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Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

140 Participants Needed

Inebilizumab + Blinatumomab for Lupus

Recruiting at 21 trial locations

Overseen ByAmgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Amgen

Disqualifiers: Low eGFR, Organ damage, Transplant, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the trial involves participants with inadequate responses to previous treatments, it's possible that some medications may need to be adjusted. Please consult with the trial coordinators for specific guidance.

How is the drug combination of Inebilizumab and Blinatumomab unique for treating lupus?

The combination of Inebilizumab and Blinatumomab for lupus is unique because it involves two drugs that target different aspects of the immune system. Inebilizumab targets B cells, which are part of the immune system involved in lupus, while Blinatumomab is known for its use in certain blood cancers, suggesting a novel approach to managing lupus by potentially reducing immune system overactivity.¹ ² ³ ⁴ ⁵

What is the purpose of this trial?

The main objective is to assess the safety and tolerability of inebilizumab in adult participants with active and refractory systemic lupus erythematosus (SLE) with nephritis (Subprotocol A) and to assess the safety and tolerability of subcutaneous (SC) blinatumomab in adult participants with active and refractory SLE with nephritis (Subprotocol B) and in adult participants with active refractory rheumatoid arthritis (RA) (Subprotocol C).

Research Team

Principal Investigator

Amgen

Eligibility Criteria

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.

Inclusion Criteria

My lupus is currently active.

My ANA test result is 1:80 or higher.

My urine protein to creatinine ratio is 1.5 or higher.

See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive inebilizumab or blinatumomab based on their subprotocol assignment

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

Blinatumomab
Inebilizumab

Trial Overview 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).

Participant Groups

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.

Blinatumomab is already approved in European Union, United States for the following indications:

Approved in European Union as Blincyto for:

Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (BCP-ALL)
High-risk first relapse BCP-ALL

Approved in United States as Blincyto for:

Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (BCP-ALL)
First or second complete remission with minimal residual disease (MRD)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Findings from Research

In a study of 7 patients with resistant cutaneous lupus erythematosus (CLE), 83% showed significant clinical improvement after 6 to 12 months of treatment with belimumab, with one patient achieving complete response and four achieving partial responses.

Belimumab was well-tolerated, leading to the discontinuation of oral corticosteroids in all patients, and only one serious adverse event (bacteremia) was reported, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Resistant and progressive cutaneous lupus erythematosus treated with belimumab: A retrospective monocentric study].Dresco, F., Puzenat, E., Delobeau, M., et al.[2020]

Blisibimod is a highly potent inhibitor of B cell activating factor (BAFF) and is currently being evaluated for its efficacy and safety in treating systemic lupus erythematosus (SLE) in clinical trials, including the ongoing phase 3 CHABLIS-SC1 trial.

The unique tetravalent 'peptibody' structure of blisibimod may enhance its effectiveness, and its targeted approach towards specific 'responder populations' suggests it could become a significant treatment option for both SLE and IgA nephropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blisibimod for treatment of systemic lupus erythematosus: with trials you become wiser.Scheinberg, MA., Hislop, CM., Martin, RS.[2018]

In a study of 8 patients with lupus nephritis treated with belimumab, 6 patients experienced a reduction in proteinuria to normal levels, indicating improved kidney function.

Belimumab treatment also led to a decrease in anti-DNA levels and normalization of complement levels in most patients, suggesting a positive impact on serological activity associated with lupus nephritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efectiveness of belimumab in the treatment of lupus nephritis: analysis of 8 cases.de la Rubia Navarro, M., Ivorra Cortés, JR., Grau García, E., et al.[2022]