A new study is currently in progress at Clinical Unit Cambridge (CUC) at Addenbrooke’s Hospital in Cambridge for lupus patients with skin symptoms.

The study aims to establish whether the inflammatory reaction caused by lupus compares well with the reaction in the skin of healthy volunteers who are exposed to ultraviolet B (UVB) light from a lamp.

If the inflammatory reactions between people with cutaneous lupus erythematosus (CLE or skin lupus) and healthy volunteers are alike, it will help researchers to understand whether the immune responses are similar.

The findings from this study may help the clinical unit design future studies of new medicines which target the immune system, with the potential to improve treatment of autoimmune conditions like CLE.

What does the study hope to find out?

If the exposure to UVB in healthy volunteers can be shown to mimic skin inflammation in lupus, this model in healthy volunteers could be adopted in the early phases of medicines development for autoimmune diseases.

This will mean that when a new medication for autoimmune disease is first tested, it can be done by looking at the effect it has on the inflammation of skin exposed to UVB light in a healthy volunteer. If a trial medicine is proven to affect the inflammatory pathways in healthy volunteers, it may then be progressed to patient studies.

This could potentially speed up the process of developing new medicines for autoimmune disease because there will be a greater understanding of the potential impact of the medicine on the immune system. It may also help prevent unnecessary dosing of patients with a drug which has little potential to be effective in reducing inflammation in later phases of medicines development.

Who can take part and what does the study involve?

• Adults of any gender aged 18-60 who have a diagnosis of lupus and skin symptoms (cutaneous lupus erythematosus) on their back, arms, or legs.

Each participant would have three study sessions.

• The first is a screening visit in Clinical Unit Cambridge (CUC) which will start with a comprehensive consent talk. If the participant decides to take part after the consent talk, a medical history, physical examination, and some tests will be performed to ensure that it is appropriate to enrol in the study.
• The next session will be the study visit (Day 1) in CUC. This will involve providing two skin biopsies (one from an area affected by CLE and the other from an unaffected area), one sample of blister fluid (blisters are induced by a suction method) from an area not affected by CLE and blood samples. The samples from unaffected skin will be taken from the forearm.  All study procedures have been previously used in clinical research and have been proven to be of low risk and well tolerated.
• The final session is a follow-up to confirm healing of the sites where samples for this study were collected. The participant will be given a choice of completing this session from home by telephone or attending CUC. The participant will also be asked to complete a questionnaire about their experience with the study and send it back to the CUC.

How do I get involved?

Participants with CLE will not have any UVB exposure or receive any other treatment as part of the study. Participants will be compensated for their time and commitment. Reasonable travel and accommodation costs for the participant, and a companion if needed, will be reimbursed.

 

If you would like to take part REGISTER HERE or email clinical.trials@gsk.com for more information or discuss it further by phoning Shirley Blayney on 01223 296005 at the CUC Cambridge.