Inclusion active in April 2021
The discoid lupus erythematosus (DLE) and subacute cutaneous lupus erythematosus (SCLE) are variants of systemic lupus erythematosus that predominantly affects the skin. Lupus erythematosus is an autoimmune disease that can affect any organ system. It is caused by antibodies that bind to certain antigens in the tissue and cause chronic inflammation with the deterioration of the structure and/or weakening of tissue function. There is no treatment for any form of lupus in which patients have no symptoms in the long run. Glucocorticoids, antimalarials, and various topical preparations are used, but there is still no biological therapy for this disease. The Solmed Polyclinic is one of the international centers conducting a phase 3 clinical trial that analyzes the efficacy and safety of a new biological drug in achieving disease remission.
Which patients may be potential candidates to participate in the trial?
- Women and men aged 18-75.
- Clinical and laboratory diagnosis of DLE or SCLE (patients without prior biopsy will have a biopsy at the beginning of the study).
- Active disease despite standard therapy.
- They are willing to use contraception for the duration of the trial.