Open-label Trial of Tofacitinib in Cutaneous Sarcoidosis and Granuloma Annulare

Granuloma Annulare Clinical Trial

Official title: Open-label Trial of Tofacitinib in Cutaneous Sarcoidosis and Granuloma Annulare

Status Completed

Clinical Trial Summary

To investigate the ability of tofacitinib, a Janus kinase (JAK) inhibitor, to treat patients with cutaneous sarcoidosis and granuloma annulare during 6 months of therapy.

Clinical Trial Description

An open-label clinical trial of tofacitinib in cutaneous sarcoidosis and GA. The hypothesis is that Janus Kinase (JAK) 1/3 inhibition with tofacitinib will be effective for the treatment these two diseases. Tofacitinib will be administered at a dose of 5 mg twice daily and response to therapy will be assessed at months 1, 3, and 6 of therapy. The primary outcomes will be improvement in the Cutaneous Sarcoidosis Activity and Morphology Instrument (CSAMI) and Granuloma Activity Scoring Index (GASI) after 6 months of tofacitinib therapy. Secondary outcomes will include improvement in internal organ sarcoidosis (i.e. lung, cardiac) and skin related quality of life. Pre- and on treatment PET-CT scans will be performed in patients with sarcoidosis with internal organ involvement. Pre- and on treatment blood collection and skin biopsies will be performed for correlative scientific studies using RNA sequencing, immunohistochemistry (IHC), and cytokine profiling. ;

Related Conditions & MeSH terms

• Cutaneous Sarcoidosis
• Granuloma
• Granuloma Annulare
• Sarcoidosis

• NCT number: NCT03910543
• Study type: Interventional
• Source: Yale University
• Status: Completed
• Phase: Phase 1
• Start date: April 11, 2019
• Completion date: June 1, 2021