What side effects are associated with this type of intervention?

Common treatments for Rheumatoid Arthritis that involve immune modulation, such as TNF inhibitors, methotrexate, abatacept, and tocilizumab, have several known side effects. TNF inhibitors can cause infections, including TB, and have been associated with rapid progression of lung disease in RA-ILD patients. Methotrexate may lead to liver toxicity, interstitial lung disease, and bone marrow suppression. Abatacept is generally well-tolerated but can cause infections and has been linked to lung function deterioration in some cases. Tocilizumab can stabilize lung function but also has potential adverse lung effects and increases the risk of infections.

What prior FDA approvals exist?

FDA-approved treatments for Rheumatoid Arthritis that involve immune modulation include several biologic DMARDs. These include TNF inhibitors such as etanercept, infliximab, and adalimumab, which target TNF-alpha to reduce inflammation. Other biologics include abatacept, which modulates T-cell activation, and rituximab, which targets CD20 on B cells. Additionally, JAK inhibitors like tofacitinib and upadacitinib, which interfere with the JAK-STAT signaling pathway, have also been approved. These treatments aim to modulate the immune response to control RA symptoms and progression.

What other types of research exist?

Promising novel alternatives to VIB4920 for RA treatment include: 1) YLB113, a biosimilar of etanercept, which has shown comparable efficacy, safety, and immunogenicity to the reference product in a phase 3 study. 2) PF-06651600 (ritlecitinib), a JAK3/TEC inhibitor, which demonstrated efficacy and safety in a phase II study. 3) ABP 798, a biosimilar to rituximab, which has shown similar efficacy, safety, and immunogenicity to the rituximab reference product in clinical trials.

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VIB4920 for Rheumatoid Arthritis (CONTROL-RA Trial)

Phase 2

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult 18-75 years of age

Documented positive test for rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide antibody (ACPA)

Must not have

Vaccination with a live vaccine within the past 30 days

Women who are pregnant or breast-feeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 16 to week 40

Summary

This trial is testing if adding VIB4920 to existing Rheumatoid Arthritis treatments can help patients who haven't responded well to those treatments. It focuses on adults with moderate to high Rheumatoid Arthritis activity in the U.S. The goal is to see if VIB4920 can improve symptom control when used with current medications.

Who is the study for?

Adults aged 18-70 with Rheumatoid Arthritis (RA) who haven't responded well to TNFi treatments can join. They must have been diagnosed at least 6 months ago, show certain levels of disease activity and joint tenderness/swelling, and be on stable doses of specific RA medications. Participants need to be vaccinated against COVID-19 as per CDC guidelines for immunocompromised individuals.

What is being tested?

The trial is testing VIB4920, a new potential treatment for RA. Some patients will add VIB4920 to their current TNFi therapy for 12 weeks, while others will take it without TNFi or receive a placebo. The goal is to see if VIB4920 improves symptoms in those not helped by TNFi alone.

What are the potential side effects?

Potential side effects are not detailed here but may include reactions similar to other immune-modulating drugs such as infusion reactions, increased risk of infections, blood disorders, liver enzyme elevations, or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old.

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I have tested positive for rheumatoid arthritis markers.

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I have at least 4 tender and 4 swollen joints.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not received a live vaccine in the last 30 days.

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I am not pregnant or breast-feeding.

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I have a history of primary immunodeficiency.

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I haven't had cancer in the last 5 years, except for certain skin cancers or cervical cancer treated locally.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 16 to week 40

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 16 to week 40

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 to week 40 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of participants achieving low disease activity by Simplified Disease Activity Index (SDAI)

Secondary study objectives

Incidence of adverse events of special interest (AESI)

Incidence of grade 2 or higher adverse events (AEs)

Incidence of serious adverse events

+12 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: VIB4920 without TNFiExperimental Treatment1 Intervention

Participants will stop TNFi after randomization to this arm, and receive VIB4920 in an evaluator-blinded fashion intravenously at a dose of 1500 mg at weeks 0, 2, 4, 8, and 12 while maintaining all other background disease-modifying RA therapy (e.g., methotrexate, hydroxychloroquine, etc.) through the study period. This arm is evaluator blinded (not aware of treatment status), with the participant aware of treatment status but evaluator is not, due to not using a TNFi placebo for this study

Group II: VIB4920 with TNFiExperimental Treatment1 Intervention

Participants will receive VIB4920 in a blinded fashion intravenously at a dose of 1500 mg at weeks 0, 2, 4, 8, and 12 and continue all background disease-modifying RA therapy, including the TNFi, through the study period

Group III: VIB4920 Placebo with TNFiPlacebo Group1 Intervention

Participants will receive VIB4920 placebo in a blinded fashion intravenously at weeks 0, 2, 4, 8, and 12 and continue all background disease-modifying RA therapy, including the TNFi, through the study period VIB4920 placebo consists of 0.9% normal saline in 250mL bags.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Rheumatoid Arthritis (RA) often involve immune modulation to reduce inflammation and prevent joint damage. TNF inhibitors block tumor necrosis factor, a cytokine involved in systemic inflammation. IL-6 inhibitors target interleukin-6, another cytokine that promotes inflammation and joint destruction. JAK inhibitors interfere with Janus kinases, enzymes that facilitate cytokine signaling involved in the inflammatory process. These treatments are crucial for RA patients as they help control disease activity, reduce symptoms, and prevent long-term joint damage, thereby improving quality of life. VIB4920, being studied for its potential to enhance clinical disease control when added to TNF inhibitor therapy, represents another approach to modulating the immune response in RA.

Is there a need for new therapies for rheumatoid arthritis?