Characterisation of the interferon response following a UV challenge

• Research type

  Research Study

• Full title

  An open-label study to characterise the interferon signature following a cutaneous ultraviolet B challenge in male and female healthy participants aged 18 to 60 years, and to provide insight into its relevance to patients with cutaneous lupus erythematosus.

• IRAS ID

  301268

• Contact name

  Michalis Kostapanos

• Contact email

  michalis.x.kostapanos@gsk.com

• Sponsor organisation

  GSK

• Duration of Study in the UK

  0 years, 5 months, 0 days

• Research summary

  This study is being conducted by GSK to improve our understanding of how the immune system works. We want to understand how one component of the immune response (the interferon response) changes in healthy participants following an ultraviolet B (UVB) challenge. Interferons are proteins which can be activated in many ways and have a role in both the immune response to infection and in autoimmune diseases.

  This study will investigate activation of the interferon pathway following exposure of the skin on the inner forearm to UVB. UVB is part of the non-visible light spectrum of normal daylight. Samples will be collected before and after the UVB exposure so that changes in immune markers and genes can be assessed. These samples will be compared with those taken from patients with cutaneous lupus erythematous (CLE); an autoimmune disease involving the skin.

  The information from this study may help us design future experiments to assess new medicines which target the immune system, with potential to improve treatment of conditions like CLE.

  The study will consist of 2 parts, Part 1 and Part 2.

  Both parts will include:
  • A screening period of up to 30days

  •A study period of up to 3 days

  • A follow-up visit after the last day of assessments.

  Part 1 (Healthy Participants):
  30 participants
  Each participant will receive a UVB challenge and samples will be collected before and after UVB exposure.

  Part 2: (Patients with CLE)
  10 participants

  Each participant will have samples collected from an area of skin affected by CLE and an area that is not affected by CLE. There will be no UVB challenge in Part 2.

  This study will have no direct medical benefit to the participants. It is a GSK-sponsored study, conducted in an (MHRA)-accredited clinical research unit in the United Kingdom, with appropriate safety and compliance facilities.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  21/LO/0533

• Date of REC Opinion

  3 Sep 2021

• REC opinion

  Further Information Favourable Opinion