CUG252 for Lupus

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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug CUG252 for treating lupus?

The research does not provide direct evidence about CUG252, but it mentions that belimumab, a similar type of drug, has shown promising results in treating lupus. This suggests that drugs targeting similar pathways might be effective for lupus. ^{1 2 3 4 5}

What safety data exists for CUG252 or similar treatments in humans?

The research articles provided do not contain specific safety data for CUG252 or similar treatments under different names for lupus or other conditions. ^{4 6 7 8 9}

How does the drug CUG252 differ from other lupus treatments?

CUG252 may be unique in targeting the interferon-inducible Ifi200-family genes, which are linked to lupus susceptibility. This approach could potentially modulate the immune response differently compared to existing treatments. ^{10 11 12 13 14}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

IFN-α confers resistance of systemic lupus erythematosus nephritis to therapy in NZB/W F1 mice. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Development and Validation of a Novel Evidence-Based Lupus Multivariable Outcome Score for Clinical Trials. [2019]

3. Canada pubmed.ncbi.nlm.nih.gov

SLICC/ACR Damage Index in Afro-Caribbean patients with systemic lupus erythematosus: changes in and relationship to disease activity, corticosteroid therapy, and prognosis. [2004]

4. England pubmed.ncbi.nlm.nih.gov

Biologicals for the treatment of systemic lupus erythematosus? [2013]

5. United States 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. [2022]

6. England 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). [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Lessons Learned From the Clinical Trials of Novel Biologics and Small Molecules in Lupus Nephritis. [2018]

8. Portugal pubmed.ncbi.nlm.nih.gov

Belimumab in the treatment of Portuguese Systemic Lupus Erythematosus patients: a real-life multicenter study. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Drug monitoring in systemic lupus erythematosus: a systematic review. [2018]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Interferon-inducible Ifi200-family genes as modifiers of lupus susceptibility. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Interferon-inducible p202 in the susceptibility to systemic lupus. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Disruption of mutually negative regulatory feedback loop between interferon-inducible p202 protein and the E2F family of transcription factors in lupus-prone mice. [2021]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Interferon-inducible Ifi200-family genes in systemic lupus erythematosus. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

CD72 negatively regulates B lymphocyte responses to the lupus-related endogenous toll-like receptor 7 ligand Sm/RNP. [2018]