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

Last updated: August 30, 2021
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

3

Condition

Rash

Psoriasis And Psoriatic Disorders

Warts

Treatment

N/A

Clinical Study ID

NCT03073200
16367
I1F-MC-RHCD
2016-003331-38
  • Ages 6-17
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a diagnosis of moderate-to-severe plaque-type psoriasis for at least 6 monthsprior to baseline as determined by the investigator.
  • Have Psoriasis Area and Severity Index (PASI) score ≥12 and a Static Physician GlobalAssessment (sPGA) ≥3 and body surface area involvement ≥10% at screening and baseline.
  • Are candidates for phototherapy or systemic treatment or considered by theinvestigator as not adequately controlled by topical therapies.
  • Male subjects agree to use a reliable method of birth control during the study.
  • Female subjects: Participants of childbearing age or childbearing potential who aresexually active who test negative for pregnancy must be counselled and agree to useeither 1 highly effective method of contraception or 2 acceptable methods ofcontraception combined for the duration of the study and for at least 12 weeksfollowing the last dose of study drug, or remain abstinent during the study and for atleast 12 weeks following the last dose of study drug.
  • Both the child or adolescent and a parent or legal guardian are able to understand andfully participate in the activities of the clinical study and sign their assent andconsent, respectively.
  • All immunizations are up-to-date in agreement with current immunization guidelines asnoted by country specific paediatric authorities (e.g., the American Academy ofPaediatrics). Note, subjects who are not up to date or have never been immunized arenot to be enrolled in the trial.

Exclusion

Exclusion Criteria:

  • Have pustular, erythrodermic, and/or guttate forms of psoriasis.
  • Have drug-induced psoriasis.
  • Have clinical and/or laboratory evidence of untreated latent or active tuberculosis (TB).
  • Participants with a documented history of immune deficiency syndrome.
  • Have any other active or recent infection, including chronic or localized infections,within 4 weeks of baseline.
  • Subjects with a known history of malignancy, lymphoproliferative disease, includinglymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease,such as lymphadenopathy and/or splenomegaly unless ruled out by biopsy.
  • Have used any therapeutic agent targeted at reducing interleukin-17.
  • Have received other therapies within the specified time frames prior to screening (seebelow):
  • adalimumab and infliximab 60 days, abatacept 90 days, anakinra 7 days, or anyother biologic disease-modifying antirheumatic drug 5 half-lives.
  • systemic therapy for psoriasis and psoriatic arthritis (PsA) (other than above,eg, methotrexate, cyclosporine), phototherapy (eg, photochemotherapy [psoralenplus ultraviolet A]) in the previous 4 weeks.

Study Design

Total Participants: 201
Study Start date:
March 28, 2017
Estimated Completion Date:
March 23, 2021

Connect with a study center

  • Centro de Investigaciones Metabólicas (CINME)

    Ciudad Autonoma de Buenos Aire, Buenos Aires C1056ABJ
    Argentina

    Site Not Available

  • Fundación Estudios Clínicos- Servicio de Dermatología

    Rosario, Santa Fe 5200
    Argentina

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Buenos Aire, C1425DKG
    Argentina

    Site Not Available

  • Instituto de Neumonología y Dermatología

    Buenos Aires, C1425BEA
    Argentina

    Site Not Available

  • Psoriahue Medicina Interdisciplinaria

    Buenos Aires, C1425DKG
    Argentina

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

    Tucuman, T4000AXL
    Argentina

    Site Not Available

  • Institute for Skin Advancement

    Calgary, Alberta T3A 2N1
    Canada

    Site Not Available

  • Lynderm Research Inc

    Markham, Ontario L3P1X2
    Canada

    Site Not Available

  • The Hospital for Sick Children

    Toronto, Ontario M5G 1X8
    Canada

    Site Not Available

  • K. Papp Clinical Research Inc

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • Hospital Ste Justine

    Montreal, Quebec H3T 1C5
    Canada

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

    Ontario, N2J 1C4
    Canada

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

    St. John's, A1A 5E8
    Canada

    Site Not Available

  • Detska fakultni nemocnice

    Brno, 613 00
    Czechia

    Site Not Available

  • Fakultni nemocnice Hradec Kralove

    Hradec Kralove, 500 05
    Czechia

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Hradec Králové, 500 05
    Czechia

    Site Not Available

  • Fakultni Nemocnice Plzen

    Plzen-Bory, 305 99
    Czechia

    Site Not Available

  • LF UK - Fakultni poliklinika

    Praha, 120 00
    Czechia

    Site Not Available

  • Fakultni nemocnice Kralovske Vinohrady

    Praha 10, 100 34
    Czechia

    Site Not Available

  • Nemocnice Na Bulovce

    Praha 8, 180 81
    Czechia

    Site Not Available

  • Centre hospitalier universitaire Pellegrin

    Bordeaux, 33076
    France

    Site Not Available

  • Hôpital Femme Mère Enfant

    Bron, 69500
    France

    Site Not Available

  • CHU de Nice Hopital de L'Archet

    Nice, 06202
    France

    Site Not Available

  • GH Necker - Enfants Malades

    Paris Cedex 15, 75743
    France

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Saint Etienne Cedex 2, 42055
    France

    Site Not Available

  • Universitätsklinikum Erlangen

    Erlangen, Bayern 91054
    Germany

    Site Not Available

  • Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

    Frankfurt am Main, Hessen 60590
    Germany

    Site Not Available

  • Universitätsklinikum Essen

    Essen, Nordrhein-Westfalen 45147
    Germany

    Site Not Available

  • Universitätsklinikum Münster

    Münster, Nordrhein-Westfalen 48149
    Germany

    Site Not Available

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, Rheinland-Pfalz 55131
    Germany

    Site Not Available

  • ISA GmbH

    Berlin, 10789
    Germany

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Hamburg, 20354
    Germany

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Hessen, 60590
    Germany

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

    Kiel, 24105
    Germany

    Site Not Available

  • SZTE AOK Borgyogyaszati es Allergologiai Klinika

    Szeged, Csongrad 6720
    Hungary

    Site Not Available

  • Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika

    Debrecen, Hajdu-Bihar 4032
    Hungary

    Site Not Available

  • Allergo-Derm Bakos Kft

    Szolnok, Jasz-Nagykun-Szolnok 5000
    Hungary

    Site Not Available

  • Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

    Budapest, 1123
    Hungary

    Site Not Available

  • Oroshaza Varosi Onkormanyzat Korhaza

    Oroshaza, 5901
    Hungary

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

    Orosháza, 5901
    Hungary

    Site Not Available

  • Hospital Infantil de Mexico

    Ciudad de Mexico, Federal District 06720
    Mexico

    Site Not Available

  • Health Pharma Professional Research, S.A. de C.V.

    Mexico, Federal District 03810
    Mexico

    Site Not Available

  • Instituto Dermatologico de Jalisco Dr. Jose Barba Rubio

    Zapopan, Jalisco 45190
    Mexico

    Site Not Available

  • Hospital Univ. Dr. Jose Eleuterio Gonzalez

    Monterrey, Nuevo León 64460
    Mexico

    Site Not Available

  • RM Pharma Specialists S.A. de C.V.

    Distrito Federal, 3100
    Mexico

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

    México, 03810
    Mexico

    Site Not Available

  • Arke Estudios Clinicos S.A. de C.V.

    Veracruz, 91910
    Mexico

    Site Not Available

  • Universitair Medisch Centrum St Radboud Nijmegen

    Nijmegen, 6525 GL
    Netherlands

    Site Not Available

  • "Dermed" Centrum Medyczne Sp. z o.o.

    Lodz, 90-265
    Poland

    Site Not Available

  • Centralny Szpital Kliniczny MSW

    Warszawa, 02-507
    Poland

    Site Not Available

  • DermMEDICA Sp. z o.o.

    Wroclaw, 51-318
    Poland

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Wrocław, 51-318
    Poland

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Łódź, 90-265
    Poland

    Site Not Available

  • Office of Dr. Samuel Sanchez PSC

    Caguas, 00727
    Puerto Rico

    Site Not Available

  • Grupo Dermatologico de Carolina

    Carolina, 00985
    Puerto Rico

    Site Not Available

  • Ponce School of Medicine CAIMED Center

    Ponce, 00716
    Puerto Rico

    Site Not Available

  • GCM Medical Group PSC

    San Juan, 00917
    Puerto Rico

    Site Not Available

  • GBUZ Clinical dermatology and venereological dispensary

    Krasnodar, 350000
    Russian Federation

    Site Not Available

  • Center of Children's Health

    Moscow, 119991
    Russian Federation

    Site Not Available

  • LLC ArsVitae NorthWest

    Saint Petersburg, 194223
    Russian Federation

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

    Saint-Petersburg, 194223
    Russian Federation

    Site Not Available

  • Hospital Sant Joan de Déu

    Esplugues de Llobregat, Barcelona 08950
    Spain

    Site Not Available

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Barcelona, 08950
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Tien Q. Nguyen, MD inc. DBA First OC Dermatology

    Fountain Valley, California 92708
    United States

    Site Not Available

  • Stanford University Hospital

    Palo Alto, California 94304
    United States

    Site Not Available

  • University of California Davis-Dermatology

    Sacramento, California 95816
    United States

    Site Not Available

  • University of California, San Francisco

    San Francisco, California 94115
    United States

    Site Not Available

  • Children's Hospital of Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Children's National Medical Center

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Children's National Medical Center

    Washington, D.C., District of Columbia 20010
    United States

    Site Not Available

  • Olympian Clinical Research

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Solutions Through Advanced Research, Inc.

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • Forward Clinical Trials, Inc

    Tampa, Florida 33624
    United States

    Site Not Available

  • University of South Florida

    Tampa, Florida 33612
    United States

    Site Not Available

  • Advanced Medical Research

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • Arlington Dermatology

    Arlington Heights, Illinois 60005
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Arlington Dermatology

    Rolling Meadows, Illinois 60008
    United States

    Site Not Available

  • The South Bend Clinic

    South Bend, Indiana 46617
    United States

    Site Not Available

  • Dermatology and Skin Cancer Specialists

    Rockville, Maryland 20850
    United States

    Site Not Available

  • University of Missouri

    Columbia, Missouri 65212
    United States

    Site Not Available

  • SSM Health Cardinal Glennon Children's Hospital

    Saint Louis, Missouri 63104
    United States

    Site Not Available

  • SSM Health Cardinal Glennon Children's Hospital

    St. Louis, Missouri 63104
    United States

    Site Not Available

  • Psoriasis Treatment Center of Central New Jersey

    East Windsor, New Jersey 08520
    United States

    Site Not Available

  • SUNY Downstate

    Brooklyn, New York 11203
    United States

    Site Not Available

  • University of North Carolina Dermatology and skin Cancer Cen

    Chapel Hill, North Carolina 27516
    United States

    Site Not Available

  • Wright State Physicians Dermatology

    Dayton, Ohio 46435
    United States

    Site Not Available

  • Wright State Physicians Dermatology

    Fairborn, Ohio 45324
    United States

    Site Not Available

  • Ohio State Univ College Of Medicine

    Gahanna, Ohio 43230
    United States

    Site Not Available

  • Oregon Dermatology and Research Center

    Portland, Oregon 97210
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Dermatology and Skin Surgery Center

    Exton, Pennsylvania 19341
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Modern Research Associates PLLC

    Dallas, Texas 75231
    United States

    Site Not Available

  • University of Texas Medical School at Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • Austin Institute for Clinical Research, Inc.

    Pflugerville, Texas 78660
    United States

    Site Not Available

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas 78218
    United States

    Site Not Available

  • University of Utah

    Murray, Utah 84107
    United States

    Site Not Available

  • Virginia Clinical Research

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Seattle Children's Hospital Research Foundation

    Seattle, Washington 98105
    United States

    Site Not Available

  • University of Wisconsin-Madison Hospital and Health Clinic

    Madison, Wisconsin 53792-4108
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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