LAVENDER

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Double blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Anifrolumab in Adults with Chronic and/or Subacute Cutaneous Lupus Erythematosus who are Refractory and/or Intolerant to Antimalarial Therapy

• IRAS ID

  1007864

• Contact name

  Julia Pinkhasov

• Contact email

  julia.pinkhasov@astrazeneca.com

• Sponsor organisation

  AstraZeneca AB

• Clinicaltrials.gov Identifier

  NCT06015737

• Research summary

  The immune system typically serves to protect the body against external agents such as infections. However, in the case of a condition called SCLE (Subacute Cutaneous Lupus Erythematosus), the immune system also turns against the individual’s own body, leading to damage to organs and a variety of symptoms. SCLE is one specific type of cutaneous lupus, which primarily affects the skin. Individuals with SCLE typically develop skin rashes or lesions. The term ‘Subacute’ in SCLE refers to the level of inflammation observed in a skin biopsy.
  Anifrolumab is a medication that reduces the activation of the immune system, thereby reducing the manifestations of SCLE. Previous clinical studies have evaluated the efficacy of anifrolumab in patients with Systemic lupus erythematosus (SLE) and results from these studies provided evidence that skin lesions in patients with SLE improved after treatment with anifrolumab. However, detailed characterisation of the subtype of Cutaneous lupus erythematosus (CLE) was not made in these studies, and no randomised controlled studies of anifrolumab have been conducted in participants with CLE as the primary condition. The aim of this 2-stage study is to evaluate the efficacy and safety of anifrolumab administered subcutaneously once weekly in adult participants with chronic and/or subacute CLE despite receiving standard therapy. Stage 1 of the study is designed to inform the sponsor regarding the sample size for Stage 2. Participants will take part in either Stage 1 or Stage 2. The study will be performed in approximately 460 adult participants aged 18 to 70 years (inclusive). Stage 1 of the study is planned to be performed in approximately 100 participants and Stage 2 in approximately 360 participants. The study duration for a participant in each stage of the study, including visit windows will be a maximum of 71 weeks.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  24/LO/0413

• Date of REC Opinion

  9 Jul 2024

• REC opinion

  Further Information Favourable Opinion