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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1275CRD3004 | Other Identifier | Janssen Research & Development, LLC | |
| 2019-004225-24 | EudraCT Number | ||
| 2023-504978-38-00 | Registry Identifier | EUCT number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open- Label Ustekinumab Intravenous (IV): Induction Period | Experimental | 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]). |
|
| Ustekinumab Subcutaneous (SC) Every 8 Weeks (q8w): Maintenance Period | Experimental | 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. |
|
| Ustekinumab SC Every 12 Weeks (q12w): Maintenance Period | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ustekinumab | Drug | Ustekinumab will be administered intravenously in induction period and subcutaneously in maintenance period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Clinical Remission at Induction Week 8 | Number of participants with clinical remission in induction period will be assessed. Clinical remission is defined as having a Pediatric Crohn's Disease Activity Index (PCDAI) score less than or equal to (<=) 10 points. PCDAI is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdominal tenderness or mass, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. | Week 8 |
| Number of Participants with Adverse Events (AEs) | An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product. | Up to Week 74 |
| Number of Participants with Serious Adverse Events (SAEs) | A 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; is medically important. | Up to Week 74 |
| Number of Participants with AEs leading to Discontinuation of Study Intervention | Number of participants with AEs leading to discontinuation of study intervention will be reported. | Up to Week 74 |
| Number of Participants with AEs of Interest | Number of participants with AEs of interest (any newly identified malignancy, or case of active tuberculosis [TB], or opportunistic infection occurring after the first administration of study intervention[s]) will be reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Clinical Remission as Assessed by short Pediatric Crohn's Disease Activity Index (sPCDAI) | Number of participants with clinical remission in induction period as assessed by sPCDAI will be reported. Clinical remission is defined as PCDAI score and sPCDAI score <= 10 points. | Week 6 (Induction period) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemours DuPont Hospital for Children | Wilmington | Delaware | 19803 | United States | ||
| Children's Center for Digestive Health Care |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41843763 | Derived | De Greef E, Turner D, Kierkus J, Korczowski B, Meglicka M, Cohen SA, Hyams JS, Griffiths AM, Rosh JR, Strauss R, Van Limbergen E, Adedokun OJ, Kim L, Volger S; UNITI Jr study Group. Ustekinumab therapy for moderately to severely active pediatric Crohn's disease: UNITI Jr study safety and efficacy results in patients weighing at least 40 kg. J Crohns Colitis. 2026 Mar 10;20(3):jjag011. doi: 10.1093/ecco-jcc/jjag011. |
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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
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Induction period is an open-label period and maintenance period is a double-blind period.
| Placebo | Drug | Matching placebo will be administered as SC injection. |
|
| Up to Week 74 |
| Number of Participants with Abnormalities in Clinical Laboratory Parameters | Number of participants with abnormalities in clinical laboratory parameters (such as hematology and chemistry) will be reported. | Up to Week 52 |
| Number of Participants with Reactions Temporally Associated with Intravenous (IV) Infusion (Induction Period) | Number of participants with reactions temporally associated with IV infusion in induction period will be reported. | Up to Week 8 (Induction period) |
| Number of Participants with Subcutaneous (SC) Injection-Site Reactions (Maintenance Period) | Number of participants with SC injection-site reactions in maintenance period will be reported. | Up to Week 44 (Maintenance period) |
| Serum Ustekinumab Concentrations | Serum ustekinumab concentrations will be reported. | Up to Week 52 |
| Number of Participants with Clinical Remission at Maintenance Week 44 | Number of participants with clinical remission in maintenance period will be assessed. This will be assessed among participants who are in clinical response at induction week-8 (I-8). Clinical remission is defined as having a PCDAI score <= 10 points. PCDAI is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdominal tenderness or mass, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. | Week 44 (Maintenance Period) |
| Number of Participants with Clinical Response |
Number of participants with clinical response in induction period will be reported. |
| Week 8 (Induction period) |
| Number of Participants with Clinical Response as Assessed by sPCDAI | Number of participants with clinical response in induction period as assessed by sPCDAI will be reported. Clinical response is defined as a reduction from baseline in the PCDAI score of greater than or equal to (>=) 12.5 points with a total PCDAI score not more than 30. | Week 6 (Induction period) |
| Number of Participants with Endoscopic Response as Assessed by Simplified Endoscopic Score-Crohn's Disease (SES-CD) | Number of participants with endoscopic response as assessed by SES-CD in maintenance period will be reported. Endoscopic response is defined as a reduction in SES-CD score of >= 50 percent (%) or SES-CD score <= 2 in participants with a baseline SES-CD score of >= 3. The SES-CD score is based on the evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any other lesions, and presence/type of narrowing/strictures) across 5 ileocolonic segments. Each endoscopic component is scored from 0 to 3 for each segment, and a total score is derived from the sum of all the component scores (range, 0 to 60). | Week 8 (Maintenance period) |
| Number of Participants with Clinical Response | Number of participants with clinical response in maintenance period will be reported. | Week 8 (Maintenance period) |
| Number of Participants with Clinical Remission | Number of participants with clinical remission in maintenance period will be reported. | Week 44 (Maintenance period) |
| Number of Participants with Endoscopic Response as Assessed by SES-CD | Number of participants with endoscopic response as assessed by SES-CD in maintenance period will be reported. Endoscopic response is defined as a reduction in SES-CD score of >= 50 percent (%) or SES-CD score <= 2 in participants with a baseline SES-CD score of >= 3. The SES-CD score is based on the evaluation of 4 endoscopic components (presence/size of ulcers, proportion of mucosal surface covered by ulcers, proportion of mucosal surface affected by any other lesions, and presence/type of narrowing/strictures) across 5 ileocolonic segments. Each endoscopic component is scored from 0 to 3 for each segment, and a total score is derived from the sum of all the component scores (range, 0 to 60). | Week 44 (Maintenance period) |
| Number of Participants with Clinical Response | Number of participants with clinical response in maintenance period will be reported. | Week 44 (Maintenance period) |
| Number of Participants with Corticosteroid-free Clinical Remission | Number of participants with corticosteroid-free clinical remission in maintenance period will be reported. Corticosteroid-free clinical remission is PCDAI score <= 10 points and not receiving corticosteroids for at least 90 days prior to Week 44. | Week 44 (Maintenance period) |
| Number of Participants with Clinical Remission at Week 44 (Maintenance Period) who are in Clinical Remission at Week 8 (Induction Period) | Number of participants with clinical remission at Week 44 (maintenance period) who are in clinical remission at Week 8 (induction period) will be reported. | Week 44 (Maintenance Period) |
| Atlanta |
| Georgia |
| 30342 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Morristown Memorial Hospital | Morristown | New Jersey | 07962 | United States |
| Levine Childrens at Atrium Health | Charlotte | North Carolina | 28207 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Penn State Hershey Children's Hospital | Hershey | Pennsylvania | 17033 | United States |
| Cook Childrens Medical Center | Fort Worth | Texas | 76104 | United States |
| Pediatric Specialists Of Virginia | Fairfax | Virginia | 22031 | United States |
| Universitair Kinderziekenhuis Koningin Fabiola | Brussels | 1020 | Belgium |
| Cliniques Universitaires Saint Luc | Brussels | 1200 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| UZ Brussel | Jette | 1090 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| Universitätsklinikum Aachen | Aachen | 52074 | Germany |
| Charite-Universitätsmedizin Berlin - Berlin | Berlin | 13353 | Germany |
| Universitatsklinikum Essen | Essen | 45147 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Dr. von Haunersches Kinderspital | Munich | 80337 | Germany |
| KUNO Klinik St. Hedwig | Regensburg | 93049 | Germany |
| Universitatsklinikum Ulm | Ulm | 89075 | Germany |
| Semmelweis Egyetem | Budapest | 1083 | Hungary |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | 4032 | Hungary |
| Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz | Miskolc | 3526 | Hungary |
| Szabolcs Szatmar Bereg Varmegyei Oktatokorhaz | Nyíregyháza | 4400 | Hungary |
| Szegedi Tudományegyetem, Gyermekgyógyászati Klinika és Gyermekegészségügyi Centrum | Szeged | 6720 | Hungary |
| Yitzhak Shamir Medical Center | Be’er Ya‘aqov | 70300 | Israel |
| Carmel Medical Center | Haifa | 34362 | Israel |
| Shaare Zedek Medical Center | Jerusalem | 9103102 | Israel |
| Schneider Children's Medical Center | Petah Tikva | 4920235 | Israel |
| Juntendo University Hospital | Bunkyō City | 113 8431 | Japan |
| Gunma University Hospital | Gunma | 371-0034 | Japan |
| Kindai University Nara Hospital | Ikoma | 630-0293 | Japan |
| Kurume University Hospital | Kurume | 830-0011 | Japan |
| Saitama Childrens Medical Center | Saitama Shi | 330-8777 | Japan |
| Miyagi Children's Hospital | Sendai | 989-3126 | Japan |
| National Center for Child Health and Development | Setagaya Ku | 157 8535 | Japan |
| Jichi Medical University Hospital | Shimotsuke | 329-0498 | Japan |
| Mie University Hospital | Tsu | 514 8507 | Japan |
| Szpital im. M. Kopernika | Gdansk | 80 803 | Poland |
| Uniwersytecki Szpital Dzieciecy w Krakowie | Krakow | 30 663 | Poland |
| Korczowski Bartosz Gabinet Lekarski | Rzeszów | 35-302 | Poland |
| WIP Warsaw IBD Point Profesor Kierkus | Warsaw | 04 501 | Poland |
| Instytut Pomnik Centrum Zdrowia Dziecka | Warsaw | 04 730 | Poland |
| Kazan State Medical University | Kazan' | 420138 | Russia |
| Russian National Research Medical University named after N.I.Pirogov | Moscow | 119571 | Russia |
| Privolzhsky Research Medical University of Ministry of Health of Russian Federation | Nizhny Novgorod | 603950 | Russia |
| Yaroslavl Regional Children's Clinical Hospital | Yaroslavl | 150032 | Russia |
| Birmingham Children's Hospital | Birmingham | B4 6NH | United Kingdom |
| University Hospitals Bristol and Weston NHS Foundation Trust | Bristol | BS2 8BJ | United Kingdom |
| Cambridge University Hospitals NHS Foundation Trust | Cambridge | CB2 0QQ | United Kingdom |
| Royal Hospital for Children and Young People | Edinburgh | EH16 4TJ | United Kingdom |
| Royal London Hospital | London | E1 2AT | United Kingdom |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 13, 2026 | Jun 9, 2026 | 61 | ||
| Jul 2, 2026 |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000069549 | Ustekinumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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