Study of Ixekizumab (LY2439821) in Children 6 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Eli Lilly and Company
Study ID
NCT03073200
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ixekizumab — DRUG
    Administered SC
  • Placebo — DRUG
    Administered SC
  • Etanercept — DRUG
    Administered SC

Study Details

The purpose of this study is to evaluate the safety and efficacy of ixekizumab in pediatric participants with moderate-to-severe plaque psoriasis.

Key Dates

Start date
Mar 28, 2017
Status verified
Aug 2021
Primary completion
Feb 7, 2019
Completion
Mar 23, 2021

Study Design

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

Arms

  • Experimental: Ixekizumab
    Ixekizumab given subcutaneously (SC) during the double-blind treatment period and the open-label maintenance period.
  • Placebo Comparator: Placebo
    Placebo given SC during the double-blind treatment period and then ixekizumab given SC during the open-label maintenance period.
  • Experimental: Open-Label Etanercept
    Etanercept given SC during the double-blind treatment period and then ixekizumab given SC during the open-label maintenance period. Participants will only be randomized to etanercept in countries where it is approved for severe pediatric psoriasis treatment.

Primary Outcome Measure

Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) (Placebo and Ixekizumab) [ Time Frame: Week 12 ]

Locations (25)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-
Tien Q. Nguyen, MD inc. DBA First OC DermatologyFountain ValleyCalifornia92708-
Children's National Medical CenterWashington D.C.District of Columbia20010-
Olympian Clinical ResearchClearwaterFlorida33756-
Solutions Through Advanced Research, Inc.JacksonvilleFlorida32256-
Forward Clinical Trials, IncTampaFlorida33624-
University of South FloridaTampaFlorida33612-
Advanced Medical ResearchSandy SpringsGeorgia30328-
Northwestern UniversityChicagoIllinois60611-
University of Chicago Medical CenterChicagoIllinois60637-
Arlington DermatologyRolling MeadowsIllinois60008-
The South Bend ClinicSouth BendIndiana46617-
University of MissouriColumbiaMissouri65212-
SSM Health Cardinal Glennon Children's HospitalSt LouisMissouri63104-
Psoriasis Treatment Center of Central New JerseyEast WindsorNew Jersey08520-
University of North Carolina Dermatology and skin Cancer CenChapel HillNorth Carolina27516-
Wright State Physicians DermatologyFairbornOhio45324-
Ohio State Univ College Of MedicineGahannaOhio43230-
Oregon Dermatology and Research CenterPortlandOregon97210-
Oregon Health and Science UniversityPortlandOregon97239-
Dermatology and Skin Surgery CenterExtonPennsylvania19341-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Modern Research Associates PLLCDallasTexas75231-
Texas Dermatology and Laser SpecialistsSan AntonioTexas78218-
Virginia Clinical ResearchNorfolkVirginia23502-

Find similar trials in Birmingham, AL

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
University of Alabama at Birmingham· Birmingham, ALTien Q. Nguyen, MD inc. DBA First OC Dermatology· Fountain Valley, CAChildren's National Medical Center· Washington D.C., DCOlympian Clinical Research· Clearwater, FLSolutions Through Advanced Research, Inc.· Jacksonville, FLForward Clinical Trials, Inc· Tampa, FL

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