Evaluating Study Drug 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)

Enrolling By Invitation
18 years - 99 years
All
Phase 2
5 participants needed
1 Location

Brief description of study

The research study is being conducted to investigate if the study drug BIIB059 can reduce disease activity and inflammation in people with active Cutaneous Lupus Erythematosus compared to a placebo. Participants will complete the following research procedures: demography and medical history, previous CLE therapy, SARS-CoV-2 (COVID-19) test, chest X-ray, skin biopsy, Systemic Lupus Erythematosus (SLE) assessment, skin assessments, skin photography, physical examination, vital signs, electrocardiogram (ECG), diary review, questionnaires, blood and urine tests, concomitant therapies/procedures, recording of signs or symptoms of illness, optional blood test for genetic research, optional future scientific research. Participation will last for 80 weeks (about 18 months) in total.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Lupus,Cutaneous Lupus Erythematosus
  • Age: 18 years - 99 years
  • Gender: All
Updated on 04 Aug 2024. Study ID: 852092
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Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

Contact Office of Clinical Research