Clinical trial NCT03073200: Study of Ixekizumab (LY2439821) in Children 6 to Less Than 18 Years With Moderate-to-Severe Plaque Psoriasis
Official title: Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of Ixekizumab in Patients From 6 to Less Than 18 Years of Age With Moderate-to-Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque Psoriasis
Keywords: children
psoriasis treatment
adolescents
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2017-03-08
Enrollment: 201
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 Criteria:

* Have a diagnosis of moderate-to-severe plaque-type psoriasis for at least 6 months prior to baseline as determined by the investigator.
* 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 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, 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.

Primary outcomes:
measure: Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) (Placebo and Ixekizumab)
timeFrame: Week 12
measure: Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) (Placebo and Ixekizumab)
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)
timeFrame: Week 12
measure: Percentage of Participants With a sPGA (0)
timeFrame: Week 12
measure: Percentage of Participants With a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)
timeFrame: Week 12
measure: Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)
timeFrame: Week 4
measure: Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1)
timeFrame: Week 4
measure: Percentage of Participants With an Improvement of ≥4 in Those Who Had a Baseline Itch Numeric Rating Scale (NRS) Score of ≥4
timeFrame: Week 12
measure: Percentage of Participants Achieving Children's Dermatology Life Quality Index (CDLQI)/Dermatology Life Quality Index (DLQI) (0/1)
timeFrame: Week 12
measure: Change From Baseline on the Nail Psoriasis Severity Index (NAPSI)
timeFrame: Baseline, Week 12
measure: Change From Baseline on the Psoriasis Scalp Severity Index (PSSI)
timeFrame: Baseline, Week 12
measure: Change From Baseline on the Palmoplantar Psoriasis Severity Index (PPASI)
timeFrame: Baseline, Week 12
measure: Number of Participants With Anti-Ixekizumab Antibodies
timeFrame: Baseline through Week 48
measure: Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss)
timeFrame: Week 12
measure: Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) (Etanercept Approved Countries)
timeFrame: Week 12
measure: Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) (Etanercept Approved Countries)
timeFrame: Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Fountain Valley
country: United States
facility: Tien Q. Nguyen, MD inc. DBA First OC Dermatology
state: California
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Clearwater
country: United States
facility: Olympian Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Solutions Through Advanced Research, Inc.
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Tampa
country: United States
facility: Forward Clinical Trials, Inc
state: Florida
city: Sandy Springs
country: United States
facility: Advanced Medical Research
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Rolling Meadows
country: United States
facility: Arlington Dermatology
state: Illinois
city: South Bend
country: United States
facility: The South Bend Clinic
state: Indiana
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Saint Louis
country: United States
facility: SSM Health Cardinal Glennon Children's Hospital
state: Missouri
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central New Jersey
state: New Jersey
city: Chapel Hill
country: United States
facility: University of North Carolina Dermatology and skin Cancer Cen
state: North Carolina
city: Fairborn
country: United States
facility: Wright State Physicians Dermatology
state: Ohio
city: Gahanna
country: United States
facility: Ohio State Univ College Of Medicine
state: Ohio
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Exton
country: United States
facility: Dermatology and Skin Surgery Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: Modern Research Associates PLLC
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research
state: Virginia
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
state: Buenos Aires
city: Rosario
country: Argentina
facility: Fundación Estudios Clínicos- Servicio de Dermatología
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Instituto de Neumonología y Dermatología
city: Buenos Aires
country: Argentina
facility: Psoriahue Medicina Interdisciplinaria
city: Calgary
country: Canada
facility: Institute for Skin Advancement
state: Alberta
city: Markham
country: Canada
facility: Lynderm Research Inc
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research Inc
state: Ontario
city: Montreal
country: Canada
facility: Hospital Ste Justine
state: Quebec
city: Brno
country: Czechia
facility: Detska fakultni nemocnice
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Plzen-Bory
country: Czechia
facility: Fakultni Nemocnice Plzen
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Praha 8
country: Czechia
facility: Nemocnice Na Bulovce
city: Praha
country: Czechia
facility: LF UK - Fakultni poliklinika
city: Bordeaux
country: France
facility: Centre hospitalier universitaire Pellegrin
city: Bron
country: France
facility: Hôpital Femme Mère Enfant
city: Nice
country: France
facility: CHU de Nice Hopital de L'Archet
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
state: Bayern
city: Frankfurt am Main
country: Germany
facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt
state: Hessen
city: Münster
country: Germany
facility: Universitätsklinikum Münster
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
state: Rheinland-Pfalz
city: Berlin
country: Germany
facility: ISA GmbH
city: Szeged
country: Hungary
facility: SZTE AOK Borgyogyaszati es Allergologiai Klinika
state: Csongrad
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika
state: Hajdu-Bihar
city: Szolnok
country: Hungary
facility: Allergo-Derm Bakos Kft
state: Jasz-Nagykun-Szolnok
city: Budapest
country: Hungary
facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
city: Oroshaza
country: Hungary
facility: Oroshaza Varosi Onkormanyzat Korhaza
city: Ciudad de Mexico
country: Mexico
facility: Hospital Infantil de Mexico
state: Federal District
city: Monterrey
country: Mexico
facility: Hospital Univ. Dr. Jose Eleuterio Gonzalez
state: Nuevo León
city: Distrito Federal
country: Mexico
facility: RM Pharma Specialists S.A. de C.V.
city: Veracruz
country: Mexico
facility: Arke Estudios Clinicos S.A. de C.V.
city: Nijmegen
country: Netherlands
facility: Universitair Medisch Centrum St Radboud Nijmegen
city: Lodz
country: Poland
facility: "Dermed" Centrum Medyczne Sp. z o.o.
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSW
city: Wroclaw
country: Poland
facility: DermMEDICA Sp. z o.o.
city: Caguas
country: Puerto Rico
facility: Office of Dr. Samuel Sanchez PSC
city: Carolina
country: Puerto Rico
facility: Grupo Dermatologico de Carolina
city: Ponce
country: Puerto Rico
facility: Ponce School of Medicine CAIMED Center
city: San Juan
country: Puerto Rico
facility: GCM Medical Group PSC
city: Krasnodar
country: Russian Federation
facility: GBUZ Clinical dermatology and venereological dispensary
city: Moscow
country: Russian Federation
facility: Center of Children's Health
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Déu
state: Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Eli Lilly and Company
name: 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
References:
citation: 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.