Study to Evaluate Tulisokibart in Adults With Psoriatic Arthritis (MK-7240-015)
ConditionPsoriatic Arthritis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMerck Sharp & Dohme LLC
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Tulisokibart
DrugSubcutaneous administration
Placebo
DrugSubcutaneous administration
Treatment groups
140 Participants
are divided into 4 treatment groupsGroup A: High-Dose RegimenExperimental treatment 1 intervention
Group B: Medium-Dose RegimenExperimental treatment 1 intervention
Group C: Low-Dose RegimenExperimental treatment 1 intervention
Group D: Placebo RegimenPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 16Secondary outcomes
1
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 162
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 163
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 164
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 142Sponsors and contacts
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Source ClinicalTrials.gov