A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis

Sponsors

Lead Sponsor: Janssen Research & Development, LLC

Source Janssen Research & Development, LLC
Brief Summary

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).

Detailed Description

UC is a chronic disease of the large intestine, in which the lining of the colon becomes inflamed and develops ulcers. Guselkumab is a fully human immunoglobulin G1 lambda monoclonal antibody (mAb) that binds to human interleukin (IL)-23 with high affinity. The study is designed to answer scientific questions pertaining to the efficacy and safety of guselkumab in the treatment of moderately to severely active UC. Overall, the study will evaluate long-term guselkumab treatment. Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points.

Overall Status Recruiting
Start Date 2019-09-26
Completion Date 2025-12-29
Primary Completion Date 2022-06-29
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Induction Study 1: Clinical Response at Week 12 Week 12
Induction Study 2: Clinical Remission at Week 12 Week 12
Maintenance Study: Clinical Remission at Week 44 Week 44
Secondary Outcome
Measure Time Frame
Induction Study 1: Clinical Remission at Week 12 Week 12
Induction Study 1: Symptomatic Remission at Week 12 Week 12
Induction Study 1: Endoscopic Healing at Week 12 Week 12
Induction Study 1: Histo-Endoscopic Mucosal Healing at Week 12 Week 12
Induction Study 1: Endoscopic Normalization at Week 12 Week 12
Induction Study 2: Symptomatic Remission at Week 12 Week 12
Induction Study 2: Endoscopic Healing at Week 12 Week 12
Induction Study 2: Clinical Response at Week 12 Week 12
Induction Study 2: Histo-Endoscopic Mucosal Healing at Week 12 Week 12
Induction Study 2: Symptomatic Remission at Week 4 Week 4
Induction Study 2: Symptomatic Remission at Week 2 Week 2
Induction Study 2: Endoscopic Normalization at Week 12 Week 12
Maintenance Study: Symptomatic Remission at Week 44 Week 44
Maintenance Study: Endoscopic Healing at Week 44 Week 44
Maintenance Study: Corticosteroid-free Clinical Remission at Week 44 Week 44
Maintenance Study: Clinical Response at Week 44 Week 44
Maintenance Study: Histo-Endoscopic Mucosal Healing at Week 44 Week 44
Maintenance Study: Clinical Remission at Week 44 Among the Participants Who had Achieved Clinical Remission at Maintenance Baseline Week 44
Maintenance Study: Endoscopic Normalization at Week 44 Week 44
Enrollment 950
Condition
Intervention

Intervention Type: Drug

Intervention Name: Placebo

Description: Participants will receive matching placebo IV or SC.

Intervention Type: Drug

Intervention Name: Guselkumab

Description: Participants will receive guselkumab IV or SC.

Eligibility

Criteria:

Inclusion Criteria: - Documented diagnosis of ulcerative colitis (UC) - Moderately to severely active UC, defined by modified Mayo score - Demonstrated inadequate response or intolerance to medical therapies specified in the protocol - Screening laboratory test results within the parameters specified in the protocol Exclusion Criteria: - Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease or clinical findings suggestive of Crohn's disease - UC limited to the rectum only or to less than (<) 20 centimeter (cm) of the colon - Presence of a stoma - Presence or history of a fistula - Receiving prohibited medications and/or treatment

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Janssen Research & Development, LLC Clinical Trial Study Director Janssen Research & Development, LLC
Overall Contact

Last Name: Study Contact

Phone: 844-434-4210

Email: [email protected]

Location
Facility: Status:
Alabama Medical Group | Mobile, Alabama, 36608, United States Withdrawn
University of Arizona | Tucson, Arizona, 85724, United States Not yet recruiting
UC San Diego | La Jolla, California, 92093, United States Withdrawn
Om Research LLC | Lancaster, California, 93534, United States Recruiting
UCLA | Los Angeles, California, 90095, United States Not yet recruiting
San Francisco Research Institute | San Francisco, California, 94127, United States Not yet recruiting
Peak Gastroenterology Associates | Colorado Springs, Colorado, 80907, United States Withdrawn
Peak Gastroenterology Associates | Colorado Springs, Colorado, 80907, United States Recruiting
Florida Research Network, LLC | Gainesville, Florida, 32605, United States Completed
University of Florida | Gainesville, Florida, 32608, United States Recruiting
Harmony Medical Research Institute, Inc. | Hialeah, Florida, 33016, United States Recruiting
River City Clinical Research | Jacksonville, Florida, 32207, United States Withdrawn
UF Health Jacksonville Gastroenterology- Emerson | Jacksonville, Florida, 32209, United States Recruiting
I.H.S. Health. LLC | Kissimmee, Florida, 34741, United States Completed
San Marcus Research Clinic, Inc. | Miami Lakes, Florida, 33014, United States Withdrawn
Columbus Clinical Services LLC | Miami, Florida, 33125, United States Recruiting
Orlando Health | Orlando, Florida, 32806, United States Withdrawn
Synexus Clinical Research US, Inc | Pinellas Park, Florida, 33781, United States Not yet recruiting
Univ. of South Florida Med. Group | Tampa, Florida, 33606, United States Not yet recruiting
GCP Clinical Research | Tampa, Florida, 33609, United States Withdrawn
Alliance Clinical Research | Tampa, Florida, 33615, United States Withdrawn
Emory Clinic | Atlanta, Georgia, 30322, United States Not yet recruiting
Atlanta Gastroenterology Associates | Atlanta, Georgia, 30342, United States Not yet recruiting
Atlanta Center For Gastroenterology | Decatur, Georgia, 30033, United States Recruiting
Gastroenterolgy Associates of Central GA | Macon, Georgia, 31201, United States Recruiting
University of Chicago | Chicago, Illinois, 60637, United States Not yet recruiting
Illinois Gastroenterology Institute, S.C. | Peoria, Illinois, 61606, United States Withdrawn
Community Clinical Research Center | Anderson, Indiana, 46011, United States Withdrawn
IU Health University Hospital | Indianapolis, Indiana, 46202, United States Withdrawn
University of Iowa Health Care | Iowa City, Iowa, 52242, United States Withdrawn
Health Science Research Center | Pratt, Kansas, 67124, United States Recruiting
Tri-State Gastroenterology Assoc | Crestview Hills, Kentucky, 41017, United States Recruiting
CroNOLA, LLC | Houma, Louisiana, 70360, United States Withdrawn
Gastroenterologist Lafayette - Jacque F. Noel III MD | Lafayette, Louisiana, 70503-2638, United States Withdrawn
Louisiana Research Center | Shreveport, Louisiana, 71105, United States Withdrawn
Chevy Chase Clinical Research | Chevy Chase, Maryland, 20815, United States Withdrawn
Capitol Research | Rockville, Maryland, 20850, United States Withdrawn
Lahey Hospital & Medical Center | Burlington, Massachusetts, 01805, United States Withdrawn
Baystate Medical Center | Springfield, Massachusetts, 01199, United States Not yet recruiting
Clinical Research Institute of Michigan, LLC | Chesterfield, Michigan, 48047, United States Recruiting
Revive Research Institute | Farmington Hills, Michigan, 48334, United States Recruiting
Minnesota Gastroenterology, P.A | Minneapolis, Minnesota, 55446, United States Withdrawn
Mid-America Gastro-Intestinal Consultants | Kansas City, Missouri, 64111, United States Not yet recruiting
Barnes-jewish Hospital | Saint Louis, Missouri, 63108, United States Recruiting
Somnos Clinical Research | Lincoln, Nebraska, 68510, United States Withdrawn
Las Vegas Medical Research | Las Vegas, Nevada, 89113, United States Recruiting
United Health Services Hospitals Office of Clinical Trials | Johnson City, New York, 13790, United States Not yet recruiting
University of North Carolina at Chapel Hill | Chapel Hill, North Carolina, 27514, United States Recruiting
Duke University Hospital Medical Center | Raleigh, North Carolina, 27609, United States Not yet recruiting
Ohio State University Hospital | Columbus, Ohio, 43210, United States Withdrawn
Synexus Clinical Research US, Inc | Columbus, Ohio, 43212, United States Not yet recruiting
Great Lakes Medical Research, LLC | Westlake, Ohio, 44145, United States Recruiting
Digestive Disease Specialists Inc | Oklahoma City, Oklahoma, 73112, United States Recruiting
Synexus Clinical Research US, Inc | Anderson, South Carolina, 29621-2062, United States Not yet recruiting
Medical University of South Carolina | Charleston, South Carolina, 29425, United States Withdrawn
Gastroenterology Associates of Orangeburg, SC | Orangeburg, South Carolina, 29118, United States Recruiting
Erlanger Health System | Chattanooga, Tennessee, 37403, United States Withdrawn
Vanderbilt University Medical Center | Nashville, Tennessee, 37212, United States Recruiting
The University of Texas at Austin | Austin, Texas, 78712, United States Withdrawn
Pinnacle Clinical Resesrch | Austin, Texas, 78757, United States Not yet recruiting
Inquest Clinical Research | Baytown, Texas, 77521, United States Withdrawn
Crescent Health Clinical | DeSoto, Texas, 75115, United States Withdrawn
El Paso Integrated Physicians Group, P.A. | El Paso, Texas, 79912, United States Withdrawn
Baylor College of Medicine | Houston, Texas, 77025, United States Recruiting
GI Specialists of Houston | Houston, Texas, 77346, United States Withdrawn
Caprock Gastro Research | Lubbock, Texas, 79424, United States Recruiting
Tyler Research Institute, LLC | Tyler, Texas, 75701, United States Recruiting
Gastroenterology Associates of Tidewater | Chesapeake, Virginia, 23320, United States Recruiting
Medical College Of Virginia Hospital | Richmond, Virginia, 23249, United States Withdrawn
UW-Harborview Medical Center | Seattle, Washington, 98104, United States Not yet recruiting
University of Washington | Seattle, Washington, 98195, United States Withdrawn
Velocity Clinical Research Spokane | Spokane, Washington, 99202, United States Recruiting
Providence Medical Group | Spokane, Washington, 99208, United States Recruiting
Hospital de Clínicas José de San Martín | Buenos Aires, 1121, Argentina Withdrawn
CEMIC (Centro de Educación Médica e Investigaciones Clínicas) | Buenos Aires, 1431, Argentina Recruiting
Cer Instituto Medico | Buenos Aires, 1878, Argentina Recruiting
Cinme - Centro De Investigaciones Metabolicas | Buenos Aires, C1027AAP, Argentina Recruiting
Hospital General de Agudos José Maria Ramos Mejía | Buenos Aires, C1221ADC, Argentina Recruiting
Expertia S.A | Caba, C1128AAF, Argentina Withdrawn
Centro Médico Dra. De Salvo | Caba, C1426ABP, Argentina Recruiting
Clínica Adventista Belgrano | Ciudad De Buenos Aires, C1430EGF, Argentina Recruiting
Instituto Médico Elsa Pérez I.M.E.P | Ciudadela, B1702BLP, Argentina Withdrawn
Sanatorio Duarte Quiroz | Cordoba, X5002AOQ, Argentina Recruiting
Hospital de Alta Complejidad en Red 'El Cruce' | Florencio Varela, 1888, Argentina Recruiting
HIGA San Martin | La Plata, 1904, Argentina Withdrawn
Centro de Investigaciones Medicas Mar Del Plata | Mar Del Plata, B7600FYK, Argentina Recruiting
Fundación de Estudios Clínicos | Rosario, 2000, Argentina Recruiting
Hospital Provincial del Centenario | Rosario, 2000, Argentina Recruiting
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica | San Juan, 05400, Argentina Withdrawn
Sanatorio 9 de Julio | San Miguel de Tucuman, 4000, Argentina Withdrawn
Centro Medico Privado de Reumatologia | San Miguel De Tucuman, T4000AXL, Argentina Withdrawn
Sanatorio Vicente Lopez - La Torre | Vicente Lopez, B1602BWT, Argentina Withdrawn
Southern Adelaide Health Network | Bedfford Park, 5042, Australia Withdrawn
Emeritus Research | Camberwell, 3124, Australia Recruiting
Monash Health | Clayton, 3156, Australia Recruiting
St Vincent's hospital | Darlinghurst, 2010, Australia Withdrawn
Western Health | Footscray, 3011, Australia Recruiting
Frankston Gastrointestinal and Liver Specialists | Frankston, 3199, Australia Withdrawn
Austin Health | Heidelberg, 3084, Australia Withdrawn
Fiona Stanley Hospital | Murdoch, 6150, Australia Recruiting
Royal Perth Hospital | Perth, 6000, Australia Not yet recruiting
Mater Hospital | South Brisbane, 4101, Australia Recruiting
St John of God Subiaco Hospital | Subiaco, 6008, Australia Recruiting
Princess Alexandra Hospital | Woolloongabba, 4102, Australia Recruiting
Medizinische Universität Innsbruck | Innsbruck, 6020, Austria Not yet recruiting
Universitätsklinikum Salzburg - Landeskrankenhaus | Salzburg, 5020, Austria Not yet recruiting
Akh Wien | Vienna, 1090, Austria Not yet recruiting
AZ Sint-Lucas | Brugge, 8310, Belgium Recruiting
Hopital Erasme | Brussels, 1070, Belgium Recruiting
CHU Saint-Pierre | Bruxelles, 1000, Belgium Not yet recruiting
AZ Maria Middelares | Gent, 9000, Belgium Recruiting
Universitair Ziekenhuis Gent | Gent, 9000, Belgium Not yet recruiting
Algemeen Ziekenhuis Jan Palfijn Merksem | Merksem, 2170, Belgium Recruiting
Centre Hospitalier De Mouscron | Mouscron, 7700, Belgium Not yet recruiting
Algemeen Ziekenhuis Delta | Roeselare, 8800, Belgium Recruiting
Hospital e Maternidade Celso Pierro | Campinas, 13590-900, Brazil Recruiting
CDC - Centro Digestivo de Curitiba | Curitiba, 80430-180, Brazil Recruiting
Eurolatino Pesquisas Medicas Ltda | Juiz de Fora, 36033-318, Brazil Recruiting
Instituto Méderi de Pesquisa e Saúde | Passo Fundo, 99010-120, Brazil Recruiting
Hospital de Clínicas de Porto Alegre/ HCPA / UFRGS | Porto Alegre, 90035-903, Brazil Recruiting
NPCRS - Nucleo de Pesquisa Clinica do Rio Grande do Sul | Porto Alegre, 90430-001, Brazil Recruiting
UFRJ-Hospital Universitário Clementino Fraga Filho | Rio de Janeiro, 21941-913, Brazil Not yet recruiting
CLIAGEN - Clinica de Atencao em Gastroenterologia Especializada e Nutricao | Salvador, 41500-300, Brazil Recruiting
Onco Star SP Oncologia Ltda | Sao Paulo, 04532-030, Brazil Recruiting
CPQuali Pesquisa Clinica LTDA ME | São Paulo, 01228-900, Brazil Recruiting
BR Trials | São Paulo, 03325-050, Brazil Not yet recruiting
Universidade Federal Do Piaui - Campos Universitario | Teresina, 64049-550, Brazil Recruiting
Eurolatino Pesquisas Médicas | Uberlândia, 38400-368, Brazil Recruiting
Medical Centre Asklepii OOD | Dupnitsa, 2600, Bulgaria Recruiting
Medical Center-1-Sevlievo EOOD | Sevlievo, 5400, Bulgaria Recruiting
2-nd MHAT | Sofia, 1202, Bulgaria Recruiting
4th MHAT - Sofia | Sofia, 1606, Bulgaria Not yet recruiting
DCC Convex EOOD | Sofia, 1680, Bulgaria Recruiting
Acibadem City Clinic - Oncology Center | Sofia, 1784, Bulgaria Recruiting
MHAT 'St. Marina' EAD | Varna, 9010, Bulgaria Not yet recruiting
MHAT Dr Stefan Cherkezov | Veliko Tarnovo, 5000, Bulgaria Not yet recruiting
GIRI Gastrointestinal Research Institute | Vancouver, British Columbia, V6Z 2K5, Canada Recruiting
Health Sciences Centre | Winnipeg, Manitoba, R3A 1R9, Canada Not yet recruiting
Nova Scotia Health Authority | Halifax, Nova Scotia, B3H 1V7, Canada Not yet recruiting
Mount Sinai Hospital | Toronto, Ontario, M5G 1X5, Canada Withdrawn
Toronto Immune & Digestive Health Institute Inc. | Toronto, Ontario, M6A 3B4, Canada Not yet recruiting
Hopital Maisonneuve-Rosemont | Montréal, Quebec, H1T 2M4, Canada Not yet recruiting
Royal University Hospital | Saskatoon, Saskatchewan, S7N 0W8, Canada Recruiting
Capital Medical University, Beijing Friendship Hospital | Beijing, 100050, China Recruiting
Peking University Third Hospital | Beijing, 100191, China Recruiting
China-Japan Union Hospital of Jilin University | Changchun, 130033, China Not yet recruiting
The second Xiangya Hospital of Central South University | Changsha, 200120, China Recruiting
The Third Xiangya Hospital of Central Sourth University | Changsha, 40013, China Recruiting
West China Hospital of Sichuan University | Chengdu, 610041, China Recruiting
Daping Hospital | Chongqing, 400042, China Not yet recruiting
The Second Hospital To Dalian Medical University | Dalian, 116027, China Recruiting
First Affiliated Hospital of Gannan Medical University | Ganzhou, 341000, China Recruiting
The First Affiliated Hospital, Sun Yat-sen University | Guangzhou, 510080, China Recruiting
Sun Yat-sen University - The Sixth Affiliated Hospital Guangdong Gastrointestinal Hospital | Guangzhou, 510610, China Recruiting
The First Affiliated Hospital, Zhejiang University College of Medicine | Hangzhou, 310003, China Recruiting
The Second Affiliated Hospital of Zhejiang University | Hangzhou, 310003, China Recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou, 310016, China Recruiting
The 1st affiliated hospital of Anhui Medical University | Hefei, 230022, China Not yet recruiting
First Affiliated Hospital of Kunming Medical Unversity | Kunming, 650032, China Not yet recruiting
The First Affiliated Hospital of NanChang University | Nanchang, 330006, China Recruiting
Nanjing Drum Tower Hospital | Nanjing, 210008, China Recruiting
Zhongda Hospital,Southeast University | Nanjing, 210009, China Recruiting
Jiangsu Province Hospital | Nanjing, 210029, China Not yet recruiting
Ruijing Hospital Affiliated To Shanghai Jiaotong University School Of Medicine | Shanghai, 200025, China Recruiting
Shengjing Hospital of China Medical University | Shenyang, 110004, China Recruiting
The Second Hospital Affiliated To Suzhou University | Suzhou, 215168, China Recruiting
The first affiliated hospital of suzhou University | Suzhou, China Not yet recruiting
Tianjin Medical University General Hospital | Tianjin, 300011, China Recruiting
Wuhan Union Hospital | Wuhan, 430022, China Recruiting
Tongji Hospital, Tongji Medical College of HUST | Wuhan, 430030, China Recruiting
Wuxi People's Hospital | Wuxi, 214023, China Recruiting
Nemocnice Ceske Budejovice, a.s. | Ceske Budejovice, 37001, Czechia Not yet recruiting
Asclepiades - interna a gastroenterologie s.r.o | Havirov, 736 01, Czechia Recruiting
MUDr. Gregar s.r.o. | Olomouc, 779 00, Czechia Recruiting
Vitkovicka nemocnice a.s. | Ostrava, 703 84, Czechia Recruiting
Artroscan s.r.o. | Ostrava, 722 00, Czechia Recruiting
AXON Clinical s.r.o. | Prague, 15000, Czechia Recruiting
ResTrial GastroEndo, s.r.o | Praha 4, 143 00, Czechia Recruiting
Nemocnice na Homolce | Praha 5, 150 30, Czechia Recruiting
Klinicke centrum ISCARE | Praha 9, 190 00, Czechia Recruiting
Nemocnice Strakonice, a.s. | Strakonice, 386 29, Czechia Recruiting
CHU caen | Caen, 14033, France Recruiting
Hôpital Beaujon | Clichy, 92110, France Not yet recruiting
CHRU de Lille - Hôpital Claude Huriez | Lille, 59000, France Recruiting
Hopital Saint Eloi | Montpellier, 34295, France Recruiting
CHU Hotel Dieu, CIC IMAD | Nantes, 44000, France Withdrawn
CHU de Nice Hopital de l Archet | Nice Cedex 3, 62002, France Recruiting
Hopital Saint Antoine | Paris, 75571, France Recruiting
Hopital Haut-Leveque, CMC Magellan | Pessac, 33604, France Recruiting
Centre Hospitalier Lyon Sud | Pierre-Bénite, 69495, France Recruiting
CHU Reims | Reims, 51100, France Withdrawn
CHU Saint-Etienne - Hôpital Nord | Saint-Priest en Jarez, 42270, France Recruiting
CHRU Hôpital de Hautepierre | Strasbourg Cedex, 67098, France Recruiting
CHU Rangueil | Toulouse, 31059, France Recruiting
CHRU Nancy-Brabois | Vandoeuvre-les-Nancy, 54511, France Recruiting
Universitaetsklinikum Charite, Campus Virchow Klinikum | Berlin, 13353, Germany Recruiting
Universitätsklinikum Carl-Gustav-Carus Dresden | Dresden, 1307, Germany Withdrawn
BSF Studiengesellschaft | Halle, 6108, Germany Recruiting
Hamburgisches Forschungsinstitut fuer CED, HaFCED e.K. | Hamburg, 20251, Germany Withdrawn
Medizinische Hochschule Hannover | Hannover, 30625, Germany Recruiting
Universitaetsklinikum Heidelberg | Heidelberg, 69120, Germany Not yet recruiting
Praxisgemeinschaft Jerichow | Jerichow, 39319, Germany Recruiting
Evangelisches Krankenhaus Kalk | Köln, 51103, Germany Not yet recruiting
Städtisches Klinikum Lüneburg | Lueneburg, 21339, Germany Recruiting
Zentrum für Gastroenterologie Saar MVZ GmbH | Saarbrücken, 66111, Germany Recruiting
Universitaetsklinikum Tuebingen | Tuebingen, 72076, Germany Withdrawn
Universitaetsklinikum Ulm | Ulm, 89081, Germany Recruiting
Synexus Magyarorszag Kft. | Budapest, 1036, Hungary Not yet recruiting
Magyar Honvedseg Egeszsegugyi Kozpont | Budapest, 1062, Hungary Recruiting
Semmelweis Egyetem | Budapest, 1082, Hungary Recruiting
Semmelweis Egyetem, Ii. Belgyogyaszati Klinika | Budapest, 1088, Hungary Recruiting
Vasutegeszsegugyi Nonprofit Kozhasznu Kft Debreceni Kozpont | Debrecen, 4025, Hungary Recruiting
Debreceni Egyetem Klinikai Kozpont | Debrecen, H-4032, Hungary Recruiting
Bugat Pal Korhaz | Gyongyos, 3200, Hungary Recruiting
Synexus Magyarorszag Kft | Gyula, 5700, Hungary Not yet recruiting
Szegedi Tud.Egyetem Szent-Gyorgyi Albert Klin. Közp. | Szeged, 6720, Hungary Not yet recruiting
St Vincent's University Hospital | Dublin 4, D04T6F4, Ireland Not yet recruiting
Beaumont Hospital | Dublin, 9, Ireland Not yet recruiting
University Hospital Galway - Ireland | Galway, H91YR71, Ireland Not yet recruiting
Haemek Medical Center - Afula | Afula, 1834111, Israel Withdrawn
Rambam Medical Center | Haifa, 31096, Israel Recruiting
Bnai Zion Medical Center | Haifa, 3449419, Israel Recruiting
Wolfson Medical Center | Holon, 58100, Israel Recruiting
Shaare Zedek Medical Center | Jerusalem, 91031, Israel Recruiting
Hadassah Hebrew University Medical Center | Jerusalem, 91120, Israel Withdrawn
Lev Talpiot Clinic | Jerusalem, 93624, Israel Recruiting
Galilee Medical Center | Naharia, 2210001, Israel Recruiting
Tel Aviv Sourasky Medical Center | Tel Aviv, 6423914, Israel Not yet recruiting
Policlinico Sant'Orsola Malpighi | Bologna, 40138, Italy Recruiting
Azienda Ospedaliera Universitaria Careggi | Firenze, 50134, Italy Withdrawn
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milano, 20122, Italy Recruiting
Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar | Negrar ( Ve), 37024, Italy Recruiting
Azienda Ospedaliera di Padova | Padova, 35128, Italy Not yet recruiting
Ospedale Villa Sofia-Cervello | Palermo, 90146, Italy Not yet recruiting
Azienda Ospedaliera G.Salvini Ospedale di Rho | RHO, Italy Recruiting
Università Campus Biomedico di Roma | Roma, 00128, Italy Recruiting
Fondazione Policlinico Gemelli Università Cattolica | Roma, 00168, Italy Recruiting
Istituto Clinico Humanitas Rozzano, IRCCS | Rozzano, 20089, Italy Not yet recruiting
Casa Sollievo della Sofferenza, IRCCS | San Giovanni Rotondo, 71013, Italy Recruiting
AO Ordine Mauriziano | Torino, 10128, Italy Not yet recruiting
Tokyo Medical and Dental University Medical Hospital | Bunkyo-Ku, 113-8519, Japan Recruiting
The Jikei University Kashiwa Hospital | Chiba, 277 -8567, Japan Recruiting
Juntendo University Hospital Urayasu | Chiba, 279-0021, Japan Recruiting
Fukuoka University Chikushi Hospital | Chikushino, 818-8502, Japan Recruiting
Ehime Prefectural Central Hospital | Ehime, 790-0024, Japan Recruiting
Sai Clinic, Gastrointestinal and Protology Divisions | Fujiidera-shi, 583-0027, Japan Not yet recruiting
Kitakyushu Municipal Medical Center | Fukuoka-ken, 802-0077, Japan Recruiting
Fukuoka University Hospital | Fukuoka, 814-0180, Japan Recruiting
Fukushima Medical University Hospital | Fukushima, 960-1295, Japan Recruiting
Gifu University Hospital | Gifu, 501-1194, Japan Not yet recruiting
Hachinohe City Hospital | Hachinohe, 031-8555, Japan Not yet recruiting
Tokai University Hachioji Hospital | Hachioji, 192-0032, Japan Recruiting
Hakodate Goryokaku Hospital | Hakodate, 040-8611, Japan Not yet recruiting
Hirosaki National Hospital | Hirosaki, 036-8545, Japan Recruiting
Hirosaki University Hospital | Hirosaki, 036-8563, Japan Recruiting
Kure Kyosai Hospital | Hiroshima, 737-8505, Japan Recruiting
Asahikawa Medical University Hospital | Hokkaido, 078-8510, Japan Recruiting
Mito Saiseikai General Hospital | Ibaraki, 311-4198, Japan Recruiting
Shimane University Hospital | Izumo, 693-8501, Japan Recruiting
Kagawa Prefectural Central Hospital | Kagawa, 760-8557, Japan Recruiting
Kagoshima University Hospital | Kagoshima City, 890-8544, Japan Recruiting
Imamura General Hospital | Kagoshima, 890-0064, Japan Recruiting
Izuro Imamura Hospital | Kagoshima, 892-0824, Japan Recruiting
Sameshima Hospital | Kagoshima, 892-0846, Japan Recruiting
St.Marianna University School of Medicine | Kanagawa, 216-8511, Japan Recruiting
Matsushima Clinic | Kanagawa, 220-0045, Japan Recruiting
Kanazawa University Hospital | Kanazawa, 920-8641, Japan Recruiting
National Hospital Organization Kanazawa Medical Center | Kanazawa, 920-8650, Japan Recruiting
Nara Medical University Hospital | Kashihara, 634-8522, Japan Recruiting
Medical corporation Kokikai Tsujinaka Hospital Kashiwanoha | Kashiwa, 277-0871, Japan Not yet recruiting
Kyushu Rosai Hospital | Kitakyushu, 800-0296, Japan Recruiting
Aoyama Naika Clinic | Kobe, 650-0015, Japan Recruiting
Kobe University Hospital | Kobe, 650-0017, Japan Recruiting
Kochi National Hospital | Kochi, 780-8077, Japan Recruiting
Yamanashi Prefectural Central Hospital | Kofu, 400-8506, Japan Recruiting
National Hospital Organization Kure Medical Center and Chugoku Cancer Center | Kure, 736-0023, Japan Recruiting
University Hospital Kyoto Perfectural University of Medicine | Kyoto, 602-8566, Japan Recruiting
National Hospital Organization Matsumoto Medical Center | Matsumoto, 399-8701, Japan Recruiting
Kitasato University Kitasato Institute Hospital | Minato-ku, 108-8642, Japan Recruiting
Kyorin University Hospital | Mitaka, 181-8611, Japan Not yet recruiting
Takagi Clinic | Miyagi, 981-3213, Japan Recruiting
Osaki Citizen Hospital | Miyagi, 989-6183, Japan Recruiting
Iwate Medical University Hospital | Morioka, 020-8505, Japan Recruiting
Nagoya University Hospital | Nagoya, 466-8560, Japan Recruiting
Nagoya City University Hospital | Nagoya, 467-8602, Japan Recruiting
Nagaoka Chuo General Hospital | Niigata, 940-8653, Japan Recruiting
The Hospital of Hyogo College of Medicine | Nishinomiya, 663-8501, Japan Recruiting
Oita Red Cross Hospital | Oita, 870-0033, Japan Recruiting
Shinbeppu Hospital | Oita, 874-8538, Japan Recruiting
Nakagami Hospital | Okinawa, 904-2195, Japan Recruiting
Kindai University Hospital | Osaka-Sayama, 589-8511, Japan Recruiting
Japanese Red Cross Osaka Hospital | Osaka, 543-8555, Japan Recruiting
Osaka City University Hospital | Osaka, 545-8586, Japan Recruiting
Higashiosaka City Medical Center | Osaka, 578-8588, Japan Withdrawn
Izumiotsu Municipal Hospital | Osaka, 595-0027, Japan Recruiting
Japan Community Health Care Organization Saitama Medical Center | Saitama, 330-0074, Japan Recruiting
Toho University Sakura Medical Center | Sakura, 285-8741, Japan Not yet recruiting
Sapporo Tokushukai Hospital | Sapporo, 004-0041, Japan Not yet recruiting
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital | Sapporo, 060-0033, Japan Recruiting
Sapporo Medical University Hospital | Sapporo, 060-8543, Japan Recruiting
Sapporo Higashi Tokushukai Hospital | Sapporo, 065-0033, Japan Recruiting
National Hospital Organization Higashi Ohmi General Medical Center | Shiga, 527-8505, Japan Withdrawn
Tokyo Yamate Medical Center | Shinjuku-ku, 169-0073, Japan Recruiting
Matsuda Hospital | Shizuoka, 432-8061, Japan Recruiting
Tokushima University Hospital | Tokushima, 770-8503, Japan Recruiting
The Jikei University Hospital | Tokyo, 105-8471, Japan Recruiting
Tokyo Metropolitan Bokutoh Hospital | Tokyo, 1308575, Japan Recruiting
National Hospital Organization Tokyo Medical Center | Tokyo, 152-8902, Japan Recruiting
Mie University Hospital | Tsu, 514-8507, Japan Recruiting
Yokkaichi Hazu Medical Center | Yokkaichi, 510-0016, Japan Recruiting
Yokohama Municipal Citizen&#39;s Hospital | Yokohama, 221-0855, Japan Not yet recruiting
University of Fukui Hospital | Yoshida, 910-1193, Japan Recruiting
Prince Hamza Hospital | Amman- Tareq, 11947, Jordan Not yet recruiting
Jordan University Hospital | Amman, 11942, Jordan Not yet recruiting
Istishari Hospital | Amman, Jordan Not yet recruiting
Khalidi Hospital and Medical Center | Amman, Jordan Not yet recruiting
King Abdullah University Hospital | Irbid, Jordan Not yet recruiting
Korea University Ansan Hospital | Ansan-si, 15355, Korea, Republic of Recruiting
Inje University Haeundae Paik Hospital | Busan, 612-896, Korea, Republic of Recruiting
Yeungnam University Medical Center | Daegu, 42415, Korea, Republic of Recruiting
Gachon University Gil Medical Center | Incheon, 21565, Korea, Republic of Recruiting
Seoul National University Bundang Hospital | Seongnam-si, 13620, Korea, Republic of Recruiting
Kyung Hee University Medical Center | Seoul, 02447, Korea, Republic of Recruiting
Severance Hospital, Yonsei University Health System | Seoul, 03722, Korea, Republic of Recruiting
Asan Medical Center | Seoul, 05505, Korea, Republic of Recruiting
Samsung Medical Center | Seoul, 06351, Korea, Republic of Recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul, 06591, Korea, Republic of Recruiting
Chung-Ang University Hospital | Seoul, 06973, Korea, Republic of Recruiting
The Catholic University of Korea St. Vincent's Hospital | Suwon-si, 16247, Korea, Republic of Recruiting
Ajou University Hospital | Suwon, 16499, Korea, Republic of Recruiting
Pauls Stradins Clinical University Hospital | Riga, LV-1002, Latvia Not yet recruiting
Pauls Stradins Clinical University Hospital | Riga, LV1002, Latvia Not yet recruiting
Health Centre 4 Centre of Diagnostics | Riga, LV1003, Latvia Not yet recruiting
Digestive Diseases Centre GASTRO | Riga, LV1079, Latvia Not yet recruiting
Hospital Serdang | Kajang, 43000, Malaysia Recruiting
Hospital University Sains Malaysia | Kelantan, 16150, Malaysia Recruiting
Pusat Perubatan Universiti Kebangsaan Malaysia | Kuala Lumpur, 56000, Malaysia Recruiting
University Malaya Medical Centre | Kuala Lumpur, 59100, Malaysia Recruiting
Onze Lieve Vrouwe Gasthuis | Amsterdam, 1091 AC, Netherlands Recruiting
Albert Schweitzer Ziekenhuis | Dordrecht, 3318 AT, Netherlands Recruiting
Radboudumc | Nijmegen, 6525 GA, Netherlands Recruiting
Jeroen Bosch Ziekenhuis | S-Hertogenbosch, 5223 GZ, Netherlands Not yet recruiting
Auckland City Hospital | Auckland, 1142, New Zealand Not yet recruiting
Christchurch Hospital | Christchurch, 8140, New Zealand Not yet recruiting
Dunedin Hospital | Dunedin, 9016, New Zealand Recruiting
Waikato Hospital | Hamilton, 3204, New Zealand Not yet recruiting
Gastromed Kralisz Romatowski Stachurska Sp. j. | Bialystok, 15-322, Poland Recruiting
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy | Bydgoszcz, 85-164, Poland Recruiting
Centrum medyczne plejady | Krakow, 30-363, Poland Recruiting
Centrum Medyczne Promed | Krakow, 31-513, Poland Recruiting
Centrum Medyczne Szpital św. Rodziny | Lodz, 90-302, Poland Withdrawn
Gastromed ZOZ | Lublin, 20-583, Poland Recruiting
Medicome Sp z o.o. | Oswiecim, 32-600, Poland Recruiting
Centrum Medyczne Medyk | Rzeszow, 35-326, Poland Recruiting
Endoskopia Sp z o.o. | Sopot, 81-756, Poland Recruiting
Twoja Przychodnia - Szczecinskie Centrum Medyczne | Szczecin, 71-434, Poland Recruiting
GASTROMED Kopon, Zmudzinski i wspolnicy SP.j., Specjalistyczne Centrum Gastrologii i Endoskopii | Torun, 87-100, Poland Recruiting
H-T Centrum Medyczne Endoterapia | Tychy, 43-100, Poland Withdrawn
WIP Warsaw IBD Point Profesor Kierkus | Warszawa, 00-728, Poland Recruiting
Centralny Szpital Kliniczny Mswia | Warszawa, 02-507, Poland Recruiting
NZOZ Vivamed | Warszawa, 03-580, Poland Withdrawn
Wojskowy Instytut Medyczny | Warszawa, 04-349, Poland Recruiting
Melita Medical Sp. z o.o. | Wroclaw, 50-449, Poland Recruiting
Centrum Zdrowia WroMedica | Wroclaw, 51-685, Poland Recruiting
ETG Zamosc | Zamosc, 22-400, Poland Recruiting
Centro Hospitalar e Universitário de Coimbra, EPE | Coimbra, 3000-075, Portugal Recruiting
Centro Hospitalar do Porto, EPE | Porto, 4099-001, Portugal Recruiting
Centro Hospitalar de São João, EPE | Porto, 4200-319, Portugal Recruiting
Centro Hospitalar de Entre o Douro e Vouga, E.P.E | Santa Maria da Feira, 4520-211, Portugal Recruiting
Centro Hospitalar de Tondela Viseu, EPE | Viseu, 3504-509, Portugal Recruiting
LLC Evimed | Chelyabinsk, 454048, Russian Federation Withdrawn
Chelyabinck Regional Clinical Hospital | Chelyabinsk, 454076, Russian Federation Withdrawn
Medical Center Meditsinskie Tekhnologii | Ekaterinburg, 620075, Russian Federation Recruiting
OOO MO New Hospital | Ekaterinburg, 620109, Russian Federation Recruiting
Irkutsk State Medical Academy of Postgraduate Education | Irkutsk, 664079, Russian Federation Withdrawn
Immanuel Kant Baltic Federal University | Kaliningrad, 236016, Russian Federation Recruiting
Kazan State Medical University | Kazan, 420012, Russian Federation Not yet recruiting
Kemerovo Regional Clinical Hospital | Kemerovo, 650066, Russian Federation Withdrawn
GUZ of Moscow City Clinical Hospital #24 | Moscow, 127015, Russian Federation Withdrawn
Road Clinical Hospital at the Nizhny Novgorod Station of the Russian Railways | Nizhniy Novgorod, 603140, Russian Federation Recruiting
Medical Center SibNovoMed LLC | Novosibirsk, 630005, Russian Federation Recruiting
LLC 'Novosibirsk Gastrocentr' | Novosibirsk, 630007, Russian Federation Recruiting
Budgetary Healthcare Intitution of Omsk Region | Omsk, Russian Federation Withdrawn
City Clinical Hospital #2 | Perm, 614068, Russian Federation Recruiting
Rostov State Medical University | Rostov-On-Don, 344022, Russian Federation Recruiting
Rostov State Medical University | Rostov-On-Don, 344022, Russian Federation Not yet recruiting
Elizavetinskaya hospital | Saint Petersburg, 195257, Russian Federation Not yet recruiting
All-Russian Center of Emergency and Radiation Medicine MCRS | Saint-Petersburg, 194044, Russian Federation Not yet recruiting
Eco-safety Ltd | Saint-Petersburg, 196143, Russian Federation Recruiting
Medical University Reaviz | Samara, 443001, Russian Federation Recruiting
NUZ 'Railway Clinical Hospital on Samara station of LLC 'Russian Railways' | Samara, 443041, Russian Federation Recruiting
Regional Hospital of War Veterans | Saratov, 410053, Russian Federation Not yet recruiting
International Medical Centre SOGAZ | St-Petersburg, 191186, Russian Federation Recruiting
Regional Clinical Hospital | Tver, 170036, Russian Federation Withdrawn
GBUZ Respublican Clinical Hospital n.a. GG Kuvatova | Ufa, 450005, Russian Federation Recruiting
City Clinical Hospital # 21 | Ufa, 450071, Russian Federation Recruiting
Ulyanovsk Regional Clinical Hospital | Ulyanovsk, 432063, Russian Federation Not yet recruiting
Regional Clinical Hospital | Yaroslavl, 150062, Russian Federation Recruiting
University Clinical Hospital Center Dr Dragisa Misovic- Dedi | Belgrade, 11000, Serbia Not yet recruiting
Zvezdara University Medical Center | Belgrade, 11000, Serbia Not yet recruiting
General Hospital Sombor | Sombor, 25000, Serbia Not yet recruiting
General Hospital Dr Djordje Joanovic | Zrenjanin, 23000, Serbia Not yet recruiting
FNsP F.D.R. Banska Bystrica | Banska Bystrica, 975 17, Slovakia Not yet recruiting
Gastroenterology Department GASTROMART s.r.o. | Bardejov, 085 01, Slovakia Not yet recruiting
Gastroenterology Center ASSIDUO | Bratislava, 811 08, Slovakia Not yet recruiting
University Hospital in Bratislava, Ruzinov Hospital | Bratislava, 820 07, Slovakia Not yet recruiting
University Hospital in Bratislava, St. Cyril and Method Hospital | Bratislava, 851 07, Slovakia Not yet recruiting
ENDOMED s.r.o | Kosice, 040 13, Slovakia Not yet recruiting
GASTRO I. s.r.o. | Presov, 080 01, Slovakia Not yet recruiting
Accout Center, s.r.o., Gastroenterologická ambulancia | Sahy, 93601, Slovakia Not yet recruiting
Hosp. Univ. Germans Trias I Pujol | Badalona, 08916, Spain Recruiting
Hosp. Clinic I Provincial de Barcelona | Barcelona, 08036, Spain Recruiting
Hosp. Univ. Dr. Josep Trueta | Girona, 17007, Spain Recruiting
Hosp. Univ. La Paz | Madrid, 28046, Spain Recruiting
Hosp. Univ. Marques de Valdecilla | Santander, 39008, Spain Recruiting
Hosp. Virgen Del Rocio | Sevilla, 41013, Spain Recruiting
Hosp. Ntra. Sra. de Valme | Sevilla, 41014, Spain Recruiting
Hosp. Univ. Miguel Servet | Zaragoza, 50009, Spain Withdrawn
Södra Älvsborgs Sjukhus, Kirurgkliniken, Borås | Boras, SE-501 82, Sweden Withdrawn
Karolinska Universitetssjukhuset | Stockholm, SE-171 76, Sweden Recruiting
Uppsala University | Uppsala, SE-75185, Sweden Recruiting
Chang-Hua Christian Hospital | Changhua, 50006, Taiwan Recruiting
Taichung Veterans General Hospital | Taichung, 40705, Taiwan Recruiting
National Taiwan University Hospital | Taipei, 10002, Taiwan Recruiting
Chang-Gung Memorial Hospital, LinKou Branch | Taoyuan, 33305, Taiwan Recruiting
Ankara Gulhane Training and Research Hospital | Ankara, 06010, Turkey Withdrawn
Ankara University | Ankara, 06100, Turkey Not yet recruiting
Dışkapı Yıldırım Beyazıd Training and Research Hospital | Ankara, 06110, Turkey Not yet recruiting
Hacettepe University Hospital | Ankara, 06230, Turkey Recruiting
Gazi University Hospital | Ankara, 06560, Turkey Recruiting
Ankara Sehir Hastanesi | Ankara, 06800, Turkey Not yet recruiting
Istanbul University Cerrahpasa Medical Faculty | Istanbul, 34098, Turkey Recruiting
Acibadem Kozyatagi Hospital | Istanbul, 34734, Turkey Recruiting
BAU Medical Park Goztepe Hospital | Istanbul, 34742, Turkey Recruiting
Dokuz Eylul University Medical Faculty | Izmir, 35330, Turkey Not yet recruiting
Kocaeli University Medical Faculty | Kocaeli, 41380, Turkey Recruiting
Mersin University Medical Faculty Hospital | Mersin, 33110, Turkey Recruiting
Ivano-Frankivsk Regional Clinical Hospital | Ivano-Frankivsk, 76008, Ukraine Recruiting
Communal Nonprofit Enterprise 'City Clinical Hospital # 2 N.A. Prof. O.O. Shalimov' | Kharkiv, 61037, Ukraine Recruiting
SI 'L.T. Maloyi National Institute of Therapy of National Academy of Medical Sciences of Ukraine' | Kharkiv, 61039, Ukraine Recruiting
Municipal Institution 'Kherson City Clinical Hospital n.a. Y.Y.Karabelesh' | Kherson, 73003, Ukraine Recruiting
Kyiv City Clinical Hospital #18 | Kyiv, 01030, Ukraine Recruiting
Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies' | Kyiv, 02091, Ukraine Recruiting
Lviv Clinical Hospital on Railway Transport of Affiliate Healthcare center of JSC Ukrainian Railway | Lviv, 79007, Ukraine Recruiting
Communal Nonprofit Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital' | Lviv, 79010, Ukraine Recruiting
Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council | Odesa, 65025, Ukraine Recruiting
Sumy State University, Sumy Regional Clinical Hospital | Sumy, 40022, Ukraine Recruiting
Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital' | Ternopil, 46002, Ukraine Recruiting
MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council | Uzhgorod, 88000, Ukraine Withdrawn
Medical Center Ltd 'Health Clinic', Department Of General Therapy | Vinnytsya, 21009, Ukraine Recruiting
Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov | Vinnytsya, 21018, Ukraine Recruiting
Addenbrooke's Hospital | Cambridge, CB2 2QQ, United Kingdom Not yet recruiting
Glasgow Royal Infirmary | Glasgow, G4 0SF, United Kingdom Not yet recruiting
Royal Free Hospital | London, NW3 2QG, United Kingdom Withdrawn
Guy's and St Thomas' Hospital | London, SE1 7EH, United Kingdom Recruiting
Chelsea And Westminster Hospital | London, SW109NH, United Kingdom Not yet recruiting
St George's Hospital | London, SW17 0QT, United Kingdom Recruiting
Whiston Hospital | Prescot, L35 5DR, United Kingdom Withdrawn
Location Countries

Argentina

Australia

Austria

Belgium

Brazil

Bulgaria

Canada

China

Czechia

France

Germany

Hungary

Ireland

Israel

Italy

Japan

Jordan

Korea, Republic of

Latvia

Malaysia

Netherlands

New Zealand

Poland

Portugal

Russian Federation

Serbia

Slovakia

Spain

Sweden

Taiwan

Turkey

Ukraine

United Kingdom

United States

Verification Date

2021-06-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 8
Arm Group

Label: Induction Study 1: Guselkumab Dose 1

Type: Experimental

Description: Participants will receive guselkumab dose 1 intravenously (IV) in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.

Label: Induction Study 1: Guselkumab Dose 2

Type: Experimental

Description: Participants will receive guselkumab dose 2 IV in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.

Label: Induction Study 1: Placebo IV

Type: Placebo Comparator

Description: Participants will receive matching placebo IV in Induction Study 1. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. Clinical nonresponders will be administered guselkumab IV.

Label: Induction Study 2: Guselkumab IV

Type: Experimental

Description: Participants will receive guselkumab IV in Induction Study 2. Subsequent study treatment will be determined by the participant's clinical response status at Week 12.

Label: Induction Study 2: Placebo IV

Type: Placebo Comparator

Description: Participants will receive matching placebo IV in Induction Study 2. Subsequent study treatment will be determined by the participant's clinical response status at Week 12. Clinical nonresponders will be administered guselkumab IV.

Label: Maintenance Study: Maintenance Dose Regimen 1

Type: Experimental

Description: Participants will receive guselkumab maintenance dose regimen 1 subcutaneously (SC) every 4 weeks (q4w).

Label: Maintenance Study: Maintenance Dose Regimen 2

Type: Experimental

Description: Participants will receive guselkumab maintenance dose regimen 2 SC every 8 weeks (q8w).

Label: Maintenance Study: Placebo SC

Type: Placebo Comparator

Description: Participants will receive matching placebo SC q4w.

Acronym QUASAR
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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