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This 76-week, 3-part Phase 1b/2 study is intended to evaluate the pharmacological properties (pharmacokinetics and pharmacodynamics), safety, tolerability and preliminary effectiveness of TOFA administrated to young adults (18-30 years) with moderately to severely active SLE-CL. Subjects will be studied at the Cincinnati Children's Hospital Medical Center (CCHMC) and recruited locally.
Cohort 1 (n=10, weight > 40kg and age > 18 years and ≤ 30 years ) will undergo intense PK-sampling to determine exposures following TOFA dosed at 5 mg BID. TOFA dose escalation will not be considered for inadequate response of SLE-CL.
Cohort 2 (n=10, weight > 40kg and age > 18 years and ≤ 30 years) will be treated with the same dose as Cohort 1. No PK sampling will occur for Cohort 2. Enrollment of Cohort 2 will only start once Cohort 1 has completed 8 weeks of TOFA and results of PK analyses from Cohort 1 are available.
- Part A (up to week 8) requires stable background medications;
- Part B (up to week 24) allows for tapering of corticosteroids (CS) in the setting of significant clinical improvement of SLE-CL as defined by a decrease in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score by >50% from baseline , and
- Part C (until week 76) permits tapering of other background medications in subjects with clinical remission of SLE- CL (CLASI activity score=0). TOFA dosing is kept stable during Part C.
Cincinnati Childrens Hospital Medical Center
Children's Hospital Medical Center, Cincinnati
Published on BioPortfolio: 2017-09-21T02:23:22-0400
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