Deucravacitinib for Sarcoidosis and Granuloma Annulare

Overseen By Nicole Olszewski, LPN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Yale University

Must be taking: Methotrexate, Prednisone

Must not be taking: Immunosuppressants, TNF-α inhibitors

Disqualifiers: Malignancy, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

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

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the TYK2 inhibitor deucravacitinib 6mg twice daily for 6 months

6 months

Regular visits for assessment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Deucravacitinib

Trial Overview The 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

Group I: Granuloma Annulare Experimental Treatment 1 Intervention

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

Group II: Cutaneous Sarcoidosis Experimental Treatment 1 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:

• Moderate to severe plaque psoriasis

Approved in European Union as Sotyktu for:

• Moderate to severe plaque psoriasis

Approved in Canada as Sotyktu for:

• Moderate to severe plaque psoriasis

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania