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

NCT03073200 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: 16367I1F-MC-RHCD2016-003331-38
• Study Type: interventional
• Target: 201
• Locations: 13 countries
• Sites: 69

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.

Conditions

Plaque Psoriasis

Keywords

children; psoriasis treatment; adolescents

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) (Placebo and Ixekizumab)

  PASI combines assessments of the extent of body surface involvement in 4 regions (head \& neck(h), trunk(t), arms(u), legs(l)) \& severity of scaling (S), redness (R), \& plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total body surface area (BSA) affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = \>0% to \<10%, 2 = 10% to \<30%, 3 = 30% to \<50%, 4 = 50% to \<70%, 5 = 70% to 90%, 6 = 90% to 100%. Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).

  Week 12

• Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1) (Placebo and Ixekizumab)

  Static Physician Global Assessment (sPGA): The physician's global assessment of the Participant's psoriasis lesions at a given time point. Plaques are assessed for induration, erythema, and scaling, and an overall rating of psoriasis severity is given using the anchors of clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of plaque psoriasis.

  Week 12

Secondary Outcomes (14)

• Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)

  Week 12

• Percentage of Participants With a sPGA (0)

  Week 12

• Percentage of Participants With a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)

  Week 12

• Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)

  Week 4

• Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1)

  Week 4

Study Arms (3)

Ixekizumab

EXPERIMENTAL

Ixekizumab given subcutaneously (SC) during the double-blind treatment period and the open-label maintenance period.

Drug: Ixekizumab

Placebo

PLACEBO COMPARATOR

Placebo given SC during the double-blind treatment period and then ixekizumab given SC during the open-label maintenance period.

Drug: Placebo

Open-Label Etanercept

EXPERIMENTAL

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.

Drug: Etanercept

Interventions

Ixekizumab DRUG

Administered SC

Also known as: LY2439821

Ixekizumab

Placebo DRUG

Administered SC

Placebo

Etanercept DRUG

Administered SC

Open-Label Etanercept

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (69)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

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

Fountain Valley, California, 92708, United States

Location

Children's National Medical Center

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

Location

Olympian Clinical Research

Clearwater, Florida, 33756, United States

Location

Solutions Through Advanced Research, Inc.

Jacksonville, Florida, 32256, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Forward Clinical Trials, Inc

Tampa, Florida, 33624, United States

Location

Advanced Medical Research

Sandy Springs, Georgia, 30328, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Arlington Dermatology

Rolling Meadows, Illinois, 60008, United States

Location

The South Bend Clinic

South Bend, Indiana, 46617, United States

Location

University of Missouri

Columbia, Missouri, 65212, United States

Location

SSM Health Cardinal Glennon Children's Hospital

St Louis, Missouri, 63104, United States

Location

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, United States

Location

University of North Carolina Dermatology and skin Cancer Cen

Chapel Hill, North Carolina, 27516, United States

Location

Wright State Physicians Dermatology

Fairborn, Ohio, 45324, United States

Location

Ohio State Univ College Of Medicine

Gahanna, Ohio, 43230, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Dermatology and Skin Surgery Center

Exton, Pennsylvania, 19341, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Modern Research Associates PLLC

Dallas, Texas, 75231, United States

Location

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

Virginia Clinical Research

Norfolk, Virginia, 23502, United States

Location

Centro de Investigaciones Metabólicas (CINME)

Ciudad Autonoma de Buenos Aire, Buenos Aires, C1056ABJ, Argentina

Location

Fundación Estudios Clínicos- Servicio de Dermatología

Rosario, Santa Fe Province, 5200, Argentina

Location

Instituto de Neumonología y Dermatología

Buenos Aires, C1425BEA, Argentina

Location

Psoriahue Medicina Interdisciplinaria

Buenos Aires, C1425DKG, Argentina

Location

Institute for Skin Advancement

Calgary, Alberta, T3A 2N1, Canada

Location

Lynderm Research Inc

Markham, Ontario, L3P1X2, Canada

Location

K. Papp Clinical Research Inc

Waterloo, Ontario, N2J 1C4, Canada

Location

Hospital Ste Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Detska fakultni nemocnice

Brno, 613 00, Czechia

Location

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05, Czechia

Location

Fakultni Nemocnice Plzen

Plzen-Bory, 305 99, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady

Prague, 100 34, Czechia

Location

LF UK - Fakultni poliklinika

Prague, 120 00, Czechia

Location

Nemocnice Na Bulovce

Prague, 180 81, Czechia

Location

Centre hospitalier universitaire Pellegrin

Bordeaux, 33076, France

Location

Hôpital Femme Mère Enfant

Bron, 69500, France

Location

CHU de Nice Hopital de L'Archet

Nice, 06202, France

Location

Universitätsklinikum Erlangen

Erlangen, Bavaria, 91054, Germany

Location

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, 48149, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

ISA GmbH

Berlin, 10789, Germany

Location

SZTE AOK Borgyogyaszati es Allergologiai Klinika

Szeged, Csongrád megye, 6720, Hungary

Location

Debreceni Egyetem Klinikai Kozpont Borgyogyaszati Klinika

Debrecen, Hajdú-Bihar, 4032, Hungary

Location

Allergo-Derm Bakos Kft

Szolnok, Jász-Nagykun-Szolnok, 5000, Hungary

Location

Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

Budapest, 1123, Hungary

Location

Oroshaza Varosi Onkormanyzat Korhaza

Orosháza, 5901, Hungary

Location

Hospital Infantil de Mexico

Mexico City, Federal District, 06720, Mexico

Location

Hospital Univ. Dr. Jose Eleuterio Gonzalez

Monterrey, Nuevo León, 64460, Mexico

Location

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

Distrito Federal, 3100, Mexico

Location

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

Veracruz, 91910, Mexico

Location

Universitair Medisch Centrum St Radboud Nijmegen

Nijmegen, 6525 GL, Netherlands

Location

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

Lodz, 90-265, Poland

Location

Centralny Szpital Kliniczny MSW

Warsaw, 02-507, Poland

Location

DermMEDICA Sp. z o.o.

Wroclaw, 51-318, Poland

Location

Office of Dr. Samuel Sanchez PSC

Caguas, PR, 00727, Puerto Rico

Location

Grupo Dermatologico de Carolina

Carolina, PR, 00985, Puerto Rico

Location

Ponce School of Medicine CAIMED Center

Ponce, PR, 00716, Puerto Rico

Location

GCM Medical Group PSC

San Juan, 00917, Puerto Rico

Location

GBUZ Clinical dermatology and venereological dispensary

Krasnodar, 350000, Russia

Location

Center of Children's Health

Moscow, 119991, Russia

Location

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Related Publications (1)

• 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.

  PMID: 35416908 DERIVED

Related Links

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

MeSH Terms

Interventions

ixekizumab; Etanercept

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 8, 2017
• Study Start: March 28, 2017
• Primary Completion: February 7, 2019
• Study Completion: March 23, 2021
• Last Updated: September 27, 2021
• Results First Posted: March 17, 2020

Record last verified: 2021-08-16

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

US (25); FR (3); NL (1); CA (4); CZ (6); DE (5); ME (4); AR (4); PR (4); PL (3); ES (3); HU (5); RU (2)