AzTrials
AzTrials

Crohn DiseasePhase 3CHARGENCT07499232

A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

A Phase 3 study testing Guselkumab and Risankizumab in people with Crohn Disease, run by Janssen Research & Development, LLC at 164 sites in 17 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to assess how well guselkumab works when compared to risankizumab in participants with moderately to severely active Crohn's Disease (CD; a long-term condition causing severe inflammation of the intestinal tract). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn Disease
What is being tested?
Guselkumab and Risankizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
530 participants
Where
164 sitesin 17 countries
Study dates
21 Apr 2026to 11 Dec 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has CD or fistulizing Crohn's Disease (CD) of at least 12 weeks' duration, with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, and/or endoscopy
  • Have moderately to severely active CD, defined as baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (>=) 220 but less than or equal to (<=) 450
  • Baseline endoscopic evidence of active ileal and/or colonic CD as assessed by central endoscopy reading at the screening endoscopy defined as a screening Simple Endoscopic Score for Crohn's Disease (SES CD) >= 4 (for participants with isolated ileal disease) or >= 6 (for participants with colonic or ileocolonic disease), based on the presence of ulceration in any 1 of the 5 ileocolonic segments, resulting in the following specified ulceration component scores:
  • a minimum score of 1 for the component of "size of ulcers" AND
  • a minimum score of 1 for the component of "ulcerated surface"
  • In the opinion of the investigator, participant's disease is appropriate to treat with the maintenance dosing regimens utilized in the study
  • Adhere to the requirements for concomitant medications for the treatment of CD as mentioned in the protocol

Who cannot join

  • Has complications of CD such as symptomatic strictures or stenoses, short gut syndrome, active draining stoma or significant fistulizing disease or any other manifestation anticipated to require surgery within the next year, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with guselkumab or risankizumab
  • Currently has or is suspected to have an abscess
  • Has an active fistula during screening or at Week 0 with an anticipated need for surgery
  • Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks, before first dose of study intervention
  • Currently has a malignancy or has a history of malignancy within 5 years before screening

Trial locations and contacts

164 sites in 17 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

164 sites in 17 countries

United States41 sites, 39 recruiting

  • Clinnova Research

    Anaheim, California, 92805

    Recruiting

  • Morehouse School of Medicine

    Atlanta, Georgia, 30310

    Recruiting

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30342

    Suspended

  • Westchester Putnam Gastroenterology

    Carmel, New York, 10512

    Recruiting

  • DFW Clinical Trials

    Carrollton, Texas, 75010

    Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599 7080

    Recruiting

  • Charlotte Gastroenterology and Hepatology, PLLC

    Charlotte, North Carolina, 28207

    Recruiting

  • Heartland Medical Research Inc

    Clive, Iowa, 50325

    Recruiting

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907

    Recruiting

  • Digestive Health Specialists of the Southeast

    Dothan, Alabama, 36305

    Recruiting

  • Michigan Center of Medical Research

    Farmington Hills, Michigan, 48334

    Recruiting

  • Woodholme Gastroenterology Associates

    Glen Burnie, Maryland, 21061

    Recruiting

  • Medical Research Center of Connecticut

    Hamden, Connecticut, 06518

    Recruiting

  • Green Leaf Clinical Trials

    Jacksonville, Florida, 32258

    Recruiting

  • Gastroenterology Clinic of Acadiana

    Lafayette, Louisiana, 70503

    Recruiting

  • Gastro Care Institute

    Lancaster, California, 93534

    Recruiting

  • United Gastroenterologists

    Los Alamitos, California, 90720

    Recruiting

  • TLC Clinical Research Inc

    Los Angeles, California, 90048

    Recruiting

  • GastroIntestinal Bioscience

    Los Angeles, California, 90067

    Recruiting

  • Lubbock Gastroenterology

    Lubbock, Texas, 79424

    Recruiting

  • Gastroenterology Associates of Central GA

    Macon, Georgia, 31201

    Recruiting

  • Great Lakes Gastroenterology Research, LLC

    Mentor, Ohio, 44060

    Recruiting

  • Sanchez Clinical Research, Inc

    Miami, Florida, 33157-6575

    Recruiting

  • Biodax Medical Research Trials

    Miami, Florida, 33186

    Recruiting

  • East View Medical Research

    Mobile, Alabama, 36608

    Recruiting

  • GI Pros Research

    Naples, Florida, 34102

    Recruiting

  • Lucida Clinical Trials

    New Bedford, Massachusetts, 02740

    Recruiting

  • New York Gastroenterology Associates

    New York, New York, 10028

    Recruiting

  • Lenox Hill Hospital

    New York, New York, 10075

    Suspended

  • Comprehensive Gastrointestinal Health Libertyville

    Northbrook, Illinois, 60062

    Recruiting

  • Digestive Disease Specialists Inc

    Oklahoma City, Oklahoma, 73114

    Recruiting

  • Orlando Health Digestive Health Institute

    Orlando, Florida, 32806

    Recruiting

  • Gastroenterology Research of America, LLC

    San Antonio, Texas, 78229

    Recruiting

  • Southern Star Research Institute, LLC

    San Antonio, Texas, 78229

    Recruiting

  • Medical Associates Research Group, Inc.

    San Diego, California, 92123

    Recruiting

  • Louisiana State University Health Sciences Center Shreveport

    Shreveport, Louisiana, 71103

    Recruiting

  • Palmetto Primary and Specialty Care Physicians, Charleston

    Summerville, South Carolina, 29486

    Recruiting

  • GCP Clinical Research

    Tampa, Florida, 33609

    Recruiting

  • Cotton-O'Neil Clinical Research Center

    Topeka, Kansas, 66606

    Recruiting

  • The University of Texas Health Science Center at Tyler

    Tyler, Texas, 75708

    Recruiting

  • Frontier Clinical Research

    Uniontown, Pennsylvania, 15401

    Recruiting

Other trials in United States

France12 sites, 12 recruiting

  • CHU Amiens Picardie

    Amiens, 80000

    Recruiting

  • Clermont Ferrand University Hospital

    Clermont-Ferrand, 63000

    Recruiting

  • Institut Prive MICI Clinique des Cedres

    Échirolles, 38130

    Recruiting

  • Aphm - Hopital Nord

    Marseille, 13015

    Recruiting

  • CHU Nantes - Hotel Dieu

    Nantes, 44000

    Recruiting

  • Clinique Ambroise Pare

    Neuilly-sur-Seine, 92200

    Recruiting

  • CHU Nimes

    Nîmes, 30900

    Recruiting

  • Aphp Hopital Saint Antoine

    Paris, 75012

    Recruiting

  • APHP - Hopital Bichat - Claude Bernard

    Paris, 75018

    Recruiting

  • Hospices Civils de Lyon CHU Lyon Sud

    Pierre-Bénite, 69495

    Recruiting

  • CHU de Reims

    Reims, 51100

    Recruiting

  • Centre Hospitalier Universitaire de Nancy - Hôpital Central

    Vandœuvre-lès-Nancy, 54511

    Recruiting

Other trials in France

Germany9 sites, 9 recruiting

  • GASTRO-Studien

    Berlin, 10825

    Recruiting

  • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF)

    Berlin, 12203

    Recruiting

  • Universitatsklinikum Erlangen

    Erlangen, 91054

    Recruiting

  • Praxiszentrum Fur Gastroenterologie und Endoskopie Grevenbroich

    Grevenbroich, 41515

    Recruiting

  • Universitatsklinikum Jena

    Jena, 07747

    Recruiting

  • Universitatsklinikum Schleswig Holstein Kiel

    Kiel, 24105

    Recruiting

  • St. Marien und St. Annastiftskrankenhaus

    Ludwigshafen am Rhein, 67067

    Recruiting

  • Universitaetsklinikum Mannheim

    Mannheim, 68167

    Recruiting

  • Klinikum rechts der Isar der TU Munchen

    München, 81675

    Recruiting

Other trials in Germany

Spain9 sites, 9 recruiting

  • Hosp. Gral. Univ. Dr. Balmis

    Alicante, 03010

    Recruiting

  • Hosp. Clinic de Barcelona

    Barcelona, 08036

    Recruiting

  • Hosp. Arquitecto Marcide

    Ferrol, 15405

    Recruiting

  • Hosp. de Cabuenes

    Gijón, 33394

    Recruiting

  • Hosp. Univ. Dr. Josep Trueta

    Girona, 17007

    Recruiting

  • Hosp. Univ. de Torrejon

    Madrid, 28850

    Recruiting

  • Hosp. de Navarra

    Navarra, 31008

    Recruiting

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706

    Recruiting

  • Hosp. Virgen Macarena

    Seville, 41009

    Recruiting

Other trials in Spain

United Kingdom9 sites, 9 recruiting

  • Barts Health NHS Trust

    Greater London, E1 2AJ

    Recruiting

  • London North West University Healthcare NHS Trust

    Greater London, NW10 7NS

    Recruiting

  • West Middlesex University Hospital

    Iselworth, TW7 6AF

    Recruiting

  • University College London Hospitals Nhs Foundation Trust

    London, NW1 2PG

    Recruiting

  • Royal Free Hospital

    London, NW3 2QG

    Recruiting

  • Chelsea And Westminster Hospital

    London, SW10 9NH

    Recruiting

  • Imperial College London

    London, W120HS

    Recruiting

  • Norfolk and Norwich University Hospital

    Norwich, NR4 7UQ

    Recruiting

  • New Cross Hospital

    Wolverhampton, WV10 0QP

    Recruiting

Other trials in United Kingdom

Austria8 sites, 8 recruiting

  • LKH-Univ. Klinikum Graz

    Graz, 8036

    Recruiting

  • Medizinische Universitatsklinik Innsbruck

    Innsbruck, 6020

    Recruiting

  • Kepler Universitatsklinikum GmbH

    Linz, 4021

    Recruiting

  • LKH - Universitätsklinikum der PMU Salzburg

    Salzburg, 5020

    Recruiting

  • Krankenhaus der Barmherzigen Brüder

    Vienna, 1020

    Recruiting

  • Medical University Vienna

    Vienna, 1090

    Recruiting

  • Klinikum Wels Grieskirchen

    Wels, 4600

    Recruiting

  • Universitatsklinikum Wiener Neustadt

    Wiener Neustadt, 2700

    Recruiting

Other trials in Austria

Canada8 sites, 8 recruiting

  • Gastroenterology and Internal Medicine Research Institute (GIRI)

    Edmonton, Alberta, T5R 1W2

    Recruiting

  • Charlton Digestive Disease Centre

    Hamilton, Ontario, L8N1Y2

    Recruiting

  • London Digestive Disease Institute

    London, Ontario, N6K 1M6

    Recruiting

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 0C1

    Recruiting

  • Clinique IMD

    Montreal, Quebec, H3H1E3

    Recruiting

  • Taunton Surgical Centre

    Oshawa, Ontario, L1J 0C7

    Recruiting

  • Toronto Immune and Digestive Health Institute Inc

    Toronto, Ontario, M6A 3B4

    Recruiting

  • GIRI Gastrointestinal Research Institute

    Vancouver, British Columbia, V6Z 2K5

    Recruiting

Other trials in Canada

Denmark8 sites, 8 recruiting

  • Aarhus University Hospital

    Aarhus C, 8200

    Recruiting

  • Sydvestjysk Sygehus

    Esbjerg, 6700

    Recruiting

  • NAU New Aalborg University Hospital

    Gistrup, 9260

    Recruiting

  • Herlev Hospital

    Herlev, 2730

    Recruiting

  • Nordsjaellands Hospital, Hillerod

    Hilleroed, 3400

    Recruiting

  • Hvidovre Hospital

    Hvidovre, 2650

    Recruiting

  • Bispebjerg Hospital

    København NV, 2400

    Recruiting

  • Odense UH og Svendberg sygehus

    Odense C, 5000

    Recruiting

Other trials in Denmark

Hungary8 sites, 8 recruiting

  • Obudai Egeszsegugyi Centrum Kft

    Budapest, 1036

    Recruiting

  • Semmelweis Egyetem 1

    Budapest, 1082

    Recruiting

  • Semmelweis Egyetem 2

    Budapest, 1083

    Recruiting

  • Semmelweis Egyetem

    Budapest, 1088

    Recruiting

  • Endomedix

    Budapest, 1139

    Recruiting

  • Pannónia Magánorvosi Centrum Kft

    Budapest, H-1136

    Recruiting

  • Clinexpert Gyongyos Kft

    Gyöngyös, 3200

    Recruiting

  • Szegedi Tudomanyegyetem

    Szeged, 6725

    Recruiting

Other trials in Hungary

Poland8 sites, 8 recruiting

  • Centrum Medyczne Medis ManerMed Sp Z O O

    Bydgoszcz, 85 229

    Recruiting

  • Centrum Medyczne Plejady

    Krakow, 30363

    Recruiting

  • Centrum Medyczne Promed

    Krakow, 31-513

    Recruiting

  • Centrum Medyczne 'Medyk' Sp. z o.o. K.

    Rzeszów, 35-326

    Recruiting

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, 71-434

    Recruiting

  • GASTROMED Kopon Zmudzinski i wspolnicy SP j Specjalistyczne Centrum Gastrologii i Endoskopii

    Torun, 87 100

    Recruiting

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw, 02-781

    Recruiting

  • Medical Network Sp z o o

    Warsaw, 04 501

    Recruiting

Other trials in Poland

Belgium7 sites, 7 recruiting

  • ULB Erasme Ziekenhuis

    Brussels, 1070

    Recruiting

  • Cliniques Universitaires Saint Luc

    Brussels, 1200

    Recruiting

  • Ziekenhuis Oost-Limburg

    Genk, 3600

    Recruiting

  • Ghent University Hospital

    Ghent, 9000

    Recruiting

  • Universitair Ziekenhuis Leuven

    Leuven, 3000

    Recruiting

  • CHU de Liege

    Liège, 4000

    Recruiting

  • Algemeen Ziekenhuis Delta

    Roeselare, 8800

    Recruiting

Other trials in Belgium

China7 sites, 7 recruiting

  • Changzhou No 2 Peoples Hospital

    Changzhou, 213018

    Recruiting

  • Chongqing General Hospital

    Chongqing, 400014

    Recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, 350005

    Recruiting

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510261

    Recruiting

  • The Sixth Affiliated Hospital Sun Yat sen University

    Guangzhou, 510655

    Recruiting

  • Zhongda Hospital Southeast University

    Nanjing, 210009

    Recruiting

  • Renmin Hospital of Wuhan University

    Wuhan, 430060

    Recruiting

Other trials in China

Czechia7 sites, 7 recruiting

  • Fakultni nemocnice Brno

    Brno, 62500

    Recruiting

  • Vojenska nemocnice Brno

    Brno, 636 00

    Recruiting

  • Gastroenterologie, s.r.o., Hradec Kralove

    Hradec Kralova, 500 02

    Recruiting

  • Hepato-gastroenterologie HK, s.r.o.

    Hradec Králové, 500 12

    Recruiting

  • Fakultni Nemocnice Ostrava

    Ostrava-Poruba, 708 00

    Recruiting

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 00

    Recruiting

  • Fakultni Thomayerova nemocnice

    Prague, 14000

    Recruiting

Other trials in Czechia

Italy7 sites, 7 recruiting

  • A O U Sant Orsola Malpighi

    Bologna, 40138

    Recruiting

  • Azienda Sanitaria dell'Alto Adige - Ospedale di Bolzano

    Bolzano, 39100

    Recruiting

  • Azienda Ospedaliero Universitaria San Martino

    Genova, 16132

    Recruiting

  • IRCCS Ospedale San Raffaele

    Milan, 20132

    Recruiting

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    Roma, 00168

    Recruiting

  • Istituto Clinico Humanitas

    Rozzano, 20089

    Recruiting

  • Ospedale Mauriziano Torino

    Torino, 10128

    Recruiting

Other trials in Italy

Slovakia7 sites, 7 recruiting

  • FNsP F. D. Roosevelta Banska Bystrica

    Banská Bystrica, 975 17

    Recruiting

  • Cliniq s.r.o.

    Bratislava, 811 09

    Recruiting

  • ENDOMED s.r.o

    Košice, 040 13

    Recruiting

  • Fakultna nemocnica s poliklinikou Nove Zamky

    Nové Zámky, 940 34

    Recruiting

  • GASTRO I. s.r.o.

    Prešov, 080 01

    Recruiting

  • Gastro LM s.r.o.

    Prešov, 080 01

    Recruiting

  • Vseobecna nemocnica Rimavska Sobota

    Rimavská Sobota, 979 12

    Recruiting

Other trials in Slovakia

Sweden6 sites, 6 recruiting

  • Linkoping University Hospital

    Linköping, 58185

    Recruiting

  • Sahlgrenska Universitetssjukhuset, Mölndal Sjukhus

    Mölndal, 431 30

    Recruiting

  • Ersta sjukhus

    Stockholm, 116 30

    Recruiting

  • Sodersjukhuset

    Stockholm, 118 83

    Recruiting

  • Karolinska Universitetssjukhuset

    Stockholm, 171 76

    Recruiting

  • Akademiska Sjukhuset

    Uppsala, 751 85

    Recruiting

Other trials in Sweden

Netherlands3 sites, 3 recruiting

  • Maastricht UMC

    Maastricht, 6229 HX

    Recruiting

  • Radboud Umcn

    Nijmegen, 6525 GA

    Recruiting

  • St. Elisabeth Ziekenhuis

    Tilburg, 5022 GC

    Recruiting

Other trials in Netherlands

About this study

Official title: A Phase 3b, Multicenter, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of Guselkumab Versus Risankizumab in the Treatment of Participants With Moderately to Severely Active Crohn's Disease

The purpose of this study is to assess how well guselkumab works when compared to risankizumab in participants with moderately to severely active Crohn's Disease (CD; a long-term condition causing severe inflammation of the intestinal tract).

Conditions
Crohn Disease
Being tested
Guselkumab, Risankizumab
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GuselkumabDrug

    Also called CNTO1959

    Guselkumab will be administered.

  • RisankizumabDrug

    Risankizumab will be administered.

Study groups in NCT07499232
Study groupRoleWhat they receive
GuselkumabExperimentalParticipants will receive guselkumab induction dose subcutaneously (SC) at Weeks 0, 4, and 8 followed by guselkumab maintenance dose SC once every 4 weeks (q4w) from Week 12 through Week 52.
Receives: Drug: Guselkumab
RisankizumabExperimentalParticipants will receive risankizumab induction dose intravenously (IV) at Weeks 0, 4, and 8 followed by risankizumab maintenance dose SC once every 8 weeks (q8w) from Week 12 through Week 52.
Receives: Drug: Risankizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Deep Remission at Week 52

    Deep remission is a composite endpoint defined as achieving both clinical remission and endoscopic remission at the participant level. Clinical remission is defined as Crohn's Disease Activity Index (CDAI) score less than (<) 150-point. CDAI will be assessed by collecting information on 8 different CD-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600. Higher score indicates higher disease activity. Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) less than or equal to (<=) 4 with at least a 2-point reduction from baseline and no sub score greater than (>) 1 in any individual component and score can range from 0 to 56. Higher scores indicating severe disease.

    Measured: At Week 52

Secondary outcomes (7)

  1. Composite Endpoint of Number of Participants with Clinical Remission and Endoscopic Response at Week 52

    Clinical remission is defined as CDAI score < 150-point. CDAI will be assessed by collecting information on 8 different CD-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600. Higher score indicates higher disease activity. Endoscopic response is defined as >50 percent (%) improvement from baseline in the SES CD or SES-CD score <= 2 or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. This is a composite endpoint defined to measure achievement of both clinical remission and endoscopic response.

    Measured: At Week 52

  2. Number of Participants with Endoscopic Remission at Week 52

    Endoscopic remission is defined as SES-CD <= 4 with at least a 2-point reduction from baseline and no sub score > 1 in any individual component and score can range from 0 to 56. Higher scores indicating severe disease.

    Measured: At Week 52

  3. Number of Participants with Clinical Remission at Week 52

    Clinical remission is defined as CDAI score < 150-point. CDAI will be assessed by collecting information on 8 different CD-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600. Higher score indicates higher disease activity.

    Measured: At Week 52

  4. Number of Participants with Steroid-Free Clinical Remission at Week 52

    Steroid-free clinical remission is defined as clinical remission at Week 52 and not receiving corticosteroids for at least 90 days prior to Week 52. Clinical remission is defined as CDAI score < 150-point.

    Measured: At Week 52

  5. Number of Participants with Abnormalities in Laboratory Parameters

    Number of participants with abnormalities in laboratory parameters (hematology and chemistry) will be reported.

    Measured: Up to Week 148

  6. Number of Participants With Change From Baseline in Laboratory Abnormalities

    Number of participants with change from baseline in laboratory abnormalities (hematology and chemistry) will be reported.

    Measured: Up to week 148

  7. Number of Participants with Adverse Events (AEs), Serious AEs and AEs Leading to Discontinuation of Study Intervention

    An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important.

    Measured: Up to Week 165

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2026
  2. Study start21 Apr 2026
  3. Primary completion15 Nov 2028 (estimated)
  4. Study completion11 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
530 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07499232
Sponsor's protocol ID
CNTO1959CRD3009
Other IDs
CNTO1959CRD3009
Acronym
CHARGE
Status last verified
Nov 2026
First submitted
23 Mar 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Guselkumab and Risankizumab in people with Crohn Disease, run by Janssen Research & Development, LLC at 164 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 164 sites in United States, France, Germany, Spain, United Kingdom and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Deep Remission at Week 52 (time frame: At Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07499232.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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