An Efficacy, Safety, and Pharmacokinetics Study of Subcutaneously Administered Ustekinumab in the Treatment of Moderate to Severe Chronic Plaque Psoriasis in Pediatric Participants Greater Than or Equal to 6 to Less Than 12 Years of Age

Part of paid clinical trials in San Diego, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT02698475
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 11 Years
Healthy Volunteers
Not accepted

Interventions

  • Ustekinumab 0.75 mg/kg — DRUG
    Participants weighing less than (\<) 60 kilograms will receive ustekinumab 0.75 milligram per kilogram (mg/kg) at Weeks 0 and 4 followed by every 12 weeks dosing with the last dose at Week 40. Eligible participants for LTE period will continue to receive ustekinumab 0.75 mg/kg up to Week 248.
  • Ustekinumab 45 mg — DRUG
    Participants weighing greater than or equal to (\>=) 60 kg to less than or equal to (\<=) 100 kg will receive ustekinumab 45 mg at Weeks 0 and 4 followed by every 12 weeks dosing with the last dose at Week 40. Eligible participants for LTE period will continue to receive ustekinumab 45 mg up to Week 248.
  • Ustekinumab 90 mg — DRUG
    Participants weighing \>100 kg will receive ustekinumab 90 mg at Weeks 0 and 4 followed by every 12 weeks dosing with the last dose at Week 40. Eligible participants for LTE period will continue to receive ustekinumab 90 mg up to Week 248.

Study Details

The purpose of this study is to evaluate the efficacy and safety of ustekinumab in pediatric participants aged greater than or equal to (\>=) 6 through less than (\<) 12 years with moderate to severe chronic plaque psoriasis

Key Dates

Start date
May 31, 2016
Status verified
Sep 2021
Primary completion
Dec 31, 2017
Completion
Oct 31, 2020

Study Design

Enrollment
44 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ustekinumab Group
    Participants will receive 1 of the following dose levels depending on their weight: participants weighing less than (\<) 60 kg will receive Ustekinumab 0.75 milligram per kilogram (mg/kg); participants weighing greater than or equal to (\>=) 60 kg to less than or equal to (\<=) 100 kg will receive ustekinumab 45 mg; participants weighing \>100 kg will receive ustekinumab 90 mg, at Weeks 0 and 4 followed by every 12 weeks dosing with the last dose at Week 40. Eligible participants who enter the long-term extension (LTE) period will continue receiving ustekinumab every 12 weeks (q12w) beginning at Week 56 up to Week 248.

Primary Outcome Measure

Percentage of Participants With Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12 [ Time Frame: Week 12 ]

Locations (7)

FacilityCityStateZIPSite coordinators
-San DiegoCalifornia--
-ChicagoIllinois--
-IndianapolisIndiana--
-St LouisMissouri--
-ArlingtonTexas--
-DallasTexas--
-NorfolkVirginia--

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By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease

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