A clinical trial for people who have lupus with skin symptoms
Lupus is a chronic 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 systemic or cutaneous lupus 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 study.
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 review and sign the informed consent document and continue with the screening process to check that you meet the study requirements. If your diagnosis of lupus has not been confirmed before, we will take a sample of your skin to do this.
Condition
Systemic or cutaneous lupus erythematosus
Age
Aged 18-75 years
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.
Additional eligibility criteria
- You have a confirmed diagnosis of active cutaneous or systemic lupus erythematosus
- You have skin symptoms despite treatment with standard medications for at least 3 months
- You are willing to stop using topical medications (creams or lotions) on the affected skin areas we will be examining during the study
- You must not have any other skin disorder that might affect the results of the study (e.g., psoriasis or drug-related lupus)
- You must not have had any type of cancer in the last 5 years (apart from skin cancer or cervical cancer in some cases)
- You must not have a history of any major organ or bone marrow transplant
What to expect
If you consent, you will go through screening assessments to make sure this study 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).
You and the study staff will not know which you are receiving. You will receive the study treatment every 4 weeks at Day 1, Week 4, and Week 8. After that, you will receive the study treatment every 8 weeks from Week 16 to Week 40. If you are receiving placebo and your symptoms do not improve, you will be given the active treatment from Week 16.
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 60 weeks
