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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1275CRD1001 | Other Identifier | Janssen Research & Development, LLC | |
| 2016-001956-22 | EudraCT Number |
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The purpose of this study is to evaluate the pharmacokinetics (PK) of ustekinumab in subjects from 2 through less than (<) 18 years old in the USA, or 6 through less than (<) 18 years old in other countries and determine if it is similar to that observed in adults with moderately to severely active Crohn's disease (CD). Also to assess the safety, immunogenicity and efficacy of ustekinumab in the treatment of moderately to severely active CD. The main part of the study continues to Week 16, at which point all subjects who are receiving benefit from ustekinumab maintenance therapy (as determined by the investigator) are eligible to enter the long-term extension (LTE) and continue to receive ustekinumab. The study extension ends at Week 268 or upon availability of the LTE basket study (CNTO1275ISD3001) whichever occurs first. If participants do not consent/assent to the LTE basket study, they will continue safety follow-up for approximately 20 weeks after the last study agent administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1: Ustekinumab Dose Regimen 1 | Experimental | Subjects will receive a single intravenous (IV) induction dose of 3 milligram per kilogram (mg/kg) for subjects less than < 40 kilogram (kg) or 130 milligram (mg) for subjects greater than or equal to >= 40 kg at Week 0 followed by subcutaneous (SC) maintenance dose of 2 mg/kg for subjects < 40 kg or 90 mg for subjects >= 40 kg at week 8. |
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| Group2: Ustekinumab Dose Regimen 2 | Experimental | Subjects will receive a single Intravenous (IV) dose of 9 mg/kg for subjects <40 kg or 390 mg for subjects >= 40 kg at Week 0 followed by SC maintenance dose of 2 mg/kg for subjects <40 kg or 90 mg for subjects >= 40 kg at week 8. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ustekinumab | Drug | Subjects will receive a single IV administration of ustekinumab (3 mg/kg for subjects <40 kg or 130 mg for subjects >= 40 kg in Group 1 and 9 mg/kg for subjects < 40 kg or 390 mg for subjects >= 40 kg in group 2) at week 0 followed by SC administration of ustekinumab (2 mg/kg for subjects < 40 kg or 90 mg for subjects >= 40 kg at Week 8. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Ustekinumab Concentrations Over Time | Serum samples will be collected to measure seum concentrations of Ustekinumab. | Up to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response as Measured by the Pediatric Crohn's Disease Activity Index (PCDAI) Score | Clinical Response is defined as greater than or equal to (>=) 15-point reduction from baseline in the total Pediatric Crohn's Disease Activity Index (PCDAI) score, accompanied by a total PDCAI score of less than or equal to (<=) 30 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. |
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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 |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Connecticut Childrens Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40357993 | Derived | Hasskamp J, Meinhardt C, Timmer A. Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2025 May 13;5(5):CD007572. doi: 10.1002/14651858.CD007572.pub4. |
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|
| Week 6 |
| Clinical Remission as Measured by the Pediatric Crohn's Disease Activity Index (PCDAI) Score | Clinical remission is defined as PCDAI score of less than or equal to (<=) 10. 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 |
| Hartford |
| Connecticut |
| 06106 |
| United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Children's Center For Digestive Healthcare, Llc | Atlanta | Georgia | 30342 | United States |
| Methodist Medical Center of Illinois | Peoria | Illinois | 61602 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Mount Sinai | New York | New York | 10029 | United States |
| Childrens Hospital Of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Center For Digestive Health Systems-Greenville | Greenville | South Carolina | 29615 | 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 |
| Stollery Children's Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| British Columbia Children's Hospital | Vancouver | British Columbia | V6H3V4 | Canada |
| Children's Hospital of Western Ontario | London | Ontario | N6A 5W9 | Canada |
| Hospital For Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| Centre Hospitalier Sainte Justine | Montreal | Quebec | H3T 1C5 | Canada |
| Hôpital Necker | Paris | 75015 | France |
| Hôpital Robert Debré | Paris | 75019 | France |
| Dr. von Haunersches Kinderspital | Munich | 80337 | Germany |
| HELIOS Klinikum Wuppertal GmbH | Wuppertal | 42283 | Germany |
| Instytut Centrum Zdrowia Matki Polki | Lodz | 93 338 | Poland |
| WIP Warsaw IBD Point Profesor Kierkus | Warsaw | 00-728 | Poland |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu | Wroclaw | 50 369 | Poland |
| 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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