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Clinical Trial Summary

This is a single-arm, single-site, proof-of-concept study that will evaluate the treatment of 10 participants with systemic lupus erythematosus (SLE) who have a history of cutaneous lupus with Tofacitinib.


Clinical Trial Description

Once consented, study participants meeting all entry criteria will undergo 25 days of treatment with tofacitinib (11 mg orally daily). Tofacitinib will be distributed to eligible participants at Visit 2 (Day 1) and the first dose will be taken on Day 2. The last dose is the morning of Visit 5 (Day 26).Ultraviolet B (UVB)-mediated cutaneous apoptosis and ancillary mechanistic studies will be evaluated in phototests, skin biopsies and blood samples collected before and after treatment. This study will assess whether a 25-day regimen of tofacitinib impacts photosensitivity following UVB exposure in individuals with systemic lupus and a history of cutaneous lupus. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05048238
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Completed
Phase Phase 1
Start date September 30, 2022
Completion date February 29, 2024

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