Edecesertib for Cutaneous Lupus Erythematosus

Recruiting at 19 trial locations

Overseen By Gilead Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Gilead Sciences

Disqualifiers: Highly active SLE, Psoriasis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

33 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, edecesertib, to determine its effectiveness in treating Cutaneous Lupus Erythematosus (CLE), a skin condition associated with lupus. Researchers aim to understand the body's reaction to this drug and any potential side effects. Participants will receive either edecesertib or a placebo (a non-active pill) for up to 12 weeks. The trial seeks individuals diagnosed with CLE who currently have active skin symptoms and have not responded well to standard treatments like topical or oral steroids. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

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

Research has shown that edecesertib, also known as GS-5718, was tested for safety in earlier studies focused on cutaneous lupus erythematosus (CLE), a skin condition. Results indicated that edecesertib was generally safe and well-tolerated, with no major reports of serious side effects.

The treatment is now in a Phase 2 trial, which typically involves more participants to gather additional safety information. Although this phase does not provide complete safety details, it suggests that earlier research deemed edecesertib safe enough for testing on a larger group.

These findings are encouraging, but more data from ongoing studies will help confirm its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Cutaneous Lupus Erythematosus?

Edecesertib is unique because it introduces a novel approach to treating cutaneous lupus erythematosus by targeting specific pathways involved in the disease's progression. Unlike traditional treatments, which often include antimalarials like hydroxychloroquine or immunosuppressants such as methotrexate, edecesertib offers a new active ingredient that aims to reduce inflammation more precisely. Researchers are excited about this treatment because it has the potential to offer faster relief with possibly fewer side effects, bringing new hope to patients who struggle with current options.

What evidence suggests that edecesertib might be an effective treatment for Cutaneous Lupus Erythematosus?

Research is exploring how edecesertib, which participants in this trial may receive, might benefit individuals with Cutaneous Lupus Erythematosus (CLE), a skin condition. Although limited data exists on its effectiveness for CLE, researchers believe the treatment might help by reducing the disease's activity in the skin. Previously known as GS-5718, earlier studies focused on its effects on the body and the body's response. Early research suggests understanding how the body processes and reacts to this drug is crucial. While solid evidence is still being gathered, ongoing research aims to provide clearer results. ^{1 3 5 6 7}

Who Is on the Research Team?

Gilead Study Director

Principal Investigator

Gilead Sciences

Are You a Good Fit for This Trial?

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.

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

My lupus affects only one specific area of my body.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Edecesertib
• Edecesertib Placebo
• GS-5718
• GS-5718 Placebo

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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 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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05629208

Study of Edecesertib in Participants With Cutaneous Lupus ... The goal of this clinical study is to test how edecesertib (formerly known as GS-5718) can be useful in treating Cutaneous Lupus Erythematosus (CLE) in ...

2. clinicaltrials.eu clinicaltrials.eu/trial/study-of-gs-5718-for-patients-with-cutaneous-lupus-erythematosus-cle/

Study of GS-5718 for Patients with Cutaneous Lupus ... The purpose of the study is to assess how effective and safe GS-5718 is in reducing the activity of skin disease in people with CLE, with or ...

3. withpower.com withpower.com/trial/phase-2-lupus-erythematosus-systemic-2-2023-4813a

Edecesertib for Cutaneous Lupus Erythematosus The available research does not provide specific data on the effectiveness of Edecesertib for Cutaneous Lupus Erythematosus. The studies focus on developing ...

4. trials.arthritis.org trials.arthritis.org/trials/NCT05629208

Study of Edecesertib in Participants With Cutaneous Lupus ... The goal of this clinical study is to test how edecesertib (formerly known as GS-5718) can be useful in treating Cutaneous Lupus Erythematosus (CLE) in ...

5. gileadclinicaltrials.com gileadclinicaltrials.com/study?nctid=NCT04809623

Study of Edecesertib in Participants With Cutaneous Lupus ... The primary objective of this study is to evaluate the safety and tolerability of edecesertib (formerly GS-5718) in participants with cutaneous lupus ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04809623

Study of Edecesertib in Participants With Cutaneous Lupus ... The primary objective of this study is to evaluate the safety and tolerability of edecesertib (formerly GS-5718) in participants with cutaneous lupus ...

7. delta.larvol.com delta.larvol.com/Products/?ProductId=54af402a-5b69-495f-8d79-ccfbeca80436

edecesertib (GS-5718) / Gilead Discovery of Edecesertib (GS-5718): A Potent, Selective Inhibitor of IRAK4. (PubMed, J Med Chem) - "GS-5718 was safe and well-tolerated in IND-enabling ...