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Monoclonal Antibodies

Imvotamab for Lupus

Verified Trial
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
Age ≥ 18 years at the time of signing ICF
Highly active SLE disease, as demonstrated by a total systemic lupus erythematosus disease activity index (SLEDAI-2K) total score of ≥ 10 at screening
Must not have
Any lupus-associated neuropsychiatric disease.
Active lupus nephritis with estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2, calculated according to the Chronic Kidney Disease Epidemiology Collaboration equation, classified as World Health Organization (WHO) Class IV.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 52
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if a new drug, imvotamab, is safe and tolerated in people with severe lupus who have not responded to other treatments.

Who is the study for?
This trial is for adults over 18 with severe systemic lupus erythematosus (SLE) who haven't responded to treatments like methotrexate or belimumab. They should have active SLE and a high disease activity score but stable standard care doses up to Week 8. Not eligible if pregnant, breastfeeding, planning pregnancy soon, have severe kidney issues, take high-dose steroids, neuropsychiatric lupus complications, drug-induced lupus or recent severe anti-phospholipid syndrome.
What is being tested?
The study tests the safety and effectiveness of Imvotamab in patients with serious SLE. Participants will receive Imvotamab intravenously while keeping their usual SLE medications constant to see how well it works when other therapies fail.
What are the potential side effects?
While specific side effects of Imvotamab are not listed here, common side effects for drugs treating autoimmune conditions like SLE may include allergic reactions at the infusion site, increased risk of infections due to immune system suppression, nausea and potential liver enzyme abnormalities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My lupus is very active, with a SLEDAI score of 10 or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a brain or nerve condition related to lupus.
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I have severe lupus affecting my kidneys with low kidney function.
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I am taking more than 30 mg of prednisone or its equivalent daily.

Timeline

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
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
9 Previous Clinical Trials
517 Total Patients Enrolled
Rebecca KunderStudy DirectorIGM Biosciences
2 Previous Clinical Trials
50 Total Patients Enrolled
~4 spots leftby Jun 2025
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