What is the mechanism of action of this treatment?

Common treatments for lupus, such as those being studied in the trial CUG252, primarily focus on modulating the immune system to reduce inflammation and autoimmunity. These treatments often target specific components of the immune system, such as cytokines, B cells, and T cells, to prevent them from attacking the body's own tissues. For example, some therapies inhibit the production of proinflammatory cytokines or block their receptors, while others interfere with the signaling pathways that activate immune cells. By precisely targeting these immune mechanisms, these treatments aim to reduce disease activity and prevent flare-ups, ultimately improving the quality of life for lupus patients.

What side effects are associated with this type of intervention?

Common treatments for Lupus, particularly those involving immune modulation to reduce inflammation and autoimmunity, include glucocorticoids, hydroxychloroquine, and immunosuppressive agents like azathioprine, belimumab, and anifrolumab. Glucocorticoids can cause side effects such as hyperglycemia, increased infection risk, bone loss, and neuropsychiatric issues. Hydroxychloroquine is generally well-tolerated but can cause gastrointestinal upset and, rarely, retinal toxicity. Azathioprine may lead to bone marrow suppression and liver toxicity. Belimumab and anifrolumab, both biologics, can increase the risk of infections and infusion reactions.

What prior FDA approvals exist?

The FDA has approved several treatments for systemic lupus erythematosus (SLE) that focus on immune modulation to reduce inflammation and autoimmunity. Notable among these is belimumab (Benlysta), a monoclonal antibody that inhibits B-lymphocyte stimulator (BLyS), reducing the activity of B cells which are implicated in lupus. Another approved treatment is anifrolumab (Saphnelo), which targets the type I interferon receptor, a key player in the inflammatory process of lupus. These treatments aim to modulate the immune system to control the disease's activity and reduce symptoms.

What other types of research exist?

Promising novel alternatives to CUG252 for Lupus patients include: 1) Cucurbitacin IIb, which has shown potential in balancing Th17 and Treg cells and improving kidney injury in SLE models. 2) Biologic agents targeting specific cytokines such as IL-17 and IL-23 inhibitors, which are being explored for their anti-inflammatory effects. 3) Advanced immunomodulatory therapies like abatacept, which modulates T cell activation and has shown benefits in autoimmune conditions. Patients should discuss these options with their healthcare provider to determine the best course of treatment.

← Back to Search

Monoclonal Antibodies

CUG252 for Lupus

Verified Trial

Phase 1

Recruiting

Research Sponsored by Cugene Inc.

Eligibility Criteria Checklist

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

Must have

Male or female participant, aged 18 to 65 years (inclusive), at time of consent

If a participant is taking azathioprine, antimalarial, mycophenolate mofetil, or methotrexate, the medication(s) must have been started a minimum of 12 weeks prior to Screening and at a stable dose for a minimum of 8 weeks prior to Screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 pre dose through day 64

Summary

This trial tests CUG252, a new medicine for people with Systemic Lupus Erythematosus (SLE). It aims to enhance beneficial immune cells while reducing unwanted immune activity. The study will check its safety and effectiveness over time.

Who is the study for?

This trial is for adults aged 18-65 with mild-to-moderate Systemic Lupus Erythematosus (SLE). Participants must have been diagnosed at least 6 months prior and have a stable medication regimen if they're taking prednisone or other specific SLE treatments. They should also meet certain body weight criteria.

What is being tested?

The study tests the safety of multiple doses of a new drug, CUG252, compared to a placebo in people with SLE. The goal is to see how well participants tolerate this potential new treatment for lupus symptoms.

What are the potential side effects?

While the side effects are being studied, common issues may include reactions at the injection site, flu-like symptoms, headaches, or gastrointestinal discomfort. Since it's an immune-related treatment, there might be risks of altering immune function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 65 years old.

Select...

I have been on stable doses of specific medications for at least 8 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 pre dose through day 64

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 pre dose through day 64

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 pre dose through day 64 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

CUG252 or placebo will be administered to participants in a 3:1 ratio.

Group II: PlaceboPlacebo Group1 Intervention

CUG252 or placebo will be administered to participants in a 3:1 ratio.

0 / 2Eligibility criteria met

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 those being studied in the trial CUG252, primarily focus on modulating the immune system to reduce inflammation and autoimmunity. These treatments often target specific components of the immune system, such as cytokines, B cells, and T cells, to prevent them from attacking the body's own tissues. For example, some therapies inhibit the production of proinflammatory cytokines or block their receptors, while others interfere with the signaling pathways that activate immune cells. By precisely targeting these immune mechanisms, these treatments aim to reduce disease activity and prevent flare-ups, ultimately improving the quality of life for lupus patients.

Mechanistic Paradigms of Natural Plant Metabolites as Remedial Candidates for Systemic Lupus Erythromatosus.The 2018 pipeline of targeted therapies under clinical development for Systemic Lupus Erythematosus: a systematic review of trials.A Systems Biology-Based Investigation into the Pharmacological Mechanisms of Sheng-ma-bie-jia-tang Acting on Systemic Lupus Erythematosus by Multi-Level Data Integration.