CompletedPhase 2

Safety and Efficacy of KRP203 in Subacute Cutaneous Lupus Erythematosus

Germany, Greece10 participantsStarted 2011-02

Plain-language summary

This study will assess the safety and efficacy of KRP203 in clinically active subacute cutaneous lupus erythematosus patients, who have demonstrated inadequate response to standard treatment, such as antimalarials.

Who can participate

Age range18 Years – 65 Years

SexALL

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Exclusion criteria

✕. Patients with preexisting nephritis, central nervous or pulmonary involvement or any major internal organ damage, either related or unrelated to lupus, which are deemed by the Investigator to be clinically significant. Patients having signs or symptoms of other autoimmune diseases such as systemic lupus erythematosus or Sjogren's syndrome are allowed to enter the study at the Investigator's discretion.
✕. Patients who have been treated with:
✕. Pregnant, planning to get pregnant, and/or lactating females or males planning to father a child within time period of the study or subsequent exclusionary period.

What they're measuring

Efficacy of KRP203 in reduction of severity of symptoms, as measured using the activity score of the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)

Timeframe: 12 weeks

Trial details

NCT IDNCT01294774

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-10

View on ClinicalTrials.gov More Subacute Cutaneous Lupus Erythematosus trials