Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Dazodalibep, MEDI4920
VIB4920 · 7 trials · 9 indications
Includes treatment emergent serious adverse events (TESAEs) and adverse events of special interest (AESIs).
The ESSDAI is a systemic disease activity index for SS, assessing 12 domains (Constitutional, Salivary Glands, Lungs, Kidneys, Musculoskeletal, Peripheral Nervous System, Central Nervous System, Vascular, Gastrointestinal, Hematological, Ocular, and Extraglandular Manifestations). Each domain is graded for activity (0 = no activity to 3 = high activity) and weighted (1 for Biological to 6 for Muscular) based on its clinical significance, with the final score calculated as the sum of all weighted domain scores. The theoretical range is 0 to 123, with disease activity categorized as low (\<5), moderate (5-13), and high (≥14). A positive change form baseline represents an increase in symptoms.
The ESSPRI is a self-assessment tool for evaluating symptoms of dryness, fatigue, and pain (articular and/or muscular) in SS. Participants rate each of the three domains on a 0-10 numerical scale (0 = no; 10 maximal imaginable severity). All domains are equally weighted, and the total score is the mean of the three domain scores. The maximum total score for the ESSPRI assessment is 10. A positive change form baseline represents an increase in symptoms.
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.)
Histological grading of acute allograft rejection from biopsy specimens was based on Banff criteria 2017. Grade IA: Moderate tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade IB: Severe tubulitis and at least moderate total cortical inflammation and at least moderate scarred cortical inflammation and other known causes ruled out. Grade II. Arterial intimal fibrosis with mononuclear cell inflammation, formation of neointima.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Dazodalibep | EXPERIMENTAL | Participants who completed the 48-week dazodalibep or placebo treatment in trials HZNP-DAZ-301 or HZNP-DAZ-303 will receive assigned dose Dose A of dazodalibep for an additional 132 weeks. |
| Dazodalibep Dose 1 | EXPERIMENTAL | Participants will be administered dose 1 of dazodalibep by intravenous (IV) infusion. |
| Dazodalibep Dose 2 | EXPERIMENTAL | Participants will be administered dose 2 of dazodalibep by IV infusion. |
| Placebo | PLACEBO_COMPARATOR | Participants will be administered placebo by IV infusion. |
| VIB4920 Dose 1 in Population 1 | EXPERIMENTAL | Participants in population 1 will receive IV VIB4920 Dose 1 in Stage I and placebo matched to VIB4920 in Stage II. |
| Placebo in Population 1 | PLACEBO_COMPARATOR | Participants in population 1 will receive IV placebo matched to VIB4920 in Stage I and IV VIB4920 Dose 1 in Stage II. |
| VIB4920 Dose 1 in Population 2 | EXPERIMENTAL | Participants in population 2 will receive IV VIB4920 Dose 1 in Stage I and placebo matched to VIB4920 in Stage II. |
| Placebo in Population 2 | PLACEBO_COMPARATOR | Participants in population 2 will receive IV placebo matched to VIB4920 in Stage I and IV VIB4920 Dose 1 in Stage II. |
| 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. |
| Belatacept+VIB4920 | EXPERIMENTAL | Participants will be admitted to the transplant center for the administration of VIB4920 and belatacept (with Thymoglobulin and corticosteroids) and will be discharged on Day 3/4 at the discretion of the investigator. Participants will return to the study center to receive study drugs (VIB4920 and /or belatacept) weekly for 2 visits, then every 2 weeks for 5 visits, and then monthly for 9 visits for safety monitoring. |
| VIB4920 75 mg | EXPERIMENTAL | Participants will receive a single IV dose of VIB4920 75 mg Q2W from Day 1 up to 12 weeks. |
| VIB4920 500 mg | EXPERIMENTAL | Participants will receive a single IV dose of VIB4920 500 mg Q2W from Day 1 up to 12 weeks. |
| VIB4920 1000 mg | EXPERIMENTAL | Participants will receive a single IV dose of VIB4920 1000 mg Q2W from Day 1 up to 12 weeks. |
| VIB4920 1500 mg | EXPERIMENTAL | Participants will receive a single IV dose of VIB4920 1500 mg Q2W from Day 1 up to 12 weeks. |
| Name | Type | Description |
|---|---|---|
| Dazodalibep | DRUG | Dazodalibep will be given intravenously (IV). |
| Placebo | DRUG | IV infusion |
| VIB4920 | DRUG | Intravenous Dose 1. |
| Belatacept | DRUG | Protocol versions 1 through 4: Belatacept 10 mg/kg by intravenous (IV) infusion on post-op Day 1, repeated on post-op Day 3 or 4 (timing is at investigator's discretion), and at the end of Weeks 2, 4, 8 and 12; then 5 mg/kg IV every 4 weeks from Week 16 to Week 48. |
| Thymoglobulin | DRUG | Protocol versions 1 and 2: Thymoglobulin 3.0 mg/kg by intravenous (IV) infusion prior to reperfusion of the allograft on the day of transplantation surgery (Day 0) (1 dose). Protocol versions 3 and 4: Thymoglobulin 1.5 mg/kg by intravenous infusion prior to reperfusion of the allograft on the day of transplantation surgery (Day 0), prior to VIB4920+belatacept infusion on post-op Day 1, on post-op Day 2, and prior to VIB4920+belatacept infusion on post-op Day 3 or 4. |
| Methylprednisolone | DRUG | Protocol versions 1 and 2: Methylprednisolone by IV infusion (500, 250, 125 and 60 mg on Days 0, 1, 2 and 3, respectively) followed by oral administration of prednisone 30 mg per day on Days 4, 5, and 6. Protocol versions 3 and 4: Methylprednisolone by IV infusion (500, 250, 125 and 60 mg on Days 0, 1, 2 and 3, respectively) followed by oral administration of prednisone 30 mg per day on Days 4, 5, 6 and 7. Participants may be tapered to at least 20 mg per day on Day 8, to at least 10 mg per day on Day 15, and to at least 5 mg per day on Day 22. Discontinuation of prednisone following the post-op Day 28 visit. |
Inclusion Criteria: Participants are eligible to be included in the study only if all the following criteria apply: * Participant has provided informed consent before initiation of any study specific activities/procedures. * Must have been eligible to receive and have received IP (dazodalibep or p...
VIB4920 is an investigational small molecule developed by Amgen Inc. (ticker: AMGN) for immunology indications. It has been studied in adult onset rheumatoid arthritis, rheumatoid arthritis, Sjögren's syndrome, and for prophylaxis of allograft rejection in kidney transplant recipients. It is not approved and remains in clinical development.
VIB4920 has been evaluated as a treatment for adult onset rheumatoid arthritis and rheumatoid arthritis. A Phase 1b study (NCT02780388) and a Phase 2 study (NCT04163991) tested its safety and efficacy in participants with rheumatoid arthritis. It is investigational and not approved for any use.
VIB4920 is developed by Amgen Inc., which trades under the ticker AMGN. Amgen is the sponsor of the clinical trials evaluating VIB4920 in rheumatoid arthritis, Sjögren's syndrome, and kidney transplant recipients.
VIB4920 is in Phase 1 development according to its overall program status, though individual completed trials have reached Phase 2. It is an investigational drug and has not been approved by the FDA for any indication.
VIB4920 has been studied in four completed trials: NCT02780388 (Phase 1b, adult onset rheumatoid arthritis), NCT04163991 (Phase 2, rheumatoid arthritis), NCT04129164 (Phase 2, Sjögren's syndrome), and NCT04046549 (Phase 2, kidney transplant allograft rejection prophylaxis). All trials are completed and no active trials are ongoing.
Yes, VIB4920 is also known as MEDI4920. The Phase 1b study in adult onset rheumatoid arthritis was conducted under the name MEDI4920, while later studies use VIB4920. Both names refer to the same investigational drug developed by Amgen.