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Trial record 1 of 7 for:    STELARA Crohn's
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A Pharmacokinetic Study of Ustekinumab in Pediatric Subjects With Moderately to Severely Active Crohn's Disease (STELARA)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2016 by Janssen Research & Development, LLC
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT02968108
First received: October 24, 2016
Last updated: November 16, 2016
Last verified: November 2016
  Purpose
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 220.

Condition Intervention Phase
Crohn Disease
Drug: Ustekinumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double-blind Pharmacokinetic Study of Ustekinumab in Pediatric Subjects With Moderately to Severely Active Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Serum Ustekinumab Concentrations Over Time [ Time Frame: Up to Week 16 ] [ Designated as safety issue: No ]
    Serum samples will be collected to measure seum concentrations of Ustekinumab.


Secondary Outcome Measures:
  • Clinical Response as Measured by the Pediatric Crohn's Disease Activity Index (PCDAI) Score [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
    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.

  • Clinical Remission as Measured by the Pediatric Crohn's Disease Activity Index (PCDAI) Score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: December 2016
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group1: Ustekinumab Dose Regimen 1
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.
Drug: Ustekinumab
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.
Experimental: Group2: Ustekinumab Dose Regimen 2
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.
Drug: Ustekinumab
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.

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be a pediatric subject 2 to less than (<) 18 years old in the US, 6 to <18 years old elsewhere, of either gender
  • Have Crohn's disease (CD) or fistulizing CD of at least 3 months duration, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
  • Must have moderately to severely active CD defined by: Baseline pediatric Crohn's disease activity index (PCDAI) score of greater than (>)30 and at least one of the following: 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 >250 milligram per kilogram (mg/kg) at screening or ileocolonoscopy with evidence of active CD (defined as ulcerations in the ileum and/or colon) during screening into this study including at the baseline visit
  • Prior or current medication for CD must include at least 1 of the following: Current treatment with at least 1 of the following therapies: oral corticosteroids, the immunomodulators azathioprine, 6-MP, or methotrexate, or currently have or have had a history of corticosteroid dependency, or have a history of failure to respond to, or tolerate, at least 1 of the following therapies including oral or IV corticosteroids or the immunomodulators 6-mercaptopurine, azathioprine, or methotrexate,or have required more than 3 courses of oral or IV corticosteroids in the past year
  • Have negative stool results for enteric pathogens. Stool studies must include a stool culture and Clostridium difficile toxin assay. These must have been performed during screening or the current episode of disease exacerbation as long as the stool studies were performed within 4 months prior to the first administration of study agent

Exclusion Criteria:

  • Has complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestation that might be anticipated to require surgery, 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
  • Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks prior to baseline, or 8 weeks prior to baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery. Participant with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses identified
  • Has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months prior to baseline
  • Has a draining (that is (i.e.), functioning) stoma or ostomy
  • 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), or clinically significant hepatomegaly or splenomegaly
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02968108

Contacts
Contact: This study is not yet recruiting patients. Please check back for future recruiting sites, or email JNJ.CT@sylogent.com

Locations
United States, California
Not yet recruiting
Los Angeles, California, United States
United States, Connecticut
Not yet recruiting
Hartford, Connecticut, United States
United States, Georgia
Not yet recruiting
Atlanta, Georgia, United States
United States, Illinois
Not yet recruiting
Peoria, Illinois, United States
United States, Pennsylvania
Not yet recruiting
Philadelphia, Pennsylvania, United States
Belgium
Not yet recruiting
Brussel, Belgium
Not yet recruiting
Gent, Belgium
Not yet recruiting
Jette, Belgium
Not yet recruiting
Leuven, Belgium
Canada, Alberta
Not yet recruiting
Edmonton, Alberta, Canada
Canada, British Columbia
Not yet recruiting
Vancouver, British Columbia, Canada
Canada, Ontario
Not yet recruiting
London, Ontario, Canada
Not yet recruiting
Toronto, Ontario, Canada
Canada, Quebec
Not yet recruiting
Montreal, Quebec, Canada
Germany
Not yet recruiting
Bochum, Germany
Not yet recruiting
Munich, Germany
Not yet recruiting
Wuppertal, Germany
Poland
Not yet recruiting
Lodz, Poland
Withdrawn
Rzeszow, Poland
Not yet recruiting
Warszawa, Poland
Not yet recruiting
Wroclaw, Poland
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02968108     History of Changes
Other Study ID Numbers: CR108233  CNTO1275CRD1001  2016-001956-22 
Study First Received: October 24, 2016
Last Updated: November 16, 2016
Health Authority: United States: Food and Drug Administration
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Canada: Health Canada - BGTD
Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Ustekinumab
Dermatologic Agents

ClinicalTrials.gov processed this record on December 08, 2016