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Open-label Study of Tofacitinib for Moderate to Severe Skin Involvement in Young Adults With Lupus

2017-09-21 02:23:22 | BioPortfolio

Summary

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.

Study Design

Conditions

Cutaneous Lupus

Intervention

Tofacitinib

Location

Cincinnati Childrens Hospital Medical Center
Cincinnati
Ohio
United States
45229

Status

Recruiting

Source

Children's Hospital Medical Center, Cincinnati

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-09-21T02:23:22-0400

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A form of lupus erythematosus in which the skin may be the only organ involved or in which skin involvement precedes the spread into other body systems. It has been classified into three forms - acute (= LUPUS ERYTHEMATOSUS, SYSTEMIC with skin lesions), subacute, and chronic (= LUPUS ERYTHEMATOSUS, DISCOID).

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Tuberculosis of the skin. It includes scrofuloderma and tuberculid, but not LUPUS VULGARIS.

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