* CLEan

• Research type

  Research Study

• Full title

  A randomized, double-blind, placebo controlled, proof of concept study assessing the efficacy and safety of the RIPK1-inhibitor SAR443122 in patients with moderate to severe subacute or discoid/chronic cutaneous lupus erythematosus

• IRAS ID

  291448

• Contact name

  Kathy Taghipour

• Contact email

  kathy.taghipour@nhs.net

• Sponsor organisation

  Sanofi Aventis

• Eudract number

  2020-004703-14

• Clinicaltrials.gov Identifier

  NCT04781816

• Clinicaltrials.gov Identifier

  WHO, U1111-1246-6784

• Duration of Study in the UK

  0 years, 10 months, 2 days

• Research summary

  The purpose of the study is to test the treatment named SAR443122 in adults with moderate to severe Cutaneous Lupus Erythematosus (CLE)where the symptoms are not adequately controlled by standard of care or when use of those therapies are not advisable. The objective is to understand whether SAR443122 has any beneficial effects and is safe in these patients on a dose of 300 mg twice a day.
  For this purpose, periodical clinical and laboratory evaluations, as well as skin biopsies, skin photos, questionnaires at site and at home, will be performed to evaluate any beneficial effects and to monitor the safety of the study treatment. At the same time, blood testing will be done to measure the amount of study treatment in the body and biologic substance that may help to understand the relationship between the study treatment and CLE condition.

  At the end of screening period, if the patient is eligible for the study, they will be randomised to 1 of 2 groups. One group of participants will receive placebo and another group will receive the study drug SAR443122.

  If the participant consents they will be required to attend at least 6 onsite visits at different intervals over a 20 week period. Assessments will include blood and urine samples, physical examinations and vital signs, Skin biopsies(maximum 2)and patients will be required to complete questionnaire's on their CLE.

  The study will include approximately 88 participants, around 4 from the UK.

  A pharmaceutical company (Sanofi Aventis) is sponsoring this study.

  This study is planned to take part in 2 - 3 NHS centres in the UK.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  22/NW/0252

• Date of REC Opinion

  21 Apr 2021

• REC opinion

  Further Information Favourable Opinion