guselkumab crohn's disease phase 3

A Phase 2b Randomized, Double-blind, Active-and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Induction and Maintenance Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Sev . The binding of guselkumab to IL-23 blocks interaction between extracellular IL-23 to the cell surface IL-23R receptor, inhibiting IL-23specific intracellular signaling and subsequent activation of cytokine production. Induction therapy with the selective interleukin-23 inhibitor risankizumab in patients with moderate-to-severe Crohn's disease: a randomised, double-blind, placebo-controlled phase 2 study. ClinicalTrials.gov Identifier: NCT05347095, Interventional David T. Rubin, MD (Conceptualization: Equal; Data curation: Equal; Formal analysis: Equal; Methodology: Equal; Writing original draft: Equal; Writing review & editing: Equal). Percentage of participants who achieve combined clinical response and clinically assessed fistula response among participants with CDAI >220 at baseline at baseline will be reported. Participants will receive ustekinumab by intravenous (IV) infusion, followed by subcutaneous (SC) injection. At Week 12, non-responders will receive active treatment (ustekinumab) administered by intravenous (IV) infusion followed by subcutaneous (SC) injection. (Clinical Trial), A Phase 2/3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease, Experimental: Phase 2 (GALAXI 1): Group 1 (Guselkumab), Experimental: Phase 2 (GALAXI 1): Group 2 (Guselkumab), Experimental: Phase 2 (GALAXI 1): Group 3 (Guselkumab), Active Comparator: Phase 2 (GALAXI 1): Group 4 (Ustekinumab), Experimental: Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab), Experimental: Phase 3 (GALAXI 2 and 3): Group 1 and Group 2 (Guselkumab), Active Comparator: Phase 3 (GALAXI 2 and 3): Group 3 (Ustekinumab), Experimental: Phase 3 (GALAXI 2 and 3): Group 4 (Placebo/Ustekinumab), 18 Years and older (Adult, Older Adult), Digestive Health Specialists of the Southeast, Huntsville, Alabama, United States, 35801, Scottsdale, Arizona, United States, 85259, Scottsdale, Arizona, United States, 85260, Anaheim, California, United States, 92805, Apple Valley, California, United States, 92307, Beverly Hills, California, United States, 90211, El Cajon, California, United States, 92020, La Jolla, California, United States, 92093, Lancaster, California, United States, 93534, Los Angeles, California, United States, 90033, Los Angeles, California, United States, 90095, Mission Viejo, California, United States, 92691, Murrieta, California, United States, 92563, Sacramento, California, United States, 95817, Sacramento, California, United States, 95821, San Diego, California, United States, 91941, San Diego, California, United States, 92114, Walnut Creek, California, United States, 94598, Colorado Springs, Colorado, United States, 80920, New Haven, Connecticut, United States, 06510, Washington, District of Columbia, United States, 20007, Coconut Creek, Florida, United States, 33066, Fort Lauderdale, Florida, United States, 33308, Elite Research Network - Nature Coast Clinical Research, LLC, Jacksonville, Florida, United States, 32209, Lakewood Ranch, Florida, United States, 34211, Miami, Florida, United States, 33157-6575, Pinellas Park, Florida, United States, 33781, Saint Cloud, Florida, United States, 34769, Saint Petersburg, Florida, United States, 33705, Fairview Heights, Illinois, United States, 62208, Indianapolis, Indiana, United States, 46202, Digestive Research Alliance of Michiana, LLC, South Bend, Indiana, United States, 46635, Lexington, Kentucky, United States, 40506, Louisville, Kentucky, United States, 40202, Louisville, Kentucky, United States, 40206, Baton Rouge, Louisiana, United States, 70809, Lafayette, Louisiana, United States, 70503, New Orleans, Louisiana, United States, 70121, New Orleans, Louisiana, United States, 70124, LSUHSC Shreveport Feist-Weiller Cancer Center, Shreveport, Louisiana, United States, 71103, Shreveport, Louisiana, United States, 71105, Baltimore, Maryland, United States, 21201, Institute for Digestive Health and Liver Disease, Baltimore, Maryland, United States, 21202-2102, Baltimore, Maryland, United States, 21208, Harvard Medical School-Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States, 02215, Burlington, Massachusetts, United States, 01805, Chelmsford, Massachusetts, United States, 01824, Worcester, Massachusetts, United States, 01655, Clinical Research Institute of Michigan, LLC, Chesterfield, Michigan, United States, 48047, Huron Gastroenterology Associates Center for Digestive Care, Ypsilanti, Michigan, United States, 48197, Minneapolis, Minnesota, United States, 55446, Saint Louis, Missouri, United States, 63110, Advanced Gastroenterology of Bergen County, Englewood Cliffs, New Jersey, United States, 07632, Atlantic Digestive Health Institute/ Atlantic IBD Center, Morristown, New Jersey, United States, 07960, Plainsboro, New Jersey, United States, 08536, Hartsdale, New York, United States, 10530, Jackson Heights, New York, United States, 11372, Middletown, New York, United States, 10941, NYU Langone Long Island Clinical Research Associates, Rochester, New York, United States, 14642, Asheville, North Carolina, United States, 28801, Chapel Hill, North Carolina, United States, 27599, Charlotte Gastroenterology and Hepatology, PLLC, Charlotte, North Carolina, United States, 28207, Charlotte, North Carolina, United States, 28277, Fayetteville, North Carolina, United States, 28304, Greenville, North Carolina, United States, 27834, Kinston, North Carolina, United States, 28501, Mount Airy, North Carolina, United States, 27030, Winston-Salem, North Carolina, United States, 27103, Wexner Medical Center at the Ohio State University, Great Lakes Gastroenterology Research, LLC, Northshore Gastroenterology Research, LLC, Oklahoma City, Oklahoma, United States, 73112, Philadelphia, Pennsylvania, United States, 19107, Pittsburgh, Pennsylvania, United States, 15212-4756, Sayre, Pennsylvania, United States, 18840, Scranton, Pennsylvania, United States, 18508, Smithfield, Pennsylvania, United States, 15478, Wyomissing, Pennsylvania, United States, 19610, Providence, Rhode Island, United States, 02903, Providence, Rhode Island, United States, 02905, Anderson, South Carolina, United States, 29621-2062, Charleston, South Carolina, United States, 29406, Charleston, South Carolina, United States, 29425, Greenville, South Carolina, United States, 29615, Gastroenterology Associates of Orangeburg, SC, Orangeburg, South Carolina, United States, 29118, Chattanooga, Tennessee, United States, 37404, Germantown, Tennessee, United States, 38138, Hermitage, Tennessee, United States, 37076, Johnson, Tennessee, United States, 37614-1700, Knoxville, Tennessee, United States, 37920, Nashville, Tennessee, United States, 37212-1610, Baylor College Of Medicine - Dept Of Dermatology, Gastroenterology Clinic Of San Antonio P A, Gastroenterology Research of America, LLC, Digestive Health Research of North Texas, LLC, Wichita Falls, Texas, United States, 76301, Charlottesville, Virginia, United States, 22908, Chesapeake, Virginia, United States, 23320, Petersburg, Virginia, United States, 23805, Gastroenterology Consultants of Southwest Virginia, Roanoke, Virginia, United States, 24014-1372, Northwest Gastroenterology Associates - USA, Bellevue, Washington, United States, 98004, Seattle, Washington, United States, 98195, Huntington, West Virginia, United States, 25701, Medical College of Wisconsin-Froedtert Hospital, Milwaukee, Wisconsin, United States, 53226, Universittsklinikum Salzburg - Landeskrankenhaus, Republican Research Centre of Radiation Medicine and Human E, University Clinical Centre of the Republic of Srpska, Banja Luka, Bosnia and Herzegovina, 78000, Universidade Estadual Paulista 'Julio De Mesquita Filho', Centro Digestivo de Curitiba - Instituto de Pesquisa Clnica, Instituto Goiano de Gastroenterologia e Endoscopia Digestiva, Irmandade Santa Casa de Misericordia de Porto Alegre, Hospital da Crianca Santo Antonio de Porto Alegre, UFRJ-Hospital Universitrio Clementino Fraga Filho, Universidade Federal da Bahia (UFBA) - Complexo Hospitalar U, CEMEC - Centro Multidisciplinar de Estudos Clnicos, Irmandade da Santa Casa da Misericrdia de Santos, Fundacao Faculdade Regional De Medicina De Sao Jose Do Rio Preto, Instituto de Assistencia Medica ao Servidor Publico Estadual - IAMSPE, Centro de Estudos Clnicos do Interior Paulista - CECIP, Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein, Universidade Federal Do Piaui - Campos Universitario, Gastroenterology and Internal Medicine Research Institute (GIRI), New Westminster, British Columbia, Canada, Vancouver, British Columbia, Canada, V7M 2H4, Victoria, British Columbia, Canada, V8V 3M9, University of Alberta- Ziedler Ledcor Centre, Pharmaceutical Integrated Research Company, The Military General Hospital of Beijing PLA, China-Japan Union Hospital of Jilin University, The second Xiangya Hospital of Central South University, Xiangya Hospital Central South University, The Second Affiliated Hospital of Chongqing Medical University, Third Military Medical University Daping Hospital Cancer Center, First Affiliated Hospital of Gannan Medical University, The First Affiliated Hospital Sun Yat-Sen University, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, ZhuJiang Hospital of Southern Medical University, Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital, The Second Affiliated Hospital of Zhejiang University, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, The 1st affiliated hospital of Anhui Medical University, First Affiliated Hospital of Kunming Medical Unversity, The First Affiliated Hospital of NanChang University, Second Military Medical University (SMMU), Ruijin Hospital, Shanghai Jiao Tong University, The first hospital of China medical university, Shengjing Hospital of China Medical University, University of Hong Kong-Shenzhen Hospital, The first affiliated hospital of suzhou University, Tianjin Medical University General Hospital, The First Affiliated Hospital of Wenzhou Medical University, Zhangzhou Municipal Hospital of Fujian Province, Hospital San Ignacio de la Universidad Javeria, Corporacion para Estudios en Salud Clinica CES - Gastroenterology, Hospital General de Medelln-Luz Castro de Gutirrez - E.S.E, Centre Hospitalier Universitaire (CHU) de Caen, Hopitaux Universitaires Paris Nord Val de Seine - Hopital Beaujon, Centre Hospitalier Universitaire(CHU) - Hopital Henri Mondor, Groupement Hospitalier Universitaire Ouest, Hpitaux Universitaires de Strasbourg - Hpital de Hautepierre, LTD 'Georgia Archangel St. Michael Multiprofile Clinical Hospital', Ltd Central University Clinic by Academician N.Kipshidze, Israel Georgian medical research clinic Helsicore, LTD Unimed Kakheti- Telavi Referral Hospital, Gastroenterologische Spezialpraxis - Berlin-Karlshorst, Universitaetsklinikum Charite, Campus Virchow Klinikum, Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus, Curiositas ad Sanum Studien und Beratungs GmBH, Martin-Luther-Universitaet Halle-Wittenberg - Universitaetsk, Martini-Klinik am Universittsklinikum Hamburg-Eppendorf Urologie, Universitatsklinikum Schleswig-Holstein - Kiel, Gastroenterologie und Hepatologie am Johannisplatz, Zentrum fr Gastroenterologie Saar MVZ GmbH, Sotiria General State Hospital of Chest Diseases, szak-Kzp-budai Centrum, j Szent Jnos Krhz s Szakrendel Budai Csaldkzpont, Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Kaposi Mr Oktat Krhz, Kardiolgiai Rszleg. Clinically assessed fistula remission is defined as 100% closure of all treated external openings, without development of new fistulas or abscesses and without any drainage by the external openings, occurring spontaneously or after gentle finger compression. Janssen's guselkumab succeeded in the phase 3 Discover programme by meeting the primary endpoints in active moderate to severe psoriatic arthritis (PsA). Participants will receive matching placebo to maintain the blind. O.O.Bogomolets National Medical University, Kyiv City Clinical Hospital #18, LLC Treatment and Diagnostic Center Adonis Plus, Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies', Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud, Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway', CI of Kyiv RC Kyiv Regional Clinical Hospital, Communal Nonprofit Enterprise Clinical Hospital of Emergency Hospital of Lviv, MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council, Private Small Enterprise Medical Center Pulse, South Eastern Health and Social Care Trust, Synexus Midlands Clinical Research Centre, Nottingham University Hospitals NHS Trust, Sandwell and West Birmingham Hospitals NHS Trust-Sandwell Gene, Janssen Research & Development, LLC Clinical Trial. after L.G. . Clinical remission is defined as CDAI score <150. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04397263. AEs are coded using MedDRA, version 23.0. Percentage of participants who achieve clinically assessed fistula response at Week 24 will be reported. Clinical remission is defined as CDAI <150. Drug: Placebo Drug: Guselkumab: Phase 2 Phase 3: Detailed Description: . Percentage of participants who achieve combined clinical response and clinically assessed fistula response at Week 24 and Week 48 will be reported. IL-23p19 inhibition with guselkumab resulted in clinical and endoscopic improvement in patients with Crohns disease with an inadequate response or intolerance to prior conventional or biologic therapy supporting initiation of pivotal induction and maintenance studies in Crohns disease. 4 This comparison will proceed to a phase 3 investigation. Please enable it to take advantage of the complete set of features! The presence of antibodies to guselkumab in serum was determined by a validated, sensitive, and drug-tolerant assay that incorporates an acid dissociation step to improve detection ofanti-guselkumab antibodies in the presence of excess guselkumab. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03466411. The total SES-CD score at week 12 was based on all observed segments scored at week 12. Conclusions: NCT03466411 A Phase 3, Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Subject with Moderately to Severely Active Crohn's Disease Associated Conditions Inflammatory Bowel Disease (IBD) Principal Investigator Muhammed Hasan, MD Sponsor Listing a study does not mean it has been evaluated by the U.S. Federal Government. Sokolov, Saint Petersburg, Russian Federation, 194291, Saint Petersburg, Russian Federation, 197110, City Hospital named after St. Martyr Elizabeth, Saint-Petersburg, Russian Federation, 195257, Saint-Petersburg, Russian Federation, 196247, NUZ 'Railway Clinical Hospital on Samara station of LLC 'Russian Railways', Northen-Western State Medical University n.a. Choosing to participate in a study is an important personal decision. Although the lowest dose (200 mg) had the greatest numeric reduction from baseline in CDAI score at week 12, the differences between the individual dose groups were small and not considered clinically meaningful. In Phase 2, safety and efficacy of guselkumab dose regimens will be evaluated to support the selection of induction and maintenance dose regimens for confirmatory evaluation in Phase 3. Time to clinical fistula remission will be reported. Participants who . Santa Maria, Centro Hospitalar Lisboa Norte EPE - Hospital Pulido Valente, Hospital de Portimao-Centro Hospitalar do Barlavento Algarvio, H. Santo Antnio - Centro Hospitalar do Porto, Centro Hospitalar de Entre o Douro e Vouga, E.P.E, VA Caribbean Healthcare System - San Juan VA Medical Center, Clinical-Diagnostic Center Euromedservice, JSC, State Scientific Centre of Coloproctology, Nizhniy Novgorod, Russian Federation, 603018, Novgorod Regional Clinical Hospital n.a. Individual Participant Data (IPD) Sharing Statement: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. Efficacy and safety of guselkumab in patients with active psoriatic arthritis: a randomised, double-blind, placebo-controlled, phase 2 study. Why Should I Register and Submit Results? Susana Gonzalez, MD (Conceptualization: Equal; Data curation: Equal; Formal analysis: Equal; Investigation: Equal; Methodology: Equal; Supervision: Equal; Writing original draft: Equal; Writing review & editing: Equal). GALAXI-1, a phase 2, double-blind, placebo-controlled study, randomized patients 1:1:1:1:1 to intravenous guselkumab 200 mg, 600 mg, or 1200 mg at weeks 0, 4, and 8; intravenous ustekinumab approximately 6 mg/kg at week 0 and 90 mg subcutaneously at week 8; or placebo. At week 12, significantly greater reductions in Crohn's Disease Activity Index from baseline (least squares means: 200 mg: -160.4, 600 mg: -138.9, and 1200 mg: -144.9 vs placebo: -36.2; all, P < .05) and significantly greater proportions of patients achieved clinical remission in each guselkumab group vs placebo (Crohn's Disease Activity Index <150; 57.4%, 55.6%, and 45.9% vs 16.4%; all, P < .05). Endoscopic response is defined as at least 50% improvement from baseline in SES-CD score or SES-CD score 2. 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