Study of Tulisokibart for Psoriatic Arthritis

Researchers are studying a new medicine called tulisokibart to see if it can help adults with active Psoriatic Arthritis (PsA). This study will compare tulisokibart to a placebo, which looks like the study medicine but has no active drug. The goal is to find out if tulisokibart can reduce PsA symptoms and if it is safe and well-tolerated. You may be able to join if you are between 18 and 80 years old, have had PsA for at least six months, and also have active plaque psoriasis or a history of it. The main way researchers will measure success is by looking at the percentage of participants who show a 20% improvement in their PsA symptoms after 16 weeks. The current status of this study is unclear.

Study design
This is an interventional study with an estimated 140 participants. It includes a 16-week placebo-controlled period.
What's involved
Participants will receive either tulisokibart or a placebo through subcutaneous injections. The study involves a 16-week placebo-controlled period, followed by a long-term extension of 112 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 16 weeks to assess the primary endpoint. There is also a long-term extension period of 112 weeks.

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NCT07486960

Study to Evaluate Tulisokibart in Adults With Psoriatic Arthritis (MK-7240-015)

Recruiting
PHASE2Ages 18–80InterventionalTreatment
Merck Sharp & Dohme LLC
~140 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:TulisokibartPlacebo

At a glance

Recruiting sites
50 of 50 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants Achieving American College of Rheumatology 20% Response Criteria (ACR20) at Week 16
Measured over Week 16
Psoriatic Arthritis
50 sites across 30 states
Region M. de Santiago6
California3
Kuyavian-Pomeranian Voivodeship3
Spain3
Arizona2
Florida2
Maryland2
Pennsylvania2
  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

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Eligibility criteria

Inclusion

Has a clinical diagnosis of PsA and fulfillment of the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria at Screening, with symptom onset ≥6 months before Screening.
Has a diagnosis of active plaque psoriasis or documented history of plaque psoriasis.
Has history of biologic disease-modifying antirheumatic drug (bDMARD)-naïve or bDMARD-inadequate response/intolerant.

Exclusion

Has any arthritis with onset before age 17 years or current diagnosis of inflammatory joint disease other than PsA (such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, myositis, etc), or any other conditions that may, in the judgment of the investigator, interfere with the assessment of PsA.
Has a skin condition diagnosis, other than psoriasis that may, in the judgment of the investigator, interfere with the assessment of psoriasis.
Has a history of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \<5 years before Randomization.
Has any active infection.
Has known allergies, hypersensitivity, or intolerance to tulisokibart of its excipients.
  • Percentage of Participants Achieving American College of Rheumatology 20% Response Criteria (ACR20) at Week 16Week 16

    ACR20 response is defined as a ≥20% improvement in a) tender joint count based on 68 joints and swollen joint count based on 66 joints (0= absent; 1= present) and b) ≥20% improvement in ≥3 of 5 components: i) Health Assessment Questionnaire Disability Index (HAQ-DI) (0=without any difficulty; 3= unable to do; a higher score=worse disability); ii) Physician Global Assessment of Disease Activity (PGA) (0= not active to 10= very active; a higher score= more active disease); iii) Patient's Global Assessment of Disease Activity (PtGA) (0= not active to 10= very active; a higher score= more active disease); iv) Patient assessment of Pain Severity (0= no pain to 10= most severe pain; a higher score = more pain); v) High-sensitivity C-reactive protein (hsCRP) blood values (lower value indicates less inflammation).