What side effects are associated with this type of intervention?

Common treatments for Lupus, particularly immunomodulatory and immunosuppressive agents, have a range of side effects. Monoclonal antibodies like PF-04236921 can cause headache, nausea, diarrhea, and in some cases, serious adverse events such as herpes zoster infection. Immunosuppressive drugs like rituximab and cyclophosphamide are associated with risks of severe infections and other adverse events. Lenalidomide, another immunomodulatory drug, is linked to higher rates of neutropenia and infections. These treatments aim to manage disease activity but require careful monitoring due to their potential side effects.

What prior FDA approvals exist?

The FDA has approved several immunomodulatory and immunosuppressive agents for the treatment of Lupus. Notably, belimumab, a monoclonal antibody that inhibits B-lymphocyte stimulator (BLyS), was approved for systemic lupus erythematosus (SLE). Additionally, immunosuppressive drugs like mycophenolate mofetil and cyclophosphamide are commonly used off-label for severe lupus nephritis. These treatments aim to reduce the immune system's activity to prevent further tissue damage.

What other types of research exist?

Promising novel alternatives to CC-97540 for Lupus patients in 2024 include: 1) Tofacitinib, a Janus kinase inhibitor, which has shown potential in treating refractory autoimmune conditions. 2) Rituximab, a monoclonal antibody targeting CD20, which has been effective in various autoimmune diseases. 3) Mycophenolate mofetil, an immunosuppressive agent used in resistant autoimmune conditions. These therapies have demonstrated efficacy and safety in clinical trials for autoimmune diseases and may offer viable options for Lupus treatment.

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CC-97540 for Severe Refractory Lupus

Phase 1

Recruiting

Research Sponsored by Bristol-Myers Squibb

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 at week 24

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called CC-97540. It aims to help people with severe autoimmune diseases that don't get better with regular treatments. Researchers want to see if the drug is safe, how it moves through the body, and if it can improve patients' health.

Who is the study for?

This trial is for people with severe, hard-to-treat Systemic Lupus Erythematosus (SLE). Participants must meet specific SLE criteria and have active disease in major organs. They should have tried at least two treatments like cyclophosphamide or mycophenolic acid without success.

What is being tested?

The study tests the safety, initial effectiveness, and how the body processes CC-97540 in participants with tough SLE cases. It also involves pre-treatment drugs Fludarabine and Cyclophosphamide to prepare the immune system.

What are the potential side effects?

Potential side effects may include reactions related to immune system suppression such as increased infection risk, possible negative effects on bone marrow function leading to blood disorders, nausea, hair loss from chemotherapy agents.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 24 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 in proteinuria measured by urine protein creatinine ratio (UPCR)

Change in the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)

Participants with an improvement from baseline of the Revised Composite Response Index in Systemic Sclerosis (CRISS)

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Administration of CC-97540Experimental Treatment4 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tocilizumab

2012

Completed Phase 4

~1840

CC-97540

2020

Completed Phase 1

~30

Fludarabine

2012

Completed Phase 4

~1860

Cyclophosphamide

2010

Completed Phase 4

~2310

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 hydroxychloroquine, corticosteroids, and immunosuppressive agents like cyclophosphamide and mycophenolate mofetil, work by modulating or suppressing the immune system to reduce inflammation and prevent organ damage. Hydroxychloroquine interferes with the communication of immune cells, reducing autoantibody production. Corticosteroids decrease inflammation by inhibiting multiple inflammatory pathways. Immunosuppressive agents like cyclophosphamide and mycophenolate mofetil inhibit the proliferation of immune cells, thereby reducing the immune system's attack on the body's own tissues. These mechanisms are crucial for Lupus patients as they help control disease activity, prevent flares, and protect vital organs from damage.

New therapeutic strategies in systemic lupus erythematosus management.