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Monoclonal Antibodies

Inebilizumab + Blinatumomab for Lupus

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.

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.
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).
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 below
Select...
I have been diagnosed with lupus and lupus nephritis.
Select...
My blood test shows high levels of anti-dsDNA antibodies.
Select...
My blood test shows elevated Anti-Smith antibodies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

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

Trial Design

5Treatment groups
Experimental Treatment
Group I: Subprotocol B: Blinatumomab Medium-doseExperimental Treatment1 Intervention
Participants will receive blinatumomab medium-dose administered via SC injection.
Group II: Subprotocol B: Blinatumomab Low-doseExperimental Treatment1 Intervention
Participants will receive blinatumomab low-dose administered via SC injection.
Group III: Subprotocol B: Blinatumomab High-doseExperimental Treatment1 Intervention
Participants will receive blinatumomab high-dose administered via SC injection.
Group IV: Subprotocol A: Inebilizumab 4 DosesExperimental Treatment1 Intervention
Participants will receive 4 doses of inebilizumab administered via an IV infusion.
Group V: 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
Blinatumomab
2014
Completed Phase 3
~1230
Inebilizumab
2015
Completed Phase 3
~240

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,433 Previous Clinical Trials
1,395,111 Total Patients Enrolled
2 Trials studying Lupus
17 Patients Enrolled for Lupus
MDStudy DirectorAmgen
971 Previous Clinical Trials
939,283 Total Patients Enrolled
2 Trials studying Lupus
17 Patients Enrolled for Lupus
~33 spots leftby Aug 2026
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