Psoriatic Arthritis study: Deucravacitinib
Official title Deucravacitinib-TNFi Combination Therapy for Difficult-to-Control Psoriatic Disease
ClinicalTrials.gov ID: NCT07280702
What this study is testing
What is Deucravacitinib?
An investigational oral tablet being studied as a potential treatment for psoriatic arthritis (PsA). It is designed to selectively inhibit the TYK2 enzyme, which helps reduce inflammatory signaling in the immune system.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether adding deucravacitinib to your current PsA treatment improves symptoms and quality of life.
- Who it's for
- You may be able to join if you have psoriatic arthritis that is not well controlled with your current medicines.
- What's involved
- You would take deucravacitinib (a pill that blocks a specific immune signal) while staying on your usual treatment. You will attend clinic visits and answer short questionnaires about your symptoms.
- Time commitment
- The study lasts several months and requires clinic visits every few weeks.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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...
- If on csDMARD (methotrexate [MTX], sulfasalazine [SSZ], leflunomide [LEF], hydroxychloroquine [HCQ]), the participant must have been on it for at...
- If on MTX, the route of administration and dose must be stable and the dose must be ≤ 25 mg/week.
You likely can't join 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...
- Systemic agents other than anti-TNF or csDMARD (ie. MTX, leflunomide, sulfasalazine, hydroxychloroquine) must have ceased \> 6 months prior to...
- Doses or glucocorticoids \>15mg daily prednisone or equivalent.
- Severe cardiovascular, hepatic, or renal impairment.
See the full eligibility 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...
- 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...
- 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 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
- 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.
- 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...
- 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...
- 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...
- 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 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Dallas, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.