A clinical trial for people who have lupus with skin symptoms.
Lupus is an inflammatory disease which can affect a person’s skin, joints, kidneys, lungs, nervous system and other organs.
This study will test a potential medicine for people with lupus (systemic or cutaneous) who have skin symptoms that have not responded to standard treatments.
We will be looking at how the study medicine affects the skin in affected areas, and whether it improves skin symptoms (and other symptoms in people with systemic lupus).
Who may participate
By volunteering in clinical research, you can make a difference. Thank you for your interest in joining this trial.
We are enrolling people aged 18 to 75 years who have lupus with skin symptoms that have not responded to standard treatments after 3 months.
If you choose to participate, you will receive care from a dedicated team of specialists and be part of the community helping us learn more about investigational treatments for lupus. If your diagnosis of lupus has not been confirmed before, we will take a sample of your skin to do this.
Many factors, including genetics, race, ethnicity, and sex can impact how people respond to a medicine. That is why it is so important that clinical trials include people of all backgrounds. The greater the diversity among clinical trial participants, the more we can learn about potential medicines, including how they work for different people.
Condition
Systemic or cutaneous lupus erythematosus
Age
Aged 18-75
Sex
Male or Female
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
What to expect
If you consent, you will go through screening assessments to make sure this trial is right for you. If you have not previously had a skin biopsy to confirm your diagnosis, we will do this.
You will be assigned by chance, like pulling a number out of a hat, to receive the study medicine (2 in 3 chance) or a placebo (1 in 3 chance). A placebo does not have any medicine in it but looks just like the medicine being studied. In this trial, there is a greater chance of you receiving the study medicine than the placebo.
You will receive the study treatment every 4 weeks on Day 1, Week 4 and Week 8. After that, you will receive the study treatment every 8 weeks from Week 16 to Week 40. After 12 weeks, participants taking placebo who have not shown improvement in their symptoms (non-responders) will then receive the study medicine from week 16 until the end of the treatment period (Week 40).
Skin biopsies will be taken at Day 1 and Week 12, with an optional biopsy at Week 32, to look at the effects on your skin.
Length of study treatment
40 weeks
Number of study visits
12 site visits and 4 phone calls
Long-term follow up
Up to week 60
Frequently asked questions
You should expect to be in the study up to 65 weeks.
You and the study staff will not know which you are receiving. You will be assigned by chance, like pulling a number out of a hat, to receive the study medicine (2 in 3 chance) or a placebo (1 in 3 chance).
Your participation in this study is completely optional. You can choose to stop participating in the study at any time, for any reason. Choosing not to participate in this study will not affect your future medical care.
Your study doctor will discuss all the possible risks and benefits of participating in this study with you before you choose to enroll. You can choose to no longer participate in the study at any time.
Yes. Taking part in this study is completely voluntary. You can decide to end your participation at any point during the study and this will not affect your regular medical care.
