What side effects are associated with this type of intervention?

Common treatments for Lupus, such as leflunomide, hydroxychloroquine, glucocorticoids, and immunosuppressive agents like azathioprine and mycophenolate, have various side effects. Leflunomide can cause transient elevation in ALT, hypertension, and transient leucopenia. Hydroxychloroquine is generally well-tolerated but can cause gastrointestinal upset and, rarely, retinal toxicity. Glucocorticoids, especially in high doses, can lead to hyperglycemia, increased infection risk, bone loss, and neuropsychiatric effects. Immunosuppressive agents like azathioprine and mycophenolate can cause bone marrow suppression, liver toxicity, and gastrointestinal disturbances.

What prior FDA approvals exist?

FDA-approved treatments for lupus include belimumab, a monoclonal antibody that inhibits B-lymphocyte stimulator (BLyS), and anti-IFNαR monoclonal antibodies, which target the type I interferon receptor. These treatments aim to modulate the immune system to reduce lupus activity. Belimumab has demonstrated efficacy in clinical trials, particularly for systemic lupus erythematosus (SLE), and is used to manage the disease by reducing autoantibody production and controlling disease flares.

What other types of research exist?

Promising novel alternatives to CUG252 for lupus patients in 2024 include biologic therapies such as rituximab and belimumab, which have shown efficacy and a relatively favorable safety profile. Additionally, ongoing research into new biologics and small molecule inhibitors may provide further options. Hormonal treatments, particularly those that avoid estrogen, may also be considered for their safety in lupus patients.

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CUG252 for Lupus

Phase 1

Waitlist Available

Led By Martin K Kankam, MD, PhD

Research Sponsored by Cugene Inc.

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 up to 10 weeks

Awards & highlights

Summary

This trial is testing a new drug called CUG252 in healthy adults to check if it is safe and tolerable. The study focuses on its initial safety profile.

Who is the study for?

This trial is for non-smoking adults aged 18-65 with a BMI of 18.0 to 32.0 kg/m2, who are generally healthy as confirmed by medical exams and tests. People with tuberculosis, infections, chronic medication use including immunosuppressants or steroids, drug/alcohol addiction within the past year, cancer history, significant allergies or abnormal test results can't participate.

What is being tested?

The study is testing CUG252's safety when given in increasing doses under the skin to healthy volunteers compared to a placebo (a substance with no active drug). It aims to understand how well people tolerate it and what happens inside the body after taking it.

What are the potential side effects?

Potential side effects aren't specified but may include reactions at the injection site, general discomfort or changes in vital signs like blood pressure and heart rate since this is an early-phase trial assessing tolerability.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number and percentage of subjects with Treatment Emergent Adverse Events

Secondary study objectives

Change in the number and percentages of immune cells

Immunogenicity of CUG252

Pharmacokinetics profile of CUG252 (AUC)

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CUG252Experimental Treatment1 Intervention

Participants will be randomized in a 3:1 ratio to CUG252 or placebo. CUG252 or placebo will be administered at a single ascending dose in healthy volunteers.

Group II: PlaceboPlacebo Group1 Intervention

Participants will be randomized in a 3:1 ratio to CUG252 or placebo. CUG252 or placebo will be administered at a single ascending dose in healthy volunteers.

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 systemic lupus erythematosus (SLE) include hydroxychloroquine, glucocorticoids, and immunosuppressive agents like azathioprine and belimumab. Hydroxychloroquine works by modulating the immune system and reducing inflammation, which helps prevent flare-ups. Glucocorticoids suppress the immune response and inflammation rapidly, providing quick relief from severe symptoms. Immunosuppressive agents inhibit the activity of the immune system to prevent it from attacking the body's own tissues. These mechanisms are crucial for lupus patients as they help manage the chronic inflammation and autoimmunity characteristic of the disease, thereby improving quality of life and reducing organ damage. The trial CUG252, which assesses the safety and tolerability of a new subcutaneous treatment, is part of ongoing efforts to find more effective and safer therapies for lupus.

Neurological Complications in Patients with Systemic Lupus Erythematosus.The Role of Neutrophils and Neutrophil Extracellular Traps in Vascular Damage in Systemic Lupus Erythematosus.New Trials in Lupus and where Are we Going.