A Study to Assess the Safety and Efficacy of Secukinumab in Alleviating Symptoms of Discoid Lupus Erythematosus
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|ClinicalTrials.gov Identifier: NCT03866317|
Recruitment Status : Not yet recruiting
First Posted : March 7, 2019
Last Update Posted : March 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Discoid Lupus Erythematosus||Drug: Secukinumab||Phase 2|
Discoid lupus erythematosus (DLE) is a cutaneous manifestation of lupus that can exist either as part of systemic lupus erythematosus (SLE), or as a chronic cutaneous condition with no systemic involvement. While the skin-limited, chronic form, has no impact on mortality, it can have significant morbidity, as lesions are painful and scarring. While some patients respond well to use of steroids, whether topical or intralesional, antimalarials such as hydroxychloroquine, or traditional immuno-suppressants there is a significant proportion of patients who remain non-responsive to these treatments, or require high dosages of these, oral steroids, or experimental therapies to suppress the condition. For this group of patients there is a high clinical need to find alternate therapies.
Although the pathways of inflammation are poorly understood, one cytokine of potential interest is IL-17A. Immunohistochemical analysis of skin samples from 89 subjects showed that expression of IL-17A was higher in DLE, SCLE and SLE patients than in negative control subjects (all p<0.05). Serum IL-17A concentrations were higher in DLE and SLE patients than in negative controls (p<0.05), a finding confirmed in studies of DLE in different populations.
Recently secukinumab (Cosentyx), an anti-IL-17A monoclonal antibody, has been approved for use in psoriasis after rapid and sustained results in clinical trials. It has also found promise in other inflammatory conditions where IL-17A signaling is believed to be important, such as uveitis.
Given its good safety profile, its impressive response in psoriasis and steroid-unresponsive inflammatory conditions, and the immunohistochemical evidence that IL-17A may be important in the inflammatory path of DLE, the investigators propose a pilot study of secukinumab in discoid lupus erythematosus.
|Study Type :||Interventional|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study to Assess the Safety and Efficacy of Secukinumab in Alleviating Symptoms of Discoid Lupus Erythematosus|
|Estimated Study Start Date :||May 2019|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||December 2020|
Secukinumab 300 mg injection at week 0, 1, 2, 3, 4, then every 4 weeks until week 12
All subjects will receive secukinumab 300 mg injections subcutaneously at week 0, 1, 2, 3, 4, then every 4 weeks until week 12.
Other Name: Cosentyx
- To determine the efficacy of Secukinumab in Discoid Lupus Erythematosus by clinical responder rate at week 16. [ Time Frame: 16 week ]By using the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)