Deucravacitinib-TNFi Combination for Difficult-to-Control Psoriatic Disease
This study is looking at whether adding deucravacitinib to your current treatment for Psoriatic Arthritis (PsA) can better control your symptoms and improve your quality of life. We are testing deucravacitinib, given as a tablet, alongside your existing anti-TNF therapy. You might receive deucravacitinib or a placebo (an inactive tablet). This study is for adults aged 18-65 with confirmed PsA and ongoing symptoms despite stable anti-TNF treatment. The main goal is to see if this combination helps reduce the amount of body surface affected by psoriasis and the number of swollen or tender joints after 24 weeks.
- Study design
- This study plans to enroll 128 participants. It is an interventional study, meaning participants will receive either deucravacitinib or a placebo.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The main results will be measured at 24 weeks after starting treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07280702
Deucravacitinib-TNFi Combination Therapy for Difficult-to-Control Psoriatic Disease
Recruiting
PHASE4Ages 18–65InterventionalTreatmentUniversity of Texas Southwestern Medical CenterInvestigator-initiated
~128 participants
Updated 2026-09-01 on ClinicalTrials.gov
What's tested:DeucravacitinibPlacebo
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients achieving a novel composite endpoint of BSA </= 1 AND SJC </= 1) OR (BSA </= 1 AND TJC </= 1) at 24 weeks
Measured over 24 weeks
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- Joseph F. Merola, MD MMSc · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
Exclusion
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.
Positive testing for human immunodeficiency virus 1 or 2 by antibody testing at screening.
History of active TB prior to the screening visit, signs or symptoms of active TB at screening, positive QuantiFERON®-TB Gold (or equivalent) test result or 2 successive indeterminate QuantiFERON®-TB Gold (or equivalent) test results at screening.
History of chronic or recurrent infectious disease.
History of VTE, MACE, active solid malignancy or history of malignancy \<5 years, any hematologic malignancy; history of multiple serious infections requiring hospitalization in the past 5 years, history of opportunistic infection, any condition which in the opinion of the investigator would pose a safety risk or inability to assess key endpoints in the study.
History of fibromyalgia/central sensitization, or other joint disease which in the opinion of the investigator would make musculoskeletal disease activity assessment challenging in the context of this study.
History of other inflammatory dermatosis which in the opinion of the investigator would make skin disease activity assessment challenging in the context of this study (eg atopic, contact dermatitis, etc).
Exclude use of topicals except for mild to mid-potency topical steroids for use only in cosmetically sensitive areas such as the face.
What this trial measures
- Proportion of patients achieving a novel composite endpoint of BSA </= 1 AND SJC </= 1) OR (BSA </= 1 AND TJC </= 1) at 24 weeks24 weeks
Proportion of patients achieving a novel composite endpoint of BSA \</= 1 AND SJC \</= 1) OR (BSA \</= 1 AND TJC \</= 1) at 24 weeks