CUG252 for Lupus

Not currently recruiting at 11 trial locations

Overseen By Cugene, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Cugene Inc.

Must be taking: Prednisone, Azathioprine, Antimalarials, others

Must not be taking: Vaccines, IL-2, Anti-TNF, others

Disqualifiers: SARS-CoV-2, Severe renal, Neuropsychiatric, others

Compensation: Varies

Number of Visits: Unknown

Duration: 64 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety of a new treatment called CUG252, an experimental therapy for individuals with Systemic Lupus Erythematosus (SLE), a condition where the immune system attacks the body. The study will assess how participants handle different doses of the treatment compared to a placebo. Individuals diagnosed with SLE for at least six months and experiencing minimal to moderate symptoms might be eligible to join. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

If you're taking prednisone, azathioprine, antimalarial, mycophenolate mofetil, or methotrexate, you can continue as long as the doses have been stable for a certain period before the trial. However, if you're on other specific medications like certain immunosuppressants or have had recent vaccinations, you may need to stop them before joining the trial.

Is there any evidence suggesting that CUG252 is likely to be safe for humans?

Research shows that CUG252 has been tested in healthy adults to assess its safety and tolerability. In these tests, researchers administered different doses to observe the body's reaction to the treatment. The results indicated that CUG252 was generally well-tolerated, with most participants not experiencing serious side effects. However, since this study is in an early phase, it primarily focuses on understanding the treatment's safety for people with lupus, a condition where the immune system attacks healthy tissue. Although there is no clear data from lupus patients yet, early tests in healthy volunteers suggest that CUG252 might be safe. It is important to note that this study is one of the initial steps in testing, so more data is needed to confirm its safety in lupus patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lupus?

Researchers are excited about CUG252 for lupus because it introduces a novel approach to treating this autoimmune condition. Unlike existing treatments such as corticosteroids and immunosuppressants, which broadly suppress the immune system, CUG252 potentially offers a more targeted mechanism of action. This treatment aims to modulate specific pathways involved in lupus, potentially reducing side effects and improving patient outcomes. The promise of a more precise treatment solution is what makes CUG252 stand out and generates enthusiasm in the medical community.

What evidence suggests that CUG252 might be an effective treatment for Lupus?

Research shows that treatments targeting B cells, which help produce antibodies, have yielded promising results for Systemic Lupus Erythematosus (SLE). These treatments have improved lupus symptoms in 51–58% of patients, according to the SLE Responder Index, a tool used to measure symptom improvement. In this trial, participants will receive either CUG252 or a placebo. Although specific data on CUG252's effectiveness is limited, it is being developed to adjust the immune system similarly. Related studies have demonstrated good results with similar treatments, suggesting that CUG252 might also effectively manage lupus. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

BMI greater than or equal to 18 and less than 39 kg/m2 at Screening

My lupus activity is low to moderate.

I have been on a stable dose of 20 mg/day or less of prednisone for at least 8 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple ascending doses of CUG252 or placebo subcutaneously

64 days

Multiple visits for dose administration and monitoring

Follow-up

Participants are monitored for safety, PK, PD, and preliminary efficacy after the last dose

Up to 64 days post first dose

What Are the Treatments Tested in This Trial?

Interventions

• CUG252

Trial Overview 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.

How Is the Trial Designed?

Group I: CUG252 Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Cugene Inc.

Lead Sponsor

Trials

2

Recruited

70+

Published Research Related to This Trial

In a study of 38 Portuguese patients with Systemic Lupus Erythematosus (SLE), belimumab demonstrated significant effectiveness, with SLE Responder Index (SRI) response rates increasing from 51.9% at 6 months to 91.7% at 24 months, indicating a reduction in disease activity.

Belimumab was associated with a good safety profile, with only five patients experiencing adverse events, primarily infections, and the treatment led to a significant decrease in disease activity markers and daily steroid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Belimumab in the treatment of Portuguese Systemic Lupus Erythematosus patients: a real-life multicenter study. Fernandes, BM., Barreira, S., Fonseca, JE., et al.[2021]

In a study of 85 systemic lupus erythematosus (SLE) patients treated with rituximab, 46.8% achieved a complete response and 34.2% a partial response, indicating significant clinical improvement over an average follow-up of 9.6 months.

The treatment showed a favorable safety profile, with only one infusion reaction leading to discontinuation and a reported infection rate of 19.5 per 100 patient years, including six severe infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes and safety of rituximab treatment for patients with systemic lupus erythematosus (SLE) - results from a nationwide cohort in Germany (GRAID). Witt, M., Grunke, M., Proft, F., et al.[2015]

Belimumab is on track to become the first new drug approved for systemic lupus erythematosus (SLE) in decades, showing promising efficacy in recent trials.

Preliminary results for epratuzumab also indicate potential benefits for lupus patients, suggesting that biologics may significantly improve treatment options and outcomes for this challenging disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biologicals for the treatment of systemic lupus erythematosus? Gunnarsson, I., van Vollenhoven, RF.[2013]

In a 52-week study involving patients with systemic lupus erythematosus (SLE), higher baseline levels of biomarkers BLyS and APRIL were linked to better treatment responses to atacicept, with flare rates decreasing significantly from 75.7% in the placebo group to 32.0% in the atacicept 150 mg group.

Increased exposure to atacicept was associated with lower flare rates and greater reductions in immunoglobulin levels and B cell counts, indicating a dose-response relationship that could help identify patients who would benefit most from the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post Hoc Analysis of the Phase II/III APRIL-SLE Study: Association Between Response to Atacicept and Serum Biomarkers Including BLyS and APRIL. Gordon, C., Wofsy, D., Wax, S., et al.[2022]

The review found that data on medication toxicities in patients with systemic lupus erythematosus (SLE) is limited, and the incidence of adverse events from commonly used drugs does not appear to be higher in SLE patients compared to those with other conditions.

Current strategies for monitoring drug toxicity in SLE are largely based on expert opinion rather than strong scientific evidence, highlighting a need for more rigorous research to improve safety and monitoring practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug monitoring in systemic lupus erythematosus: a systematic review. Schmajuk, G., Yazdany, J.[2018]

Systemic lupus erythematosus (SLE) presents significant challenges for drug development, with only one drug, belimumab, approved through traditional clinical trials, highlighting the complexity of the disease and the need for better trial designs.

Despite past failures, there is a surge in clinical trial activity specifically targeting lupus nephritis, suggesting that new treatments may soon be approved to address the unmet needs of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons Learned From the Clinical Trials of Novel Biologics and Small Molecules in Lupus Nephritis. Furie, R., Toder, K., Zapantis, E.[2018]

The Lupus Multivariable Outcome Score (LuMOS) was developed using data from two pivotal trials of belimumab, demonstrating its ability to effectively measure treatment outcomes in systemic lupus erythematosus (SLE).

LuMOS showed significantly higher scores in patients treated with belimumab compared to placebo, outperforming the existing SLE Responder Index 4 (SRI-4) in distinguishing between responders and nonresponders, which could enhance future clinical trial analyses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Validation of a Novel Evidence-Based Lupus Multivariable Outcome Score for Clinical Trials. Abrahamowicz, M., Esdaile, JM., Ramsey-Goldman, R., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05866861

A Study in Participants With Mild-to-moderate Systemic ... The main purpose of this study is to evaluate the safety and tolerability of CUG252 following multiple ascending doses in participants with Systemic Lupus ...

2. withpower.com withpower.com/trial/phase-1-lupus-erythematosus-systemic-3-2023-f12af

CUG252 for Lupus · Info for Participants In a study of 38 Portuguese patients with Systemic Lupus Erythematosus (SLE), belimumab demonstrated significant effectiveness, with SLE Responder Index (SRI) ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12146670/

New Mechanisms and Therapeutic Targets in Systemic Lupus ... Treatments targeting B cells, which are the source of these antibodies, achieved Systemic Lupus Erythematosus Responder Index scores of 51–58% ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05328557

NCT05328557 | A Phase Ia Study to Evaluate the Safety, ... This is a Phase Ia study of CUG252, comprising a randomized, double-blind, placebo-controlled, single ascending dose in healthy adult subjects.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39438922/

Predictive biomarkers for low-dose IL-2 therapy efficacy in ... Background: Low-dose IL-2 (Ld-IL2) has shown favorable therapeutic effects in systemic lupus erythematosus (SLE) therapy. However, previous ...

6. delta.larvol.com delta.larvol.com/Products/?ProductId=a1ff244f-9d75-4e94-a0c3-cdf36f555562

CUG-252 / Cugene, AbbVie A Phase Ia Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered CUG252 in Normal Healthy Volunteers.