What is the GARDENIA-SLE clinical research study?

The purpose of the GARDENIA-SLE clinical research study is to assess the efficacy and safety of an investigational medicine in participants with moderate to severe lupus.

In this study, the effects of the investigational medicine will be compared against placebo. A placebo looks just like the investigational medicine and is given in the same way but has no active ingredients in it. Taking part in studies that include a placebo group helps researchers accurately measure the effects of the investigational medicine.

The main part of the study lasts about 1 year, with an option to join a 2-year extension study. During the extension study, all participants will receive the investigational medicine, even those who received placebo during the main study.

About 600 participants will take part in GARDENIA-SLE at approximately 260 sites worldwide.

What can I expect if I participate?

If you choose to take part in the study, you will be expected to complete certain activities. These include attending study visits and taking part in specific assessments and procedures, such as completing health-related questionnaires, undergoing physical examinations, and providing blood samples.

During the study, you will also be asked to:

Inform the site staff about any other medicines or treatments you take.
Follow study instructions, including taking the investigational medicine or placebo as directed.

These are some of your responsibilities during the study; the site staff will explain all requirements in detail.

Why should I consider participating?

Taking part in this study may give you the opportunity to contribute to research that aims to improve understanding of lupus and possible future treatment options.

What else should I know?

All medicines can carry risks, and the investigational medicine used in this study may cause side effects, including effects that are not yet known. Before you decide, you will receive detailed information about possible risks and your rights as a participant, and your health will be closely monitored throughout the study. Participation is voluntary, and you can leave the study at any time and for any reason.

Also:

All study-required visits, tests, and medication will be provided at no cost to you.
Reimbursement for study-required travel may also be provided.
You may receive regular health checks and care from a study team experienced in managing lupus. However, there is no guarantee that you will benefit medically, and your condition may improve, stay the same, or worsen.

During the study, the site staff will always be happy to support you if you have any questions.

How can I take part?

If you wish to take part in GARDENIA-SLE, you can fill in the pre-screening questionnaire below to see if you may be eligible.

You may be eligible to participate if you:

Are 18 to 75 years old

Have been diagnosed with lupus for at least 24 weeks

Are currently taking medication to treat lupus

There are other requirements to participate. A full medical check-up will be done to see if you can join this study. If you have other questions, share this website with your doctor to discuss this study.

Pre-screening questionnaire

This questionnaire does not contain all of the requirements you need to meet to participate. If you are eligible for this study, you will also receive a copy of the Informed Consent Form when you first visit the clinical study site, which will include additional information.

Please click on the answer that best applies to you.