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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 52

Awards & highlights

Study Summary

This trial will test if a drug (imvotamab) is safe and tolerable in people with RA who have failed other treatments. Placebos will also be given.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

IGM Biosciences, Inc.Lead Sponsor

7 Previous Clinical Trials

345 Total Patients Enrolled

Rebecca KunderStudy DirectorIGM Biosciences

1 Previous Clinical Trials

18 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots in this research project?

"As per clinicaltrials.gov, this medical trial is presently in the process of recruiting volunteers as it was posted on September 13th 2023 and updated last October 11th 2023."

Answered by AI

What risks, if any, are associated with the Imvotamab (Dose Escalation) course of treatment?

"Due to the fact that this trial is only at Phase 1, our team has rated Imvotamab (Dose Escalation)'s safety as a low score of 1 because there are comparatively few data points in support."

Answered by AI

How many participants have been recruited for this clinical trial so far?

"Affirmative, the information available on clinicaltrials.gov confirms that this trial is presently recruiting its participants. It was first posted on September 13th 2023 and has most recently been amended on October 11th of the same year. 24 individuals need to be enrolled for testing at 7 different medical centres."

Answered by AI

How many individual sites are overseeing this research endeavor?

"Patients can be enrolled in this clinical trial at Arizona Arthritis & Rheumatology Research, PLLC in Flagstaff, as well as Precision Comprehensive Clinical Research Solutions located in Glendale and Arthritis and Rheumatic Disease Specialties based in San Leandro. There are an additional 7 sites available for enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 1b Study of Imvotamab in Moderate to Severe Rheumatoid Arthritis

2023. "A Phase 1b Study of Imvotamab in Moderate to Severe Rheumatoid Arthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06087406.

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