Deucravacitinib-TNFi Combination Therapy for Difficult-to-Control Psoriatic Disease
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 65 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether adding deucravacitinib to current psoriatic arthritis treatment improves symptoms and quality of life. It is for adults ages 18–65 whose skin or joint symptoms are not well controlled by anti-TNF medicine, which blocks a cause of swelling.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 18–65 and have confirmed psoriatic arthritis, a disease that causes joint pain and swelling.
- You can agree to join after learning about the study and can follow study instructions.
- You have taken a steady anti-TNF treatment for at least 6 months but still have raised, scaly skin patches covering more than 3% of your body, or more than 2 swollen joints and more than 3 tender joints.
- You may also take one standard disease-control drug: methotrexate, sulfasalazine, leflunomide, or hydroxychloroquine. You must have taken it for at least 12 weeks, with a steady dose for at least 28 days before starting.
- Dose limits are methotrexate: 25 mg per week; sulfasalazine: 3 g per day; hydroxychloroquine: 400 mg per day; and leflunomide: 20 mg per day. The way you take methotrexate must also stay the same.
- If you stopped these drugs, you must have been off methotrexate, sulfasalazine, or hydroxychloroquine for at least 28 days, or leflunomide for at least 12 weeks before starting.
- If you take an NSAID, a medicine for pain and swelling, your dose must be steady for at least 14 days before starting.
- If you take steroid pills, your dose must be steady for at least 28 days and no higher than 15 mg of prednisone per day, or an equal dose of another steroid. If you do not currently take them, you must have been off them for at least 28 days.
Who can't join
- More than 2 anti-TNF treatments failed to help; a TYK2 or JAK blocker failed to help; or an IL-17 or IL-23 blocker did not help from the start. You also cannot join if deucravacitinib caused an allergy or you could not tolerate it.
- You used other whole-body treatments within 6 months before the study, apart from allowed anti-TNF and standard disease-control drugs; take steroid doses above the study limit; or use skin treatments other than mild-to-medium steroid creams only on areas such as the face.
- You have severe heart, liver, or kidney problems; a history of clots in veins or major heart or blood vessel events; current cancer in an organ or tissue, cancer within the past 5 years, or any history of blood cancer.
- You had an active infection or illness with fever within 14 days before starting, or a serious infection needing hospital care or injected infection medicine within 60 days. Ongoing or repeated infections, current treatment for a long-term infection, or repeated serious infections needing hospital care in the past 5 years also exclude you.
- You had shingles or herpes sores within 30 days before study group assignment, or have a history of serious herpes infection, including infection of the eyes or brain, widespread infection, or more than 2 shingles episodes in 2 years.
- You have a known or suspected weak immune system, including past spleen removal or infections that usually affect people with weak immune systems. You received a live vaccine within 60 days before starting, or plan one during treatment or within 60 days afterward.
- You have evidence of hepatitis B or C, or test positive for HIV. Past active tuberculosis (TB), signs of active TB, a positive TB blood test, or 2 unclear TB blood tests also exclude you.
- You have fibromyalgia, increased pain sensitivity, another joint disease, or another skin disease that would make symptoms hard to measure. Any other condition the study doctor thinks would make the study unsafe or results hard to assess also excludes you.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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.
Study sites (1)
TX
- UT Southwestern Medical Center · Dallas, TX 75390Joseph F Merola, MD MMSc · Study contact · 917-671-8192 · joseph.merola@utsouthwestern.eduAleuna Lee, PhD, CCRC · Study contact · 214-645-8968 · aluena.lee@utsouthwestern.eduMore trials in Dallas