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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
Awards & highlights
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 belowSelect...
I cannot tolerate at least 2 different types of advanced arthritis medications.
Select...
I have at least 6 swollen and 6 tender joints.
Select...
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:Select...
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.
Select...
I have not taken specific excluded medications for rheumatoid arthritis.
Select...
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
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 IV QW x 4 dosesPlacebo Group1 Intervention
Placebo administered intravenously
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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Who is running the clinical trial?
IGM Biosciences, Inc.Lead Sponsor
8 Previous Clinical Trials
223 Total Patients Enrolled
Rebecca KunderStudy DirectorIGM Biosciences
2 Previous Clinical Trials
28 Total Patients Enrolled
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