What side effects are associated with this type of intervention?

Common treatments for Cutaneous Lupus Erythematosus (CLE) include immunosuppressive agents, antimalarials, and biologics. Immunosuppressive agents, such as methotrexate and azathioprine, can cause side effects like liver toxicity, bone marrow suppression, and increased risk of infections. Antimalarials, such as hydroxychloroquine, may lead to gastrointestinal disturbances, skin rashes, and, rarely, retinal toxicity. Biologics, which target specific components of the immune system, can cause injection site reactions, increased risk of infections, and potential allergic reactions. Patients should discuss these potential side effects with their healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved several treatments for Cutaneous Lupus Erythematosus (CLE), including antimalarials like hydroxychloroquine and corticosteroids, which are commonly used to manage symptoms. Additionally, immunosuppressive agents such as methotrexate and mycophenolate mofetil are also utilized. Biologic agents like belimumab, which targets B-lymphocyte stimulator (BLyS), have been approved for systemic lupus erythematosus and are sometimes used off-label for CLE. These treatments aim to reduce inflammation and modulate the immune response, which are key aspects of managing CLE.

What other types of research exist?

Promising novel alternatives to Edecesertib for Cutaneous Lupus Erythematosus patients in 2024 include: <ol> <li>Lebrikizumab - an anti-IL-13 monoclonal antibody showing efficacy in atopic dermatitis.</li> <li></li> </ol> Fezakinumab - an IL-22 antagonist with promising results in reducing disease severity in atopic dermatitis. 3. Ustekinumab - an IL-12/IL-23 inhibitor, effective in treating psoriasis and potentially beneficial for CLE. 4. Secukinumab - an IL-17A inhibitor, effective in psoriasis and psoriatic arthritis, which may offer benefits for CLE.

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Protein Kinase Inhibitor

Edecesertib for Cutaneous Lupus Erythematosus

Phase 2

Recruiting

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

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

Must have

Cutaneous Lupus Erythematosus Disease Area and Severity Index activity - A (CLASI-A) score (excluding alopecia) of ≥ 8 and CLASI-A erythema score of ≥ 4 during screening and on Day 1. Individuals with SLE must have Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of ≥ 4 at screening

Presence of at least 1 representative lupus skin lesion amenable to punch biopsy and individual willingness to undergo skin punch biopsy at 2 time points

Must not have

Have highly active SLE (including but not limited to lupus nephritis, neuropsychiatric SLE, and/or vasculitis)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions to Edecesertib as compared to the placebo group. This includes tracking how their bodies react to and process the medication.

Eligibility Criteria

Inclusion Criteria

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

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

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I have a lupus skin lesion suitable for biopsy and agree to two biopsies.

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I have been diagnosed with systemic or cutaneous lupus.

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I have active cutaneous lupus affecting two different body areas.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12

Secondary study objectives

Proportion of Participants With Cutaneous Lupus Activity Investigator Global Assessment (CLA-IGA) Score of 0 or 1 at Week 12

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: EdecesertibExperimental Treatment1 Intervention

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

Group II: Edecesertib PlaceboPlacebo Group1 Intervention

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

0 / 5Eligibility 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 Cutaneous Lupus Erythematosus (CLE) often involve immunomodulatory and anti-inflammatory agents. These treatments work by targeting specific pathways in the immune system to reduce inflammation and autoimmunity. For example, biologics like anti-IFNαR monoclonal antibodies inhibit interferon pathways, which are crucial in the inflammatory process of CLE. This is important for CLE patients as it helps to control the overactive immune response, reducing skin lesions and improving quality of life. Understanding these mechanisms allows for more targeted and effective treatments, potentially leading to better management of the disease.

Anti-IFNαR Mabs for the treatment of systemic lupus erythematosus.