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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002995-29 | EudraCT Number | ||
| CNTO1959PSO3009 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to evaluate the efficacy of guselkumab compared with secukinumab for the treatment of participants with moderate to severe plaque-type psoriasis.
The study consists of Screening Phase(4 weeks before administration of study drug),Active Treatment Phase(Week 0-Week 44),Follow Up Phase(Week 44-Week 56).During various study periods,safety assessments(example[e.g] recording of adverse events,Vital signs,Tuberculosis evaluation,Chest radiograph,Urine pregnancy Test);Efficacy assessments(e.g IGA,PASI);Clinical Laboratory Assessments(e.g haematology,chemistry);Biomarkers/Genetic evaluations,will be performed per the study procedures.The primary hypotheses are that guselkumab treatment is non-inferior to secukinumab as assessed by proportion of participants achieving PASI 90 response at Week 48 with noninferiority margin of 10% and,once non-inferiority is established,that guselkumab is superior to secukinumab as assessed by proportion of participants achieving PASI 90 response at Week 48.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I: Guselkumab Plus Placebo | Experimental | Participants will receive 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections will be administered to maintain the blind. |
|
| Group II: Secukinumab | Active Comparator | Participants will receive 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guselkumab | Drug | Participants will receive 1 injection of active guselkumab at Weeks 0, 4, 12, 20, 28, 36, and 44. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48 | The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved a PASI-75 Response at Both Week 12 and 48 | Percentage of participants who achieved PASI-75 response at both Week 12 and 48 was reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Southern California Permanente Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39224116 | Derived | Blauvelt A, Chen Y, Branigan PJ, Liu X, DePrimo S, Keyes BE, Leung M, Fakharzadeh S, Yang YW, Munoz-Elias EJ, Krueger JG, Langley RG. Differential Pharmacodynamic Effects on Psoriatic Biomarkers by Guselkumab Versus Secukinumab Correlate with Long-Term Efficacy: An ECLIPSE Substudy. JID Innov. 2024 Jun 26;4(5):100297. doi: 10.1016/j.xjidi.2024.100297. eCollection 2024 Sep. | |
| 38485863 |
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Out of total 1,048 randomized participants, 534 were assigned to receive Guselkumab + Placebo and 514 subjects were assigned to receive Secukinumab.
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| ID | Title | Description |
|---|---|---|
| FG000 | Guselkumab 100 mg + Placebo | Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 5, 2017 | Aug 1, 2019 |
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| Placebo | Drug | Participants will receive 1 injection of placebo at Weeks 0, 4, 12, 20, 28, 36, and 44 and 2 injections of placebo at Weeks 1, 2, 3, 8, 16, 24, 32, and 40. |
|
| Secukinumab | Drug | Participants will receive 2 injections of active secukinumab at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. |
|
|
| Week 12 and 48 |
| Percentage of Participants Who Achieved a PASI-90 Response at Week 12 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. Due to failing to achieve superiority of prior secondary endpoint, no formal statistical testing was performed for endpoints from this point onwards. | Week 12 |
| Percentage of Participants Who Achieved a PASI-75 Response at Week 12 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline. | Week 12 |
| Percentage of Participants Who Achieved a PASI-100 Response at Week 48 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 100 response was defined as 100% reduction in PASI relative to baseline. | Week 48 |
| Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) at Week 48 | The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). | Week 48 |
| Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 48 | The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). | Week 48 |
| Percentage of Participants Who Achieved a PASI-90 Response at Both Week 16 and 48 | Percentage of participants who achieved PASI-90 response at both Week 16 and 48 was reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. | Week 16 and 48 |
| Percentage of Participants Who Achieved a PASI-75 Response at Week 16 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline. | Week 16 |
| Percentage of Participants Who Achieved a PASI-90 Response at Week 16 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. | Week 16 |
| Percentage of Participants Who Achieved a PASI-90 Response at All 7 Visits From Week 24 Through Week 48 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. Percentage of participants who achieved a PASI-90 response at all 7 visits from Week 24 to 48 (Week 24, 28, 32, 36, 40, 44 and 48) was reported. | Week 24 up to Week 48 |
| Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 16 | The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). | Week 16 |
| Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 12 | The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). | Week 12 |
| Percentage of Participants Who Achieved PASI-75 Response at Week 48 Among PASI-75 Responders at Week 12 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline. | Week 48 |
| Percentage of Participants Who Achieved PASI-90 Response at Week 48 Among PASI-90 Responders at Week 16 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90 percent (%) reduction in PASI relative to baseline. | Week 48 |
| Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. PASI produces a numeric score that can range from 0 (no psoriasis) to 72.Participants with >=50%, >= 75%, >=90% and 100% improvement in PASI from baseline were considered PASI 50, 75, 90 and PASI 100 responders, respectively. | Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56 |
| Percentage of Participants With IGA Responses Through Week 56 | The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). | Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56 |
| Percent Improvement From Baseline in PASI Through Week 56 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. | Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and Week 56 |
| Los Angeles |
| California |
| 90027 |
| United States |
| Dermatology Specialists | Oceanside | California | 92056 | United States |
| MedDerm Associates | San Diego | California | 92103 | United States |
| San Luis Dermatology & Laser Clinic, Inc | San Luis Obispo | California | 93405 | United States |
| Southern California Dermatology | Santa Ana | California | 92701 | United States |
| Clinical Research Center of Connecticut | Danbury | Connecticut | 06810 | United States |
| Olympian Clinical Research | Clearwater | Florida | 33757 | United States |
| Florida Academic Dermatology Centers | Coral Gables | Florida | 33134 | United States |
| Renstar Medical Research | Ocala | Florida | 34470 | United States |
| Park Avenue Dermatology | Orange Park | Florida | 32073 | United States |
| Atlanta Dermatology, Vein & Research Center | Alpharetta | Georgia | 30022 | United States |
| Advanced Medical Research | Atlanta | Georgia | 30328 | United States |
| Marietta Dermatology Clinical Research | Marietta | Georgia | 30060 | United States |
| Arlington Dermatology | Rolling Meadows | Illinois | 60008 | United States |
| Northshore Universite Healthsystem | Skokie | Illinois | 60077 | United States |
| Dawes Fretzin Clinical Research Group | Indianapolis | Indiana | 46256 | United States |
| Indiana Clinical Trial Center | Plainfield | Indiana | 46168 | United States |
| Dermatology Specialists | Louisville | Kentucky | 40241 | United States |
| DermAssociates, PC | Rockville | Maryland | 20850 | United States |
| Great Lakes Research Group | Bay City | Michigan | 48706 | United States |
| Henry Ford Medical Center | Detroit | Michigan | 49202 | United States |
| Hamzavi Dermatology | Fort Gratiot | Michigan | 48059 | United States |
| Somerset Skin Centre | Troy | Michigan | 48084 | United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | United States |
| Central Dermatology | St Louis | Missouri | 63117 | United States |
| Windsor Dermatology | East Windsor | New Jersey | 08520-2505 | United States |
| Academic Dermatology Associates | Albuquerque | New Mexico | 87106 | United States |
| Dermatology Consulting Services, PLLC | High Point | North Carolina | 27262 | United States |
| Dermatologists of Greater Columbus | Bexley | Ohio | 43209 | United States |
| The Ohio State University | Gahanna | Ohio | 43230 | United States |
| Central Sooner Research | Norman | Oklahoma | 73071 | United States |
| Oregon Dermatology and Research Center | Portland | Oregon | 97210 | United States |
| Oregon Medical Research Center | Portland | Oregon | 97223 | United States |
| University of Pittsburgh Department of Dermatology | Pittsburgh | Pennsylvania | 15213 | United States |
| Clinical Partners | Johnston | Rhode Island | 02919 | United States |
| Austin Dermatology Associates | Austin | Texas | 78705 | United States |
| Modern Research Associates | Dallas | Texas | 75231 | United States |
| Menter Dermatology Research Institute | Dallas | Texas | 75246-1615 | United States |
| Suzanne Bruce and Associates - The Center for Skin Research | Houston | Texas | 77056-4132 | United States |
| Progressive Clinical Research | San Antonio | Texas | 78213 | United States |
| Dermatology Clinical Research Center of San Antonio | San Antonio | Texas | 78229 | United States |
| Virginia Clinical Research | Norfolk | Virginia | 23322 | United States |
| Dermatology Associates of Seattle | Seattle | Washington | 98101-1498 | United States |
| The Skin Centre | Benowa | 4217 | Australia |
| Sinclair Dermatology | East Melbourne | 3002 | Australia |
| Fremantle Dermatology | Fremantle | 6160 | Australia |
| Clinical Trials SA Pty Ltd | Hectorville | 5073 | Australia |
| Premier Specialists | Kogarah | 2217 | Australia |
| St George Dermatology & Skin Cancer Centre | Kogarah | 2217 | Australia |
| Skin&Cancer Foundation Inc | Melbourne | 3053 | Australia |
| Royal Melbourne Hospital | Parkville | 3050 | Australia |
| Westmead Hospital | Westmead | 2145 | Australia |
| Woden Dermatology | Woden | 2606 | Australia |
| Veracity Clinical Research | Woolloongabba | 4102 | Australia |
| Dermatrials Research | Hamilton | Ontario | L8N 1Y2 | Canada |
| Guenther Dermatology Research Centre | London | Ontario | N6A 3H7 | Canada |
| North Bay Dermatology Centre | North Bay | Ontario | P1B 3Z7 | Canada |
| Skin Centre for Dermatology | Peterborough | Ontario | K9J 5K2 | Canada |
| Toronto Research Centre | Toronto | Ontario | M3H5Y8 | Canada |
| CCA Medical Research Corporation | Ajax | L1S7K8 | Canada |
| Stratica Medical | Edmonton | T5K 1X3 | Canada |
| Eastern Canada Research Associates | Halifax | B3H 1Z2 | Canada |
| DermEdge Research | Mississauga | L5H 1G9 | Canada |
| Innovaderm Research | Montreal | H2K4L5 | Canada |
| Centre Dermatologique | Québec | G1V 4X7 | Canada |
| Dr. Chih-ho Hong Medical | Surrey | V3R 6A7 | Canada |
| K. Papp Clinical Research | Waterloo | N2J 1C4 | Canada |
| XLR8 Medical Research | Windsor | N8W 1E6 | Canada |
| Nemocnice Jihlava | Jihlava | 586 33 | Czechia |
| Kozni ambulance Kutna Hora, s.r.o. | Kutná Hora | 248 01 | Czechia |
| DERMAMEDICA s.r.o. | Náchod | 547 01 | Czechia |
| Nemocnice Novy Jicin a.s. | Nový Jičín | 741 01 | Czechia |
| Fakultni nemocnice Ostrava | Ostrava- Poruba | 708 52 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady | Prague | 775 20 | Czechia |
| Dermatologicka ambulance | Svitavy | 568 02 | Czechia |
| Masarykova nemocnice v Usti nad Labem | Ústí nad Labem | Czechia |
| CHU Bordeaux - Hopital St Andre | Bordeaux | 33000 | France |
| ICH Hopital A. Morvan | Brest | 29200 | France |
| Groupe Hospitalier La Rochelle - Re - Aunis | La Rochelle | 17019 | France |
| Le Bateau Blanc | Martigues | 13500 | France |
| CHU Nantes - Hotel Dieu | Nantes | 44093 | France |
| CHU de Nice Hopital de l Archet | Nice | 06200 | France |
| Hopital Charles Nicolle | Rouen | 76031 | France |
| Hopital Larrey CHU de Toulouse | Toulouse | 31000 | France |
| Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center | Berlin | 10117 | Germany |
| ISA GmbH | Berlin | 10789 | Germany |
| Universitatsklinikum Bonn | Bonn | 53105 | Germany |
| Klinische Forschung Dresden GmbH | Dresden | 01069 | Germany |
| University Hospital Dresden | Dresden | 01307 | Germany |
| Universitatsklinikum Essen | Essen | 45122 | Germany |
| Universitatsklinikum Frankfurt | Frankfurt am Main | 60590 | Germany |
| Universitaetsklinik Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| SCIderm GmbH | Hamburg | 20354 | Germany |
| MensingDerma research GmbH | Hamburg | 22391 | Germany |
| Universitatsklinikum Schleswig-Holstein - Kiel | Kiel | 24105 | Germany |
| Universitaetsklinik Luebeck | Lübeck | 23538 | Germany |
| Hautarztpraxis | Mahlow | 15831 | Germany |
| Technische Universitaet Muenchen | München | 80802 | Germany |
| Universitaetsklinikum Muenster | Münster | 48149 | Germany |
| Universitaetsklinik Tuebingen | Tübingen | 72076 | Germany |
| Centrovital | Witten | 58453 | Germany |
| Semmelweis Egyetem | Budapest | 1085 | Hungary |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | 4032 | Hungary |
| Somogy Megyei Kaposi Mor Oktatokorhaz | Kaposvár | 7400 | Hungary |
| Bacs-kiskun Megyei Korhaz | Kecskemét | 6000 | Hungary |
| Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz | Miskolc | 3529 | Hungary |
| Pecsi Tudomanyegyetem | Pécs | 7632 | Hungary |
| Szegedi Tudomanyegyetem | Szeged | 6720 | Hungary |
| Markusovszky Egyetemi Oktatokorhaz | Szombathely | 9700 | Hungary |
| Medmare Egeszsegugyi Es Szolgaltato Bt. | Veszprém | 8200 | Hungary |
| NZOZ Osteo-Medic S.C. Artur Racewicz i Jerzy Supronik | Bialystok | 15-351 | Poland |
| Specderm Poznańska sp. j. | Bialystok | 15-375 | Poland |
| Szpital Uniwersytecki nr 1 im. Dr A. Jurasza | Bydgoszcz | 85-094 | Poland |
| Centrum Kliniczno Badawcze | Elblag | 82-300 | Poland |
| Copernicus Podmiot Leczniczy Sp. z o.o | Gdansk | 80-298 | Poland |
| Malopolskie Centrum Medyczne | Krakow | 30-510 | Poland |
| Centrum Badawcze Wspolczesnej Terapii | Lodz | 90-242 | Poland |
| Dermed Centrum Medyczne Sp. z o.o | Lodz | 90-265 | Poland |
| Solumed S.C. | Poznan | 60-529 | Poland |
| CRC Sp. z o.o. | Poznan | 60-848 | Poland |
| Lubelskie Centrum Diagnostyczne | Świdnik | 21-040 | Poland |
| NZOZ Poradnia Dermatologiczno-Wenerologiczna Mediderm | Torun | 87-100 | Poland |
| Przychodnia Specjalistyczna High-Med | Warsaw | 01-817 | Poland |
| Wojskowy Instytut Medyczny | Warsaw | 04-141 | Poland |
| DermMedica Sp. z o.o. | Wroclaw | 51-318 | Poland |
| Centrum Medyczne WroMedica | Wroclaw | 51-685 | Poland |
| Hosp. Univ. Fundacion Alcorcon | Alcorcón | 28922 | Spain |
| Hosp. Gral. Univ. de Alicante | Alicante | 03010 | Spain |
| Hosp. Univ. Germans Trias I Pujol | Badalona | 08916 | Spain |
| Hosp. Univ. de Cruces | Barakaldo | 48903 | Spain |
| Hosp. Del Mar | Barcelona | 08003 | Spain |
| Hosp. de La Santa Creu I Sant Pau | Barcelona | 8041 | Spain |
| Hosp. Univ. de Basurto | Bilbao Vizcaya | 48009 | Spain |
| Hosp. Reina Sofia | Córdoba | 14004 | Spain |
| Hosp. Univ. Infanta Leonor | Madrid | 28031 | Spain |
| Hosp. Univ. 12 de Octubre | Madrid | 28041 | Spain |
| Hosp. Univ. La Paz | Madrid | 28046 | Spain |
| Hosp. Univ. de Torrejon | Madrid | 28850 | Spain |
| Hosp. de Manises | Manises | 46940 | Spain |
| Hosp. Provincial de Pontevedra | Pontevedra | 36003 | Spain |
| Hosp. Univ. I Politecni La Fe | Valencia | 046026 | Spain |
| Derived |
| Egeberg A, Conrad C, Gorecki P, Wegner S, Buyze J, Acciarri L, Thaci D. Response Types and Factors Associated with Response Types to Biologic Therapies in Patients with Moderate-to-Severe Plaque Psoriasis from Two Randomized Clinical Trials. Dermatol Ther (Heidelb). 2024 Mar;14(3):745-758. doi: 10.1007/s13555-024-01123-1. Epub 2024 Mar 15. |
| 37906417 | Derived | Strober B, Coates LC, Lebwohl MG, Deodhar A, Leibowitz E, Rowland K, Kollmeier AP, Miller M, Wang Y, Li S, Chakravarty SD, Chan D, Shawi M, Yang YW, Thaҫi D, Rahman P. Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis. Drug Saf. 2024 Jan;47(1):39-57. doi: 10.1007/s40264-023-01361-w. Epub 2023 Oct 31. |
| 31402114 | Derived | Reich K, Armstrong AW, Langley RG, Flavin S, Randazzo B, Li S, Hsu MC, Branigan P, Blauvelt A. Guselkumab versus secukinumab for the treatment of moderate-to-severe psoriasis (ECLIPSE): results from a phase 3, randomised controlled trial. Lancet. 2019 Sep 7;394(10201):831-839. doi: 10.1016/S0140-6736(19)31773-8. Epub 2019 Aug 8. |
| FG001 | Secukinumab 300 mg | Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full analysis set (FAS) included all participants randomized at Week 0.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Guselkumab 100 mg + Placebo | Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56. |
| BG001 | Secukinumab 300 mg | Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Achieved a Psoriasis Area and Severity Index (PASI)-90 Response at Week 48 | The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. | FAS population included. Participants who met treatment failure criteria (who discontinued study agent due to lack of efficacy or adverse event of psoriasis and/or who initiated protocol-prohibited psoriasis medications/therapies) prior to Week 48 or who had a missing PASI score at Week 48 were considered PASI 90 non-responders at Week 48. | Posted | Number | Percentage of participants | Week 48 |
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| Secondary | Percentage of Participants Who Achieved a PASI-75 Response at Both Week 12 and 48 | Percentage of participants who achieved PASI-75 response at both Week 12 and 48 was reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline. | FAS population included. Participants who met treatment failure criteria (who discontinued study agent due to lack of efficacy or adverse event of psoriasis and/or who initiated protocol-prohibited psoriasis medications/therapies) prior to Week 48 or who had a missing PASI score at Week 12 or 48 were considered as non-responders for this endpoint. | Posted | Number | Percentage of participants | Week 12 and 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved a PASI-90 Response at Week 12 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. Due to failing to achieve superiority of prior secondary endpoint, no formal statistical testing was performed for endpoints from this point onwards. | FAS population included. Participants who met treatment failure criteria prior to Week 12, who had a missing PASI score at Week 12 were considered PASI 90 non-responders at Week 12. | Posted | Number | Percentage of participants | Week 12 |
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| Secondary | Percentage of Participants Who Achieved a PASI-75 Response at Week 12 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline. | FAS population included. Participants who met treatment failure criteria prior to Week 12 or who had a missing PASI score at Week 12 were considered PASI 75 non-responders at Week 12. | Posted | Number | Percentage of participants | Week 12 |
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| Secondary | Percentage of Participants Who Achieved a PASI-100 Response at Week 48 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 100 response was defined as 100% reduction in PASI relative to baseline. | FAS population included. Participants who met treatment failure criteria prior to Week 48 or who had a missing PASI score at Week 48 were considered PASI 100 non-responders at Week 48. | Posted | Number | Percentage of participants | Week 48 |
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| Secondary | Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) at Week 48 | The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). | FAS population included. Participants who met treatment failure criteria prior to Week 48 or who had a missing IGA score at Week 48 were considered IGA cleared (0) non-responders at Week 48. | Posted | Number | Percentage of participants | Week 48 |
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| Secondary | Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 48 | The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). | FAS population included. Participants who met treatment failure criteria prior to Week 48 or who had a missing IGA score at Week 48 were considered IGA cleared (0) or minimal (1) non-responders at Week 48. | Posted | Number | Percentage of participants | Week 48 |
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| Secondary | Percentage of Participants Who Achieved a PASI-90 Response at Both Week 16 and 48 | Percentage of participants who achieved PASI-90 response at both Week 16 and 48 was reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. | FAS population included. Participants who met treatment failure criteria prior to Week 48 or who had a missing PASI score at Week 16 or 48 were considered as non-responders for this endpoint. | Posted | Number | Percentage of participants | Week 16 and 48 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved a PASI-75 Response at Week 16 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline. | Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria prior to Week 16 or who had a missing PASI score at Week 16 were considered PASI 75 non-responders at Week 16. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Percentage of Participants Who Achieved a PASI-90 Response at Week 16 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. | Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria prior to Week 16 or who had a missing PASI score at Week 16 were considered PASI 90 non-responders at Week 16. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Percentage of Participants Who Achieved a PASI-90 Response at All 7 Visits From Week 24 Through Week 48 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. Percentage of participants who achieved a PASI-90 response at all 7 visits from Week 24 to 48 (Week 24, 28, 32, 36, 40, 44 and 48) was reported. | FAS population included. Participants who met treatment failure criteria prior to Week 48 or who had missing PASI score at any visit from Week 24 through 48 were considered as non-responders for this endpoint. | Posted | Number | Percentage of participants | Week 24 up to Week 48 |
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| Secondary | Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 16 | The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). | Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria prior to Week 16 or who had a missing IGA score at Week 16 were considered non-responders for this endpoint. | Posted | Number | Percentage of participants | Week 16 |
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| Secondary | Percentage of Participants With Investigator's Global Assessment (IGA) Score Cleared (0) or Minimal (1) at Week 12 | The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). | Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria prior to Week 12 or who had a missing IGA score at Week 12 were considered non-responders for this endpoint. | Posted | Number | Percentage of participants | Week 12 |
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| Secondary | Percentage of Participants Who Achieved PASI-75 Response at Week 48 Among PASI-75 Responders at Week 12 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 75 response was defined as at least a 75% reduction in PASI relative to baseline. | Full analysis set included all the participants randomized at Week 0 and who achieved PASI 75 response at Week 12. Participants who met treatment failure criteria prior to Week 48 or who had missing PASI score at Week 48 were considered as non-responders for this endpoint. | Posted | Number | Percentage of participants | Week 48 |
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| Secondary | Percentage of Participants Who Achieved PASI-90 Response at Week 48 Among PASI-90 Responders at Week 16 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 90 response was defined as at least a 90 percent (%) reduction in PASI relative to baseline. | Full analysis set included all the participants randomized at Week 0 and who achieved PASI-90 response at Week 16. Participants who met treatment failure criteria prior to Week 48 or who had missing PASI score at Week 48 were considered as non-responders for this endpoint. | Posted | Number | Percentage of participants | Week 48 |
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| Secondary | Percentage of Participants Who Achieved PASI Response (PASI 100, PASI-90, PASI-75 and PASI-50) Over Time From Week 1 to Week 56 | PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body is divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. PASI produces a numeric score that can range from 0 (no psoriasis) to 72.Participants with >=50%, >= 75%, >=90% and 100% improvement in PASI from baseline were considered PASI 50, 75, 90 and PASI 100 responders, respectively. | Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria or who had missing PASI score were considered as non-responders for the specific visit. | Posted | Number | Percentage of participants | Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56 |
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| Secondary | Percentage of Participants With IGA Responses Through Week 56 | The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). | Full analysis set included all the participants randomized at Week 0. Participants who met treatment failure criteria or who had missing IGA score were considered as non-responders for the specific visit. | Posted | Number | Percentage of participants | Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 56 |
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| Secondary | Percent Improvement From Baseline in PASI Through Week 56 | The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. | Full analysis set included all the participants randomized at Week 0. Here 'n' signifies the number of participants analyzed at specified point. Zero percent improvement was assigned from the point when participants met treatment failure criteria and no other data imputation was applied. | Posted | Mean | Standard Deviation | Percent improvement | Week 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and Week 56 |
|
Up to Week 56
Safety analysis set included all randomized and treated participants who received at least 1 dose of study agent (partial or complete) at Week 0 according to the actual treatment received during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Guselkumab 100 mg + Placebo | Participants received 1 injection of active guselkumab and 1 injection of placebo when guselkumab is scheduled to be administered (Weeks 0, 4, 12, 20, 28, 36, and 44) or 2 injections of placebo when no guselkumab is scheduled to be administered (Weeks 1, 2, 3, 8, 16, 24, 32, and 40). Placebo injections were administered to maintain the blind. Participants were continued to follow-up period from Week 44 through Week 56. | 0 | 534 | 33 | 534 | 249 | 534 |
| EG001 | Secukinumab 300 mg | Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56. | 0 | 511 | 37 | 511 | 254 | 511 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Atrioventricular Block Complete | Cardiac disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Coronary Artery Occlusion | Cardiac disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Wolff-Parkinson-White Syndrome | Cardiac disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Macular Fibrosis | Eye disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Crohn's Disease | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Leukoplakia Oral | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Umbilical Hernia | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Exercise Tolerance Decreased | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Drug-Induced Liver Injury | Hepatobiliary disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Anaphylactoid Reaction | Immune system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Abscess Limb | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Labyrinthitis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Neuroborreliosis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Clavicle Fracture | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Femoral Neck Fracture | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Foot Fracture | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Ligament Rupture | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Meniscus Injury | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Skull Fracture | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Tendon Rupture | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Upper Limb Fracture | Injury, poisoning and procedural complications | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Electrocardiogram Repolarisation Abnormality | Investigations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Rotator Cuff Syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Spinal Column Stenosis | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Spinal Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Invasive Ductal Breast Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Non-Small Cell Lung Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Mixed Anxiety and Depressive Disorder | Psychiatric disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Acute Kidney Injury | Renal and urinary disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Bartholin's Cyst | Reproductive system and breast disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Nasal Cyst | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Nasal Polyps | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Chronic Cutaneous Lupus Erythematosus | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Drug Eruption | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Rash Morbilliform | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Finger Amputation | Surgical and medical procedures | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 21.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 21.0 | Non-systematic Assessment |
|
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 8, 2018 | Aug 1, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000588857 | guselkumab |
| C555450 | secukinumab |
Not provided
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| CANADA |
|
| CZECH REPUBLIC |
|
| FRANCE |
|
| GERMANY |
|
| HUNGARY |
|
| POLAND |
|
| SPAIN |
|
| UNITED STATES |
|
| <0.001 |
| Superiority |
| OG001 | Secukinumab 300 mg | Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56. |
|
|
|
| OG001 | Secukinumab 300 mg | Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56. |
|
|
|
Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56. |
|
|
|
Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56. |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| OG001 |
| Secukinumab 300 mg |
Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56. |
|
|
|
| Secukinumab 300 mg |
Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56. |
|
|
|
| Secukinumab 300 mg |
Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56. |
|
|
|
| OG001 | Secukinumab 300 mg | Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56. |
|
|
|
|
|
|
|
|
|
| OG001 |
| Secukinumab 300 mg |
Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56. |
|
|
| OG001 |
| Secukinumab 300 mg |
Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56. |
|
|
| OG001 | Secukinumab 300 mg | Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56. |
|
|
|
|
| Secukinumab 300 mg |
Participants received 2 injections of active secukinumab subcutaneously (SC) at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44. Participants were continued to follow-up period from Week 44 through Week 56. |
|
|