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Monoclonal Antibodies

Imvotamab for Inflammatory Myopathies

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
If using oral corticosteroids (OCS), must be on a stable dose equivalent to ≤ 30 mg/day of prednisone for at least 4 weeks prior to first study treatment
Active IIM despite treatment with corticosteroids and at least 1 immunosuppressive or immunomodulatory standard-of-care agent determined at the discretion of the investigator after at least 3 months of treatment
Must not have
Has inclusion body myositis or myositis-associated with other connective tissue disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time frame: up to week 50
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test how safe and well-tolerated imvotamab is for patients with Moderate-Severe Idiopathic Inflammatory Myopathies who have not responded to previous treatments.

Who is the study for?
This trial is for patients with moderate to severe idiopathic inflammatory myopathies, which include conditions like muscular dystrophy and polymyositis. It's specifically for those who haven't responded well to previous treatments.
What is being tested?
The study is testing the safety and how well people can tolerate Imvotamab, a drug given intravenously (through the vein), in individuals with certain muscle inflammation diseases that have been resistant to other therapies.
What are the potential side effects?
While specific side effects of Imvotamab are not listed here, common ones may include reactions at the infusion site, potential allergic responses, fatigue, fever, or body aches. Each person might experience these differently.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on a stable dose of steroids equivalent to 30 mg/day of prednisone or less for at least 4 weeks.
Select...
My inflammatory muscle disease hasn't improved after 3 months of treatment with steroids and another immune system medication.
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I am 18 years old or older.
Select...
I have been diagnosed with a specific type of inflammatory muscle disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have inclusion body myositis or myositis related to another connective tissue disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time frame: up to week 50
This trial's timeline: 3 weeks for screening, Varies for treatment, and time frame: up to week 50 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and tolerability of imvotamab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Imvotamab (Dose Escalation)Experimental Treatment1 Intervention
Imvotamab administered intravenously

Find a Location

Who is running the clinical trial?

IGM Biosciences, Inc.Lead Sponsor
8 Previous Clinical Trials
253 Total Patients Enrolled
Rebecca KunderStudy DirectorIGM Biosciences
2 Previous Clinical Trials
58 Total Patients Enrolled
~6 spots leftby Aug 2025
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