What side effects are associated with this type of intervention?

Common treatments for Lupus, particularly those that inhibit B-lymphocyte activity like Belimumab, often have side effects including infusion reactions, infections, and hypersensitivity reactions. Rituximab, another B-cell inhibitor, can cause infusion reactions, serum-sickness-like reactions, and rarely, progressive multifocal leukoencephalopathy (PML). Other immunosuppressants such as methotrexate and azathioprine may lead to liver toxicity, bone marrow suppression, and increased risk of infections.

What prior FDA approvals exist?

Belimumab, a monoclonal antibody that inhibits B-lymphocyte stimulator (BLyS), was the first drug specifically approved by the FDA for the treatment of systemic lupus erythematosus (SLE) in over 50 years. It works by reducing the activity of B cells, which are responsible for the production of autoantibodies that contribute to the disease. Other treatments for lupus include standard immunosuppressive drugs like cyclophosphamide and mycophenolate mofetil, as well as corticosteroids, which help manage inflammation and immune response. These treatments, however, are often associated with significant side effects and varying degrees of efficacy, highlighting the need for more targeted and safer therapeutic options.

What other types of research exist?

Promising novel alternatives to Belimumab for Lupus patients include DS-7011a, which is currently being studied for its efficacy in treating SLE. Other potential alternatives could involve therapies targeting different immune pathways, such as inhibitors of interleukin-17 (IL-17) or interleukin-23 (IL-23), which have shown efficacy in other autoimmune conditions and may offer benefits for SLE patients.

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Monoclonal Antibodies

DS-7011a for Lupus

Phase 1 & 2

Waitlist Available

Research Sponsored by Daiichi Sankyo

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening up to week 16

Summary

This trial is testing DS-7011a, a new medicine for patients with lupus. It aims to see if it is safe and effective by blocking part of the immune system to reduce inflammation and organ damage.

Who is the study for?

Adults over 18 with confirmed systemic lupus erythematosus (SLE) for at least 6 months, who have active skin symptoms despite treatment, and a BMI of 18-40. Participants must be COVID-19 vaccinated and agree to not join other studies during this one. Exclusions include severe herpes infection history, other conditions that could affect the study or pose risks, certain infections within the last 12 weeks, active neuropsychiatric SLE, recent serious infections or lupus nephritis treatments.

What is being tested?

The trial is testing DS-7011a against a placebo in patients with SLE and cutaneous lupus erythematosus. It aims to find a safer and more effective treatment than current options by comparing improvements between those taking the actual drug versus those on a placebo.

What are the potential side effects?

While specific side effects of DS-7011a are not listed here, clinical trials typically monitor for any adverse reactions ranging from mild (like headaches or nausea) to severe (such as allergic reactions or organ inflammation). Patients will be closely observed for any such effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening up to week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening up to week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening up to week 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change From Baseline in Autoantibodies Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus

Change From Baseline in Complement Factors Following Administration of DS-7011a in Participants With Systemic Lupus Erythematosus

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DS-7011aExperimental Treatment1 Intervention

Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who will be randomized to receive DS-7011a 20 mg/kg every 4 weeks by intravenous infusion.

Group II: PlaceboPlacebo Group1 Intervention

Participants with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) who will be randomized to receive placebo every 4 weeks by intravenous infusion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

DS-7011a

2022

Completed Phase 1

~80

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for lupus, such as Belimumab, work by targeting the B-lymphocyte stimulator (BLyS), which is crucial for the survival and activity of B cells. By inhibiting BLyS, Belimumab reduces the production of autoantibodies that contribute to the inflammation and tissue damage seen in lupus. This mechanism is significant for lupus patients because it directly addresses the underlying autoimmune process, potentially leading to better disease control and fewer side effects compared to traditional immunosuppressive therapies.