drugset / Trial / NCT03288324

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

NCT03288324

NaSingle-groupOpen-labelTreatment

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 (18-45 years) with moderately to severely active SLE-CL. Subjects will be studied at the Cincinnati Children's Hospital Medical Center (CCHMC) and in Cleveland at MetroHealth Medical Center.

Timeline

Start
2017-08-23
Primary completion
2022-11-01
Completion
2023-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Tofacitinib Small molecule 5 mg