A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
ASTRO
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab Subcutaneous Induction Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
4 other identifiers
interventional
418
25 countries
236
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2022
Longer than P75 for phase_3
236 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2022
CompletedFirst Posted
Study publicly available on registry
September 6, 2022
CompletedStudy Start
First participant enrolled
September 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 2, 2024
CompletedResults Posted
Study results publicly available
December 9, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 6, 2028
ExpectedApril 13, 2026
April 1, 2026
1.6 years
August 19, 2022
October 16, 2025
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (8)
Percentage of Participants in Symptomatic Remission at Week 12
Week 12
Percentage of Participants With Endoscopic Improvement at Week 12
Week 12
Percentage of Participants in Clinical Response at Week 12
Week 12
Percentage of Participants With Histologic-endoscopic Mucosal Improvement at Week 12
Week 12
Percentage of Participants in Clinical Remission at Week 24
Week 24
- +3 more secondary outcomes
Study Arms (3)
Group 1: Guselkumab
EXPERIMENTALParticipants will receive guselkumab (Dose 1) subcutaneous (SC) injection followed by guselkumab (Dose 2) SC injection.
Group 2: Guselkumab
EXPERIMENTALParticipants will receive guselkumab (Dose 1) SC injection followed by guselkumab (Dose 3) SC injection.
Group 3: Placebo
PLACEBO COMPARATORParticipants will receive matching placebo SC injection.
Interventions
Guselkumab (Dose 1) will be administered as SC injection.
Eligibility Criteria
You may qualify if:
- Signed informed consent form
- years of age or older
- Documented diagnosis of ulcerative colitis (UC) at least 12 weeks prior to screening
- Moderately to severely active UC as per the modified Mayo score
- Demonstrated inadequate response to or intolerance of conventional therapy and/or advanced therapy as defined in the protocol
You may not qualify if:
- Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease
- Surgery within 8 weeks before screening or planned surgery during the study that may confound the evaluation of benefit from study intervention
- Receiving prohibited medications and treatments
- UC limited to the rectum only
- Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) corona virus disease (COVID-19) infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (236)
Research Solutions of Arizona
Litchfield Park, Arizona, 85340, United States
Om Research LLC 1
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, 15501-405, 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)
Related Publications (1)
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.
PMID: 41544637DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Medical Leader Pediatrics Immunology
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2022
First Posted
September 6, 2022
Study Start
September 13, 2022
Primary Completion
April 2, 2024
Study Completion (Estimated)
October 6, 2028
Last Updated
April 13, 2026
Results First Posted
December 9, 2025
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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