RecruitingPHASE1INTERVENTIONAL

A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese, and Japanese Participants and CTD-ILD Participants

This early-stage research is exploring a new drug called GSK4527363. The main goals are to check its safety, see how well people tolerate it, and understand how it works in the body. The study involves different groups: healthy volunteers (including those of Chinese and Japanese background), people with an autoimmune condition called Systemic Lupus Erythematosus (SLE or lupus), and individuals with lung disease linked to other connective tissue conditions (CTD-ILD). Researchers will also be looking for any immune responses to the drug and compare it to a dummy treatment (placebo) or an existing medication called Belimumab.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

GlaxoSmithKline

Enrolment target

142

Start

02 Sep 2024

Estimated completion

11 Jan 2028

Systemic Lupus Erythematosus

What is this study about?

This research study is an important early step in developing a new medicine called GSK4527363. We call this a 'Phase 1' study, which means the main focus is on carefully checking its safety in people for the first time. Researchers also want to understand how the body processes the medication and how it might affect the body over time. This kind of study doesn't primarily aim to prove if the drug cures a condition, but rather to gather essential safety information before it can be tested in larger groups of patients.

The study involves several different groups of people. Some healthy volunteers are taking part to help us understand the drug's basic behaviour in the body. There are also specific healthy groups of Chinese and Japanese descent to see if there are any differences in how their bodies handle the medicine. Crucially, the study includes participants with Systemic Lupus Erythematosus (SLE), an autoimmune condition where the body's immune system mistakenly attacks its own tissues, and people with a lung condition called Interstitial Lung Disease (ILD) that can be linked to other connective tissue diseases.

By studying these different groups, researchers hope to build a complete picture of GSK4527363's safety profile and how best to develop it further. The information gathered from this study will be crucial in deciding if and how this potential new treatment can progress to help people with these conditions in the future.

Key takeaways

This study is testing a new drug called GSK4527363.
It's a Phase 1 study, focused on safety and how the body handles the drug.
It involves healthy volunteers, people with lupus (SLE), and people with lung disease linked to other conditions (CTD-ILD).
You might receive the new drug, a dummy treatment (placebo), or an existing drug.
Participation includes medical checks and blood tests.
Your involvement is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for both healthy volunteers and people with specific medical conditions. Generally, participants need to be between 18 and 65 years old. Healthy volunteers generally need to be between 18 and 55 years old and in good overall health, confirmed by medical checks. We are specifically looking for healthy volunteers of Japanese or Chinese background for certain parts of the study.

If you have Systemic Lupus Erythematosus (lupus), you would need to have a confirmed diagnosis of this condition. If you have Interstitial Lung Disease (ILD) linked to a connective tissue disease, you'd need a confirmed diagnosis of both. For those with ILD, your treatment for the lung disease and underlying connective tissue disease should be stable.

For all participants, you'd generally need to weigh at least 45 kilograms (about 7 stone 1 pound) and have a body mass index (BMI) within a specific range (18 to 32). Women who could become pregnant would not be able to participate in the healthy volunteer parts of the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 65 years old?
Do you weigh at least 45 kg (about 7 stone 1 pound)?
Do you have a diagnosis of Systemic Lupus Erythematosus OR Interstitial Lung Disease linked to a connective tissue disease OR are you a healthy adult?
Are you able to attend clinic visits regularly?
Are you willing to provide informed consent?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you might receive the new medicine GSK4527363, a dummy treatment (placebo), or an existing medication called Belimumab, depending on which part of the study you are in. You will have regular visits to the clinic for medical examinations, blood tests, and other assessments to monitor your health and how your body is reacting to the treatment. These assessments help us understand how the drug is working and if there are any side effects. The total duration of your involvement, including how many visits and follow-ups you’ll need, will vary depending on the specific part of the study you join. All details would be fully explained before you agree to take part.

Potential risks and benefits

Taking part in a clinical study carries both potential benefits and risks. While you might not directly benefit from receiving the study drug, your participation could help researchers learn more about new treatments, potentially helping others in the future. As with any new medicine, there's a chance of experiencing side effects, some of which may be unexpected. All potential risks will be thoroughly explained to you, and your health will be carefully monitored throughout the study. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (27)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

GSK Investigational Site
Verified postcode
Scottsdale, United States· Withdrawn
GSK Investigational Site
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Aurora, United States· Recruiting
GSK Investigational Site
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Las Vegas, United States· Recruiting
GSK Investigational Site
Verified postcode
Columbus, United States· Recruiting
GSK Investigational Site
Verified postcode
Oklahoma City, United States· Recruiting
GSK Investigational Site
Verified postcode
Dallas, United States· Withdrawn
GSK Investigational Site
Verified postcode
Buenos Aires, Argentina· Recruiting
GSK Investigational Site
Verified postcode
Rosario, Argentina· Recruiting
GSK Investigational Site
Verified postcode
San Juan Bautista, Argentina· Recruiting
GSK Investigational Site
Verified postcode
San Miguel de Tucumán, Argentina· Recruiting
GSK Investigational Site
Verified postcode
Porto Alegre, Brazil· Recruiting
GSK Investigational Site
Verified postcode
Juiz de Fora, Brazil· Recruiting

Common questions

What is Systemic Lupus Erythematosus (SLE)?

SLE, or lupus, is a long-term autoimmune disease where your body's immune system mistakenly attacks its own healthy tissues. It can affect many parts of the body, including joints, skin, kidneys, and lungs.

What does 'Phase 1' study mean?

Phase 1 is the first stage of testing a new drug in people. The main goals are to check if the drug is safe, how much can be given, and how the body handles it, rather than primarily looking at how effective it is.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the study drug but contains no active medicine. It helps researchers understand what effects are truly due to the new drug.

What is Interstitial Lung Disease (ILD) related to connective tissue disease?

ILD is a group of lung conditions that cause scarring in the lungs, making it harder to breathe. Sometimes, it can be linked to autoimmune conditions like lupus, making it a connective tissue disease-associated ILD.

Will I know if I'm getting the study drug or a placebo?

In many clinical trials, participants don't know whether they are receiving the active drug or a placebo. This is to ensure the results are unbiased and accurate. All details about this will be explained fully before you agree to take part.

How to find out more

US GSK Clinical Trials Call Center

gskclinicalsupporthd@gsk.com 877-379-3718 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.