| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04163991 | A Study to Evaluate the Safety and Efficacy of VIB4920 in Participants With Rheumatoid Arthritis | PHASE2 | COMPLETED | 78 | — | — | Dec 9, 2019 | Dec 28, 2021 | Dec 17, 2024 | 25 | United States, Poland |
The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (0-100 mm), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from baseline indicates improvement in disease activity. Results are from a mixed-effect model for repeated measures (MMRM) analysis with treatment, visit, visit by treatment interaction, and baseline DAS28-CRP score included in the model.
Adverse event (AE): any untoward medical occurrence associated with the use of an intervention in humans, whether or not it is considered intervention-related. Serious adverse event (SAE): an AE that results in any of the following outcomes: death; life-threatening AE; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity; congenital anomaly/birth defect; other important medical event jeopardizing the participant's well-being. AEs of special interest (AESIs) include: thrombotic and embolic events; anaphylaxis and clinically significant (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade 3 or higher) hypersensitivity reactions; severe infusion-related reactions (CTCAE Grade 3 or higher); immune complex disease; severe (CTCAE Grade 3 or higher) and/or opportunistic infections; hepatic function abnormality meeting the definition of Hy's Law; malignant neoplasm. (CTCAE Grade 3=Severe; Grade 4=Life-threatening; Grade 5=Fatal.)
| Arm | Type | Description |
|---|---|---|
| VIB4920 1500 mg 4 Times | EXPERIMENTAL | Participants receive intravenous (IV) infusion of VIB4920 1500 mg on Days 1, 15, 29, and 57 |
| VIB4920 1500 mg Twice | EXPERIMENTAL | Participants receive IV infusion of VIB4920 1500 mg on Days 1 and 57, placebo on Days 15 and 29. |
| VIB4920 3000 mg Twice | EXPERIMENTAL | Participants receive IV infusion of VIB4920 3000 mg on Days 1 and 57, placebo on Days 15 and 29. |
| VIB4920 3000 mg Once | EXPERIMENTAL | Participants receive IV infusion of VIB4920 3000 mg on Day 1 and placebo on Days 15, 29, and 57. |
| Placebo | PLACEBO_COMPARATOR | Participants receive IV infusion of placebo matched to VIB4920 on Days 1, 15, 29, and 57. |
| Name | Type | Description |
|---|---|---|
| VIB4920 | DRUG | liquid for IV infusion following dilution in normal saline |
| Placebo | DRUG | 0.9% saline for IV infusion |
Principal Inclusion Criteria: 1. Male or female adults, \>= 18 years of age at time of informed consent. 2. Diagnosed with RA according to the European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) 2010 criteria \>= 6 months prior to screening. 3. Disease Activity Score in ...