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Gs-5718-03

A clinical trial is underway to assess the effectiveness, safety, and tolerability of GS-5718-03, a new drug being tested for patients with Cutaneous Lupus Erythematosus (CLE). This randomized, blinded, placebo-controlled study aims to explore the potential of GS-5718-03 in reducing skin disease activity in CLE patients, with or without Systemic Lupus Erythematosus (SLE). The trial will evaluate various aspects of the drug’s performance, including its efficacy, safety profile, and pharmacokinetic characteristics.

Table of Contents

What is GS-5718-03?

GS-5718-03 is a new medication being developed by Gilead Sciences, Inc. It is currently being studied as a potential treatment for a skin condition called Cutaneous Lupus Erythematosus (CLE)[1]. GS-5718-03 is considered a “small molecule” drug, which means it is a low molecular weight compound that can easily enter cells to perform its function[1].

What condition does GS-5718-03 treat?

GS-5718-03 is being developed to treat Cutaneous Lupus Erythematosus (CLE). CLE is a type of lupus that primarily affects the skin. It causes rashes and lesions on various parts of the body, particularly in sun-exposed areas. Some patients with CLE may also have Systemic Lupus Erythematosus (SLE), which is a more widespread form of lupus that can affect multiple organs in the body[1].

How is GS-5718-03 being studied?

GS-5718-03 is currently being evaluated in a clinical trial. This trial is a Phase 2a Proof-of-Concept study, which means it’s an early stage of testing to see if the drug shows promise in treating CLE. The study is:

  • Randomized: Participants are randomly assigned to either receive GS-5718-03 or a placebo (a substance that looks like the drug but has no active ingredients).
  • Blinded: Neither the participants nor the researchers know who is receiving the actual drug and who is receiving the placebo. This helps prevent bias in the results.
  • Placebo-controlled: The effects of GS-5718-03 will be compared to those of a placebo to determine if the drug is truly effective[1].

Who can participate in the study?

The study has specific criteria for who can participate. Some key inclusion criteria are:

  • Patients who have been diagnosed with CLE, confirmed by a skin biopsy, or who meet the criteria for Systemic Lupus Erythematosus (SLE)[1].
  • Patients with active CLE symptoms at the time of screening and on the first day of the study.
  • Patients who have a certain level of disease activity, as measured by specific scoring systems (CLASI-A and SLEDAI-2K)[1].
  • Patients who have not responded well to, or cannot tolerate, standard treatments for CLE, such as topical corticosteroids, oral corticosteroids, or other medications like hydroxychloroquine or methotrexate[1].

There are also certain conditions that would prevent someone from participating in the study, such as having only certain types of CLE (like chilblains lupus), having highly active SLE affecting other organs, or having other skin conditions that could interfere with assessing the lupus skin lesions[1].

What are the goals of the study?

The main goals of this study are:

  1. To see if GS-5718-03 is effective in reducing skin disease activity in people with CLE. This will be measured by looking at the change in a score called the CLASI-A, which assesses the severity of CLE symptoms[1].
  2. To evaluate how safe GS-5718-03 is and how well patients tolerate it. This includes monitoring for any side effects or adverse reactions[1].
  3. To understand how the drug moves through and is processed by the body (this is called pharmacokinetics or PK)[1].

How is GS-5718-03 given?

GS-5718-03 is given as a film-coated tablet that is taken by mouth (orally). The tablets contain 15 mg of the active ingredient. The maximum daily dose in the study is 30 mg, which likely means participants take two tablets per day. The treatment period in the study lasts for 12 weeks[1].

What are the potential benefits and risks?

As this is an early-stage study, the full benefits and risks of GS-5718-03 are not yet known. However, the potential benefits could include improvement in CLE symptoms, particularly the skin rashes and lesions associated with the condition.

The study will carefully monitor for any side effects or adverse reactions. Some general risks that are often associated with participating in clinical trials include:

  • The treatment may not be effective for everyone.
  • There may be unexpected side effects.
  • Participating in the study may require more time and attention than standard treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements[1].

It’s important to note that all clinical trials are closely monitored for patient safety, and participants are free to leave the study at any time if they experience uncomfortable side effects or feel the treatment is not working for them.

Aspect Details
Drug Name GS-5718-03
Condition Studied Cutaneous Lupus Erythematosus (CLE)
Study Type Randomized, blinded, placebo-controlled, Phase 2a
Primary Objective Evaluate efficacy in reducing skin disease activity
Secondary Objectives Assess safety, tolerability, and pharmacokinetics
Dosage Form 15mg film-coated tablet
Maximum Daily Dose 30mg
Treatment Duration 12 weeks
Primary Endpoint Percent change in CLASI-A score at Week 12

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to evaluate the efficacy of GS-5718-03 compared to a placebo in reducing skin disease activity for participants with Cutaneous Lupus Erythematosus (CLE), with or without Systemic Lupus Erythematosus (SLE).
  • Who can participate in this clinical trial? Participants must have active CLE, meet specific disease activity criteria, and have a history of inadequate response or intolerance to certain treatments. They must also be willing to undergo skin biopsies and comply with all study visits and assessments.
  • What is the primary measure of effectiveness in this trial? The primary measure of effectiveness is the percent change from baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index activity (CLASI-A) score at Week 12 of treatment.
  • How is the safety of GS-5718-03 being evaluated? The safety of GS-5718-03 is being evaluated by monitoring the incidence of treatment-emergent adverse events (TEAEs), serious adverse events (TESAEs), and laboratory abnormalities throughout the study.
  • What is the dosage form of GS-5718-03 used in this trial? GS-5718-03 is administered as a 15mg film-coated tablet, with a maximum daily dose of 30mg and a maximum total dose of 2520mg over the 12-week treatment period.

Ongoing Clinical Trials on Gs-5718-03

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

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Czechia Germany Spain

Glossary

  • Cutaneous Lupus Erythematosus (CLE): A type of lupus that primarily affects the skin, causing various rashes and lesions.
  • Systemic Lupus Erythematosus (SLE): An autoimmune disease that can affect multiple organs and systems in the body, including the skin, joints, kidneys, and brain.
  • CLASI-A score: Cutaneous Lupus Erythematosus Disease Area and Severity Index activity score, a measure used to assess the severity and extent of skin involvement in CLE.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Placebo: An inactive substance that looks like the drug being tested but contains no active medication.
  • Randomized trial: A study where participants are randomly assigned to different treatment groups to reduce bias.
  • Blinded study: A study where participants and/or researchers do not know which treatment is being given to reduce bias.
  • Treatment-emergent adverse events (TEAEs): Any unfavorable medical occurrence that appears or worsens after starting the study treatment.
  • Biopsy: A medical procedure where a small sample of tissue is taken from the body for examination.
  • Erythema: Redness of the skin caused by increased blood flow to superficial capillaries.

References

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