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This is a study to demonstrate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult patients with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drug therapy.
M1095-PSA-301 is a Phase 3, multicenter, randomized, parallel-group, double-blind, 3-arm, placebo-controlled study to investigate the efficacy and safety of sonelokimab 60 mg every 4 weeks (with and without an induction regimen) versus placebo in adults with active psoriatic arthritis who are naive to biologic disease-modifying antirheumatic drug therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sonelokimab dose with an induction regimen | Experimental | Subjects randomized to this arm will receive sonelokimab subcutaneously (SC) as an induction regimen of 4 doses, followed by sonelokimab SC every 4 weeks maintenance dosing starting at Week 8. |
|
| sonelokimab dose without an induction regimen | Experimental | Subjects randomized to this arm will receive sonelokimab subcutaneously every 4 weeks. |
|
| Placebo | Placebo Comparator | Subjects randomized to this arm will receive placebo subcutaneously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sonelokimab | Drug | Randomized treatment, parallel-group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response rate of participants achieving at least a 50% improvement in the American College of Rheumatology criteria (ACR50) | Proportion of participants achieving ACR50 | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate of participants achieving at least 20% improvement in the American College of Rheumatology criteria (ACR20) | Proportion of participants achieving ACR20 | Week 16 |
| Response rate of participants achieving Minimal Disease Activity (MDA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site | Avondale | Arizona | 85392 | United States | ||
| Clinical Site |
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| Placebo | Drug | Randomized treatment, parallel-group |
|
Proportion of participants achieving MDA
| Week 16 |
| Health Assessment Questionnaire- Disability Index (HAQ-DI) | Change in HAQ-DI from baseline | Week 16 |
| Psoriasis Area and Severity Index (PASI90) | Proportion of participants achieving a decrease of ≥90% in the PASI90 response at Week 16 in the subgroup of participants with psoriasis (PsO) involving ≥3% body surface area at baseline | Week 16 |
| Short- form-36 (SF-36) Physical Component Summary (PCS) | Change from Baseline in SF-36 PCS at Week 16 | Week 16 |
| van der Heijde modified Total Sharp Score (vdHmTSS) | Change from Baseline to Week 16 in joint/bone structural damage (vdHmTSS) | Week 16 |
| Chandler |
| Arizona |
| 85225 |
| United States |
| Clinical Site | Flagstaff | Arizona | 86001 | United States |
| Clinical Site | Mesa | Arizona | 85210 | United States |
| Clinical Site | Phoenix | Arizona | 85032 | United States |
| Clinical Site | Scottsdale | Arizona | 85260 | United States |
| Clinical Site | Tucson | Arizona | 85748 | United States |
| Clinical Site | San Diego | California | 92108 | United States |
| Clinical Site | Upland | California | 91786 | United States |
| Clinical Site | Avon Park | Florida | 33825 | United States |
| Clinical Site | Clearwater | Florida | 33765 | United States |
| Clinical Site | Hialeah | Florida | 33016 | United States |
| Clinical Site | Tampa | Florida | 33607 | United States |
| Clinical Site | Springfield | Illinois | 62702 | United States |
| Clinical Site | Lake Charles | Louisiana | 70605 | United States |
| Clinical Site | Baltimore | Maryland | 21224-6821 | United States |
| Clinical Site | Grand Blanc | Michigan | 48439-2451 | United States |
| Clinical Site | Leland | North Carolina | 28451 | United States |
| Clinical Site | Salisbury | North Carolina | 28144 | United States |
| Clinical Site | Statesville | North Carolina | 28625 | United States |
| Clinical Site | Middleburg Heights | Ohio | 44130 | United States |
| Clinical Site | Portland | Oregon | 97239 | United States |
| Clinical Site | Memphis | Tennessee | 38119 | United States |
| Clinical Site | Allen | Texas | 75013 | United States |
| Clinical Site | Colleyville | Texas | 76034 | United States |
| Clinical Site | Lubbock | Texas | 79424 | United States |
| Clinical Site | Plano | Texas | 75024 | United States |
| Clinical Site | Beckley | West Virginia | 25801 | United States |
| Clinical Site | Pleven | 5800 | Bulgaria |
| Clinical Site | Plovdiv | 4000 | Bulgaria |
| Clinical Site | Plovdiv | 4001 | Bulgaria |
| Clinical Site | Plovdiv | 4002 | Bulgaria |
| Clinical Site | Plovdiv | 4004 | Bulgaria |
| Clinical Site | Rousse | 7000 | Bulgaria |
| Clinical Site | Sofia | 1463 | Bulgaria |
| Clinical Site | Sofia | 1606 | Bulgaria |
| Clinical Site | Sofia | 1784 | Bulgaria |
| Clinical Site | Stara Zagora | 6003 | Bulgaria |
| Clinical Site | Calgary | T2N 4L7 | Canada |
| Clinical Site | Trois-Rivières | G9A 3X2 | Canada |
| Clinical Site | Waterloo | N2J 1C4 | Canada |
| Clinical Site | Winnipeg | R3A IM3 | Canada |
| Clinical Site | Rijeka | 51 000 | Croatia |
| Clinical Site | Zagreb | 10000 | Croatia |
| Clinical Site | Brno | 63800 | Czechia |
| Clinical Site | Břeclav | 690 02 | Czechia |
| Clinical Site | Ostrava | 70200 | Czechia |
| Clinical Site | Prague | 12850 | Czechia |
| Clinical Site | Prague | 140 00 | Czechia |
| Clinical Site | Prague | 140 59 | Czechia |
| Clinical Site | Prague | 14800 | Czechia |
| Clinical Site | Prague | 150 00 | Czechia |
| Clinical Site | Studénka | 742 13 | Czechia |
| Clinical Site | Zlín | 760 01 | Czechia |
| Clinical Site | Tallinn | 10117 | Estonia |
| Clinical Site | Tallinn | 13419 | Estonia |
| Clinical Site | Tartu | 50708 | Estonia |
| Clinical Site | Kuopio | 70100 | Finland |
| Clinical Site | Cahors | 46000 | France |
| Clinical Site | Caluire-et-Cuire | 69300 | France |
| Clinical Site | Échirolles | 38700 | France |
| Clinical Site | Montpellier | 34295 | France |
| Clinical Site | Narbonne | 11100 | France |
| Clinical Site | Nice | 06001 | France |
| Clinical Site | Rouen | 76031 | France |
| Clinical Site | Tours | 37170 | France |
| Clinical Site | Kutaisi | 4600 | Georgia |
| Clinical Site | Tbilisi | 0102 | Georgia |
| Clinical Site | Tbilisi | 0112 | Georgia |
| Clinical Site | Tbilisi | 0141 | Georgia |
| Clinical Site | Tbilisi | 0159 | Georgia |
| Clinical Site | Tbilisi | 0160 | Georgia |
| Clinical Site | Tbilisi | 0179 | Georgia |
| Clinical Site | Tbilisi | 0180 | Georgia |
| Clinical Site | Tbilisi | Georgia |
| Clinical Site | Bad Bentheim | 48455 | Germany |
| Clinical Site | Berlin | 12161 | Germany |
| Clinical Site | Berlin | 12203 | Germany |
| Clinical Site | Berlin | 13125 | Germany |
| Clinical Site | Erlangen | 91054 | Germany |
| Clinical Site | Hamburg | 20095 | Germany |
| Clinical Site | Herne | 44649 | Germany |
| Clinical Site | Munich | 80639 | Germany |
| Clinical Site | Munich | 81667 | Germany |
| Clinical Site | München | 80336 | Germany |
| Clinical Site | Athens | Attica | Greece |
| Clinical Site | Athens | 12462 | Greece |
| Clinical Site | Heraklion | 71110 | Greece |
| Clinical SIte | Budapest | 1023 | Hungary |
| Clinical Site | Budapest | 1027 | Hungary |
| Clinical Site | Budapest | 1036 | Hungary |
| Clinical Site | Debrecen | H-4032 | Hungary |
| Clinical Site | Gyula | 5700 | Hungary |
| Clinical Site | Hódmezővásárhely | 6800 | Hungary |
| Clinical Site | Kalocsa | 6300 | Hungary |
| Clinical Site | Kistarcsa | 2143 | Hungary |
| Clinical Site | Nyíregyháza | 4400 | Hungary |
| Clinical Site | Székesfehérvár | 8000 | Hungary |
| Clinical Site | Veszprém | 8200 | Hungary |
| Clinical Site | Adazi | LV2164 | Latvia |
| Clinical Site | Riga | LV-1001 | Latvia |
| Clinical Site | Kaunas | 51270 | Lithuania |
| Clinical Site | Klaipėda | LT-92288 | Lithuania |
| Clinical Site | Šiauliai | 76231 | Lithuania |
| Clinical Site | Vilnius | 01117 | Lithuania |
| Clinical Site | Bialystok | 15-879 | Poland |
| Clinical Site | Bialystok | 15707 | Poland |
| Clinical Site | Bydgoszcz | 85-065 | Poland |
| Clinical Site | Bydgoszcz | 85-168 | Poland |
| Clinical Site | Bytom | 41-902 | Poland |
| Clinical Site | Częstochowa | 42-202 | Poland |
| Clinical Site | Dąbrówka | 62-069 | Poland |
| Clinical Site | Dębica | 39-200 | Poland |
| Clinical Site | Elblag | 82-300 | Poland |
| Clinical Site | Gdynia | 81-384 | Poland |
| Clinical Site | Katowice | 40282 | Poland |
| Clinical Site | Krakow | 30-002 | Poland |
| Clinical Site | Krakow | 30-149 | Poland |
| Clinical Site | Krakow | 31-501 | Poland |
| Clinical Site | Lodz | 90-368 | Poland |
| Clinical Site | Lodz | 91-363 | Poland |
| Clinical Site | Lublin | 20-412 | Poland |
| Clinical Site | Lublin | 20-607 | Poland |
| Clinical Site | Nadarzyn | 05-830 | Poland |
| Clinical Site | Nowa Sól | 67-100 | Poland |
| Clinical Site | Olsztyn | 10-117 | Poland |
| Clinical Site | Poznan | 60-218 | Poland |
| Clinical Site | Poznan | 60-324 | Poland |
| Clinical Site | Poznan | 60-446 | Poland |
| Clinical Site | Poznan | 60-681 | Poland |
| Clinical Site | Poznan | 60-693 | Poland |
| Clinical Site | Poznan | 61-113 | Poland |
| Clinical Site | Poznan | 61-397 | Poland |
| Clinical Site | Siedlce | 08-110 | Poland |
| Clinical Site | Sochaczew | 96-500 | Poland |
| Clinical Site | Swidnica | 58100 | Poland |
| Clinical Site | Torun | 87-100 | Poland |
| Clinical Site | Warsaw | 00-874 | Poland |
| Clinical Site | Warsaw | 01-691 | Poland |
| Clinical Site | Warsaw | 02-118 | Poland |
| Clinical Site | Warsaw | 02-665 | Poland |
| Clinical Site | Warsaw | 02-677 | Poland |
| Clinical Site | Warsaw | 03-291 | Poland |
| Clinical Site | Warsaw | 04-305 | Poland |
| Clinical Site | Wołomin | 05-200 | Poland |
| Clinical Site | Wroclaw | 51-685 | Poland |
| Clinical Site | Wroclaw | 52-416 | Poland |
| Clinical Site | Wroclaw | 53-673 | Poland |
| Clinical Site | Zamość | 22400 | Poland |
| Clinical SIte | Braga | 4700-000 | Portugal |
| Clinical Site | Braga | 4710-243 | Portugal |
| Clinical Site | Lisbon | 1500-458 | Portugal |
| Clinical Site | Lisbon | 1649-035 | Portugal |
| Clinical Site | Ponte de Lima | 4990-041 | Portugal |
| Clinical Site | Bucharest | 011172 | Romania |
| Clinical Site | Bucharest | 012071 | Romania |
| Clinical Site | Bucharest | 020475 | Romania |
| Clinical Site | Bucharest | 030463 | Romania |
| Clinical Site | Bucharest | 041303 | Romania |
| Clinical Site | Timișoara | 300650 | Romania |
| Clinical Site | Belgrade | 11000 | Serbia |
| Clinical Site | Niška Banja | 18205 | Serbia |
| Clinical Site | Novi Sad | 21000 | Serbia |
| Clinical Site | Košice | 04011 | Slovakia |
| Clinical Site | Martin | 036 01 | Slovakia |
| Clinical Site | Poprad | 058 01 | Slovakia |
| Clinical Site | Rimavská Sobota | 979 01 | Slovakia |
| Clinical Site | A Coruña | 15006 | Spain |
| Clinical Site | Alcobendas | 28100 | Spain |
| Clinical Site | Bilbao | 48013 | Spain |
| Clinical Site | Castelló | 12004 | Spain |
| Clinical Site | Madrid | 28003 | Spain |
| Clinical Site | Madrid | 28046 | Spain |
| Clinical Site | Málaga | 29009 | Spain |
| Clinical Site | Sabadell | 08208 | Spain |
| Clinical Site | Santiago de Compostela | 15702 | Spain |
| Clinical Site | Santiago de Compostela | 15706 | Spain |
| Clinical Site | Seville | 41007 | Spain |
| Clinical Site | Seville | 41009 | Spain |
| Clinical Site | Seville | 41010 | Spain |
| Clinical Site | Seville | 41013 | Spain |
| Clinical Site | Valencia | 46007 | Spain |
| 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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| ID | Term |
|---|---|
| C000720946 | sonelokimab |
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