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Crohn's DiseasePhase 3MACARONI-23NCT05923073

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

A Phase 3 study testing Guselkumab in people with Crohn's Disease, run by Janssen Research & Development, LLC at 85 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
Search all trials

Trial summary

The purpose of this study is to evaluate the clinical and endoscopic efficacy of guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical response to guselkumab at Week 12. Read more about this study

Who is it for?
Ages 2 to 17 years
Conditions the study is for
Crohn's Disease
What is being tested?
Guselkumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
85 sitesin 17 countries
Study dates
13 Mar 2024to 14 Aug 2028
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 2 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Participants must have a diagnosis of Crohn's Disease (CD) or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria.
  • Participants must have moderately to severely active CD (as defined by a baseline Pediatric Crohn's Disease Activity Index [PCDAI] score greater than or equal to [>=] 30)
  • Participants must have endoscopy with evidence of active CD defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) score greater than or equal to (>=) 6 (or >=4 for participants with isolated ileal disease) within 1 month of receiving study intervention at Week 0
  • Participants must have a history of inadequate response, loss of response, or intolerance to immunomodulators (6-MP, AZA, or MTX), oral or IV corticosteroids, or biologic therapy/JAK inhibitor therapy; OR have a history of corticosteroid dependence; OR have a history of inadequate response to exclusive enteral nutrition (EEN)

Who cannot join

  • Participants has complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestation that might be anticipated to require surgery.
  • Participants must not have an abscess
  • Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline

Trial locations and contacts

85 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

85 sites in 17 countries

United States14 sites, 9 recruiting

  • Emory University

    Atlanta, Georgia, 30322

    Recruiting

  • Children's Center for Digestive Health Care

    Atlanta, Georgia, 30342

    Recruiting

  • Boston Childrens Hospital

    Boston, Massachusetts, 02115

    Recruiting

  • University of Vermont Medical Center

    Colchester, Vermont, 05446

    Completed

  • The Children's Medical Center of Dayton

    Dayton, Ohio, 45404

    Completed

  • Cook Childrens Medical Center

    Fort Worth, Texas, 76104

    Recruiting

  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06106

    Completed

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202-5225

    Completed

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

    Recruiting

  • Goryeb Children's Hospital

    Morristown, New Jersey, 07960

    Recruiting

  • Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center

    New York, New York, 10021-5663

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

    Recruiting

  • Columbia University Medical Center

    New York, New York, 10032

    Completed

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Recruiting

Other trials in United States

Japan12 sites, 8 recruiting

  • Hirosaki University Hospital

    Hirosaki, 036-8563

    Completed

  • Kagoshima University Hospital

    Kagoshima, 890-8544

    Recruiting

  • Tsujinaka Hospital Kashiwanoha

    Kashiwa-shi, 277-0871

    Completed

  • Kobe University Hospital

    Kobe, 650 0017

    Recruiting

  • Saga University Hospital

    Saga, 849-8501

    Recruiting

  • Miyagi Childrens Hospital

    Sendai, 989-3126

    Recruiting

  • National Center for Child Health and Development

    Setagaya Ku, 157 8535

    Completed

  • Juntendo University Hospital

    Tokyo, 113-8431

    Recruiting

  • Mie University Hospital

    Tsu, 514 8507

    Completed

  • Yamaguchi University Hospital

    Ube, 755-8505

    Recruiting

  • Saiseikai Yokohamashi Tobu Hospital

    Yokohama, 230-8765

    Recruiting

  • Yokohama City University Medical Center

    Yokohama, 232-0024

    Recruiting

Other trials in Japan

Brazil7 sites, 4 recruiting

  • Sociedade Campineira de Educacao e Instrucao Hospital e Maternidade Celso Pierro

    Campinas, 13060-904

    Recruiting

  • Associacao Hospitalar de Protecao a Infancia Dr. Raul Carneiro

    Curitiba, 80250-060

    Recruiting

  • Universidade Federal de Goias - Hospital das Clinicas da UFG

    Goiânia, 74605-020

    Recruiting

  • Hospital De Clinicas De Porto Alegre

    Porto Alegre, 90035-007

    Completed

  • Irmandade Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, 90035-074

    Completed

  • Centro de Ciencias e Saude da Universidade Federal do Espirito Santo-Nucleo de Doencas Infecciosas

    Vitória, 29040-091

    Completed

  • INTEGRAL Pesquisa e Ensino

    Votuporanga, 100000

    Recruiting

Other trials in Brazil

Israel6 sites, 4 recruiting

  • Shamir Medical Center Assaf Harofeh

    Be’er Ya‘aqov, 70300

    Completed

  • Soroka University Medical Center

    Beersheba, 84101

    Completed

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

    Recruiting

  • Hadassah Medical Center

    Jerusalem, 9124001

    Recruiting

  • Schneider Children's Medical Center

    Petah Tikva, 4920235

    Recruiting

  • Kaplan Medical Center

    Rehovot, 761001

    Recruiting

Other trials in Israel

Italy6 sites, 4 recruiting

  • A.O. Santi Antonio e Biagio e Cesare Arrigo

    Alessandria, 15121

    Recruiting

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

    Bergamo, 24127

    Recruiting

  • Ospedale Bellaria, U.O.Cardiologia Az. USL di Bologna

    Bologna, 40124

    Recruiting

  • Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer

    Florence, 50139

    Recruiting

  • Azienda Socio Sanitaria Territoriale Fatebenefratelli Presidio Ospedale dei Bambini Vittore Buzzi

    Milan, 20154

    Completed

  • AOU Policlinico Umberto I

    Roma, 161

    Completed

Other trials in Italy

United Kingdom6 sites, 3 recruiting

  • Royal Hospital for Sick Children

    Glasgow, G51 4TF

    Recruiting

  • Great Ormond Street Hospital

    London, WC1N 3JH

    Completed

  • Nowgen Centre, Research and Innovation

    Manchester, M13 9WL

    Completed

  • Royal Manchester Children's Hospital

    Manchester, M13 9WL

    Completed

  • John Radcliffe Hospital

    Oxford, OX3 9DU

    Recruiting

  • Sheffield Children's Hospital

    Sheffield, S10 2TH

    Recruiting

Other trials in United Kingdom

South Korea5 sites, 3 recruiting

  • Inje University Haeundae Paik Hospital

    Busan, 48108

    Completed

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Completed

  • Samsung Medical Center

    Seoul, 06351

    Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, 120-752

    Recruiting

Other trials in South Korea

Belgium4 sites, 3 recruiting

  • Universitair Ziekenhuis Brussel

    Brussels, 1090

    Recruiting

  • Cliniques Universitaires Saint Luc

    Brussels, 1200

    Completed

  • Universitair Ziekenhuis Gent

    Ghent, 9000

    Recruiting

  • UZ Leuven

    Leuven, 3000

    Recruiting

Other trials in Belgium

France4 sites, 3 recruiting

  • CHU Amiens-Hopital Nord

    Amiens, 80054

    Recruiting

  • Hôpital Jeanne de FLANDRE, CHRU LILLE

    Lille, 59037

    Recruiting

  • Hôpital Necker - Enfants Malades

    Paris, 75015

    Completed

  • Hôpital Robert Debré

    Paris, 75019

    Recruiting

Other trials in France

Norway4 sites, 2 recruiting

  • Akershus Universitetssykehus HF

    Nordbyhagen, 1474

    Recruiting

  • Oslo University Hospital

    Oslo, 424

    Completed

  • Universitetssykehuset Nord-Norge HF

    Tromsø, 9038

    Recruiting

  • St. Olavs Hospital

    Trondheim, 7030

    Completed

Other trials in Norway

Australia3 sites, 3 recruiting

  • Perth Children's Hospital

    Nedlands, 6009

    Recruiting

  • Mater Hospital Brisbane

    South Brisbane, 4101

    Recruiting

  • The Children's Hospital at Westmead

    Westmead, 2145

    Recruiting

Other trials in Australia

Canada3 sites, 1 recruiting

  • Iwk Health Centre

    Halifax, Nova Scotia, B3K 6R8

    Completed

  • London Health Sciences Centre Victoria Hospital

    London, Ontario, N6A 5W9

    Completed

  • Hospital For Sick Children

    Toronto, Ontario, M5G 1X8

    Recruiting

Other trials in Canada

Poland3 sites, 3 recruiting

  • Korczowski Bartosz Gabinet Lekarski

    Rzeszów, 35-302

    Recruiting

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 04 501

    Recruiting

  • Instytut Pomnik Centrum Zdrowia

    Warsaw, 04 730

    Recruiting

Other trials in Poland

Portugal3 sites, 3 recruiting

  • Hospital de Braga

    Braga, 4710-243

    Recruiting

  • Centro Hospitalar de Lisboa Norte Hospital Santa Maria

    Lisbon, 1649-035

    Recruiting

  • Centro Hospitalar de Sao Joao E.P.E.

    Porto, 4200-319

    Recruiting

Other trials in Portugal

Spain3 sites, 2 recruiting

  • Hosp Reina Sofia

    Córdoba, 14004

    Recruiting

  • Corporacio Sanitari Parc Tauli

    Sabadell, 8208

    Completed

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46026

    Recruiting

Other trials in Spain

Austria1 site

  • AKH - Medizinische Universitat Wien

    Vienna, 1090

    Completed

Other trials in Austria

Netherlands1 site

  • Erasmus Medisch Centrum

    Rotterdam, 3015 GD

    Completed

Other trials in Netherlands

About this study

Official title: A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23 Pathway to Establish Efficacy in Pediatric Crohn's Disease

The purpose of this study is to evaluate the clinical and endoscopic efficacy of guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical response to guselkumab at Week 12.

Conditions
Crohn's Disease
Being tested
Guselkumab
Keywords
Pediatric, Inflammatory bowel disease
Medical subject headings
Crohn Disease, Inflammatory Bowel Diseases

What participants receive

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

  • GuselkumabDrug

    Also called CNTO1959, TREMFYA

    Guselkumab will be administered subcutaneously.

  • GuselkumabDrug

    Also called CNTO1959, TREMFYA

    Guselkumab will be administered intravenously.

Study groups in NCT05923073
Study groupRoleWhat they receive
Open-label induction phase: Guselkumab Intravenously (IV)ExperimentalParticipants will receive guselkumab dose IV based on their body weight during the 12-week open-label induction phase.
Receives: Drug: Guselkumab
Open-label induction phase: Guselkumab Subcutaneously (SC)ExperimentalParticipants will receive guselkumab dose SC based on their body weight during the 12-week open-label induction phase.
Receives: Drug: Guselkumab
Double-blind maintenance phase: Guselkumab SC Dose Regimen 1ExperimentalAt the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 1 SC based on their body weight up to Week 48.
Receives: Drug: Guselkumab
Double-blind Maintenance Phase: Guselkumab SC Dose Regimen 2ExperimentalAt the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 2 SC based on their body weight up to Week 48.
Receives: Drug: Guselkumab
Open-label maintenance phase: Guselkumab SCExperimentalWeek 12 non-responders will not be randomized and will enter an open-label maintenance phase to receive guselkumab SC dosing regimen based on their body weight up to Week 48.
Receives: Drug: Guselkumab

What is being measured

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

  1. Percentage of Participants with Clinical Remission at Week 52

    Percentage of participants with clinical remission at Week 52 will be assessed. Clinical remission is defined as pediatric Crohn's Disease activity index (PCDAI) less than or equal to (<=) 10.

    Measured: Week 52

  2. Percentage of Participants Who Achieve Endoscopic Response at Week 52

    Percentage of participants who achieve endoscopic response at Week 52 will be assessed. Endoscopic response is defined as greater than or equal to (>=) 50 percent (%) reduction (global) and greater than (>) 50% reduction (U.S specific) from simplified endoscopic score-Crohn's Disease (SES-CD) score at baseline.

    Measured: Week 52

Secondary outcomes (19)

  1. Percentage of Participants with Clinical Response at Week 12

    Percentage of participants with clinical response at Week 12 will be assessed. Clinical responder is defined as a decrease from baseline in the PCDAI score of >=12.5 points with a total PCDAI score <30.

    Measured: Week 12

  2. Percentage of Participants with Clinical Response at Week 52

    Percentage of participants with clinical response at Week 52 will be assessed. Clinical responder is defined as a decrease from baseline in the PCDAI score of >=12.5 points with a total PCDAI score <30.

    Measured: Week 52

  3. Percentage of Participants with Clinical Remission at Week 12

    Percentage of participants with clinical remission at Week 12 will be assessed. Clinical remission is defined as PCDAI score <=10.

    Measured: Week 12

  4. Percentage of Participants with Endoscopic Remission at Week 52

    Percentage of participants with endoscopic remission at Week 52 will be assessed. Endoscopic remission is defined as SES-CD total score <=4 and at least a 2-point reduction from baseline and no subscore >1.

    Measured: Week 52

  5. Percentage of Participants with Corticosteroid-free Remission at Week 52

    Percentage of participants with corticosteroid-free remission at Week 52 will be assessed. Corticosteroid-free remission is defined as PCDAI score <=10 at Week 52 and not receiving corticosteroids for at least 90 days before Week 52.

    Measured: Week 52

  6. Percentage of Participants with Sustained Clinical Remission at Weeks 12, 24, and 52

    Percentage of participants with sustained clinical remission at Weeks 12, 24, and 52 will be assessed. Sustained clinical remission is defined as PCDAI <=10 at Weeks 12, 24, and 52.

    Measured: Weeks 12, 24, and 52

  7. Percentage of Participants with Clinical remission by Patient-Reported Outcome (PRO-2)

    Percentage of participants with clinical remission by PRO-2 will be assessed. Clinical remission by PRO-2 is defined as stool frequency (SF) <=3 and abdominal pain (AP) <=1 and no worsening of SF and AP from baseline.

    Measured: Week 12 and/or Week 52

  8. Serum Concentration of Guselkumab During Induction Phase

    Serum concentrations of guselkumab will be assessed. Serum samples will be analyzed to determine concentrations of guselkumab using a validated, specific, and sensitive immunoassay method.

    Measured: From Week 0 to Week 12

  9. Trough Plasma Concentration (Ctrough) of Guselkumab During Maintenance Phase

    Ctrough is defined as the serum concentration of guselkumab immediately prior (pre-dose) to the next drug administration.

    Measured: At Weeks 16, 24, 36, 48 and 52

  10. Change from Baseline in Body Weight at Weeks 12, 24, and 52

    Change from baseline in body weight at Weeks 12, 24, and 52 will be assessed.

    Measured: Baseline, Weeks 12, 24, and 52

  11. Change from Baseline in Body Weight Percentiles at Weeks 12, 24, and 52

    Change from baseline in body weight percentiles at Weeks 12, 24, and 52 will be assessed.

    Measured: Baseline, Weeks 12, 24, and 52

  12. Change from Baseline in Body Weight z-scores at Weeks 12, 24, and 52

    Change from baseline in body weight z-scores at Weeks 12, 24, and 52 will be assessed.

    Measured: Baseline, Weeks 12, 24, and 52

  13. Change from Baseline in Height at Weeks 12, 24, and 52

    Change from baseline in height at Weeks 12, 24, and 52 will be assessed.

    Measured: Baseline, Weeks 12, 24, and 52

  14. Change from Baseline in Height Percentiles at Weeks 12, 24, and 52

    Change from baseline in height percentiles at Weeks 12, 24, and 52 will be assessed.

    Measured: Baseline, Weeks 12, 24, and 52

  15. Change from Baseline in Height z-scores at Weeks 12, 24, and 52

    Change from baseline in height z-scores at Weeks 12, 24, and 52 will be assessed.

    Measured: Baseline, Weeks 12, 24, and 52

  16. Change from Baseline in Height Velocity at Weeks 12, 24, and 52

    Change from baseline in height velocity at Weeks 12, 24, and 52 will be assessed.

    Measured: Baseline, Weeks 12, 24, and 52

  17. Percentage of Participants with Clinical Remission

    Percentage of participants with clinical remission who were assigned to guselkumab dose regimen 1 and did not receive rescue therapy at Week 52 will be assessed. Clinical remission is defined as PCDAI score <=10.

    Measured: Week 52

  18. Percentage of Participants Who Achieve Endoscopic Response

    Percentage of participants who achieve endoscopic response who were assigned to q4w maintenance therapy and did not receive rescue therapy at Week 52 will be assessed. Endoscopic response is defined as >=50% reduction (global) and >50% reduction (U.S specific) from SES-CD score at baseline.

    Measured: Week 52

  19. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the intervention. An SAE is 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 64

Timeline

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

  1. First posted28 Jun 2023
  2. Study start13 Mar 2024
  3. Primary completion27 Oct 2027 (estimated)
  4. Study completion14 Aug 2028 (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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05923073
Sponsor's protocol ID
CR109212
Other IDs
CNTO1959PBCRD3007, 2021-006282-37, 2023-504735-41-00, 2023
Acronym
MACARONI-23
Status last verified
Sep 2026
First submitted
20 Jun 2023
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes
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 in people with Crohn's Disease, run by Janssen Research & Development, LLC at 85 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 4 inclusion and 3 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 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in United States, Japan, Brazil, Israel, Italy 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?

Percentage of Participants with Clinical Remission at Week 52 (time frame: Week 52). The study lists 2 primary outcomes in all. 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 NCT05923073.

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 25 Sep 2026.

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MACARONI-23 Clinical Trial NCT05923073 | AzTrials