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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1318-4301 | Registry Identifier | UTN | |
| 2025-520997-21-00 | Registry Identifier | EU CT |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Dose Regimen | Experimental | Participants receive a high dose of tulisokibart. |
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| Medium-Dose Regimen | Experimental | Participants receive a medium dose of tulisokibart. |
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| 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. |
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| Placebo Regimen | Placebo Comparator | Participants receive a matched placebo dose and are rerandomized at Week 16 to a medium or high dose of tulisokibart. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tulisokibart | Drug | Subcutaneous administration |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Arthritis & Rheumatology Associates, P.C. ( Site 5117) | Recruiting | Sun City | Arizona | 85351 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| Placebo | Drug | Subcutaneous administration |
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| 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). | 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. | 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. | 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. | Up to approximately Week 128 |
| Arizona Arthritis & Rheumatology Associates, P.C. - Tucson ( Site 5120) | Recruiting | Tucson | Arizona | 85704-1140 | United States |
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| Medvin Clinical Research - Riverside ( Site 5115) | Recruiting | Riverside | California | 92508 | United States |
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| Cohen Medical Centers ( Site 5111) | Recruiting | Thousand Oaks | California | 91360 | United States |
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| Medvin Clinical Research - Tujunga ( Site 5113) | Recruiting | Tujunga | California | 91042 | United States |
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| Arthritis and Rheumatic Disease Specialties ( Site 5105) | Recruiting | Aventura | Florida | 33180 | United States |
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| International Center for Research ( Site 5124) | Recruiting | Tampa | Florida | 33618 | United States |
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| St. Luke's Clinic - Rheumatology - Boise ( Site 5109) | Recruiting | Boise | Idaho | 83702-4565 | United States |
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| Arthritis and Rheumatism Associates - Rockville ( Site 5127) | Recruiting | Rockville | Maryland | 20850 | United States |
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| Kansas City Physician Partners ( Site 5119) | Recruiting | Kansas City | Missouri | 64111 | United States |
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| Physician Research Collaboration, LLC ( Site 5102) | Recruiting | Lincoln | Nebraska | 68516 | United States |
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| Joint and Muscle Research Institute ( Site 5108) | Recruiting | Charlotte | North Carolina | 28204 | United States |
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| Altoona Center for Clinical Research ( Site 5110) | Recruiting | Duncansville | Pennsylvania | 16635 | United States |
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| Hospital of the University of Pennsylvania ( Site 5134) | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Articularis Healthcare Group dba: Low Country Rheumatology ( Site 5128) | Recruiting | Summerville | South Carolina | 29486 | United States |
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| Greater Houston Rheumatology ( Site 5103) | Recruiting | Houston | Texas | 77095 | United States |
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| Centre Rhumatologie De L'Est ( Site 5201) | Recruiting | Rimouski | Quebec | G5L 8W1 | Canada |
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| Centre de Recherche Musculo-Squelettique ( Site 5202) | Recruiting | Trois-Rivières | Quebec | G9A 3Y2 | Canada |
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| Centro de Estudios GyC ( Site 8206) | Recruiting | Santiago | Region M. de Santiago | 7500504 | Chile |
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| Enroll SpA ( Site 8203) | Recruiting | Santiago | Region M. de Santiago | 7500587 | Chile |
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| Clinica Dermacross ( Site 8200) | Recruiting | Santiago | Region M. de Santiago | 7640881 | Chile |
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| CECIM ( Site 8205) | Recruiting | Santiago | Region M. de Santiago | 8331143 | Chile |
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| Centro Internacional de Estudios Clinicos (CIEC) ( Site 8201) | Recruiting | Santiago | Region M. de Santiago | 8420383 | Chile |
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| Clinica de la Costa S.A.S. ( Site 8301) | Recruiting | Barranquilla | Atlántico | 080020 | Colombia |
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| Centro de investigacion en reumatologia y especialidades medicas SAS (CIREEM SAS) ( Site 8306) | Recruiting | Bogota | Cundinamarca | 110221 | Colombia |
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| Fundación Valle del Lili ( Site 8302) | Recruiting | Cali | Valle del Cauca Department | 760032 | Colombia |
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| Rheuma-Research Lausitz ( Site 6409) | Recruiting | Cottbus | Brandenburg | 03042 | Germany |
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| Rheumazentrum Ruhrgebiet ( Site 6400) | Recruiting | Herne | North Rhine-Westphalia | 44649 | Germany |
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| Rheumatologische Schwerpunktpraxis ( Site 6405) | Recruiting | Berlin | 10777 | Germany |
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| HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg G ( Site 6404) | Recruiting | Hamburg | 20095 | Germany |
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| MICS Centrum Medyczne Bydgoszcz ( Site 6907) | Recruiting | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-065 | Poland |
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| MICS Centrum Medyczne Torun ( Site 6903) | Recruiting | Torun | Kuyavian-Pomeranian Voivodeship | 87-100 | Poland |
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| Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 6901) | Recruiting | Lublin | Lubusz Voivodeship | 20-607 | Poland |
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| MICS Centrum Medyczne Warszawa ( Site 6905) | Recruiting | Warsaw | Masovian Voivodeship | 00-874 | Poland |
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| Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im.Prof. El. Reicher-ul.Spartanska 1 ( Site 6906) | Recruiting | Warsaw | Masovian Voivodeship | 02-637 | Poland |
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| CHUS - Hospital Clinico Universitario ( Site 7102) | Recruiting | Santiago de Compostela | La Coruna | 15706 | Spain |
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| Hospital Vall d' Hebron ( Site 7101) | Recruiting | Barcelona | 08029 | Spain |
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| Hospital Viamed Santa Elena ( Site 7105) | Recruiting | Madrid | 28003 | Spain |
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| Hospital Universitario la Fe ( Site 7107) | Recruiting | Valencia | 46026 | Spain |
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| Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrain ( Site 7401) | Recruiting | Kiev | Kyiv Oblast | 03049 | Ukraine |
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| Edelweiss Medics ( Site 7409) | Recruiting | Kyiv | Kyivska Oblast | 02002 | Ukraine |
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| Medical Center of Limited Liability Company "Medical Center "Consilium Medical" ( Site 7415) | Recruiting | Kyiv | Kyivska Oblast | 04050 | Ukraine |
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| Lviv Clin Hospital of Planned Treatment Rehabilitation Palliative Care ( Site 7410) | Recruiting | Lviv | Lviv Oblast | 79011 | Ukraine |
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| Limited liability company "Medical center Health Clinic" ( Site 7412) | Recruiting | Vinnytsia | Vinnytsia Oblast | 21009 | Ukraine |
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| Municipal Nonprofit Enterprise "Vinnytsia Regional Clinical Hospital n.a. M. I. Pyrohov of Vinnytsia ( Site 7400) | Recruiting | Vinnytsia | Vinnytsia Oblast | 21028 | Ukraine |
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| Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 7406) | Recruiting | Kyiv | 03057 | Ukraine |
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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