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

Phase 2RecruitingNCT07486960

Merck Sharp & Dohme LLC140 enrolled

Overview

Researchers are looking for new ways to treat Psoriatic Arthritis (PsA). This study will help find out if a study medicine called tulisokibart (MK-7240) can treat symptoms of active PsA. This study assesses the efficacy, safety, and tolerability of tulisokibart in adult participants with active PsA. In this study, researchers will look at different doses of tulisokibart. Researchers want to learn if at least one of the study doses of tulisokibart works better than a placebo to lessen PsA symptoms. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of the study medicine.

This study consists of a 16-week Placebo-controlled Period and a 112-week Long-term Extension (LTE), which is composed of a 40-week Main Extension and a 72-week Optional Extension.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

140

Conditions

Psoriatic Arthritis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * 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 Criteria: The main exclusion criteria include but are not limited to the following: * 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.

Locations (50)

Arizona Arthritis & Rheumatology Associates, P.C. ( Site 5117)

Sun City, Arizona, United States

RECRUITING

Arizona Arthritis & Rheumatology Associates, P.C. - Tucson ( Site 5120)

Tucson, Arizona, United States

RECRUITING

Medvin Clinical Research - Riverside ( Site 5115)

Riverside, California, United States

RECRUITING

Cohen Medical Centers ( Site 5111)

Thousand Oaks, California, United States

Outcomes

Primary Outcomes

Percentage of Participants Achieving American College of Rheumatology 20% Response Criteria (ACR20) at Week 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).

Time frame: Week 16

Secondary Outcomes

Percentage of Participants Achieving American College of Rheumatology 50% Response Criteria (ACR50) at Week 16

ACR50 response is defined as a ≥50% improvement in a) tender joint count based on 68 joints and swollen joint count based on 66 joints (0= absent; 1= present) and b) ≥50% improvement in ≥3 of 5 components: i) HAQ-DI (0=without any difficulty; 3= unable to do; a higher score=worse disability); ii) PGA (0= not active to 10= very active; a higher score= more active disease); iii) 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) hsCRP blood values (lower value indicates less inflammation).

Time frame: Week 16

Percentage of Participants Achieving American College of Rheumatology 70% Response Criteria (ACR70) at Week 16

ACR70 response is defined as a ≥70% improvement in a) tender joint count based on 68 joints and swollen joint count based on 66 joints (0= absent; 1= present) and b) ≥70% improvement in ≥3 of 5 components: i) HAQ-DI (0=without any difficulty; 3= unable to do; a higher score=worse disability); ii) PGA (0= not active to 10= very active; a higher score= more active disease); iii) 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) hsCRP blood values (lower value indicates less inflammation).

Time frame: Week 16

Change from Baseline in HAQ-DI Score at Week 16

The HAQ-DI is a 20-item questionnaire that measures physical function. The questionnaire assesses the degree of difficulty a person has in accomplishing tasks in 8 functional area domains (dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area domain are scored from 0 to 3 (0= without any difficulty; 3= unable to do), with a higher score indicating inability to perform activity. The overall disability score (HAQ-DI) is a summation of the highest score from each domain divided by the number of domains completed and ranges from 0 to 3, with the higher value indicating worse disability.

Time frame: Baseline and Week 16

Number of Participants with ≥1 Adverse Event

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Time frame: Up to approximately Week 142

Number of Participants Who Discontinue Study Intervention Due to an AE

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Time frame: Up to approximately Week 128

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

Overview

Conditions

Interventions

Eligibility

Locations (50)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts