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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT02968108
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jan 18, 2017
Status verified
Apr 2025
Primary completion
Sep 19, 2018
Completion
Mar 18, 2022

Study Design

Enrollment
45 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Serum Ustekinumab Concentrations Over Time [ Time Frame: Up to Week 16 ]

Locations (9)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
Connecticut Childrens Medical CenterHartfordConnecticut06106-
Children's Center For Digestive Healthcare, LlcAtlantaGeorgia30342-
Emory UniversityAtlantaGeorgia30322-
Methodist Medical Center of IllinoisPeoriaIllinois61602-
Mayo ClinicRochesterMinnesota55905-
Mount SinaiNew YorkNew York10029-
Childrens Hospital Of PhiladelphiaPhiladelphiaPennsylvania19104-
Center For Digestive Health Systems-GreenvilleGreenvilleSouth Carolina29615-

Find similar trials in Los Angeles, CA

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Cedars Sinai Medical Center· Los Angeles, CAConnecticut Childrens Medical Center· Hartford, CTChildren's Center For Digestive Healthcare, Llc· Atlanta, GAEmory University· Atlanta, GAMethodist Medical Center of Illinois· Peoria, ILMayo Clinic· Rochester, MN

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