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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 52
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
Select...
My lupus is very active, with a SLEDAI score of 10 or more.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and tolerability of imvotamab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Imvotamab (Dose Escalation)Experimental Treatment1 Intervention
Imvotamab administered intravenously
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Who is running the clinical trial?
IGM Biosciences, Inc.Lead Sponsor
7 Previous Clinical Trials
351 Total Patients Enrolled
Rebecca KunderStudy DirectorIGM Biosciences
1 Previous Clinical Trials
24 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 remaining slots available for this clinical experiment?
"Clinicaltrials.gov confirms that this clinical trial, with its original post date of August 15th 2023 and most recent update on September 19th 2023, is currently seeking patients."
Answered by AI
What dangers are associated with using Imvotamab (Dose Escalation) to treat patients?
"There is limited data supporting both the efficacy and safety of Imvotamab (Dose Escalation), so it was assigned a score of 1."
Answered by AI
Who else is applying?
What site did they apply to?
Stryde Research – Allen Arthritis
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I’ve tried 3 other drugs and have been hospitalized for infection causing 2 surgeries. I want to be on a safer med with better results.
PatientReceived 2+ prior treatments
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