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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1959UCO3004 | Other Identifier | Janssen Research & Development, LLC | |
| 2022-000365-41 | EudraCT Number | ||
| 2023-504719-34-00 | Registry Identifier | EUCT number |
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The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Guselkumab | Experimental | Participants will receive guselkumab (Dose 1) subcutaneous (SC) injection followed by guselkumab (Dose 2) SC injection. |
|
| Group 2: Guselkumab | Experimental | Participants will receive guselkumab (Dose 1) SC injection followed by guselkumab (Dose 3) SC injection. |
|
| Group 3: Placebo | Placebo Comparator | Participants will receive matching placebo SC injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guselkumab Dose 1 | Drug | Guselkumab (Dose 1) will be administered as SC injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in Clinical Remission at Week 12 | Percentage of participants in clinical remission at Week 12 was reported. Clinical remission is defined as a Mayo stool frequency subscore of 0 or 1 and not increased from baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in Symptomatic Remission at Week 12 | Percentage of participants in symptomatic remission at Week 12 was reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and not increased from baseline, and a rectal bleeding subscore of 0. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity. |
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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 |
|---|---|---|---|---|---|---|
| Research Solutions of Arizona | Litchfield Park | Arizona | 85340 | United States | ||
| Om Research LLC 1 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41544637 | Derived | Long M, Allegretti JR, Danese S, Germinaro M, Baker T, Alvarez Y, Kavalam M, Han C, Jorgens S, Jiang L, Zhang H, Hisamatsu T, Rubin DT, Peyrin-Biroulet L; ASTRO Study Group. Efficacy and safety of subcutaneous guselkumab induction therapy in participants with moderately to severely active ulcerative colitis (ASTRO): a double-blind, treat-through, randomised, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2026 Apr;11(4):284-298. doi: 10.1016/S2468-1253(25)00322-X. Epub 2026 Jan 13. |
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The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Results are currently reported up to the primary completion date (02-Apr-2024). Results of remaining duration will be posted upon study completion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo matching to guselkumab subcutaneous (SC) injection every 4 weeks (q4w) from Week 0 through Week 24. All participants in the placebo group who met rescue criteria at Week 16 received rescue treatment, that is, guselkumab 400 milligrams (mg) SC injection at Weeks 16, 20, and 24. |
| FG001 |
| 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 | May 13, 2025 | Oct 16, 2025 |
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| Guselkumab Dose 2 | Drug | Guselkumab (Dose 2) will be administered as SC injection. |
|
| Guselkumab Dose 3 | Drug | Guselkumab (Dose 3) will be administered as SC injection. |
|
| Placebo | Other | Placebo will be administered as SC injection. |
|
| Week 12 |
| Percentage of Participants With Endoscopic Improvement at Week 12 | Percentage of participants with endoscopic improvement at Week 12 was reported. Endoscopic improvement is defined as an endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity. | Week 12 |
| Percentage of Participants in Clinical Response at Week 12 | Percentage of participants in clinical response at Week 12 was reported. Clinical response is defined as a decrease from baseline in the modified Mayo score by greater than or equal to (>=) 30 percent (%) and >=2 points, with either a >=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. | Week 12 |
| Percentage of Participants With Histologic-endoscopic Mucosal Improvement at Week 12 | Percentage of participants with histologic-endoscopic mucosal improvement at Week 12 was reported. Histologic-endoscopic mucosal improvement is defined as achieving a combination of histologic improvement and endoscopic improvement. Histologic improvement is defined as neutrophil infiltration in less than (<) 5% of crypts, no crypt destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system. Endoscopic improvement is defined as an endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity. | Week 12 |
| Percentage of Participants in Clinical Remission at Week 24 | Percentage of participants in clinical remission at Week 24 was reported. Clinical remission is defined as a stool frequency subscore of 0 or 1 and not increased from baseline, a rectal bleeding subscore of 0, and an endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity. | Week 24 |
| Percentage of Participants in Symptomatic Remission at Week 24 | Percentage of participants in symptomatic remission at Week 24 was reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and not increased from baseline, and a rectal bleeding subscore of 0. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity. | Week 24 |
| Percentage of Participants With Endoscopic Improvement at Week 24 | Percentage of participants with endoscopic improvement at Week 24 was reported. Endoscopic improvement is defined as an endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity. | Week 24 |
| Percentage of Participants in Clinical Response at Week 24 | Percentage of participants in clinical response at Week 24 was reported. Clinical response is defined as a decrease from baseline in the modified Mayo score by >= 30% and >=2 points, with either a >=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. | Week 24 |
| Apple Valley |
| California |
| 92307 |
| United States |
| Om Research LLC | Lancaster | California | 93534 | United States |
| Medical Associates Research Group, Inc. | San Diego | California | 92123 | United States |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80907 | United States |
| Gastro Florida | Clearwater | Florida | 33762 | United States |
| I.H.S. Health. LLC | Kissimmee | Florida | 34741 | United States |
| Columbus Clinical Services LLC | Miami | Florida | 33125 | United States |
| Vista Health Research, LLC | Miami | Florida | 33176 | United States |
| Orlando Health | Orlando | Florida | 32806 | United States |
| Theia Clincial Research, LLC | Temple Terrace | Florida | 34209 | United States |
| Digestive Healthcare of Georgia, P.C | Atlanta | Georgia | 30309 | United States |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30342 | United States |
| Gastroenterology Associates of Central GA | Macon | Georgia | 31201 | United States |
| Cotton O'Neil Digestive Health Center | Topeka | Kansas | 66606 | United States |
| Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | 48047 | United States |
| Detroit Clinical Research Center | Farmington Hills | Michigan | 48334 | United States |
| Smart Medical Research | Hollis | New York | 11423 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599-7080 | United States |
| Peters Medical Research | High Point | North Carolina | 27260 | United States |
| Dayton Gastroenterology, Inc | Dayton | Ohio | 45415 | United States |
| Gastro Intestinal Research Institute of Northern Ohio LLC | Westlake | Ohio | 44145 | United States |
| Allegheny General Hospital of Research | Pittsburgh | Pennsylvania | 15224 | United States |
| Frontier Clinical Research | Uniontown | Pennsylvania | 15401 | United States |
| Gastroenterology Associates of Orangeburg, SC | Orangeburg | South Carolina | 29118 | United States |
| Southern Star Research Institute, LLC | San Antonio | Texas | 78229 | United States |
| UT Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| Tyler Research Institute, LLC | Tyler | Texas | 75701 | United States |
| Victoria Gastroenterology | Victoria | Texas | 77407 | United States |
| Care Access Research, Ogden | Ogden | Utah | 84403 | United States |
| Gastroenterology Associates | Salt Lake City | Utah | 84124 | United States |
| Gastroenterology Associates of Tidewater | Chesapeake | Virginia | 23320 | United States |
| Cer Instituto Medico | Buenos Aires | B1878DVB | Argentina |
| Hospital General de Agudos José Maria Ramos Mejía | Buenos Aires | C1221ADC | Argentina |
| Clinica Adventista Belgrano | Ciudad de Buenos Aires | C1430EGF | Argentina |
| Sanatorio Duarte Quiroz | Córdoba | X5002AOQ | Argentina |
| Hospital Privado Universitario De Cordoba | Córdoba | X5016KEH | Argentina |
| Hospital Italiano de La Plata | La Plata | B1900AXI | Argentina |
| Centro de Investigaciones Medicas Mar Del Plata | Mar del Plata | B7600FYK | Argentina |
| Hospital Provincial del Centenario | Rosario | S2000KDS | Argentina |
| Royal Adelaide Hospital | Adelaide | 5000 | Australia |
| Royal Prince Alfred Hospital | Camperdown | 2050 | Australia |
| Monash Health | Clayton | 3168 | Australia |
| Royal Brisbane and Women's Hospital | Herston | 4029 | Australia |
| Fiona Stanley Hospital | Murdoch | 6150 | Australia |
| Royal Melbourne Hospital | Parkville | 3050 | Australia |
| IBD Clinical Trials Mater Research | South Brisbane | 4101 | Australia |
| The Queen Elizabeth Hospital | Woodville South | 5011 | Australia |
| Princess Alexandra Hospital | Woolloongabba | 4102 | Australia |
| Onze -Lieve-Vrouwziekenhuis | Aalst | 9300 | Belgium |
| CHU Saint-Pierre | Brussels | 1000 | Belgium |
| AZ Delta | Roeselare | 8800 | Belgium |
| Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu) | Botucatu | 18618-687 | Brazil |
| L2IP Instituto de Pesquisas Clinicas | Brasília | 70200-730 | Brazil |
| Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro | Campinas | 13060-904 | Brazil |
| CDC - Centro Digestivo de Curitiba | Curitiba | 80430-180 | Brazil |
| CECIP Jau - Centro de Estudos Clínicos do Interior Paulista Ltda | Jaú | 17201 130 | Brazil |
| Galileo Pesquisa Clinica | Juiz de Fora | 36033 318 | Brazil |
| Hospital das Clinicas de Porto Alegre | Porto Alegre | 90035-903 | Brazil |
| NPCRS Nucleo de Pesquisa Clinica do Rio Grande do Sul | Porto Alegre | 90430-001 | Brazil |
| CLIAGEN - Clinica de Atencao em Gastroenterologia Especializada e Nutricao | Salvador | 41500-300 | Brazil |
| Pesquisare Saude | Santo André | 09080-110 | Brazil |
| Kaiser Hospta | São José do Rio Preto | 15015-110 | Brazil |
| BR TRIALS Ensaios Clinicos e Consultoria Ltda | São Paulo | 01236030 | Brazil |
| Instituto D Or de Pesquisa e Ensino IDOR | São Paulo | 01401-002 | Brazil |
| INTEGRAL Pesquisa e Ensino | Votuporanga | 15500-269 | Brazil |
| Medical centre Asklepion | Sofia | 1606 | Bulgaria |
| DCC Convex EOOD | Sofia | 1680 | Bulgaria |
| Medical Center Leo Clinic EOOD | Targovishte | 7700 | Bulgaria |
| Fraser Clinical Trials Inc. | New Westminster | British Columbia | V3L 3W4 | Canada |
| Barrie GI Associates | Barrie | Ontario | L4M 7G1 | Canada |
| Royal University Hospital | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| China Japan Friendship Hospital | Beijing | 100029 | China |
| Peking University Third Hospital | Beijing | 100191 | China |
| West China Hospital Sichuan University | Chengdu | 610041 | China |
| Chongqing General Hospital | Chongqing | 400014 | China |
| First Affiliated Hospital of Gannan Medical University | Ganzhou | 341000 | China |
| The Second Affiliated Hospital of Guangzhou Medical University | Guangzhou | 510260 | China |
| ZhuJiang Hospital of Southern Medical University | Guangzhou | 510280 | China |
| The First Affiliated Hospital Zhejiang University College of Medicine | Hangzhou | 310003 | China |
| The Second Affiliated Hospital of Zhejiang University College of Medicine | Hangzhou | 310009 | China |
| The First Affiliated Hospital of Anhui Medical University | Hefei | 230022 | China |
| Jinhua municipal central hospital | Jinhua | 321009 | China |
| Lanzhou University Second Hospital | Lanzhou | 730030 | China |
| The first affiliated hospital of Henan University of science and technology | Luoyang | 471003 | China |
| Nanjing Drum Tower Hospital | Nanjing | 210008 | China |
| Zhongda Hospital Southeast University | Nanjing | 210009 | China |
| Ruijin Hospital Shanghai Jiao Tong University | Shanghai | 200025 | China |
| Shanghai East Hospital | Shanghai | 200123 | China |
| Shengjing Hospital Of China Medical University | Shenyang | 110004 | China |
| Shenzhen Hospital of Southern Medical University | Shenzhen | 518101 | China |
| The Second Hospital of Hebei Medical University | Shijiazhuang | 050004 | China |
| Taihe Hospital | Shiyan | 442000 | China |
| Renmin Hospital of Wuhan University | Wuhan | 430060 | China |
| Wuxi People s Hospital | Wuxi | 214023 | China |
| General Hospital of Ningxia Medical Hospital | Yinchuan | 750011 | China |
| The Second Affiliated Hospital of Zhengzhou University | Zhengzhou | 450014 | China |
| Nemocnice Ceske Budejovice a s | České Budějovice | 37001 | Czechia |
| Gastroenterologie, s.r.o., Hradec Kralove | Hradec Kralova | 500 02 | Czechia |
| Artroscan s r o | Ostrava | 722 00 | Czechia |
| Synexus Czech s.r.o. | Prague | 120 00 | Czechia |
| AXON Clinical s.r.o. | Prague | 15000 | Czechia |
| ISCARE a.s. | Prague | 190 00 | Czechia |
| CHRU Besancon Hopital Jean Minjoz | Besançon | 25030 | France |
| Hopital de Bicetre | Le Kremlin-Bicêtre | 94270 | France |
| CHRU Montpellier - Hopital Saint-Eloi | Montpellier | 34295 Cedex 5 | France |
| Clinique Ambroise Pare | Neuilly-sur-Seine | 92200 | France |
| CHU de Nice Hopital de l Archet | Nice | 06202 | France |
| Polyclinique Du Grand Sud | Nîmes | 30932 | France |
| CHU de Bordeaux - Hospital Haut-Leveque | Pessac | 33604 | France |
| Hospices Civils de Lyon HCL | Pierre-Bénite | 69495 | France |
| CHU de Reims | Reims | 51092 | France |
| Hopital d'Instruction des Armees BEGIN | Saint-Mandé | 94160 | France |
| CHU Saint Etienne Hopital Nord | Saint-Priest-en-Jarez | 42270 | France |
| CHU Rangueil | Toulouse | 31059 | France |
| CHU Nancy Brabois | Vandœuvre-lès-Nancy | 54500 | France |
| Medizinisches Versorgungszentrum (MVZ) Dachau | Dachau | 85221 | Germany |
| MVZ Sanaklinikum Duisburg | Duisburg | 47055 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Praxisgemeinschaft Jerichow | Jerichow | 39319 | Germany |
| Staedtisches Klinikum Lueneburg | Lüneburg | 21339 | Germany |
| Magyar Honvedseg Egeszsegugyi Kozpont | Budapest | 1062 | Hungary |
| Semmelweis Egyetem | Budapest | 1082 | Hungary |
| Semmelweis Egyetem AOK | Budapest | 1088 | Hungary |
| Vasutegeszsegugyi Nonprofit Kozhasznu Kft Debreceni Kozpont | Debrecen | 4025 | Hungary |
| Fortis Memorial Research Institute | Gurugram | 122002 | India |
| Asian Institute Of Gastroenterology | Hyderabad | 500032 | India |
| Kasturba Medical College Hospital | Manipal | 576104 | India |
| P D Hinduja National Hospital and Medical Research Center | Mumbai | 400016 | India |
| SIDS (Surat Institute of Digestive Sciences) Hospital and Research Centre | Surat | 395002 | India |
| Ha'Emek Medical Center | Afula | 1834111 | Israel |
| Bnai Zion Medical Center | Haifa | 3339419 | Israel |
| Wolfson Medical Center | Holon | 5822012 | Israel |
| Shaare Zedek Medical Center - Jerusalem, ISRAEL | Jerusalem | 91031 | Israel |
| Lev Talpiot Clinic | Jerusalem | 93624 | Israel |
| Galilee Medical Center | Nahariya | 2210001 | Israel |
| Chaim Sheba Medical Center | Ramat Gan | 5262000 | Israel |
| Tokyo Medical and Dental University Hospital | Bunkyō City | 113-8510 | Japan |
| Ginza central clinic | Chūōku | 1040061 | Japan |
| Sai Gastroenterology Proctology | Fujiidera-shi | 583-0027 | Japan |
| Fukuoka University Hospital | Fukuoka | 814 0180 | Japan |
| Fukushima Medical University Hospital | Fukushima | 960 1295 | Japan |
| Hachinohe City Hospital | Hachinohe | 031-8555 | Japan |
| Tokai University Hachioji Hospital | Hachiōji | 192-0032 | Japan |
| Matsuda Hospital | Hamamatsu | 432-8061 | Japan |
| National Hospital Organization Mito Medical Center | Higashiibaraki-gun | 311-3193 | Japan |
| Kagoshima University Hospital | Kagoshima | 890-8520 | Japan |
| Kagoshima IBD Gastroenterology Clinic | Kagoshima | 892-0843 | Japan |
| National Hospital Organization Kanazawa Medical Center | Kanazawa | 920-8650 | Japan |
| Tsujinaka Hospital Kashiwanoha | Kashiwa | 277-0871 | Japan |
| Kyushu Rosai Hospital | Kitakyushu | 800-0296 | Japan |
| Kumagaya General Hospital | Kumagaya-shi | 360-8567 | Japan |
| National Hospital Organization Kure Medical Center and Chugoku Cancer Center | Kure | 737-0023 | Japan |
| Tokushukai Chiba-Nishi General Hospital | Matsudo | 270-2251 | Japan |
| National Hospital Organization Matsumoto Medical Center | Matsumoto | 399-8701 | Japan |
| Yokoyama IBD Clinic | Nagoya | 460-0022 | Japan |
| Okayama Saiseikai General Hospital | Okayama | 700-0013 | Japan |
| Kinshukai Infusion Clinic | Osaka | 530-0011 | Japan |
| Japanese Red Cross Osaka Hospital | Osaka | 543 8555 | Japan |
| Oita Red Cross Hospital | Ōita | 870-0033 | Japan |
| Ishida Clinic of IBD and Gastroenterology | Ōita | 870-0823 | Japan |
| Kindai University Hospital | Ōsaka-sayama | 589-8511 | Japan |
| Dokkyo Medical University Hospital | Shimotsuga Gun | 321 0293 | Japan |
| Center Hospital of the National Center for Global Health and Medicine | Shinjuku Ku | 162 8655 | Japan |
| Tokyo Metropolitan Bokutoh Hospital | Sumida Ku | 130 8575 | Japan |
| National Hospital Organization Shizuoka Medical Center | Sunto-gun | 411-8611 | Japan |
| Juntendo University Hospital Urayasu | Urayasu | 279-0021 | Japan |
| Kanke Gastrointestinal Clinic | Utsunomiya | 320-0003 | Japan |
| Yokohama City University Medical Center | Yokohama | 232 0024 | Japan |
| The Speciality Hospital (TSH) / Advanced Clinical Center | Amman | 11194 | Jordan |
| Jordan University Hospital | Amman | 11942 | Jordan |
| Irbid Specialty Hospital | Aydoun | 21166 | Jordan |
| King Abdullah University Hospital | Irbid | 22110 | Jordan |
| Hospital Selayang | Batu Caves | 68100 | Malaysia |
| Hospital Pulau Pinang | George Town | 10990 | Malaysia |
| Hospital Sultanah Aminah | Johor Bahru | 80100 | Malaysia |
| University Malaya Medical Centre | Kuala Lumpur | 59100 | Malaysia |
| Hospital Umum Sarawak | Kuching | 93586 | Malaysia |
| Hospital Tuanku Jaafar | Seremban | 70300 | Malaysia |
| SCIENTIA Investigacion Clinica SC | Chihuahua City | 31207 | Mexico |
| Clinica de Investigacion en Reumatologia y Obesidad | Guadalajara | 44650 | Mexico |
| Clinicos Asociados BOCM, SC | Mexico City | 03300 | Mexico |
| Centro de Investigacion Clinica Acelerada S.C | Mexico City | 07369 | Mexico |
| Hospital Médica Sur Tlalpan | Mexico City | 14050 | Mexico |
| Medical Care & Research SA de CV | Mérida | 97070 | Mexico |
| Centro Regiomontano de Estudios Clínicos Roma S.C. | Monterrey | 64610 | Mexico |
| Fundacion Santos Y De La Garza Evia IBP | Monterrey | 64710 | Mexico |
| Clinical Research Institute Saltillo S.A. de C.V. | Saltillo | 25020 | Mexico |
| Oncare | San Pedro Garza García | 66220 | Mexico |
| Hutt Hospital | Boulcott | 5010 | New Zealand |
| Christchurch Hospital | Christchurch | 8011 | New Zealand |
| Dunedin Hospital | Dunedin | 9016 | New Zealand |
| Auckland City Hospital | Grafton | 1023 | New Zealand |
| Waikato Hospital | Hamilton | 3204 | New Zealand |
| Gastromed Kralisz Romatowski Stachurska Sp. j. | Bialystok | 15-322 | Poland |
| Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy | Bydgoszcz | 85-168 | Poland |
| Centrum Medyczne Lukamed Sp z o o 1 | Chojnice | 89 600 | Poland |
| Centrum Medyczne Lukamed Sp z o o | Chojnice | 89 600 | Poland |
| Centrum Medyczne Plejady | Krakow | 30 363 | Poland |
| Centrum Medyczne Promed | Krakow | 31-513 | Poland |
| Zespol Poradni Specjalistycznych REUMED Filia nr 2 | Lublin | 20-582 | Poland |
| EMC Instytut Medyczny SA PL CERTUS | Poznan | 60 309 | Poland |
| Centrum Medyczne Medyk | Rzeszów | 35-326 | Poland |
| Twoja Przychodnia - Szczecinskie Centrum Medyczne | Szczecin | 71-434 | Poland |
| GASTROMED Sp. z o.o. | Torun | 87 100 | Poland |
| Bodyclinic Sp. z o.o. sp. k | Warsaw | 03 712 | Poland |
| Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus | Warsaw | 04 501 | Poland |
| Przychodnia Vistamed | Wroclaw | 53 149 | Poland |
| Melita Medical Sp. z o.o. | Wroclaw | 53 611 | Poland |
| Pro Life Medica Sp z o o ETG Zamosc | Zamość | 22-400 | Poland |
| FNsP F.D.R. Banska Bystrica | Banská Bystrica | 975 17 | Slovakia |
| Cliniq s.r.o. | Bratislava | 811 09 | Slovakia |
| ENDOMED s.r.o | Košice | 040 13 | Slovakia |
| KM Management spol. s r.o. | Nitra | 949 01 | Slovakia |
| Inje University Haeundae Paik Hospital | Busan | 48108 | South Korea |
| Yeungnam University Hospital | Daegu | 42415 | South Korea |
| National Cancer Center | Goyang-si | 10408 | South Korea |
| Chosun university hospital | Gwangju | 61453 | South Korea |
| Korea University Ansan Hospital | Gyeonggi-do | 15355 | South Korea |
| Kangbuk Samsung Hospital | Seoul | 03181 | South Korea |
| Severance Hospital Yonsei University Health System | Seoul | 03722 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Chung-Ang University Hospital | Seoul | 06973 | South Korea |
| Kyung Hee University Hospital | Seoul | 130 050 | South Korea |
| The Catholic university of Korea, St. Vincent's Hospital | Suwon | 16247 | South Korea |
| Hosp. Univ. Germans Trias I Pujol | Badalona | 08916 | Spain |
| Hosp. Virgen Macarena | Seville | 41009 | Spain |
| Hosp. de La Marina Baixa | Villajoyosa | 03570 | Spain |
| Hosp. Univ. Miguel Servet | Zaragoza | 50009 | Spain |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Mackay Memorial Hospital | Taipei | 10449 | Taiwan |
| Istanbul University | Istanbul | 34098 | Turkey (Türkiye) |
| Ege University Medical Faculty | Izmir | 35040 | Turkey (Türkiye) |
| Mersin University Medical Faculty | Mersin | 33343 | Turkey (Türkiye) |
| Guselkumab 400 mg q4w - Guselkumab 100 mg q8w |
Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8 followed by guselkumab 100 mg SC injection every 8 weeks (q8w) starting from Week 16 through Week 24. Participants who met rescue criteria at Week 16 continued their assigned treatment regimen and received blinded sham rescue with matching placebo SC injections at Weeks 16, 20, and 24. |
| FG002 | Guselkumab 400 mg q4w - Guselkumab 200 mg q4w | Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8 followed by guselkumab 200 mg SC injection q4w starting from Week 12 through Week 24. Participants who met rescue criteria at Week 16 continued their assigned treatment regimen and received blinded sham rescue with matching placebo SC injections at Weeks 16, 20, and 24. |
| Participants Who Started Rescue Medication |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo matching to guselkumab subcutaneous (SC) injection every 4 weeks (q4w) from Week 0 through Week 24. All participants in the placebo group who met rescue criteria at Week 16 received rescue treatment, that is, guselkumab 400 milligrams (mg) SC injection at Weeks 16, 20, and 24. |
| BG001 | Guselkumab 400 mg q4w - Guselkumab 100 mg q8w | Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8 followed by guselkumab 100 mg SC injection every 8 weeks (q8w) starting from Week 16 through Week 24. Participants who met rescue criteria at Week 16 continued their assigned treatment regimen and received blinded sham rescue with matching placebo SC injections at Weeks 16, 20, and 24. |
| BG002 | Guselkumab 400 mg q4w - Guselkumab 200 mg q4w | Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8 followed by guselkumab 200 mg SC injection q4w starting from Week 12 through Week 24. Participants who met rescue criteria at Week 16 continued their assigned treatment regimen and received blinded sham rescue with matching placebo SC injections at Weeks 16, 20, and 24. |
| BG003 | 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, 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 |
| ||||||||||||||||
| AgeCategorical | 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 in Clinical Remission at Week 12 | Percentage of participants in clinical remission at Week 12 was reported. Clinical remission is defined as a Mayo stool frequency subscore of 0 or 1 and not increased from baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity. | Full analysis set (FAS) included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, combined data of guselkumab 400 mg SC induction dose group (that is, participants from guselkumab groups: 100 mg SC q8w and 200 mg SC q4w that received same induction dose of Guselkumab 400 mg SC q4w at Weeks 0, 4, and 8) is reported. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 12 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants in Symptomatic Remission at Week 12 | Percentage of participants in symptomatic remission at Week 12 was reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and not increased from baseline, and a rectal bleeding subscore of 0. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity. | FAS included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, combined data of guselkumab 400 mg SC induction dose group (that is, participants from guselkumab groups: 100 mg SC q8w and 200 mg SC q4w that received same induction dose of Guselkumab 400 mg SC q4w at Weeks 0, 4, and 8) is reported. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Endoscopic Improvement at Week 12 | Percentage of participants with endoscopic improvement at Week 12 was reported. Endoscopic improvement is defined as an endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity. | FAS included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, combined data of guselkumab 400 mg SC induction dose group (that is, participants from guselkumab groups: 100 mg SC q8w and 200 mg SC q4w that received same induction dose of guselkumab 400 mg SC q4w at Weeks 0, 4, and 8) is reported. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants in Clinical Response at Week 12 | Percentage of participants in clinical response at Week 12 was reported. Clinical response is defined as a decrease from baseline in the modified Mayo score by greater than or equal to (>=) 30 percent (%) and >=2 points, with either a >=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. | FAS included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, combined data of guselkumab 400 mg SC induction dose group (that is, participants from guselkumab groups: 100 mg SC q8w and 200 mg SC q4w that received same induction dose of guselkumab 400 mg SC q4w at Weeks 0, 4, and 8) is reported. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Histologic-endoscopic Mucosal Improvement at Week 12 | Percentage of participants with histologic-endoscopic mucosal improvement at Week 12 was reported. Histologic-endoscopic mucosal improvement is defined as achieving a combination of histologic improvement and endoscopic improvement. Histologic improvement is defined as neutrophil infiltration in less than (<) 5% of crypts, no crypt destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system. Endoscopic improvement is defined as an endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity. | FAS included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, combined data of guselkumab 400 mg SC induction dose group (that is, participants from guselkumab groups: 100 mg SC q8w and 200 mg SC q4w that received same induction dose of guselkumab 400 mg SC q4w at Weeks 0, 4, and 8) is reported. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants in Clinical Remission at Week 24 | Percentage of participants in clinical remission at Week 24 was reported. Clinical remission is defined as a stool frequency subscore of 0 or 1 and not increased from baseline, a rectal bleeding subscore of 0, and an endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity. | FAS included all randomized participants who received at least 1 (partial or complete) dose of study intervention. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants in Symptomatic Remission at Week 24 | Percentage of participants in symptomatic remission at Week 24 was reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and not increased from baseline, and a rectal bleeding subscore of 0. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity. | FAS included all randomized participants who received at least 1 (partial or complete) dose of study intervention. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Endoscopic Improvement at Week 24 | Percentage of participants with endoscopic improvement at Week 24 was reported. Endoscopic improvement is defined as an endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity. | FAS included all randomized participants who received at least 1 (partial or complete) dose of study intervention. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants in Clinical Response at Week 24 | Percentage of participants in clinical response at Week 24 was reported. Clinical response is defined as a decrease from baseline in the modified Mayo score by >= 30% and >=2 points, with either a >=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. | FAS included all randomized participants who received at least 1 (partial or complete) dose of study intervention. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 24 |
|
All-cause mortality: From screening (-8 weeks) up to Week 24; Serious adverse events (SAEs) and Other AEs: From Week 0 up to Week 24
Safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study intervention. As planned, safety data were analyzed per intervention through Week 24.
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 | Placebo (Before Rescue Medication) | Participants received placebo matching to guselkumab subcutaneous (SC) injection every 4 weeks (q4w) from Week 0 through Week 24. This arm includes data of all placebo participants excluding data after a participant was rescued with guselkumab. | 1 | 139 | 17 | 139 | 48 | 139 |
| EG001 | Placebo - Guselkumab (After Rescue Medication) | All participants in the placebo group who met rescue criteria at Week 16 received rescue treatment that is guselkumab 400 milligrams (mg) mg SC injection at Weeks 16, 20, and 24. Rescue Criteria: No improvement (no decrease) in Mayo endoscopy subscore at Week 12 as obtained during central review, when compared with baseline and a less than (<) 2 point improvement (<2 point decrease) in partial Mayo score at Weeks 12 and 16, when compared with baseline. This arm includes data occurred after a participant crossed over to guselkumab. | 0 | 52 | 1 | 52 | 5 | 52 |
| EG002 | Guselkumab 400 mg q4w - Guselkumab 100 mg q8w | Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8 followed by guselkumab 100 mg SC injection every 8 weeks (q8w) starting from Week 16 through Week 24. Participants who met rescue criteria at Week 16 continued their assigned treatment regimen and received blinded sham rescue with matching placebo SC injections at Weeks 16, 20, and 24. | 0 | 139 | 5 | 139 | 47 | 139 |
| EG003 | Guselkumab 400 mg q4w - Guselkumab 200 mg q4w | Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8 followed by guselkumab 200 mg SC injection q4w starting from Week 12 through Week 24. Participants who met rescue criteria at Week 16 continued their assigned treatment regimen and received blinded sham rescue with matching placebo SC injections at Weeks 16, 20, and 24. | 0 | 140 | 6 | 140 | 39 | 140 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Ventricular Extrasystoles | Cardiac disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Colitis Ulcerative | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Colon Dysplasia | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Frequent Bowel Movements | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pilonidal Disease | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Humerus Fracture | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Haemoglobin Decreased | Investigations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Adenocarcinoma of Colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Colitis Ulcerative | Gastrointestinal disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Injection Site Erythema | General disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 26.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 26.1 | Non-systematic Assessment |
|
Study site and investigator shall not publish study results except as required by law or as specified in a separate, written agreement between the sponsor and the study site or investigator. Sponsor will register the study and publish the study results in compliance with applicable law and may register the study or publish study results when not required.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Medical Leader Pediatrics Immunology | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 22, 2024 | Oct 16, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| Male |
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| 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 |
|
| 65 years and over |
|
| AUSTRALIA |
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| BELGIUM |
|
| BRAZIL |
|
| BULGARIA |
|
| CANADA |
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| CHINA |
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| CZECH REPUBLIC |
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| FRANCE |
|
| GERMANY |
|
| HUNGARY |
|
| INDIA |
|
| ISRAEL |
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| JAPAN |
|
| JORDAN |
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| MALAYSIA |
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| MEXICO |
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| NEW ZEALAND |
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| POLAND |
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| SLOVAKIA |
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| SOUTH KOREA |
|
| SPAIN |
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| TAIWAN |
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| TURKEY |
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| UNITED STATES |
|
Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8. This arm includes all participants that received guselkumab 400 mg induction dose.
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Combined Guselkumab 400 mg |
Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8. This arm includes all participants that received guselkumab 400 mg induction dose. |
|
|
|
Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8. This arm includes all participants that received guselkumab 400 mg induction dose. |
|
|
|
| OG002 | Guselkumab 400 mg q4w - Guselkumab 200 mg q4w | Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8 followed by guselkumab 200 mg SC injection q4w starting from Week 12 through Week 24. Participants who met rescue criteria at Week 16 continued their assigned treatment regimen and received blinded sham rescue with matching placebo SC injections at Weeks 16, 20, and 24. |
|
|
|
| OG002 | Guselkumab 400 mg q4w - Guselkumab 200 mg q4w | Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8 followed by guselkumab 200 mg SC injection q4w starting from Week 12 through Week 24. Participants who met rescue criteria at Week 16 continued their assigned treatment regimen and received blinded sham rescue with matching placebo SC injections at Weeks 16, 20, and 24. |
|
|
|
| Guselkumab 400 mg q4w - Guselkumab 200 mg q4w |
Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8 followed by guselkumab 200 mg SC injection q4w starting from Week 12 through Week 24. Participants who met rescue criteria at Week 16 continued their assigned treatment regimen and received blinded sham rescue with matching placebo SC injections at Weeks 16, 20, and 24. |
|
|
|
| OG002 | Guselkumab 400 mg q4w - Guselkumab 200 mg q4w | Participants received guselkumab 400 mg SC injection at Weeks 0, 4, and 8 followed by guselkumab 200 mg SC injection q4w starting from Week 12 through Week 24. Participants who met rescue criteria at Week 16 continued their assigned treatment regimen and received blinded sham rescue with matching placebo SC injections at Weeks 16, 20, and 24. |
|
|
|