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Monoclonal Antibodies
Inebilizumab + Blinatumomab for Lupus
Homestead, FL
Phase 2
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Diagnosis of SLE and lupus nephritis (LN) according to 2019 European League Against Rheumatism and the American College of Rheumatology classification criteria.
2. Anti-double stranded deoxyribonucleic acid (anti-dsDNA) antibodies elevated to above normal range as established by central laboratory (ie, positive results)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if two different medications, inebilizumab and blinatumomab, are safe and well-tolerated in adults with lupus and kidney inflammation.
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Who is the study for?
This trial is for adults with active, hard-to-treat systemic lupus erythematosus (SLE) and kidney inflammation. Participants must have certain antibodies in their blood, signs of kidney disease, and a recent biopsy confirming the diagnosis. People who haven't seen improvement in proteinuria or those newly diagnosed can join.Check my eligibility
What is being tested?
The trial tests Inebilizumab's safety and how well it's tolerated when given to SLE patients with nephritis (Subprotocol A), as well as Blinatumomab administered under the skin for similar patients (Subprotocol B).See study design
What are the potential side effects?
Potential side effects may include allergic reactions to medication components, infusion-related issues due to drug administration method, immune system changes leading to increased infection risk, and possible impact on liver or blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with lupus and lupus nephritis.
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My blood test shows high levels of anti-dsDNA antibodies.
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Select...
My blood test shows elevated Anti-Smith antibodies.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
8Treatment groups
Experimental Treatment
Group I: Subprotocol C: Blinatumomab Medium-doseExperimental Treatment1 Intervention
Participants will receive blinatumomab medium-dose administered via SC injection.
Group II: Subprotocol C: Blinatumomab Low-doseExperimental Treatment1 Intervention
Participants will receive blinatumomab low-dose administered via SC injection.
Group III: Subprotocol C: Blinatumomab High-doseExperimental Treatment1 Intervention
Participants will receive blinatumomab high-dose administered via SC injection.
Group IV: Subprotocol B: Blinatumomab Medium-doseExperimental Treatment1 Intervention
Participants will receive blinatumomab medium-dose administered via SC injection.
Group V: Subprotocol B: Blinatumomab Low-doseExperimental Treatment1 Intervention
Participants will receive blinatumomab low-dose administered via SC injection.
Group VI: Subprotocol B: Blinatumomab High-doseExperimental Treatment1 Intervention
Participants will receive blinatumomab high-dose administered via SC injection.
Group VII: Subprotocol A: Inebilizumab 4 DosesExperimental Treatment1 Intervention
Participants will receive 4 doses of inebilizumab administered via an IV infusion.
Group VIII: Subprotocol A: Inebilizumab 3 DosesExperimental Treatment1 Intervention
Participants will receive 3 doses of inebilizumab administered via an intravenous (IV) infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inebilizumab
2015
Completed Phase 3
~240
Blinatumomab
2020
Completed Phase 3
~1210
Find a Location
Closest Location:Homestead Associates In Research Inc· Homestead, FL
Who is running the clinical trial?
AmgenLead Sponsor
1,501 Previous Clinical Trials
1,424,524 Total Patients Enrolled
2 Trials studying Lupus
17 Patients Enrolled for Lupus
MDStudy DirectorAmgen
1,016 Previous Clinical Trials
946,958 Total Patients Enrolled
2 Trials studying Lupus
17 Patients Enrolled for Lupus