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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Texas Southwestern Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

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).

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Deucravacitinib
  • Placebo

Treatment groups

128 Participants
are divided into 2 treatment groups