weeks of treatment with 1000 mg or 1500 mg of VIB4920 in subjects with moderate to severe RA.;Secondary Objective: Not applicable;Primary end point(s): Time from last dose of VIB4920 to start of a new DMARD or biologic, or to an increase in the dose of an existing DMARD;Timepoint(s) of evaluation of this end point: 1 study visit	—

Measure

Time frame

Main Objective: The primary objective of this study is to estimate the duration of clinical efficacy of 12 weeks of treatment with 1000 mg or 1500 mg of VIB4920 in subjects with moderate to severe RA.;Secondary Objective: Not applicable;Primary end point(s): Time from last dose of VIB4920 to start of a new DMARD or biologic, or to an increase in the dose of an existing DMARD;Timepoint(s) of evaluation of this end point: 1 study visit

—

Secondary

Measure	Time frame
Secondary end point(s): Exploratory Endpoints â€¢ DAS28CRP â€¢ Rheumatoid factor (RF), anti-cyclic citrullinated peptide antibody (ACPA) â€¢ Multi-biomarker disease activity (assessed using VectraDAÂ®), exploratory biomarkers;Timepoint(s) of evaluation of this end point: 1 study visit	—

Countries

Poland

Contacts

Public ContactDaniel Falleroni

Viela Bio Inc.

FalleroniD@VielaBio.com+12403564437

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026