A Study of Guselkumab Subcutaneous Therapy in Participants With Moderately to Severely Active Crohn's Disease

Study Purpose

The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with Crohn's disease.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Diagnosis of Crohn's disease (CD) of at least 3 months in duration.
  • - Have moderate to severe CD as assessed by CDAI, stool frequency, and abdominal pain score, and Simple Endoscopic Score for Crohn's disease (SES-CD).
  • - Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD.

Exclusion Criteria:

  • - Current diagnosis of ulcerative colitis or indeterminate colitis.
  • - Complications of Crohn's disease that require surgical intervention or confound efficacy assessments.
- Unstable doses of concomitant Crohn's disease therapy

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05197049
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Janssen Research & Development, LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janssen Research & Development, LLC Clinical Trial
Principal Investigator Affiliation Janssen Research & Development, LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Belarus, Belgium, Bosnia and Herzegovina, Brazil, China, Croatia, Czechia, France, Germany, Hungary, Italy, Japan, Jordan, Korea, Republic of, Lithuania, Netherlands, New Zealand, Poland, Russian Federation, Serbia, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease
Additional Details

Crohn's disease is a chronic, progressive and potentially life-threatening disorder which may affect any part of the gastrointestinal (GI) tract. Guselkumab is a fully human immunoglobulin G1 lambda monoclonal antibody that binds to human interleukin (IL)-23, thereby blocking the binding of extracellular IL-23 to the cell surface IL-23 receptor. This binding results in inhibition of IL-23 mediated intracellular signaling, activation and cytokine production. The purpose of the study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active Crohn's disease. The overall study duration is up to 109 weeks.

Arms & Interventions

Arms

Experimental: Group 1: Guselkumab

Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 2) injection subcutaneously.

Experimental: Group 2: Guselkumab

Participants will receive guselkumab (Dose 1) injection subcutaneously followed by guselkumab (Dose 3) injection subcutaneously.

Placebo Comparator: Group 3: Placebo

Participants will receive placebo injection subcutaneously.

Interventions

Drug: - Guselkumab Dose 1

Guselkumab (Dose 1) will be administered by subcutaneous (SC) injection.

Drug: - Guselkumab Dose 2

Guselkumab (Dose 2) will be administered by SC injection.

Drug: - Guselkumab Dose 3

Guselkumab (Dose 3) will be administered by SC injection.

Drug: - Placebo

Placebo will be administered by SC injection.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Om Research LLC, Lancaster, California

Status

Not yet recruiting

Address

Om Research LLC

Lancaster, California, 93534

Harmony Medical Research Institute, Inc., Hialeah, Florida

Status

Not yet recruiting

Address

Harmony Medical Research Institute, Inc.

Hialeah, Florida, 33016

Florida Hospital, Orlando, Florida

Status

Not yet recruiting

Address

Florida Hospital

Orlando, Florida, 32803

Synexus Clinical Research US, Inc, Pinellas Park, Florida

Status

Not yet recruiting

Address

Synexus Clinical Research US, Inc

Pinellas Park, Florida, 33781

Gastroenterolgy Associates of Central GA, Macon, Georgia

Status

Recruiting

Address

Gastroenterolgy Associates of Central GA

Macon, Georgia, 31201

Tri-State Gastroenterology Assoc, Crestview Hills, Kentucky

Status

Recruiting

Address

Tri-State Gastroenterology Assoc

Crestview Hills, Kentucky, 41017

Chesterfield, Michigan

Status

Not yet recruiting

Address

Clinical Research Institute of Michigan, LLC

Chesterfield, Michigan, 48047

University of Rochester, Rochester, New York

Status

Withdrawn

Address

University of Rochester

Rochester, New York, 14642

Dayton Gastroenterology, Inc, Dayton, Ohio

Status

Not yet recruiting

Address

Dayton Gastroenterology, Inc

Dayton, Ohio, 45440

Hershey, Pennsylvania

Status

Not yet recruiting

Address

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033

Synexus Clinical Research US, Inc, Anderson, South Carolina

Status

Not yet recruiting

Address

Synexus Clinical Research US, Inc

Anderson, South Carolina, 29621-2062

Wellness Clinical Research, San Antonio, Texas

Status

Not yet recruiting

Address

Wellness Clinical Research

San Antonio, Texas, 78232

International Sites

Monash Health, Monash Medical Centre, Clayton, Australia

Status

Not yet recruiting

Address

Monash Health, Monash Medical Centre

Clayton, , 3168

Grodno University Hospital, Grodno, Belarus

Status

Not yet recruiting

Address

Grodno University Hospital

Grodno, , 230017

Vitebsk Regional Clinical Hospital, Vitebsk, Belarus

Status

Not yet recruiting

Address

Vitebsk Regional Clinical Hospital

Vitebsk, , 210037

GZA Ziekenhuizen, Antwerpen, Belgium

Status

Not yet recruiting

Address

GZA Ziekenhuizen

Antwerpen, , 2018

Imelda Ziekenhuis, Bonheiden, Belgium

Status

Not yet recruiting

Address

Imelda Ziekenhuis

Bonheiden, , 2820

Banja Luka, Bosnia and Herzegovina

Status

Not yet recruiting

Address

University hospital Clinical centre Banja Luka

Banja Luka, , 78000

Universidade Federal Do Ceara, Fortaleza, Brazil

Status

Not yet recruiting

Address

Universidade Federal Do Ceara

Fortaleza, , 60430-370

Hospital Moinhos de Vento, Porto Alegre, Brazil

Status

Not yet recruiting

Address

Hospital Moinhos de Vento

Porto Alegre, , 90035-901

Hospital Ernesto Dornelles, Porto Alegre, Brazil

Status

Not yet recruiting

Address

Hospital Ernesto Dornelles

Porto Alegre, , 90160-092

Salvador, Brazil

Status

Not yet recruiting

Address

Universidade Federal da Bahia (UFBA) - Complexo Hospitalar U

Salvador, , 40110-060

São Paulo, Brazil

Status

Not yet recruiting

Address

FMUSP - ICHC - Centro de Pesquisas Clínicas

São Paulo, , 01246-000

BR Trials, São Paulo, Brazil

Status

Not yet recruiting

Address

BR Trials

São Paulo, , 03325-050

Hangzhou, China

Status

Not yet recruiting

Address

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, , 310016

Wuxi People's Hospital, Wuxi, China

Status

Not yet recruiting

Address

Wuxi People's Hospital

Wuxi, , 214023

Opca bolnica Zadar, Zadar, Croatia

Status

Not yet recruiting

Address

Opca bolnica Zadar

Zadar, , 23000

Fakultni nemocnice Brno, Brno, Czechia

Status

Not yet recruiting

Address

Fakultni nemocnice Brno

Brno, , 636 00

Fakultni nemocnice Hradec Kralove, Hradec Kralove, Czechia

Status

Not yet recruiting

Address

Fakultni nemocnice Hradec Kralove

Hradec Kralove, , 500 05

Oblastni nemocnice Kladno a.s., Kladno, Czechia

Status

Not yet recruiting

Address

Oblastni nemocnice Kladno a.s.

Kladno, , 27259

Synexus Czech s.r.o., Prague 2, Czechia

Status

Not yet recruiting

Address

Synexus Czech s.r.o.

Prague 2, , 120 00

Fakultni nemocnice Kralovske Vinohrady, Praha 10, Czechia

Status

Not yet recruiting

Address

Fakultni nemocnice Kralovske Vinohrady

Praha 10, , 100 34

CHU de Nice Hopital de l Archet, Nice, France

Status

Not yet recruiting

Address

CHU de Nice Hopital de l Archet

Nice, , 06202

CHU Rangueil, Toulouse, France

Status

Not yet recruiting

Address

CHU Rangueil

Toulouse, , 31059

Berlin, Germany

Status

Not yet recruiting

Address

Charite Universitatsmedizin Berlin, Campus Mitte (CCM) Allergie Center

Berlin, , 10117

DRK Kliniken Westend, Berlin, Germany

Status

Not yet recruiting

Address

DRK Kliniken Westend

Berlin, , 14050

Krankenhaus Waldfriede Mitte, Berlin, Germany

Status

Not yet recruiting

Address

Krankenhaus Waldfriede Mitte

Berlin, , 14163

Synexus Clinical Research GmbH, Frankfurt, Germany

Status

Not yet recruiting

Address

Synexus Clinical Research GmbH

Frankfurt, , 60313

Synexus Clinical Research GmbH, Leipzig, Germany

Status

Not yet recruiting

Address

Synexus Clinical Research GmbH

Leipzig, , 04103

Synexus Magyarorszag Kft, Budapest, Hungary

Status

Not yet recruiting

Address

Synexus Magyarorszag Kft

Budapest, , 1036

Budapest, Hungary

Status

Not yet recruiting

Address

Észak-Közép-budai Centrum, Új Szent János Kórház és Szakrendelő Budai Családközpontú

Budapest, , 1125

Synexus Magyarorszag Kft, Gyula, Hungary

Status

Not yet recruiting

Address

Synexus Magyarorszag Kft

Gyula, , 5700

Mohacsi Korhaz, Mohacs, Hungary

Status

Not yet recruiting

Address

Mohacsi Korhaz

Mohacs, , 7700

Università Campus Biomedico di Roma, Roma, Italy

Status

Not yet recruiting

Address

Università Campus Biomedico di Roma

Roma, , 00128

Roma, Italy

Status

Not yet recruiting

Address

Azienda Ospedaliera Universitaria 'Policlinico Tor Vergata'

Roma, , 00133

Toyota Kosei Hospital, Toyota, Japan

Status

Not yet recruiting

Address

Toyota Kosei Hospital

Toyota, , 470-0396

Khalidi Hospital and Medical Center, Amman, Jordan

Status

Not yet recruiting

Address

Khalidi Hospital and Medical Center

Amman, , 11183

DongA Medical Center, Busan, Korea, Republic of

Status

Not yet recruiting

Address

DongA Medical Center

Busan, , 602739

Yeungnam University Medical Center, Daegu, Korea, Republic of

Status

Not yet recruiting

Address

Yeungnam University Medical Center

Daegu, , 42415

Kangbuk Samsung Hospital, Seoul, Korea, Republic of

Status

Not yet recruiting

Address

Kangbuk Samsung Hospital

Seoul, , 03181

Ajou University Hospital, Suwon, Korea, Republic of

Status

Not yet recruiting

Address

Ajou University Hospital

Suwon, , 16499

Wonju Christian Hospital, Wonju, Korea, Republic of

Status

Not yet recruiting

Address

Wonju Christian Hospital

Wonju, , 26426

Kaunas, Lithuania

Status

Not yet recruiting

Address

Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik

Kaunas, , 44307

Vilnius, Lithuania

Status

Not yet recruiting

Address

Vilnius University Hospital Santaros Klinikos, Public Institution

Vilnius, , LT-08661

Elisabeth-TweeSteden Ziekenhuis, Tilburg, Netherlands

Status

Not yet recruiting

Address

Elisabeth-TweeSteden Ziekenhuis

Tilburg, , 5022 GC

Waikato Hospital - Waikato, Hamilton, New Zealand

Status

Not yet recruiting

Address

Waikato Hospital - Waikato

Hamilton, , 3240

Czestochowa, Poland

Status

Not yet recruiting

Address

Synexus Polska Sp. z o.o. Oddzial w Czestochowie

Czestochowa, , 42-202

Synexus Polska Sp. z o.o., Gdańsk, Poland

Status

Not yet recruiting

Address

Synexus Polska Sp. z o.o.

Gdańsk, , 80-382

Gdynia, Poland

Status

Not yet recruiting

Address

Private Practice - Dr. Krzysztof Cymerman

Gdynia, , 81-157

Synexus Polska Sp. z o.o., Gdynia, Poland

Status

Not yet recruiting

Address

Synexus Polska Sp. z o.o.

Gdynia, , 81-537

Katowice, Poland

Status

Not yet recruiting

Address

Synexus Polska Sp. z o.o. Oddzial w Katowicach

Katowice, , 40-040

Globe Badania Kliniczne, Klodzko, Poland

Status

Withdrawn

Address

Globe Badania Kliniczne

Klodzko, , 57-300

Centrum Medyczne ProMiMed, Krakow, Poland

Status

Not yet recruiting

Address

Centrum Medyczne ProMiMed

Krakow, , 31-637

Allmedica, Nowy Targ, Poland

Status

Not yet recruiting

Address

Allmedica

Nowy Targ, , 34-400

Centrum Medyczne, Piotrkow Trybunalski, Poland

Status

Not yet recruiting

Address

Centrum Medyczne

Piotrkow Trybunalski, , 97-300

Synexus Polska Sp. z o.o., Poznan, Poland

Status

Not yet recruiting

Address

Synexus Polska Sp. z o.o.

Poznan, , 60-702

Centrum Medyczne Promed, Skorzewo, Poland

Status

Not yet recruiting

Address

Centrum Medyczne Promed

Skorzewo, , 60-185

KO-Med Centrum Medyczne, Straszów, Poland

Status

Not yet recruiting

Address

KO-Med Centrum Medyczne

Straszów, , 28-200

Endoterapia, Warsaw, Poland

Status

Not yet recruiting

Address

Endoterapia

Warsaw, , 02-653

Synexus Polska Sp. z o.o., Warszawa, Poland

Status

Not yet recruiting

Address

Synexus Polska Sp. z o.o.

Warszawa, , 01-192

Synexus Polska Sp. z o.o., Wroclaw, Poland

Status

Not yet recruiting

Address

Synexus Polska Sp. z o.o.

Wroclaw, , 50-381

Medical Center Meditsinskie Tekhnologii, Ekaterinburg, Russian Federation

Status

Not yet recruiting

Address

Medical Center Meditsinskie Tekhnologii

Ekaterinburg, , 620075

Irkutsk, Russian Federation

Status

Not yet recruiting

Address

Irkutsk State Medical Academy of Postgraduate Education

Irkutsk, , 664079

Kemerovo Region Clinical Hospital, Kemerovo, Russian Federation

Status

Not yet recruiting

Address

Kemerovo Region Clinical Hospital

Kemerovo, , 650066

GBUZ Regional Clinical Hospital, Tver, Russian Federation

Status

Not yet recruiting

Address

GBUZ Regional Clinical Hospital

Tver, , 170036

Ufa, Russian Federation

Status

Not yet recruiting

Address

GBUZ Respublican Clinical Hospital n.a. GG Kuvatova

Ufa, , 450005

GUZ Novgorod Regional Clinical Hospital, Veliky Novgorod, Russian Federation

Status

Not yet recruiting

Address

GUZ Novgorod Regional Clinical Hospital

Veliky Novgorod, , 173008

Regional Clinical Hospital, Yaroslavl, Russian Federation

Status

Not yet recruiting

Address

Regional Clinical Hospital

Yaroslavl, , 150062

Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia

Status

Withdrawn

Address

Clinical Hospital Center Bezanijska Kosa

Belgrade, , 11080

Hosp. Virgen Macarena, Sevilla, Spain

Status

Not yet recruiting

Address

Hosp. Virgen Macarena

Sevilla, , 41009

China Medical University Hospital, Taichung, Taiwan

Status

Withdrawn

Address

China Medical University Hospital

Taichung, , 40447

Hacettepe University Hospital, Ankara, Turkey

Status

Not yet recruiting

Address

Hacettepe University Hospital

Ankara, , 06230

Istanbul, Turkey

Status

Not yet recruiting

Address

Haydarpasa Numune Training and Research Hospital

Istanbul, , 34668

Dokuz Eylul Universitesi Tip Fakultesi, Izmir, Turkey

Status

Not yet recruiting

Address

Dokuz Eylul Universitesi Tip Fakultesi

Izmir, , 35210

Mersin University Medical Faculty, Mersin, Turkey

Status

Not yet recruiting

Address

Mersin University Medical Faculty

Mersin, , 33343

Chernivtsi Regional Oncology Dispencary, Chernivtsi, Ukraine

Status

Not yet recruiting

Address

Chernivtsi Regional Oncology Dispencary

Chernivtsi, , 58013

Kyiv, Ukraine

Status

Not yet recruiting

Address

LLC Treatment and Diagnostic Center Adonis Plus

Kyiv, , 02002

Kyiv, Ukraine

Status

Not yet recruiting

Address

Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'

Kyiv, , 02091

Medical Centre IBN SINA, Kyiv, Ukraine

Status

Not yet recruiting

Address

Medical Centre IBN SINA

Kyiv, , 03037

Kyiv, Ukraine

Status

Not yet recruiting

Address

Medychnyi tsentr tovarystva z obmezhenoiu vidpovidalnistiu Tsentr simeinoi medytsyny plius

Kyiv, , 4210

Lviv, Ukraine

Status

Not yet recruiting

Address

Communal City Clinical Emergency Hospital

Lviv, , 79000

Lviv, Ukraine

Status

Not yet recruiting

Address

Lviv Railway Clinical Hospital of branch 'Health Center' 'Ukrainian Railway'

Lviv, , 79000

Sumy, Ukraine

Status

Not yet recruiting

Address

Sumy State University, Sumy Regional Clinical Hospital

Sumy, , 40022

Uzhgorod, Ukraine

Status

Not yet recruiting

Address

MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council

Uzhgorod, , 88018

Vinnytsia, Ukraine

Status

Not yet recruiting

Address

Vinnytsia Yushchenko Regional Psychoneurological Hospital

Vinnytsia, , 21005

Vinnytsya, Ukraine

Status

Not yet recruiting

Address

MNPE 'Vinnytsia Regional Clinical Hospital named after M.I. Pyrogov of Vinnytsia Regional Council'

Vinnytsya, , 21018

Komunalna ustanova 'Miska likarnia №1', Zaporizhzhia, Ukraine

Status

Not yet recruiting

Address

Komunalna ustanova 'Miska likarnia №1'

Zaporizhzhia, , 69104

Fairfield General Hospital, Bury, United Kingdom

Status

Not yet recruiting

Address

Fairfield General Hospital

Bury, , BL9 7TD

King's College Hospital, London, United Kingdom

Status

Not yet recruiting

Address

King's College Hospital

London, , SE5 9RL

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