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Deucravacitinib for Sarcoidosis and Granuloma Annulare

WD
NO
Overseen ByNicole Olszewski, LPN
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Yale University
Must be taking: Methotrexate, Prednisone
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

WD

William Damsky, M.D.

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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
See 5 more

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Granuloma AnnulareExperimental Treatment1 Intervention
Group II: Cutaneous SarcoidosisExperimental Treatment1 Intervention

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

🇺🇸
Approved in United States as Sotyktu for:
🇪🇺
Approved in European Union as Sotyktu for:
🇨🇦
Approved in Canada as Sotyktu for:

Find a Clinic Near You

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 profile image

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 profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

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

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