A Real-world Study of Deucravacitinib in the Treatment of Moderate to Severe Plaque Psoriasis With Eczematous Features

NCT06999941 | Enrolling By Invitation

• 1 other identifier: 20240924103453152
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Emerging evidence indicates that psoriasis and eczema can coexist in the same patient, with reported co-prevalence rates ranging from 0.17% to 20%, suggesting that these conditions may represent a disease spectrum-referred to as Psoriasis Eczema (PsEma). Moreover, paradoxical eczema has been observed in approximately 1% to 12.1% of psoriasis patients undergoing biologic therapy, with up to 61% of affected individuals discontinuing treatment due to eczematous flares. These findings underscore an urgent need for therapeutic agents that are efficacious for PsEma. Tyrosine kinase 2 (TYK2), a member of the Janus kinase (JAK) family, is known to mediate critical signaling pathways involved in psoriasis pathogenesis, including those of type I interferons, interleukin (IL)-12, and IL-23. Additionally, TYK2 forms heterodimers with other JAK family members-such as JAK1 or JAK2-to transduce signals from cytokines like IL-13 and IL-22, which are centrally implicated in the pathophysiology of eczema. Based on this molecular profile, we hypothesize that TYK2 inhibition may not only avoid inducing eczematous reactions in psoriasis patients but may also alleviate eczematous inflammation by interfering with JAK1(JAK2)/TYK2-mediated IL-13 and IL-22 signaling. Deucravacitinib, a selective allosteric TYK2 inhibitor, has shown promising results in our clinical practice, demonstrating improvements in both psoriatic and eczematous manifestations among patients with PsEma. This study aims to prospectively evaluate the efficacy and safety of deucravacitinib in PsEma patients over a 16-week treatment period. In parallel, transcriptomic profiling of peripheral blood and lesional skin will be performed to elucidate the immunological landscape and molecular signatures underlying PsEma, thereby contributing valuable clinical and mechanistic insights into its diagnosis and management.

Conditions

Psoriasis; Eczema; JAK Inhibitor

Outcome Measures

Primary Outcomes (3)

• Percentage of patients with PASI75

  From enrollment to the end of treatment at 16 weeks

• Change from baseline in PASI

  From enrollment to the end of treatment at 16 weeks

• Proportion of patients with s-PGA 0 or 1

  From enrollment to the end of treatment at 16 weeks

Secondary Outcomes (3)

• Proportion of patients with IGA 0 or 1

  From enrollment to the end of treatment at 16 weeks

• change of BSA in eczema from baseline

  From enrollment to the end of treatment at 16 weeks

• Changes from baseline in WI-NRS

  From enrollment to the end of treatment at 16 weeks

Interventions

Deucravacitinib 6mg po qd DRUG

oral administration

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

clinical patients

You may qualify if:

• patients who present typical psoriasis and typical eczema; 2.patients present untypical psoriasis lesions, biopsy result reveals both psoriasis and eczema features; 3.BSA≥3 and IGA≥3.

You may not qualify if:

• Suffering from active autoimmune diseases; Active tuberculosis infection; Hepatitis B surface antigen positive; Uncontrolled systemic diseases such as heart failure, cerebrovascular disease, and liver and kidney dysfunction;
• Known or suspected history of immunosuppression, or although the infection has disappeared, it has been assessed by the researcher as possible Frequent publication of authors;
• History of malignant tumors in the past, or current occurrence of any malignant tumors (excluding basal tumors cured for ≥ 1 year) Cell carcinoma, local squamous cell carcinoma of the skin, or cervical cancer in situ;
• Pregnant or lactating women, or those with pregnancy plans during the trial period.

Sponsors & Collaborators

• Xi Tan: lead

Study Sites (1)

Shanghai general hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200080, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fresh frozen tissue for RNA-seq and RT-PCR, Formalin fixed tissue for IHC and HE

MeSH Terms

Conditions

Psoriasis; Eczema

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Dermatitis; Skin Diseases, Eczematous

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: physician-in-charge

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 31, 2025
• Study Start: April 24, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-04

Locations

CN (1)