What side effects are associated with this type of intervention?

Common treatments for Rheumatoid Arthritis, particularly biologic agents such as TNF inhibitors (adalimumab, infliximab, etanercept), abatacept, and rituximab, are associated with several side effects. These can include an increased risk of infections, injection site reactions, and infusion-related reactions. More serious but less common side effects include the potential for developing certain cancers, cardiovascular issues, and autoimmune conditions. Patients may also experience headaches, gastrointestinal symptoms, and hypersensitivity reactions. It is important to monitor for these side effects and discuss them with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several biologic agents and immunomodulatory drugs for the treatment of Rheumatoid Arthritis (RA). These include TNF inhibitors such as infliximab, adalimumab, and etanercept, which work by blocking tumor necrosis factor to reduce inflammation. Other biologics like abatacept, which inhibits T-cell activation, and rituximab, which targets B-cells, are also used. Additionally, JAK inhibitors like tofacitinib and baricitinib, which interfere with the Janus kinase pathway, have been approved for RA treatment.

What other types of research exist?

Promising, novel alternatives to Imvotamab for Rheumatoid Arthritis patients in 2024 include Janus kinase (JAK) inhibitors such as tofacitinib, baricitinib, upadacitinib, and filgotinib. These have shown efficacy and safety in patients with inadequate responses to methotrexate.

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Monoclonal Antibodies

Imvotamab for Rheumatoid Arthritis

Phase 1

Recruiting

Research Sponsored by IGM Biosciences, Inc.

Eligibility Criteria Checklist

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

Must have

- Intolerance to at least 2 bDMARDs in different mechanism classes or 1 bDMARD and 1 tsDMARD.

Minimum of 6 swollen (SJC) and 6 tender joints (TJC) on a 66/68 joint count at the screening and baseline visit (SJC/TJC)

Must not have

History of a rheumatologic autoimmune disease other than RA (except secondary Sjögren's syndrome), or with significant systemic involvement secondary to RA (vasculitis, pulmonary fibrosis, or Felty's syndrome); Juvenile idiopathic arthritis (JIA) or idiopathic arthritis diagnosed before the age of 16 years; Psoriatic Arthritis; Axial spondylarthritis or any other disease associated with inflammatory arthritis; Active fibromyalgia with pain symptoms or signs that would interfere with clinical assessments for RA

- Have received prior tsDMARds including but not limited to inhibitors of Janus kinase (JAK), Bruton tyrosine kinase, or tyrosine kinase 2, including baricitinib, tofacitinib, upadacitinib, filgotinib, ibrutinib, or fenebrutinib, or any investigational agent less than 3 months or 5 half-lives, whichever is longer, prior to first administration of study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 52

Summary

This trial tests the safety and tolerability of imvotamab, a new medication, in adults with severe rheumatoid arthritis who haven't responded to other treatments. The study will help understand how the drug works in the body and its effects on inflammation.

Who is the study for?

Adults over 18 with moderate to severe rheumatoid arthritis who haven't responded well to at least two different biologic or targeted synthetic DMARDs. Participants should have active disease, shown by a certain number of swollen and tender joints and high inflammation markers in blood tests. They shouldn't have other autoimmune diseases (except secondary Sjögren's syndrome) or be on high doses of steroids.

What is being tested?

The trial is testing the safety and effects of Imvotamab, an experimental medication for rheumatoid arthritis, compared to a placebo. The drug or placebo is given intravenously. The goal is to see if Imvotamab can help people who didn't get better with previous treatments.

What are the potential side effects?

While specific side effects for Imvotamab are not listed, common side effects for drugs treating rheumatoid arthritis may include injection site reactions, increased risk of infections, headaches, nausea, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I cannot tolerate at least 2 different types of advanced arthritis medications.

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I have at least 6 swollen and 6 tender joints.

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I tested positive for ACPA and/or RF.

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I have been on a stable dose of corticosteroids, not more than 10 mg/day of prednisone, for at least 2 weeks.

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I am 18 years old or older.

Exclusion Criteria

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

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I have an autoimmune disease other than RA, or my RA has severe complications.

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I have taken specific immune system targeting drugs less than 3 months ago.

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I have not taken specific excluded medications for rheumatoid arthritis.

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I have been taking more than 10 mg/day of prednisone or its equivalent in the last 2 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 52 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

To evaluate the safety and tolerability of imvotamab in participants with moderate to severe rheumatoid arthritis

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Imvotamab (Dose Escalation)Experimental Treatment1 Intervention

Imvotatmab administered intravenously

Group II: PBO IVPlacebo Group1 Intervention

Placebo administered intravenously

0 / 9Eligibility 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) include biologics and immunomodulatory drugs. Biologics, such as TNF inhibitors (e.g., infliximab) and IL-6 inhibitors, work by targeting specific components of the immune system that drive inflammation and joint damage. Immunomodulatory drugs like methotrexate suppress the overall immune response to reduce inflammation. These treatments are crucial for RA patients as they help manage symptoms, prevent joint damage, and improve quality of life. The study of Imvotamab, likely a biologic, aims to offer another targeted approach for patients who have not responded to existing therapies.

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