Deucravacitinib-TNFi Combination Therapy for Difficult-to-Control Psoriatic Disease

NCT07280702 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: STU-2025-0977
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to determine the effectiveness of adding deucravacitinib to the participant's current Psoriatic Arthritis (PsA) treatment to see if it improves their symptoms and quality of life. This study is exploring a new treatment approach that may help improve control of psoriatic disease by targeting different parts of the disease process. By combining therapies that work together, the goal is to offer better symptom relief with fewer or more manageable side effects than some current treatments.

Conditions

Psoriatic Arthritis (PsA)

Keywords

Psoriatic Arthritis; PsA; Deucravacitinib; TNF

Outcome Measures

Primary Outcomes (1)

• Proportion of patients achieving a novel composite endpoint of BSA </= 1 AND SJC </= 1) OR (BSA </= 1 AND TJC </= 1) at 24 weeks

  Proportion of patients achieving a novel composite endpoint of BSA \</= 1 AND SJC \</= 1) OR (BSA \</= 1 AND TJC \</= 1) at 24 weeks

  24 weeks

Secondary Outcomes (14)

• Safety and tolerability, measured through adverse event reporting at baseline and weeks 5, 12, 24, and 48.

  baseline and weeks 5, 12, 24, and 48

• Proportion of patients achieving Minimal Disease Activity (5/7 criteria) at weeks 24 and 48

  weeks 24 and 48

• Proportion of patients achieving Very Low Disease Activity (7/7 criteria) at weeks 24 and 48

  weeks 24 and 48

• Proportion of patients achieving Minimal Disease Activity - Skin (MDA with skin domain met) at weeks 24 and 48

  weeks 24 and 48

• Percentage achieving Psoriatic Area and Severity Index 75/90/100, PASI < 1 BL at weeks 12, 24 and 48

  baseline and weeks 12, 24 and 48

Other Outcomes (5)

• Leed's enthesitis (resolution) BL at weeks 24 and 48

  baseline and weeks 24 and 48

• Widespread pain index at baseline and at weeks 24 and 48

  baseline and weeks 24 and 48

• International Dermatology Outcome Measure Musculoskeletal Questionnaire instrument (instrument validation) at baseline and at weeks 12, 24 and 48

  baseline and weeks 12, 24 and 48

Study Arms (2)

established standard of care anti-TNF plus deucravacitinib

EXPERIMENTAL

Deucravacitinib will be administered in tablet form. Anti-TNF will be administered by injection.

Drug: Deucravacitinib

established standard of care anti-TNF plus placebo

PLACEBO COMPARATOR

Placebo will be administered in tablet form. Anti-TNF will be administered by injection.

Drug: Placebo

Interventions

Deucravacitinib DRUG

Drug will be administered in tablet form.

established standard of care anti-TNF plus deucravacitinib

Placebo DRUG

Drug will be administered in tablet form.

established standard of care anti-TNF plus placebo

Eligibility Criteria

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

You may qualify if:

• Adults aged 18-65 with confirmed psoriatic arthritis based on CASPAR criteria.
• Ability to provide informed consent and comply with study procedures.
• Patients with plaque psoriasis BSA\>3% OR PsA with \[SJC\>2 AND TJC \>3\] despite stable background anti-TNF therapy for at least 6 months, with or without csDMARDs (i.e MTX, leflunomide, sulfasalazine, hydroxychloroquine).
• Concurrent use of 1 csDMARD, and/or NSAID, and/or oral glucocorticoid is permitted but not required during the study. If such treatment was administered, then participants must meet the following requirements:
• If on csDMARD (methotrexate \[MTX\], sulfasalazine \[SSZ\], leflunomide \[LEF\], hydroxychloroquine \[HCQ\]), the participant must have been on it for at least 12 weeks and be on a stable dose for at least 28 days prior to Day 1.
• If on MTX, the route of administration and dose must be stable and the dose must be ≤ 25 mg/week.
• If on SSZ, the dose must be ≤ 3 g/day.
• If on HCQ, the dose must be ≤ 400 mg/day.
• If on LEF, the dose must be ≤ 20 mg/day. Note: If currently not on MTX, SSZ, or HCQ, the participant must not have received it for at least 28 days prior to Day 1. If currently not on LEF, the participant must not have received it for at least 12 weeks prior to Day 1.
• If on an NSAID, the participant must be on a stable dose for at least 14 days prior to Day 1.
• Stable background use of prednisone 15 mg daily or equivalent is permitted. If on oral glucocorticoids, the participant must be on a stable dose of ≤ 15 mg/day prednisone equivalent for at least 28 days prior to Day 1.
• Note: If currently not on oral glucocorticoids, the participant must not have received oral glucocorticoids within 28 days prior to Day 1

You may not qualify if:

• History of failure of more than two anti-TNF therapies, prior history of failure of TYK2 and JAK inhibitors.
• History of prior allergic reaction or intolerance to deucravacitinib.
• History of primary failure of anti-IL17, anti-IL23 is excluded. Note that prior exposure to these agents is allowed for reasons other than primary failure, eg intolerance, insurance / access issues, etc).
• Systemic agents other than anti-TNF or csDMARD (ie. MTX, leflunomide, sulfasalazine, hydroxychloroquine) must have ceased \> 6 months prior to baseline.
• Doses or glucocorticoids \>15mg daily prednisone or equivalent.
• Severe cardiovascular, hepatic, or renal impairment.
• History or evidence of outpatient active infection and/or febrile illness within 14 days prior to Day 1.
• History of serious bacterial, fungal, or viral infection requiring hospitalization or parenteral antimicrobial treatment (eg, antibiotics antiviral, antifungal, or antiparasitic agents) within 60 days prior to Day 1.
• Receipt of any therapy for chronic infection (eg, pneumocystis, herpes zoster, cytomegalovirus, invasive bacterial or fungal infections, or atypical mycobacteria) at screening.
• Recent herpes zoster or herpes simplex infection or history of serious herpes zoster or herpes simplex infection defined as:
• a) Herpes zoster or herpes simplex lesions within 30 days prior to randomization, OR
• b) History of serious herpes zoster or serious herpes simplex infection, which includes, but it is not limited to, any episode of disseminated herpes simplex, multi- dermatomal herpes zoster, herpes encephalitis, ophthalmologic herpes, and/or recurrent herpes zoster (recurrent herpes zoster is defined as more than 2 episodes in the last 2 years).
• Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status (eg, history of opportunistic infections \[eg, Pneumocystis jirovecii pneumonia, histoplasmosis, or coccidioidomycosis\], history of splenectomy, primary immunodeficiency).
• Receipt of any live vaccine within 60 days prior to Day 1 or plans to receive a live vaccine during the study or within 60 days after completing study treatment.
• Evidence of, or positive testing for, hepatitis B virus or hepatitis C virus at screening.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Joseph F. Merola, MD MMSc

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleuna Lee, PhD, CCRC

CONTACT

214-645-8968; aleuna.lee@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Chair-Dermatology

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 12, 2025
• Study Start: April 15, 2026
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (1)