Lupus Erythematosus Systemic Exacerbation Clinical Trial
Official title:
A Single-site, Investigator Initiated Open-Label Trial of H.P. Acthar Gel (Repository Corticotropin Injection)an Adrenocorticotropic Hormone (ACTH) Analogue in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)
Systemic lupus erythematosus is a serious and potentially life-threatening condition with significant unmet medical need. The aim of this Investigator Initiated, single center, open-label study is to evaluate the efficacy and safety of a daily subcutaneously (SQ) injection of H.P. Acthar Gel for 10 days with an optional 5 day rescue period for non-responders after day 10 dose. The primary objective of this study is to evaluate whether the addition of H.P. Acthar Gel to standard treatment of lupus will ameliorate the intensity of flares as measured by changes in SLEDAI score, Patient and Physician global assessments.
This is a Phase 4 Open-label Study to Evaluate the Treatment of Lupus Flares with H.P.
Acthar Gel.
The primary objective is to evaluate whether the addition of H.P. Acthar Gel to standard
treatment of lupus will ameliorate the intensity of flares as measured by changes in SLEDAI
score, Patient and Physician global assessments.
The secondary objective is to evaluate any changes to the subjects BILAG scores and markers
of inflammation, e.g. ESR and/or CRP.
The Exploratory objective will determine the feasibility of a long-term double-blind study
using H.P. Acthar Gel versus other usual treatments for lupus.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment