AMETHYST

• Research type

  Research Study

• Full title

  A 2-Part Seamless Part A (Phase 2)/Part B (Phase 3) Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of BIIB059 in Participants with Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus with or without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy (AMETHYST)

• IRAS ID

  1004768

• Contact name

  Anthony Bewley

• Contact email

  anthony.bewley@bartshealth.nhs.uk

• Sponsor organisation

  Biogen Idec Research Limited

• Eudract number

  2020-000727-40

• Clinicaltrials.gov Identifier

  NCT05531565

• Research summary

  This study is for adult patients with an autoimmune disease known as cutaneous lupus erythematosus (CLE). CLE affects the skin causing skin lesions. Other CLE symptoms include fatigue, pain, and itchy skin that can cause sleep problems. CLE can sometimes also have effects on the organs in the body, such as kidneys, joints, and heart. This is called systemic lupus erythematosus (SLE).

  Currently there are no approved drugs that are targeted to work specifically against CLE. Existing medications used in the treatment of CLE often do not work well and/or cause intolerable side effects. So there is a high need for new drugs that can reduce the impact of CLE on people’s quality of life.

  Only people who have specific types of CLE called subacute cutaneous lupus erythematosus (SCLE) or chronic cutaneous lupus erythematosus (CCLE) can take part in the study. Participants must also have been receiving standard care antimalarial medicines that do not work for them.
  This study is a randomised, double-blind, parallel-group, placebo-controlled study. This means that the participant may receive BIIB059 (the study drug) or a placebo for the first 24 weeks of the study. Randomised means participants will be put into the study drug group or the placebo group by chance. Participants have a 2:1 chance of receiving the study drug or placebo, respectively. Double-blind means that neither the participant nor the study team will know which study group the participant has been put in. For the next 24 weeks of the study (Week 24–Week 48), all participants will receive the study drug.

  The main purpose of the study is to investigate if the study drug can reduce disease activity and inflammation in people with active CLE compared to a placebo. The study will also investigate how safe the study drug is in a larger number of people with CLE.

  The study is being carried out at about 225 sites globally.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  22/LO/0502

• Date of REC Opinion

  22 Aug 2022

• REC opinion

  Further Information Favourable Opinion