Edecesertib for Cutaneous Lupus Erythematosus

Recruiting at17 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Gilead Sciences

Disqualifiers: Highly active SLE, Psoriasis, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called edecesertib to see if it can help treat a skin condition known as Cutaneous Lupus Erythematosus (CLE). The study will look at how the drug affects the body, how the body processes it, and any side effects that occur. The goal is to find out if edecesertib is an effective treatment for people with CLE.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you must stop taking your current medications. However, it mentions that participants must have had a prior intolerance or inadequate response to certain treatments, which suggests that you might need to stop or adjust some medications. Please consult with the trial coordinators for specific guidance.

What data supports the idea that the drug Edecesertib for Cutaneous Lupus Erythematosus is an effective treatment?

The available research does not provide specific data on the effectiveness of Edecesertib for Cutaneous Lupus Erythematosus. The studies focus on developing tools and questionnaires to better measure and understand the condition, but they do not include results or comparisons of Edecesertib's effectiveness. Therefore, there is no direct evidence from the provided information to support the idea that Edecesertib is an effective treatment for this condition. ^{1 2 3 4 5}

What safety data is available for Edecesertib in treating cutaneous lupus erythematosus?

The provided research does not contain specific safety data for Edecesertib (also known as GS-5718) in the treatment of cutaneous lupus erythematosus. The articles focus on other treatments, the development of outcome sets, and questionnaires for lupus erythematosus, but do not mention Edecesertib or its safety profile. ^{3 4 6 7 8}

Is the drug Edecesertib a promising treatment for Cutaneous Lupus Erythematosus?

Edecesertib is considered promising because it is being studied specifically for Cutaneous Lupus Erythematosus, a challenging skin condition. This focus suggests it could offer new hope for patients by potentially providing a more effective treatment option. ^{2 4 9 10 11}

Research Team

Gilead Study Director

Principal Investigator

Gilead Sciences

Eligibility Criteria

This trial is for individuals with Cutaneous Lupus Erythematosus (CLE) who have at least one lupus skin lesion and meet specific criteria for systemic lupus. They must have an active form of CLE, a certain severity score, and not respond well to standard treatments. People with only certain types of CLE or highly active SLE, other interfering skin conditions, significant infections or liver/cardiovascular disease cannot join.

Inclusion Criteria

My lupus affects my skin severely and is active, with a moderate to high disease activity score.

I've had a bad reaction or no improvement from standard eczema treatments.

Individuals willing to comply with all study visits and assessments

Exclusion Criteria

I have skin conditions that could affect lupus skin lesion assessment.

My lupus affects only one specific area of my body.

I have an active form of lupus affecting my kidneys, brain, or blood vessels.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive edecesertib or placebo once daily for up to 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Edecesertib (Protein Kinase Inhibitor)
• Edecesertib Placebo (Drug)
• GS-5718 (Drug)
• GS-5718 Placebo (Drug)

Trial Overview The study tests the effectiveness of Edecesertib in treating CLE. Participants will either receive Edecesertib or a placebo without knowing which one they get. The study also looks into how the body processes the drug and its effects on CLE symptoms.

Participant Groups

Group I: Edecesertib Experimental Treatment 1 Intervention

Participants will receive edecesertib 30 mg, once daily starting on Day 1 for up to 12 weeks.

Group II: Edecesertib Placebo Placebo Group 1 Intervention

Participants will receive edecesertib placebo, once daily starting on Day 1 for up to 12 weeks.

Who Is Running the Clinical Trial?

Gilead Sciences

Lead Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Findings from Research

In a study of 66 patients with cutaneous lupus erythematosus (CLE), the effectiveness of treatment outcomes varied significantly based on the thresholds used to measure improvement, highlighting the importance of selecting appropriate response criteria.

Factors influencing improvement in CLE activity and skin damage were identified, with older age at disease onset linked to better activity improvement, while certain demographics, like African-American race, were associated with poorer outcomes, emphasizing the need for tailored treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robust measurement of clinical improvement in patients with cutaneous lupus erythematosus. Nanes, BA., Zhu, JL., Chong, BF.[2022]

In a study of 83 patients with cutaneous lupus erythematosus (CLE), those with higher initial disease activity (CLASI-A scores >9) showed significant improvement in disease activity, with 72.73% experiencing positive changes compared to only 14% of those with lower scores.

Factors such as being from a minority race, having a higher baseline CLASI-A score, and a shorter disease duration were associated with better outcomes, while a baseline CLASI-D score of 10 or higher was linked to improvements in disease damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Natural history of disease activity and damage in patients with cutaneous lupus erythematosus. Ker, KJ., Teske, NM., Feng, R., et al.[2019]

A new core outcome set (COS) for cutaneous lupus erythematosus (CLE) has been proposed, which includes essential domains like skin-specific disease activity, symptoms, and health-related quality of life, aimed at standardizing clinical trials and observational studies.

Recommended physician-reported measures for assessing disease activity include the Cutaneous Lupus Erythematous Disease Area and Severity Index (CLASI) and the Cutaneous Lupus Activity Investigator Global Assessment (CLA-IGA), although no single instrument was identified as superior for patient-reported outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a working core outcome set for cutaneous lupus erythematosus: a practical approach to an urgent unmet need. Guo, LN., Perez-Chada, LM., Borucki, R., et al.[2022]

The EUSCLE Core Set Questionnaire was developed to standardize the evaluation of patients with cutaneous lupus erythematosus (CLE) across different European centers, facilitating consistent data collection and comparison.

This comprehensive tool includes six sections covering patient data, diagnosis, skin involvement, disease activity and damage, laboratory analysis, and treatment, which will help establish evidence-based clinical standards and guidelines for managing CLE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Core Set Questionnaire by the European Society of Cutaneous Lupus Erythematosus (EUSCLE). Kuhn, A., Kuehn, E., Meuth, AM., et al.[2019]

The study evaluated the EUSCLE Core Set Questionnaire in 50 patients with various subtypes of cutaneous lupus erythematosus, finding it effective for assessing clinical features and treatment strategies.

Significant differences in disease characteristics and serological features were observed among the subtypes, highlighting the questionnaire's utility in standardizing data collection in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A database analysis of cutaneous lupus erythematosus with the EUSCLE Core Set Questionnaire. Meuth, AM., Amler, S., Haust, M., et al.[2019]

In a phase II trial involving 37 patients with discoid lupus erythematosus (DLE), R-salbutamol cream 0.5% showed significant improvements in symptoms such as scaling, pain, and itching compared to a placebo, indicating its efficacy as a treatment.

The cream was found to be safe and well-tolerated, with no serious adverse events reported, suggesting it could be a promising new topical therapy for patients with therapy-resistant DLE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of R-salbutamol for topical treatment of discoid lupus erythematosus. Jemec, GB., Ullman, S., Goodfield, M., et al.[2013]

A literature review identified 109 drugs associated with cutaneous drug-induced lupus erythematosus (CDILE) in 472 patients, highlighting new drugs like anti-TNFα, proton-pump inhibitors, antineoplastic drugs, and checkpoint inhibitors that have emerged in the last decade.

Most studies on CDILE are based on case reports or small series, indicating a need for larger studies and validated classification criteria to better understand the implications of these drugs in CDILE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cutaneous drug-induced lupus erythematosus: Clinical and immunological characteristics and update on new associated drugs. Bataille, P., Chasset, F., Monfort, JB., et al.[2021]

Belimumab significantly improved clinical outcomes in 26 children with refractory childhood-onset systemic lupus erythematosus (cSLE), with 53.8% achieving Lupus Low Disease Activity State (LLDAS) after 52 weeks of treatment.

The treatment led to a decrease in disease activity, as shown by reduced urine protein levels and lower SLEDAI-2K scores, while also allowing for a significant reduction in glucocorticoid dosage, indicating both efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of belimumab for the treatment of refractory childhood-onset systemic lupus erythematosus: A single-center, real-world, retrospective study. Wang, D., Shan, C., Liu, J., et al.[2023]

In a study of 25 patients with lupus erythematosus tumidus (LET), all presented with typical smooth, erythematous plaques that resolved without scarring, and none were diagnosed with systemic lupus erythematosus during follow-up.

Histological analysis showed that 52% of biopsy specimens had minor epidermal alterations, challenging the notion that LET consistently lacks microscopic changes, and 88% of patients required antimalarial therapy, with a good response in 70% of cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lupus erythematosus tumidus: a clinical and histological study of 25 cases. Rodriguez-Caruncho, C., Bielsa, I., Fernández-Figueras, MT., et al.[2015]

Anti-TNF-alpha immunotherapy, while effective for conditions like Crohn's disease and rheumatoid arthritis, may worsen cutaneous lupus erythematosus (LE), as evidenced by a case where adalimumab exacerbated discoid LE in a patient.

A review of 128 cases in the literature indicates that anti-TNF-alpha therapy can instigate or exacerbate cutaneous LE, highlighting the need for careful management and consideration of alternative treatments in patients with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cutaneous lupus erythematosus and anti-TNF-alpha therapy: a case report with review of the literature. Levine, D., Switlyk, SA., Gottlieb, A.[2015]

Cutaneous Lupus Erythematosus (CLE) is an autoimmune skin disease characterized by a variety of clinical presentations and common histological features, including interface dermatitis and autoantibody deposits.

The disease involves complex immune responses with the infiltration of various immune cells, such as T cells and B cells, into the skin, highlighting the need for novel treatment approaches targeting these immune mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Insights in Cutaneous Lupus Erythematosus Immunopathogenesis. Garelli, CJ., Refat, MA., Nanaware, PP., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Robust measurement of clinical improvement in patients with cutaneous lupus erythematosus. [2022]

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

Natural history of disease activity and damage in patients with cutaneous lupus erythematosus. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Development of a working core outcome set for cutaneous lupus erythematosus: a practical approach to an urgent unmet need. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Development of a Core Set Questionnaire by the European Society of Cutaneous Lupus Erythematosus (EUSCLE). [2019]

5. Sweden pubmed.ncbi.nlm.nih.gov

A database analysis of cutaneous lupus erythematosus with the EUSCLE Core Set Questionnaire. [2019]

6. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of R-salbutamol for topical treatment of discoid lupus erythematosus. [2013]

7. France pubmed.ncbi.nlm.nih.gov

Cutaneous drug-induced lupus erythematosus: Clinical and immunological characteristics and update on new associated drugs. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and safety of belimumab for the treatment of refractory childhood-onset systemic lupus erythematosus: A single-center, real-world, retrospective study. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Lupus erythematosus tumidus: a clinical and histological study of 25 cases. [2015]

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

Cutaneous lupus erythematosus and anti-TNF-alpha therapy: a case report with review of the literature. [2015]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Current Insights in Cutaneous Lupus Erythematosus Immunopathogenesis. [2021]