NCT03910543

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Cutaneous Sarcoidosis
• Granuloma Annulare

Interventions

Type	Name	Description
DRUG	Tofacitinib 5 mg twice daily	Tofacitinib will be administered at a dose of 5 mg twice daily

Timeline

• Start date: 2019-04-11
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2019-04-10
• Last updated: 2021-07-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study