Psoriatic ArthritisPhase 2NCT07486960
Study to Evaluate Tulisokibart in Adults With Psoriatic Arthritis (MK-7240-015)
A Phase 2 study testing Tulisokibart in people with Psoriatic Arthritis, run by Merck Sharp & Dohme LLC at 50 sites in 8 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Tulisokibart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 50 sitesin 8 countries
- Study dates
- 20 Apr 2026to 18 Jul 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
50 sites in 8 countries.
50 sites in 8 countries
United States18 sites
Arthritis and Rheumatic Disease Specialties ( Site 5105)
Aventura, Florida, 33180
Johns Hopkins University Division of Rheumatology ( Site 5132)
Baltimore, Maryland, 21224
St. Luke's Clinic - Rheumatology - Boise ( Site 5109)
Boise, Idaho, 83702-4565
Joseph S. and Diane H. Steinberg Ambulatory Care Center ( Site 5106)
Brooklyn, New York, 11201
Joint and Muscle Research Institute ( Site 5108)
Charlotte, North Carolina, 28204
Altoona Center for Clinical Research ( Site 5110)
Duncansville, Pennsylvania, 16635
Greater Houston Rheumatology ( Site 5103)
Houston, Texas, 77095
Kansas City Physician Partners ( Site 5119)
Kansas City, Missouri, 64111
Physician Research Collaboration, LLC ( Site 5102)
Lincoln, Nebraska, 68516
Perelman Center for Advanced Medicine ( Site 5134)
Philadelphia, Pennsylvania, 19104
Medvin Clinical Research - Riverside ( Site 5115)
Riverside, California, 92508
Arthritis and Rheumatism Associates - Rockville ( Site 5127)
Rockville, Maryland, 20850
Articularis Healthcare Group dba: Low Country Rheumatology ( Site 5128)
Summerville, South Carolina, 29486
Arizona Arthritis & Rheumatology Associates, P.C. ( Site 5117)
Sun City, Arizona, 85351
International Center for Research ( Site 5124)
Tampa, Florida, 33618
Cohen Medical Centers ( Site 5111)
Thousand Oaks, California, 91360
Arizona Arthritis & Rheumatology Associates, P.C. - Tucson ( Site 5120)
Tucson, Arizona, 85704-1140
Medvin Clinical Research - Tujunga ( Site 5113)
Tujunga, California, 91042
Ukraine7 sites
Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrain ( Site 7401)
Kiev, Kyiv Oblast, 03049
Edelweiss Medics ( Site 7409)
Kyiv, Kyivska Oblast, 02002
Medical Center of Limited Liability Company "Medical Center "Consilium Medical" ( Site 7415)
Kyiv, Kyivska Oblast, 04050
Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 7406)
Kyiv, 03057
Lviv Clin Hospital of Planned Treatment Rehabilitation Palliative Care ( Site 7410)
Lviv, Lviv Oblast, 79011
Limited liability company "Medical center Health Clinic" ( Site 7412)
Vinnytsia, Vinnytsia Oblast, 21009
Municipal Nonprofit Enterprise "Vinnytsia Regional Clinical Hospital n.a. M. I. Pyrohov of Vinnytsia ( Site 7400)
Vinnytsia, Vinnytsia Oblast, 21028
Chile6 sites
Centro de Estudios GyC ( Site 8206)
Santiago, Region M. de Santiago, 7500504
Enroll SpA ( Site 8203)
Santiago, Region M. de Santiago, 7500587
Clinica Dermacross ( Site 8200)
Santiago, Region M. de Santiago, 7640881
CECIM ( Site 8205)
Santiago, Region M. de Santiago, 8331143
Bradfordhill ( Site 8212)
Santiago, Region M. de Santiago, 8420383
Centro Internacional de Estudios Clinicos (CIEC) ( Site 8201)
Santiago, Region M. de Santiago, 8420383
Poland6 sites
MICS Centrum Medyczne Bydgoszcz ( Site 6907)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-065
Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy ( Site 6904)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168
Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 6901)
Lublin, Lubusz Voivodeship, 20-607
MICS Centrum Medyczne Torun ( Site 6903)
Torun, Kuyavian-Pomeranian Voivodeship, 87-100
MICS Centrum Medyczne Warszawa ( Site 6905)
Warsaw, Masovian Voivodeship, 00-874
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im.Prof. El. Reicher-ul.Spartanska 1 ( Site 6906)
Warsaw, Masovian Voivodeship, 02-637
Germany4 sites
Rheumatologische Schwerpunktpraxis ( Site 6405)
Berlin, 10777
Rheuma-Research Lausitz ( Site 6409)
Cottbus, Brandenburg, 03042
HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg G ( Site 6404)
Hamburg, 20095
Rheumazentrum Ruhrgebiet ( Site 6400)
Herne, North Rhine-Westphalia, 44649
Spain4 sites
Hospital Vall d' Hebron ( Site 7101)
Barcelona, 08029
Hospital Viamed Santa Elena ( Site 7105)
Madrid, 28003
CHUS - Hospital Clinico Universitario ( Site 7102)
Santiago de Compostela, La Coruna, 15706
Hospital Universitario la Fe ( Site 7107)
Valencia, 46026
Colombia3 sites
Clinica de la Costa S.A.S. ( Site 8301)
Barranquilla, Atlántico, 080020
Centro de investigacion en reumatologia y especialidades medicas SAS (CIREEM SAS) ( Site 8306)
Bogota, Cundinamarca, 110221
Fundación Valle del Lili ( Site 8302)
Cali, Valle del Cauca Department, 760032
Canada2 sites
Centre Rhumatologie De L'Est ( Site 5201)
Rimouski, Quebec, G5L 8W1
Centre de Recherche Musculo-Squelettique ( Site 5202)
Trois-Rivières, Quebec, G9A 3Y2
About this study
Official title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Psoriatic Arthritis.
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.
Read the detailed description
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.
- Conditions
- Psoriatic Arthritis
- Being tested
- Tulisokibart, Placebo
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TulisokibartDrug
Also called MK-7240, PRA023
Subcutaneous administration
PlaceboDrug
Subcutaneous administration
| Study group | Role | What they receive |
|---|---|---|
| High-Dose Regimen | Experimental | Participants receive a high dose of tulisokibart. Receives: Drug: Tulisokibart |
| Medium-Dose Regimen | Experimental | Participants receive a medium dose of tulisokibart. Receives: Drug: Tulisokibart |
| Low-Dose Regimen | Experimental | Participants receive a low dose of tulisokibart and are rerandomized at Week 16 to a medium or high dose of tulisokibart. Receives: Drug: Tulisokibart |
| Placebo Regimen | Placebo comparator | Participants receive a matched placebo dose and are rerandomized at Week 16 to a medium or high dose of tulisokibart. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Week 16
Secondary outcomes (5)
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to approximately Week 128
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start20 Apr 2026
- Primary completion17 Feb 2027 (estimated)
- Study completion18 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic ArthritisStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486960
- Sponsor's protocol ID
- 7240-015
- Other IDs
- U1111-1318-4301, 2025-520997-21-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 19 Mar 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf