Phase 2b Study of Tulisokibart in Participants With Psoriatic Arthritis

Trial ID: 2025-520997-21-00
Protocol: MK-7240-015
Sponsor: Merck Sharp & Dohme LLC

Trial statistics

science

test molecules

location_city

research sites

public

countries

medical_information

disease

person_search

investigators

handshake

vendors

Diseases & Conditions

Psoriatic arthropathy

Objectives

The primary objective of this study is to evaluate the efficacy of tulisokibart compared to placebo in patients with psoriatic arthritis, defined by the proportion of participants achieving the ACR20 response at Week 16. The secondary objectives include:

Evaluation of efficacy based on the proportion of participants achieving ACR50 and ACR70 at Week 16.
Assessment of efficacy through the change from baseline in the HAQ-DI at Week 16.
Evaluation of the safety and tolerability of tulisokibart.

Participants

This clinical trial involves a total of 97 patients. The study population includes both male and female individuals within the age ranges of 3 and 4. All participants have a clinical diagnosis of psoriatic arthritis with a symptom onset of at least 6 months prior to screening. Inclusion requires the presence of active disease, characterized by at least 3 tender joints and 3 swollen joints. Additionally, subjects must have a diagnosis or documented history of plaque psoriasis. The cohort consists of individuals who have demonstrated an inadequate response or intolerance to specific disease-modifying antirheumatic drugs. The primary objectives of the study are:

To evaluate the efficacy of tulisokibart compared with placebo as assessed by the proportion of participants achieving ACR20 at Week 16.

Plans and Procedures

This Phase 2b, randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of tulisokibart in participants diagnosed with psoriatic arthritis. The primary objective is to assess efficacy by measuring the proportion of participants achieving the American College of Rheumatology 20% Response Criteria (ACR20) at Week 16. Secondary endpoints include the achievement of ACR50 and ACR70, the mean change from baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI), and the frequency of adverse events.

Treatment

The experimental treatment consists of tulisokibart, which is provided as a solution for injection in pre-filled injector. The administration route is specified as other use.

The control group receives a placebo designated as Placebo to MK-7240.

Efficacy

The efficacy of tulisokibart in participants with psoriatic arthritis will be evaluated through several predefined endpoints. The primary efficacy endpoint is the proportion of participants achieving the American College of Rheumatology 20% Response Criteria (ACR20) at Week 16.

Secondary efficacy assessments include:

The proportion of participants achieving the ACR50 at Week 16.
The proportion of participants achieving the ACR70 at Week 16.
The mean change from baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 16.

Inclusion and Exclusion Criteria

check_circle

Inclusion Criteria

Has a clinical diagnosis of psoriatic arthritis (PsA), with symptom onset ≥6 months before Screening.
Has active disease, defined as ≥3 tender joints and ≥3 swollen joints.
Has a diagnosis of active plaque psoriasis or documented history of plaque psoriasis.
Has had inadequate response or intolerance to certain disease-modifying antirheumatic drugs (DMARDs).
If on treatment with any protocol-specified drugs during the study, meets drug stable duration requirements, as applicable.

cancel

Exclusion Criteria

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 interfere with the assessment of PsA.
Has a skin condition diagnosis, other than psoriasis that may interfere with the assessment of psoriasis.
Has a diagnosis of fibromyalgia that has been active within the 12 months before randomization or would have the potential to interfere with efficacy assessments.
Has a transplanted organ and requires continued systemic immunosuppression.
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 had a diagnostic evaluation suggestive of malignancy (eg, chest or breast imaging) and the possibility of malignancy cannot be reasonably excluded following additional clinical assessments.
Has a known infection with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus.
Has any active infection.
Has active tuberculosis.
Has had major surgery within 3 months before Screening or has a major surgery (ie, surgical procedure requiring general anesthesia) planned during the study.
Has had joint surgery at joints to be assessed in the study ≤8 weeks before randomization.
Has had inadequate response, intolerance, or treatment with a targeted synthetic DMARD for ≥8 weeks.
Has received an intra-articular, trigger point, tender point, intra-bursa, or intra-tendon sheath injection <8 weeks before randomization.