Study of Ixekizumab (LY2439821) in Children 6 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis
NCT ID: NCT03073200
Last Updated: 2021-09-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
201 participants
INTERVENTIONAL
2017-03-28
2021-03-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ixekizumab
Ixekizumab given subcutaneously (SC) during the double-blind treatment period and the open-label maintenance period.
Ixekizumab
Administered SC
Placebo
Placebo given SC during the double-blind treatment period and then ixekizumab given SC during the open-label maintenance period.
Placebo
Administered SC
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.
Etanercept
Administered SC
Interventions
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Ixekizumab
Administered SC
Placebo
Administered SC
Etanercept
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have Psoriasis Area and Severity Index (PASI) score ≥12 and a Static Physician Global Assessment (sPGA) ≥3 and body surface area involvement ≥10% at screening and baseline.
* Are candidates for phototherapy or systemic treatment or considered by the investigator 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 are sexually active who test negative for pregnancy must be counselled and agree to use either 1 highly effective method of contraception or 2 acceptable methods of contraception combined for the duration of the study and for at least 12 weeks following the last dose of study drug, or remain abstinent during the study and for at least 12 weeks following the last dose of study drug.
* Both the child or adolescent and a parent or legal guardian are able to understand and fully participate in the activities of the clinical study and sign their assent and consent, respectively.
* All immunizations are up-to-date in agreement with current immunization guidelines as noted by country specific paediatric authorities (e.g., the American Academy of Paediatrics). Note, subjects who are not up to date or have never been immunized are not to be enrolled in the trial.
Exclusion Criteria
* 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, including lymphoma, 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 (see below):
* adalimumab and infliximab 60 days, abatacept 90 days, anakinra 7 days, or any other 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 \[psoralen plus ultraviolet A\]) in the previous 4 weeks.
6 Years
17 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Tien Q. Nguyen, MD inc. DBA First OC Dermatology
Fountain Valley, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Olympian Clinical Research
Clearwater, Florida, United States
Solutions Through Advanced Research, Inc.
Jacksonville, Florida, United States
University of South Florida
Tampa, Florida, United States
Forward Clinical Trials, Inc
Tampa, Florida, United States
Advanced Medical Research
Sandy Springs, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Arlington Dermatology
Rolling Meadows, Illinois, United States
The South Bend Clinic
South Bend, Indiana, United States
University of Missouri
Columbia, Missouri, United States
SSM Health Cardinal Glennon Children's Hospital
St Louis, Missouri, United States
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, United States
University of North Carolina Dermatology and skin Cancer Cen
Chapel Hill, North Carolina, United States
Wright State Physicians Dermatology
Fairborn, Ohio, United States
Ohio State Univ College Of Medicine
Gahanna, Ohio, United States
Oregon Dermatology and Research Center
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Dermatology and Skin Surgery Center
Exton, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Modern Research Associates PLLC
Dallas, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Virginia Clinical Research
Norfolk, Virginia, United States
Centro de Investigaciones Metabólicas (CINME)
Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina
Fundación Estudios Clínicos- Servicio de Dermatología
Rosario, Santa Fe Province, Argentina
Instituto de Neumonología y Dermatología
Buenos Aires, , Argentina
Psoriahue Medicina Interdisciplinaria
Buenos Aires, , Argentina
Institute for Skin Advancement
Calgary, Alberta, Canada
Lynderm Research Inc
Markham, Ontario, Canada
K. Papp Clinical Research Inc
Waterloo, Ontario, Canada
Hospital Ste Justine
Montreal, Quebec, Canada
Detska fakultni nemocnice
Brno, , Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Fakultni Nemocnice Plzen
Plzen-Bory, , Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, , Czechia
LF UK - Fakultni poliklinika
Prague, , Czechia
Nemocnice Na Bulovce
Prague, , Czechia
Centre hospitalier universitaire Pellegrin
Bordeaux, , France
Hôpital Femme Mère Enfant
Bron, , France
CHU de Nice Hopital de L'Archet
Nice, , France
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany
Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
Frankfurt am Main, Hesse, Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Rhineland-Palatinate, Germany
ISA GmbH
Berlin, , Germany
SZTE AOK Borgyogyaszati es Allergologiai Klinika
Szeged, Csongrád megye, Hungary
Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika
Debrecen, Hajdú-Bihar, Hungary
Allergo-Derm Bakos Kft
Szolnok, Jász-Nagykun-Szolnok, Hungary
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
Budapest, , Hungary
Oroshaza Varosi Onkormanyzat Korhaza
Orosháza, , Hungary
Hospital Infantil de Mexico
Mexico City, Federal District, Mexico
Hospital Univ. Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León, Mexico
RM Pharma Specialists S.A. de C.V.
Distrito Federal, , Mexico
Arke Estudios Clinicos S.A. de C.V.
Veracruz, , Mexico
Universitair Medisch Centrum St Radboud Nijmegen
Nijmegen, , Netherlands
"Dermed" Centrum Medyczne Sp. z o.o.
Lodz, , Poland
Centralny Szpital Kliniczny MSW
Warsaw, , Poland
DermMEDICA Sp. z o.o.
Wroclaw, , Poland
Office of Dr. Samuel Sanchez PSC
Caguas, PR, Puerto Rico
Grupo Dermatologico de Carolina
Carolina, PR, Puerto Rico
Ponce School of Medicine CAIMED Center
Ponce, PR, Puerto Rico
GCM Medical Group PSC
San Juan, , Puerto Rico
GBUZ Clinical dermatology and venereological dispensary
Krasnodar, , Russia
Center of Children's Health
Moscow, , Russia
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Countries
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References
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Paller AS, Seyger MMB, Magarinos GA, Pinter A, Cather JC, Rodriguez-Capriles C, Zhu D, Somani N, Garrelts A, Papp KA; IXORA-PEDS Investigators. Long-term Efficacy and Safety of Up to 108 Weeks of Ixekizumab in Pediatric Patients With Moderate to Severe Plaque Psoriasis: The IXORA-PEDS Randomized Clinical Trial. JAMA Dermatol. 2022 May 1;158(5):533-541. doi: 10.1001/jamadermatol.2022.0655.
Provided Documents
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Document Type: Study Protocol: RHCD 05 Protocol (b)_Redacted
Document Type: Study Protocol: I1F-MC-RHCD(2.1) Clinical Protocol Addendum
Document Type: Statistical Analysis Plan
Related Links
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Study of Ixekizumab (LY2439821) in Children 6 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis
Other Identifiers
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I1F-MC-RHCD
Identifier Type: OTHER
Identifier Source: secondary_id
2016-003331-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16367
Identifier Type: -
Identifier Source: org_study_id
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