Psoriatic Arthritis (PsA)Phase 4COMBoNCT07280702
Deucravacitinib-TNFi Combination Therapy for Difficult-to-Control Psoriatic Disease
A Phase 4 study testing Deucravacitinib in people with Psoriatic Arthritis (PsA), run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriatic Arthritis (PsA)
- What is being tested?
- Deucravacitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2026to 15 Dec 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Joseph F Merola, MD MMSc, 917-671-8192, joseph.merola@utsouthwestern.edu
Aleuna Lee, PhD, CCRC, 214-645-8968, aluena.lee@utsouthwestern.edu
About this study
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)
- Being tested
- Deucravacitinib, Placebo
- Keywords
- Psoriatic Arthritis, PsA, Deucravacitinib, TNF
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeucravacitinibDrug
Drug will be administered in tablet form.
PlaceboDrug
Drug will be administered in tablet form.
| Study group | Role | What they receive |
|---|---|---|
| established standard of care anti-TNF plus deucravacitinib | Experimental | Deucravacitinib will be administered in tablet form. Anti-TNF will be administered by injection. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 weeks
Secondary outcomes (14)
Safety and tolerability, measured through adverse event reporting at baseline and weeks 5, 12, 24, and 48.
Safety and tolerability, measured through adverse event reporting at baseline and weeks 5, 12, 24, and 48.
Measured: baseline and weeks 5, 12, 24, and 48
Proportion of patients achieving Minimal Disease Activity (5/7 criteria) at weeks 24 and 48
Reaching Minimal Disease Activity involves achieving 5 of 7 criteria. The 7 criteria include less than or equal to 1 tender joint count, patient global assessment of disease activity via Visual Analog Scale of less than or equal to 20, less than or equal to 1 swollen joint count, tender entheseal points of less than or equal to 1, Psoriatic Area and Severity Index of less than or equal to 1 OR Body Surface Area of less than or equal to 3 %, patient pain via Visual Analog Scale of less than or equal to 15, and Health Assessment Questionnaire - Disability Index of less than or equal to 0.5. The Minimal Disease Activity assessment will be done at weeks 24 and 48.
Measured: weeks 24 and 48
Proportion of patients achieving Very Low Disease Activity (7/7 criteria) at weeks 24 and 48
Very Low Disease Activity involves achieving 7 of 7 criteria. The 7 criteria include less than or equal to 1 tender joint count, patient global assessment of disease activity via Visual Analog Scale of less than or equal to 20, less than or equal to 1 swollen joint count, tender entheseal points of less than or equal to 1, Psoriatic Area and Severity Index of less than or equal to 1 OR Body Surface Area of less than or equal to 3 %, patient pain via Visual Analog Scale of less than or equal to 15, and Health Assessment Questionnaire - Disability Index of less than or equal to 0.5. The Very Low Disease Activity assessment will be done at weeks 24 and 48.
Measured: weeks 24 and 48
Proportion of patients achieving Minimal Disease Activity - Skin (MDA with skin domain met) at weeks 24 and 48
Minimal Disease Activity - Skin is determined by a Psoriatic Area and Severity Index of less than or equal to 1 OR Body Surface Area of less than or equal to 3 %. The Minimal Disease Activity - Skin assessment will be done at weeks 24 and 48.
Measured: weeks 24 and 48
Percentage achieving Psoriatic Area and Severity Index 75/90/100, PASI < 1 BL at weeks 12, 24 and 48
75%, 90% and 100% improvement in Psoriatic Area and Severity Index of less than 1 at baseline. This assessment will be done at weeks 12, 24 and 48.
Measured: baseline and weeks 12, 24 and 48
Percentage achieving BSA < 1% (NPF definition) BL at weeks 12, 24 and 48
Percentage achieving BSA < 1% (NPF definition) BL at weeks 12, 24 and 48
Measured: baseline and weeks 12, 24 and 48
Resolution of Spondyloarthritis Research Consortium of Canada at baseline and at weeks 24 and 48
Resolution of Spondyloarthritis Research Consortium of Canada at baseline and at weeks 24 and 48
Measured: baseline and weeks 24 and 48
Resolution of Leeds Enthesitis Index at baseline and at weeks 24 and 48
Resolution of Leeds Enthesitis Index at baseline and at weeks 24 and 48
Measured: baseline and weeks 24 and 48
Change from baseline Health Assessment Questionnaire - Disability Index at weeks 24 and 48
Change from baseline Health Assessment Questionnaire - Disability Index at weeks 24 and 48
Measured: baseline and weeks 24 and 48
Change from baseline Pruritis Numeric Rating Scale at weeks 12, 24 and 48
Change from baseline Pruritis Numeric Rating Scale at weeks 12, 24 and 48
Measured: baseline and weeks 12, 24 and 48
Change from baseline Joint pain Visual Analog Scale at weeks 12, 24 and 48
Change from baseline Joint pain Visual Analog Scale at weeks 12, 24 and 48
Measured: baseline and weeks 12, 24 and 48
Change from baseline patient global assessment of arthritis at weeks 12, 24 and 48
Change from baseline patient global assessment of arthritis at weeks 12, 24 and 48
Measured: baseline and weeks 12, 24 and 48
Change from baseline Dermatology Life Quality Index at weeks 12, 24 and 48
Change from baseline Dermatology Life Quality Index at weeks 12, 24 and 48
Measured: baseline and weeks 12, 24 and 48
Change from baseline Psoriatic Arthritis Impact of Disease 12-item Questionnaire and proportion achieving Patient Acceptable Symptom State cutoff at weeks 12, 24 and 48
Change from baseline Psoriatic Arthritis Impact of Disease 12-item Questionnaire and proportion achieving Patient Acceptable Symptom State cutoff at weeks 12, 24 and 48
Measured: baseline and weeks 12, 24 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start16 Jun 2026
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic Arthritis (PsA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Merola, University of Texas Southwestern Medical Center
- Investigators
- Joseph F. Merola, MD MMSc, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07280702
- Sponsor's protocol ID
- STU20250977
- Acronym
- COMBo
- Status last verified
- Aug 2026
- First submitted
- 17 Nov 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided