Deucravacitinib for Psoriasis
Recruiting in Palo Alto (17 mi)
Overseen byRaymond Cho, MD, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of California, San Francisco
Must not be taking: Systemic immunosuppressives
Disqualifiers: Pregnancy, Severe immunodeficiency, Tuberculosis, others
No Placebo Group
Prior Safety Data
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?
This study aims to assess cutaneous and blood immune cell function of patients with psoriasis before and after initiation of treatment with the Tyrosine kinase 2 (TYK2) blocker, deucravacitinib.
Will I have to stop taking my current medications?
The trial requires that you have not taken systemic immunosuppressives (medications that suppress the immune system) in the last 12 weeks. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.
Is deucravacitinib safe for humans?
Deucravacitinib has been shown to be generally safe in humans, with common side effects including upper respiratory infections, increased blood enzyme levels, herpes simplex infections, mouth ulcers, folliculitis (inflammation of hair follicles), and acne. Long-term use did not increase the rate of these side effects, suggesting a favorable safety profile compared to other similar treatments.12345
How is the drug deucravacitinib unique for treating psoriasis?
Deucravacitinib is unique because it is an oral medication that specifically targets and inhibits 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 affect a broader range of proteins.12567
Eligibility Criteria
Adults with moderate to severe psoriasis (covering at least 10% of their body, with a severity score of 12 or more) can join this trial. They shouldn't have tuberculosis, serious infections, be pregnant or breastfeeding, have used immunosuppressives recently, suffer from severe immune system problems, or any condition that might risk safety or data quality.Inclusion Criteria
I am 18 years old or older.
My psoriasis is severe, covering more than 10% of my body.
Exclusion Criteria
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
I have an active cancer that is affecting my whole body.
I do not have tuberculosis or any serious infection.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive treatment with deucravacitinib for 6 months
6 months
Biopsy and blood samples collected before and during treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 months
Treatment Details
Interventions
- deucravacitinib (Tyrosine kinase 2 (TYK2) blocker)
Trial OverviewThe trial is testing deucravacitinib's effect on skin and blood immune cells in psoriasis patients. It involves taking the TYK2 inhibitor deucravacitinib and monitoring how it changes the function of these cells before and after treatment starts.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: deucravacitinib treatmentExperimental Treatment1 Intervention
treatment with deucravacitinib for 6 months
deucravacitinib is already approved in United States, European Union, Canada, Australia 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
🇦🇺 Approved in Australia as Sotyktu for:
- Moderate-to-severe plaque psoriasis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California, San FranciscoSan Francisco, CA
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Who Is Running the Clinical Trial?
University of California, San FranciscoLead Sponsor
Bristol-Myers SquibbIndustry Sponsor
References
SOTYKTUTM (Deucravacitinib 6-mg Tablets)- A New Agent for the Management of Adult Plaque Psoriasis. [2023]SOTYKTUTM (deucravacitinib) is a newly approved oral agent for managing moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Deucravacitinib is a highly selective allosteric tyrosine kinase 2 inhibitor targeting dysregulated cytokine responses in psoriasis patients. Its efficacy was demonstrated in two randomized, placebo- and active comparator-controlled phase 3 trials, where a significantly higher proportion of patients, up to 58.4% (194/332), achieved lessening of symptoms at week 16. The recommended dosing regimen of deucravacitinib is 6 mg once daily. More frequent adverse reactions occurring in the deucravacitinib-treated patients include upper respiratory infection (19.2% [161/840]), increase in blood creatine phosphokinase (2.7% [23/840]), herpes simplex infection (2.0% [17/840]), mouth ulcers (1.9% [16/840]), folliculitis (1.7% [14/840]), and acne (1.4% [12/840]). Continuance of treatment for up to week 52 did not increase the exposure-adjusted rates of adverse reactions. The selectivity and specificity of deucravacitinib treatment may improve its long-term safety profile, compared to other Janus kinase inhibitors.
Deucravacitinib: First Approval. [2022]Deucravacitinib (SOTYKTU™) is a first-in-class, highly selective, oral tyrosine kinase 2 (TYK2) inhibitor. It acts via an allosteric mechanism, binding to the catalytically inactive pseudokinase regulatory domain of TYK2 and stabilizing an inhibitory interaction between the regulatory and catalytic domains. Deucravacitinib is being developed by Bristol Myers Squibb for the treatment of multiple immune-mediated diseases, including psoriasis, psoriatic arthritis, lupus and inflammatory bowel disease. It received its first approval (in the USA on 9 September 2022) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. On 26 September 2022, it was subsequently approved in Japan for the treatment of plaque psoriasis, generalized pustular psoriasis and erythrodermic psoriasis. The Marketing Authorisation Application for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis has been validated in the EU, and clinical development of the drug for the treatment of multiple immune-mediated diseases is underway in numerous countries worldwide. This article summarizes the milestones in the development of deucravacitinib leading to this first approval for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Short-, Mid-, and Long-Term Efficacy of Deucravacitinib Versus Biologics and Nonbiologics for Plaque Psoriasis: A Network Meta-Analysis. [2023]Deucravacitinib, a newly approved oral medication for the treatment of patients with moderate to severe plaque psoriasis, demonstrated efficacy versus apremilast and placebo in two phase 3 randomized controlled trials (RCTs). A systematic review and network meta-analysis (NMA) indirectly compared deucravacitinib with other relevant systemic biologic/nonbiologic treatments.
Pharmacokinetics and Safety of the Tyrosine Kinase 2 Inhibitor Deucravacitinib in Healthy Chinese Subjects. [2023]Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, blocks cytokine signaling involved in psoriasis pathogenesis. This ethnic-bridging study evaluated deucravacitinib pharmacokinetics, tolerability, and safety in healthy Chinese subjects.
Deucravacitinib in moderate-to-severe psoriasis. [2022]Psoriasis is a chronic inflammatory disease that affects up to 1 in 20 people worldwide. A patient's quality of life and health can be drastically affected by psoriasis. The number of therapies for patients with moderate to severe psoriasis has steadily grown over the past two decades, with biologic immunotherapies being the primary agents developed. However, new small-molecule oral therapies have lagged in development. Deucravacitinib is an oral small molecule that inhibits the activity of TYK2, a member of the JAK family. Deucravacitinib works by allosterically inhibiting TYK2, increasing the specificity of this agent for TYK2 rather than other members of this kinase family. Deucravacitinib has demonstrated safety and efficacy in moderate to severe plaque psoriasis in clinical trial development, with >50% of patients on deucravacitinib 6 mg daily achieving ≥75% reduction in Psoriasis Area and Severity Index score from baseline at 16 weeks versus 9-13% on placebo and 35-41% on apremilast 30 mg twice daily in phase III clinical trials.
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]Deucravacitinib is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor that demonstrated superior efficacy versus placebo and apremilast in a global phase 3 trial (POETYK PSO-1; NCT03624127) in patients with moderate to severe plaque psoriasis (N = 666). This report describes efficacy and safety in Japanese patients from this study (N = 66) who were randomly assigned to treatment with deucravacitinib 6 mg once daily (n = 32), placebo (n = 17), or apremilast 30 mg twice daily (n = 17). Patients randomized to placebo crossed over to deucravacitinib at Week 16. Patients randomized to apremilast who did not achieve ≥50% reduction from baseline in Psoriasis Area and Severity Index (PASI 50) score at Week 24 switched to deucravacitinib. The proportion of Japanese patients achieving ≥75% reduction from baseline in PASI (PASI 75) score was numerically higher with deucravacitinib versus placebo and apremilast at Week 16 (78.1% vs. 11.8% and 23.5%, respectively) and versus apremilast at Week 24 (78.1% vs. 29.4%). A numerically higher proportion of patients achieved a static Physician's Global Assessment score of 0 or 1 (clear or almost clear) with at least a two-point improvement from baseline (sPGA 0/1) with deucravacitinib versus placebo or apremilast at Week 16 (75.0% vs. 11.8% and 35.3%) and versus apremilast at Week 24 (75.0% vs. 29.4%). Findings for other clinical and patient-reported outcomes also favored deucravacitinib. Response rates were maintained through 52 weeks in the deucravacitinib group. Incidence rates for adverse events per 100 person-years (PY) in the Japanese patients were comparable across treatment groups through Week 52 (deucravacitinib, 336.8/100 PY; placebo, 321.0/100 PY; apremilast, 358.6/100 PY). The most frequently reported adverse event with deucravacitinib was nasopharyngitis. The efficacy and safety of deucravacitinib in Japanese patients was consistent with those in the global population in POETYK PSO-1.
Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial. [2022]Deucravacitinib is an oral, selective tyrosine kinase 2 inhibitor that demonstrated therapeutic benefit in a Phase 2 clinical trial of adults with moderate to severe plaque psoriasis. This analysis was designed to evaluate the effect of deucravacitinib on additional clinical and quality-of-life (QoL) outcomes and assess the relationship between these outcomes in adults with psoriasis.