Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus

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)

medical-cross
Cutaneous disorders
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All genders
person-wave 18+
world
Recruiting now

Overview
Principal Investigator: Gabriela Cobos, MD

This is a Phase 2/3 study designed to evaluate the efficacy and safety of BIIB059 for the treatment of participants with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarial therapy.

Contact Us

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Alysha Zipeto

Study details
Inclusion Criteria
  • Must have a histologically confirmed (in the past or at Screening) diagnosis of CLE with
    or without systemic manifestations.
    Must have active cutaneous manifestations at screening and randomization
    Subject has CLASI-A score ≥ 10 and CLA-IGA-R Erythema score ≥ at screening and randomization
    Subject has must have used antimalarial agents for at least 12 weeks (either continuous or cumulative) prior
    to Screening
    OR
    previously documented discontinuation of antimalarial agents due to poor tolerability
    and/or side effects, and/or lack of therapeutic effect for at least 12 weeks of treatment
Exclusion Criteria
  • Subject HIV or hepatitis C (HCV) positive
  • Positive or indeterminate QuantiFERON GOLD
  • Previous treatment with an investigational or approved agent that inhibits the IFN-1
    pathway.
Study Requirements

The study duration will be approximately 52 weeks (with option for long term extension)with 17 study visits.