Deucravacitinib for Sarcoidosis and Granuloma Annulare

Recruiting in Palo Alto (17 mi)

Overseen byWilliam Damsky, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Yale University

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

To investigate the role of an oral TYK2 inhibitor for the treatment of patients with moderate to severe sarcoidosis with cutaneous involvement (CSAMI score of 10 or greater) and GA (defined as a BSA involvement of at least 5%), which are difficult to treat.

Research Team

William Damsky, M.D.

Principal Investigator

Yale University

Eligibility Criteria

This trial is for people with moderate to severe sarcoidosis that affects the skin (CSAMI score ≥10) or Granuloma Annulare covering at least 5% of their body. Specific eligibility details are not provided, but typically there would be criteria about overall health and possibly age.

Inclusion Criteria

BSA involvement of at least 5% (GA) or CSAMI numerical score of at least 10 (sarcoidosis)

I have been on a steady dose of medication for sarcoidosis for 3 months.

Written informed consent

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Exclusion Criteria

Current smoker, history of tobacco use

I am over 50 and have a risk factor for heart disease.

I am under 18 years old.

See 15 more

Treatment Details

Interventions

Deucravacitinib (Tyrosine Kinase Inhibitor)

Trial OverviewThe trial is testing Deucravacitinib, an oral medication that inhibits TYK2, a protein involved in inflammation. It aims to see if this drug can help patients with stubborn skin-related sarcoidosis or Granuloma Annulare.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Granuloma AnnulareExperimental Treatment1 Intervention

Participants with GA will receive the TYK2 inhibitor deucravacitinib 6mg twice daily

Group II: Cutaneous SarcoidosisExperimental Treatment1 Intervention

Participants with CS will receive the TYK2 inhibitor deucravacitinib 6mg twice daily

Deucravacitinib is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Sotyktu for: