Inebilizumab + Blinatumomab for Lupus

Recruiting at 55 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Amgen

Disqualifiers: Low eGFR, Organ damage, Transplant, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

98 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments, inebilizumab and blinatumomab, to determine their safety and tolerability in individuals with difficult-to-treat systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). For SLE participants, the trial targets those with kidney inflammation (nephritis) who have not responded well to other treatments. It also includes people with RA whose disease remains active despite multiple therapies. Participants may qualify if they have SLE or RA that hasn't improved with standard treatments and face daily challenges as a result. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that inebilizumab is generally safe for patients with relapsing multiple sclerosis. Common side effects included urinary tract infections, which were usually manageable. Research indicates that patients tolerated different doses well, with a planned reduction in certain immune cells.

For blinatumomab, studies found its safety comparable to a placebo, indicating it is generally well-tolerated. In one study, most patients completed at least one treatment cycle, though a few stopped due to side effects or lack of improvement. This suggests it is safe for many but may not be suitable for everyone.

These findings provide a clearer picture of the safety of both inebilizumab and blinatumomab for those considering joining clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about inebilizumab and blinatumomab for lupus because these drugs offer unique approaches compared to standard treatments like corticosteroids and immunosuppressants. Inebilizumab targets CD19, a protein on B cells, which plays a crucial role in lupus, potentially reducing disease activity more effectively. Blinatumomab is also intriguing because it acts as a bispecific T-cell engager, redirecting the body's immune response to more effectively target and eliminate problematic cells. These mechanisms present new avenues for managing lupus, offering hope for more precise and potentially more effective treatment options.

What evidence suggests that this trial's treatments could be effective for lupus and rheumatoid arthritis?

Research has shown that inebilizumab, which participants in this trial may receive in different dosing regimens, effectively helps some people with autoimmune conditions achieve remission without ongoing treatment or flare-ups. Specifically, 57.4% of patients went into remission compared to 22.4% of those who did not receive the treatment. This suggests promise for treating lupus, particularly in reducing flare-ups. Meanwhile, blinatumomab, another treatment option in this trial, has shown a good response in patients with systemic lupus erythematosus (SLE). Early reports indicate improvements in symptoms like swelling, suggesting it might be effective for lupus treatment. Both treatments offer hope for those with hard-to-treat lupus conditions. ^{1 3 4 6 7}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

Group I: Subprotocol C: Blinatumomab Medium-dose Experimental Treatment 1 Intervention

Participants will receive blinatumomab medium-dose administered via SC injection.

Group II: Subprotocol C: Blinatumomab Low-dose Experimental Treatment 1 Intervention

Participants will receive blinatumomab low-dose administered via SC injection.

Group III: Subprotocol C: Blinatumomab High-dose Experimental Treatment 1 Intervention

Participants will receive blinatumomab high-dose administered via SC injection.

Group IV: Subprotocol B: Blinatumomab Medium-dose Experimental Treatment 1 Intervention

Participants will receive blinatumomab medium-dose administered via SC injection.

Group V: Subprotocol B: Blinatumomab Low-dose Experimental Treatment 1 Intervention

Participants will receive blinatumomab low-dose administered via SC injection.

Group VI: Subprotocol B: Blinatumomab High-dose Experimental Treatment 1 Intervention

Participants will receive blinatumomab high-dose administered via SC injection.

Group VII: Subprotocol A: Inebilizumab 4 Doses Experimental Treatment 1 Intervention

Participants will receive 4 doses of inebilizumab administered via an IV infusion.

Group VIII: Subprotocol A: Inebilizumab 3 Doses Experimental Treatment 1 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)

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

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Published Research Related to This Trial

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]

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 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]

Citations

1. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/5904/526946/Efficacy-and-Tolerability-of-Blinatumomab-in

Efficacy and Tolerability of Blinatumomab in Clinical Trial ... Response rates were 83% in newly diagnosed patients, 33% in relapsed/refractory patients, and 82% in MRD+ patients. With a median follow-up of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06789107

Blinatumomab in Refractory Active Childhood Systemic ... The goal of this clinical trial is to learn if blinatumomab works to treat refractory or active systemic lupus erythematosus (SLE) in children and adults.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11816971/

Advances in Targeted Therapy for Systemic Lupus ... At week 104, belimumab added to standard therapy improved both primary efficacy renal response (43% vs. 32%) and complete renal response (30% vs ...

4. ejcancer.com ejcancer.com/article/S0959-8049(24)00727-5/fulltext

Application of blinatumomab, a bispecific anti-CD3/CD19 T ... Two days after starting the blinatumomab infusion, the patient reported a general improvement in symptoms (reduced swelling of the fingers, ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0145212625005880

Efficacy and safety of blinatumomab for CD19 + acute ... One-year OS rates of 66.7 %, 91.7 %, and 22.2 % observed in the frontline, consolidation, and relapsed/refractory settings were similar to rates seen in ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06789107/blinatumomab-in-refractory-active-childhood-systemic-lupus-erythematosus

Blinatumomab in Refractory Active Childhood Systemic ... The goal of this clinical trial is to learn if blinatumomab works to treat refractory or active systemic lupus erythematosus (SLE) in children and adults.

7. clinicaltrials.eu clinicaltrials.eu/trial/study-of-blinatumomab-in-patients-with-autoimmune-diseases-systemic-lupus-erythematosus-systemic-sclerosis-or-granulomatosis-with-polyangiitis/

Study of Blinatumomab Treatment in Patients with Systemic ... This clinical study focuses on evaluating a medication called Blinatumomab in treating three different autoimmune conditions: Systemic Lupus ...