A Randomized, Blinded, Placebo Controlled, Phase 2a Proof-of-Concept Study to Evaluate Efficacy, Safety, and Tolerability of GS-5718 in Participants with Cutaneous Lupus Erythematosus (CLE)
This research study is looking into a new tablet called GS-5718 for adults aged 18 and over who have a skin condition called Cutaneous Lupus Erythematosus (CLE). CLE causes skin rashes and sores. We want to find out how well this new medicine works to improve CLE symptoms and if it's safe and doesn't cause too many side effects. Some people in the study will get the new tablet, and others will get a dummy tablet (a placebo) to help us compare. The main goal is to see how much the skin problems improve over 12 weeks. We are also checking for any changes in participants' health.
At a glance
What is this study about?
This research is focused on a skin condition called Cutaneous Lupus Erythematosus, often shortened to CLE. CLE can cause various skin problems, including rashes, sores, and sensitivity to the sun. These can be uncomfortable and affect daily life. Currently, people with CLE have different treatment options, but researchers are always looking for new and better ways to help manage the condition.
This particular study is trying out a new medication called GS-5718, which comes in tablet form. The main idea behind this study is to see if GS-5718 can help reduce the skin problems caused by CLE more effectively than what's currently available, or if it offers a different approach to treatment. It's a phase 2a study, which means it's an early-stage study designed to get a better idea of how well the drug works and what side effects it might have.
To make sure the results are as clear as possible, the study is 'blinded' and 'placebo-controlled'. This means that some people will receive the actual GS-5718 tablets, while others will receive a dummy tablet (a placebo) that looks the same but contains no medicine. Neither the participants nor their doctors will know who is getting which tablet. This helps us accurately determine if any improvements or side effects are truly due to the new drug. The main thing researchers will be looking at is how much the skin symptoms, measured by a special score called CLASI-A, improve over 12 weeks.
Key takeaways
- This study is testing a new tablet for a skin condition called Cutaneous Lupus Erythematosus (CLE).
- It aims to see if the new drug, GS-5718, improves skin symptoms and is safe.
- Some participants will receive the active drug, and others a dummy tablet (placebo).
- The main focus is on how much skin problems improve over 12 weeks.
- Participation includes regular clinic visits for checks and assessments.
- You can stop participating at any time.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women can take part. The study is specifically for people who have been diagnosed with Cutaneous Lupus Erythematosus (CLE).
There might be other reasons why you can or cannot join, as clinical studies have very specific rules to ensure everyone's safety and the accuracy of the results. For example, if you have certain other health conditions, are taking particular medications, or are pregnant, you might not be able to participate.
If you're interested, the study team will ask you some questions and do some checks to see if this study is right for you. It's important to be open and honest about your health history.
- Are you 18 years old or older?
- Have you been diagnosed with Cutaneous Lupus Erythematosus (CLE)?
- Are you able to attend regular clinic appointments?
- Are you comfortable with the possibility of taking a dummy tablet (placebo)?
- Are you generally in good health apart from your CLE, or as assessed by the study doctor?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you'll be given tablets to take regularly. Some participants will receive the active study drug (GS-5718), and others will receive a dummy tablet (placebo). Neither you nor your study doctor will know which you are taking. You'll have several visits to the clinic over a total of about 12 weeks. During these visits, the study team will carefully check your skin, ask about your symptoms, and monitor your overall health through blood tests and other assessments. They will be particularly looking at how your CLE skin symptoms change. There will also be follow-up appointments after you finish taking the medication to make sure you are doing well. The total duration of your participation, including follow-up, will be explained in detail by the study team.
Potential risks and benefits
Locations (3)
- —Czechia
- —Germany
- —Spain
Common questions
What is Cutaneous Lupus Erythematosus (CLE)?
CLE is a skin condition that is part of the lupus family. It causes rashes, sores, and other skin problems, often made worse by sunlight.
What is GS-5718?
GS-5718 is a new medicine, in tablet form, that researchers are testing to see if it can help people with CLE.
What does 'placebo-controlled' mean?
It means some people get the actual medicine and others get a dummy tablet (placebo) that looks the same but contains no active drug. This helps researchers compare the effects accurately.
How long will I be in the study?
The main part of the study involves taking the medication for 12 weeks, with follow-up appointments afterwards. The total duration will be discussed with you.
Can I leave the study if I change my mind?
Yes, absolutely. You can withdraw from the study at any time, for any reason, without needing to explain, and it won't affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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