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

NCT ID: NCT04673357

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-06
• Study Completion Date: 2025-03-03

Brief Summary

The purpose of this study is to evaluate the efficacy of ustekinumab dosing in inducing clinical remission (Global) and in maintaining clinical remission (US); to evaluate the safety profile and ustekinumab exposure (pharmacokinetics [PK]) in pediatric participants with moderately to severely active Crohn's disease.

Conditions

Crohn Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Open- Label Ustekinumab Intravenous (IV): Induction Period

All participants will receive a single IV administration of ustekinumab at induction Week 0 (I-0) based on body surface area (BSA) (milligram per meter square \[mg/m\^2\]) or weight-tiered induction dose (milligram per kilogram \[mg/kg\]).

Group Type: EXPERIMENTAL

Ustekinumab

Intervention Type: DRUG

Ustekinumab will be administered intravenously in induction period and subcutaneously in maintenance period.

Ustekinumab Subcutaneous (SC) Every 8 Weeks (q8w): Maintenance Period

Participants will receive SC administration of ustekinumab q8w based on BSA (mg/m\^2) or weight-tiered induction dose (mg/kg) at maintenance weeks (Weeks M)-0, M-8, M-16, M-24, M 32, and M-40 and matching placebo at Weeks M-12 and M-36 to maintain the blind.

Group Type: EXPERIMENTAL

Ustekinumab

Intervention Type: DRUG

Ustekinumab will be administered intravenously in induction period and subcutaneously in maintenance period.

Placebo

Intervention Type: DRUG

Matching placebo will be administered as SC injection.

Ustekinumab SC Every 12 Weeks (q12w): Maintenance Period

Participants will receive SC administration of ustekinumab q12w based on BSA (mg/m\^2) or weight-tiered induction dose (mg/kg) at Weeks M-0, M-12, M-24, M-36 and matching placebo at Weeks M-8, M-16, M-32, and M-40 to maintain the blind.

Group Type: EXPERIMENTAL

Ustekinumab

Intervention Type: DRUG

Ustekinumab will be administered intravenously in induction period and subcutaneously in maintenance period.

Placebo

Intervention Type: DRUG

Matching placebo will be administered as SC injection.

Interventions

Ustekinumab

Ustekinumab will be administered intravenously in induction period and subcutaneously in maintenance period.

Intervention Type: DRUG

Placebo

Matching placebo will be administered as SC injection.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Have Crohn's disease or fistulizing Crohn's disease with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by endoscopy and histology
• Must have moderately to severely active Crohn's disease (as defined by a baseline Pediatric Crohn's Disease Activity Index [PCDAI] score greater than [>] 30); have ileocolonoscopy with evidence of active Crohn's disease defined as presence of ulceration (which is equal to Simple Endoscopic Score for Crohn's disease [SES-CD] score greater than or equals to [>=] 3) during screening into this study. The ileocolonoscopy procedure must occur within approximately 3 weeks prior to the administration of study intervention at Week 0 (Induction Period). A video ileocolonoscopy recorded within 3 months prior to the Week 0 (Induction Period) visit may be used in case of rescreening of a participant who had an ileocolonoscopy but failed the initial screening for another reason, on a case-by-case basis, after consultation with the sponsor. If unable to evaluate ulceration due to stricture or inadequate bowel preparation, at least one of the following criteria may instead be applied: an abnormal C-reactive protein (CRP) (> 0.3 milligram per deciliter [mg/dL] or 3.0 milligram per liter [mg/L] at screening) or; fecal calprotectin of >= 250 milligram per kilogram [mg/kg] or >= 250 microgram per gram [mcg/g] at screening
• If receiving enteral nutrition, must have been on a stable regimen for at least 2 weeks prior to induction week 0 (Week I-0)
• Females of childbearing potential must have a negative highly sensitive urine pregnancy test at screening and at Week I-0 prior to study intervention administration

Exclusion Criteria

• Has complications of Crohn's disease such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestation that might be anticipated to require surgery, that could preclude the use of the PCDAI to assess response to therapy or would possibly confound the ability to assess the effect of treatment with ustekinumab
• Have a history of latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis, or have had a nontuberculous mycobacterial infection prior to screening
• Presence or history of any malignancy including presence or history of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (example, nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic areas), and monoclonal gammopathy of undetermined significance, or clinically significant hepatomegaly or splenomegaly
• Have a history of moderate or severe progressive or uncontrolled liver or renal insufficiency; or significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric (including suicidality), or metabolic disturbances
• Received an investigational intervention including any investigational vaccines or used an invasive investigational medical device within 3 months before the planned first dose of study intervention or is currently enrolled in an investigational study; receipt of an investigational vaccine for Coronavirus Disease 2019 (COVID-19) is not an automatic exclusion criterion

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Nemours DuPont Hospital for Children

Wilmington, Delaware, United States

Children's Center for Digestive Health Care

Atlanta, Georgia, United States

Mayo Clinic

Rochester, Minnesota, United States

Morristown Memorial Hospital

Morristown, New Jersey, United States

Levine Childrens at Atrium Health

Charlotte, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Penn State Hershey Children's Hospital

Hershey, Pennsylvania, United States

Cook Childrens Medical Center

Fort Worth, Texas, United States

Pediatric Specialists Of Virginia

Fairfax, Virginia, United States

Universitair Kinderziekenhuis Koningin Fabiola

Brussels, , Belgium

Cliniques Universitaires Saint Luc

Brussels, , Belgium

UZ Gent

Ghent, , Belgium

UZ Brussel

Jette, , Belgium

UZ Leuven

Leuven, , Belgium

Universitätsklinikum Aachen

Aachen, , Germany

Charite-Universitätsmedizin Berlin - Berlin

Berlin, , Germany

Universitatsklinikum Essen

Essen, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Dr. von Haunersches Kinderspital

Munich, , Germany

KUNO Klinik St. Hedwig

Regensburg, , Germany

Universitatsklinikum Ulm

Ulm, , Germany

Semmelweis Egyetem

Budapest, , Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, , Hungary

Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz

Miskolc, , Hungary

Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz

Nyíregyháza, , Hungary

Szegedi Tudományegyetem, Gyermekgyógyászati Klinika és Gyermekegészségügyi Centrum

Szeged, , Hungary

Yitzhak Shamir Medical Center

Be’er Ya‘aqov, , Israel

Carmel Medical Center

Haifa, , Israel

Shaare Zedek Medical Center

Jerusalem, , Israel

Schneider Children's Medical Center

Petah Tikva, , Israel

Juntendo University Hospital

Bunkyō City, , Japan

Gunma University Hospital

Gunma, , Japan

Kindai University Nara Hospital

Ikoma, , Japan

Kurume University Hospital

Kurume, , Japan

Saitama Childrens Medical Center

Saitama Shi, , Japan

Miyagi Children's Hospital

Sendai, , Japan

National Center for Child Health and Development

Setagaya Ku, , Japan

Jichi Medical University Hospital

Shimotsuke, , Japan

Mie University Hospital

Tsu, , Japan

Szpital im. M. Kopernika

Gdansk, , Poland

Uniwersytecki Szpital Dzieciecy w Krakowie

Krakow, , Poland

Korczowski Bartosz Gabinet Lekarski

Rzeszów, , Poland

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, , Poland

Instytut Pomnik Centrum Zdrowia Dziecka

Warsaw, , Poland

Kazan State Medical University

Kazan', , Russia

Russian National Research Medical University named after N.I.Pirogov

Moscow, , Russia

Privolzhsky Research Medical University of Ministry of Health of Russian Federation

Nizhny Novgorod, , Russia

Yaroslavl Regional Children's Clinical Hospital

Yaroslavl, , Russia

Birmingham Children's Hospital

Birmingham, , United Kingdom

University Hospitals Bristol and Weston NHS Foundation Trust

Bristol, , United Kingdom

Cambridge University Hospitals NHS Foundation Trust

Cambridge, , United Kingdom

Royal Hospital for Children and Young People

Edinburgh, , United Kingdom

Royal London Hospital

London, , United Kingdom

Countries

United States; Belgium; Germany; Hungary; Israel; Japan; Poland; Russia; United Kingdom

Other Identifiers

CNTO1275CRD3004

Identifier Type: OTHER

Identifier Source: secondary_id

2019-004225-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-504978-38-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CR108864

Identifier Type: -

Identifier Source: org_study_id