Deucravacitinib for Sarcoidosis and Granuloma Annulare
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how the oral medication deucravacitinib can help treat difficult skin conditions like granuloma annulare (GA) and cutaneous sarcoidosis. These conditions often cause persistent skin issues that resist usual treatments. Participants will take deucravacitinib to determine if it can reduce skin involvement caused by these conditions. Suitable candidates have been diagnosed with either GA affecting at least 5% of their skin or cutaneous sarcoidosis with significant skin involvement and are willing to stop other treatments. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
If you are taking systemic or topical therapies for granuloma annulare, you will need to stop them before the trial and remain off them during the study. For sarcoidosis, you can continue taking stable doses of certain medications like prednisone or methotrexate, but other immunosuppressants are not allowed.
Is there any evidence suggesting that this trial's treatment is likely to be safe?
Research has shown that deucravacitinib is generally safe for treating certain skin conditions. In studies involving patients with moderate to severe plaque psoriasis, the treatment was well-tolerated, with no new safety concerns identified even after five years of continuous use. This indicates long-term safety.
For granuloma annulare, clinical trials have also demonstrated the safety of deucravacitinib. Although specific studies for cutaneous sarcoidosis with this treatment are lacking, safety data from other conditions can be reassuring. The current trial is in an early phase, so safety is being closely monitored. However, based on previous results in other conditions, deucravacitinib appears to be well-tolerated so far.12345Why do researchers think this study treatment might be promising for sarcoidosis and granuloma annulare?
Deucravacitinib is unique because it targets the TYK2 enzyme, which plays a key role in the immune response driving conditions like granuloma annulare and cutaneous sarcoidosis. Most treatments for these conditions, such as corticosteroids or methotrexate, work more broadly to suppress the immune system, which can lead to side effects. By specifically inhibiting TYK2, deucravacitinib offers a more targeted approach, potentially reducing these side effects and providing more effective relief. Researchers are excited about this treatment because it represents a novel mechanism of action that could significantly improve patient outcomes.
What evidence suggests that deucravacitinib might be an effective treatment for sarcoidosis and granuloma annulare?
This trial will evaluate the effectiveness of deucravacitinib for both granuloma annulare and cutaneous sarcoidosis. Research has shown that deucravacitinib, a type of medication, holds potential for treating difficult-to-manage skin conditions. Studies have demonstrated its effectiveness for moderate-to-severe plaque psoriasis, suggesting it might also benefit other skin issues like granuloma annulare. Participants with granuloma annulare in this trial will receive deucravacitinib, and past treatments have yielded positive results.
For cutaneous sarcoidosis, specific data on deucravacitinib remains limited. However, participants with cutaneous sarcoidosis in this trial will also receive deucravacitinib. The medication targets pathways involved in skin inflammation, potentially reducing symptoms by calming the immune response in the skin. Its success in treating similar skin conditions suggests it could be effective here as well.12346Who Is on the Research Team?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the TYK2 inhibitor deucravacitinib 6mg twice daily for 6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Deucravacitinib
Deucravacitinib is already approved in United States, European Union, Canada for the following indications:
- Moderate to severe plaque psoriasis
- Moderate to severe plaque psoriasis
- Moderate to severe plaque psoriasis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
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