131 Participants Needed

Deucravacitinib for Psoriasis

Recruiting at 76 trial locations
FN
Fl
LA
Overseen ByLindsay Ackerman, Site 0050
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Bristol-Myers Squibb
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The purpose of this study is to measure the safety and effectiveness of deucravatinib in participants with non-pustular palmoplantar psoriasis and genital psoriasis.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop your current medications. It's best to discuss this with the trial team or your doctor.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.

What data supports the effectiveness of the drug Deucravacitinib for treating psoriasis?

Deucravacitinib has been shown to be effective in treating moderate to severe plaque psoriasis, with up to 58.4% of patients experiencing symptom improvement in clinical trials. It was also more effective than placebo and another drug, apremilast, in reducing psoriasis severity in Japanese patients.12345

What data supports the effectiveness of the drug Deucravacitinib for treating psoriasis?

Deucravacitinib has been shown to be effective in treating moderate to severe plaque psoriasis, with up to 58.4% of patients experiencing symptom improvement in clinical trials. In a study involving Japanese patients, 78.1% achieved significant symptom reduction compared to placebo and another drug, apremilast.12345

What is known about the safety of Deucravacitinib (Sotyktu) in humans?

Deucravacitinib (Sotyktu) has been tested in humans and is generally considered safe, with common side effects including upper respiratory infections, increased blood enzyme levels, and mild skin issues like acne. In studies, no serious adverse events were reported, and the frequency of side effects was similar to those taking a placebo (a harmless pill used for comparison).12367

Is Deucravacitinib safe for humans?

Deucravacitinib has been tested in several studies and is generally considered safe for humans. Common side effects include upper respiratory infections, increased blood enzyme levels, and mild skin issues like acne. No serious adverse events were reported in early human trials.12367

How is the drug deucravacitinib different from other psoriasis treatments?

Deucravacitinib is unique because it is an oral medication that specifically targets TYK2, a protein involved in the immune response, using an allosteric mechanism (binding to a different site than the active site). This selectivity may offer a better safety profile compared to other treatments, and it has shown significant effectiveness in reducing psoriasis symptoms in clinical trials.12589

How is the drug deucravacitinib different from other psoriasis treatments?

Deucravacitinib is unique because it is an oral medication that specifically targets TYK2, a protein involved in the immune response, using an allosteric mechanism (binding to a different site than the active site). This selectivity may offer a better safety profile compared to other treatments that target similar pathways.12589

Research Team

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for adults with moderate-to-severe non-pustular palmoplantar and genital psoriasis, who have not improved with at least one topical therapy. Participants should have stable plaque psoriasis without significant flares or changes in the last 6 months and be suitable for phototherapy or systemic treatment.

Inclusion Criteria

My doctor thinks I should get light or drug treatment.
I have had stable psoriasis on my hands and/or feet for at least 6 months.
My psoriasis is moderate to severe, with a score of 3 or more.
See 7 more

Exclusion Criteria

Other protocol-defined inclusion/exclusion criteria apply.
I have a type of psoriasis that is not plaque psoriasis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either deucravacitinib or placebo to evaluate safety and effectiveness

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Deucravacitinib
Trial Overview The study tests deucravacitinib's safety and effectiveness against a placebo in treating non-pustular palmoplantar and genital psoriasis. It aims to see if this medication can help manage symptoms better than no active treatment.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DeucravacitinibExperimental Treatment1 Intervention
Group II: Placebo followed by DeucravacitinibPlacebo Group2 Interventions

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead 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

Findings from Research

Deucravacitinib is a first-in-class oral TYK2 inhibitor that works by stabilizing an inhibitory interaction within the TYK2 enzyme, which is important for treating various immune-mediated diseases.
It received its first approval in the USA on September 9, 2022, for adults with moderate-to-severe plaque psoriasis, and has since been approved in Japan for multiple forms of psoriasis, indicating its efficacy and safety in managing these conditions.
Deucravacitinib: First Approval.Hoy, SM.[2022]
Deucravacitinib (SOTYKTUTM) is an effective oral treatment for moderate to severe plaque psoriasis, with up to 58.4% of patients showing symptom improvement by week 16 in phase 3 trials involving 840 participants.
The drug has a favorable safety profile, with common side effects like upper respiratory infections and herpes simplex infections occurring at manageable rates, and its selectivity may enhance long-term safety compared to other treatments.
SOTYKTUTM (Deucravacitinib 6-mg Tablets)- A New Agent for the Management of Adult Plaque Psoriasis.Gupta, AK., Wang, T., Vincent, K., et al.[2023]
Deucravacitinib, a selective tyrosine kinase 2 inhibitor, was found to be safe and well tolerated in a study involving 40 healthy Chinese subjects, with no serious adverse events reported.
The drug showed rapid absorption and a dose-dependent increase in systemic exposure, indicating that it effectively reaches the bloodstream and maintains consistent pharmacokinetics across different doses.
Pharmacokinetics and Safety of the Tyrosine Kinase 2 Inhibitor Deucravacitinib in Healthy Chinese Subjects.Jing, S., Lin, Y., Dockens, R., et al.[2023]

References

Deucravacitinib: First Approval. [2022]
SOTYKTUTM (Deucravacitinib 6-mg Tablets)- A New Agent for the Management of Adult Plaque Psoriasis. [2023]
Pharmacokinetics and Safety of the Tyrosine Kinase 2 Inhibitor Deucravacitinib in Healthy Chinese Subjects. [2023]
Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial. [2022]
Efficacy and safety of the selective TYK2 inhibitor, deucravacitinib, in Japanese patients with moderate to severe plaque psoriasis: Subgroup analysis of a randomized, double-blind, placebo-controlled, global phase 3 trial. [2023]
Short-, Mid-, and Long-Term Efficacy of Deucravacitinib Versus Biologics and Nonbiologics for Plaque Psoriasis: A Network Meta-Analysis. [2023]
First-in-human study of deucravacitinib: A selective, potent, allosteric small-molecule inhibitor of tyrosine kinase 2. [2023]
Deucravacitinib in moderate-to-severe psoriasis. [2022]
Matching-Adjusted Indirect Comparison of the Long-Term Efficacy of Deucravacitinib Versus Adalimumab for Moderate to Severe Plaque Psoriasis. [2023]