Study of GS-5718 for Patients with Cutaneous Lupus Erythematosus (CLE)

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What is this study about?

This clinical trial is focused on studying a condition called Cutaneous Lupus Erythematosus (CLE), which is a type of lupus that primarily affects the skin. The study will evaluate a new treatment called GS-5718, which is taken as a film-coated tablet. Participants in the trial will receive either the GS-5718 tablet or a placebo. 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 without another form of lupus known as Systemic Lupus Erythematosus (SLE).

During the study, participants will take the medication for a period of up to 12 weeks. Throughout this time, they will have regular check-ups to monitor their health and the effects of the treatment. The study will look at changes in the severity of the skin condition and any side effects that may occur. The goal is to see if GS-5718 can help reduce the symptoms of CLE and improve the quality of life for those affected by this condition.

Participants will be closely monitored for any adverse effects, and the study will also gather information on how the body processes the medication. This research is important for understanding whether GS-5718 can be a beneficial treatment option for people living with Cutaneous Lupus Erythematosus.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria related to Cutaneous Lupus Erythematosus (CLE).

A biopsy may be required to confirm the diagnosis of CLE.

2 initial assessment

An initial assessment is conducted to evaluate the severity of the skin condition using the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI-A) score.

A score of 8 or higher is required, with an erythema score of 4 or higher.

3 medication administration

Participants receive GS-5718 film-coated tablets, administered orally.

The dosage is 15 mg, taken as directed by the study protocol.

4 ongoing monitoring

Regular monitoring is conducted to assess the effectiveness and safety of the medication.

Participants are evaluated for any adverse effects or changes in their condition.

5 mid-study evaluation

At Week 12, a primary evaluation is conducted to measure the percent change in the CLASI-A score from baseline.

Secondary evaluations include the proportion of participants achieving a CLA-IGA score of 0 or 1.

6 completion of study

The study is estimated to conclude by December 20, 2024.

Final assessments are conducted to gather data on the long-term effects and safety of the treatment.

Who Can Join the Study?

Must have a confirmed diagnosis of Cutaneous Lupus Erythematosus (CLE), which is a skin condition, or meet specific criteria for Systemic Lupus Erythematosus (SLE), a condition that can affect multiple parts of the body.
Must have active CLE at the start of the study. If you have acute CLE, it should affect at least two different body areas.
Must have a certain level of skin disease activity, measured by a score called CLASI-A, which looks at the severity of skin symptoms. This score should be 8 or higher, and the redness score should be 4 or higher. If you have SLE, another score called SLEDAI-2K should be 4 or higher.
Must have at least one skin lesion that can be tested with a small skin sample, and be willing to have this procedure done twice.
Must have tried certain treatments before and either not tolerated them well or not had a good response. These treatments include topical creams like corticosteroids or calcineurin inhibitors, oral corticosteroids, and other standard treatments like chloroquine, hydroxychloroquine, azathioprine, mycophenolate mofetil (MMF), leflunomide, dapsone, or methotrexate (MTX).
Must be willing to attend all study visits and complete all assessments required by the study.
Both males and females can participate.
Participants from vulnerable populations are also eligible.

Who Cannot Join the Study?

Participants with other serious health conditions that might interfere with the study.
Individuals who are currently participating in another clinical trial.
People who have had a recent major surgery or are planning to have one during the study period.
Participants who are pregnant or breastfeeding.
Individuals with a history of allergic reactions to similar medications used in the study.
People who have used certain medications that might affect the study results within a specific time frame before the study starts.
Participants with a history of substance abuse or alcohol dependency.
Individuals who have been diagnosed with certain types of cancer.
People with severe mental health conditions that might affect their ability to participate in the study.
Participants who have been diagnosed with certain infectious diseases.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Universitaet Leipzig	Leipzig	Germany
Technische Universitaet Dresden	Dresden	Germany
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Hospital Universitario Infanta Leonor	Madrid	Spain
Hospital General De Granollers	Granollers	Spain
Ksufv azpsklldm Fprwpdp sbuyob	Prague	Czechia
Htlhhgtw Dn Lt Sucjz Cqyd I Sfbl Ppw	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	23.09.2023
Germany	Not recruiting	23.09.2023
Spain	Not recruiting	23.09.2023

Trial locations

Investigated drugs:

Gs-5718-03

GS-5718 is a medication being studied for its potential to reduce skin disease activity in people with Cutaneous Lupus Erythematosus (CLE), which may occur with or without Systemic Lupus Erythematosus (SLE). This trial aims to assess how effective, safe, and tolerable this medication is for patients with these conditions.

Investigated diseases:

Cutaneous lupus erythematosus

Cutaneous Lupus Erythematosus – Cutaneous Lupus Erythematosus (CLE) is a chronic autoimmune disease that primarily affects the skin, leading to inflammation and lesions. It is characterized by the appearance of red, scaly patches or plaques, often on sun-exposed areas such as the face, neck, and arms. The disease can vary in severity, with some individuals experiencing mild symptoms while others may have more extensive skin involvement. CLE can occur independently or in association with Systemic Lupus Erythematosus (SLE), which affects multiple organs. The progression of CLE involves periods of flare-ups and remissions, where symptoms may worsen or improve over time. Environmental factors, such as sun exposure, can trigger or exacerbate the condition.

Trial ID:

2022-501523-24-00

Protocol code:

GS-US-497-6486

NCT ID:

NCT05629208

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of GS-5718 for Patients with Cutaneous Lupus Erythematosus (CLE)

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