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



Status:Active, not recruiting
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:6 - 17
Updated:3/8/2019
Start Date:March 28, 2017
End Date:June 11, 2021

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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

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


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 PASI score ≥12 and a 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 counseled 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 pediatric authorities (e.g., the American Academy of
Pediatrics). 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.
We found this trial at
26
sites
Columbia, Missouri 65211
(573) 882-2121
Principal Investigator: Kari Martin
Phone: 573-882-8578
University of Missouri T he University of Missouri was founded in 1839 in Columbia, Mo.,...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Boni Elizabeth Elewski
Phone: 2055029960
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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59 One Mile Road
East Windsor, New Jersey 08520
609-443-4500
Principal Investigator: Jerry Bagel
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Sabre Leitenberger
Phone: 503-494-9680
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
Principal Investigator: Lucia Seminario Vidal
Phone: 813-974-4744
University of South Florida The University of South Florida is a high-impact, global research university...
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410 Market Street
Chapel Hill, North Carolina 27516
Principal Investigator: Aida Lugo-Somolinos
Phone: 984-974-3682
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Lara Wine Lee
Phone: 843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Amy Paller
Phone: 312-227-6060
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
Principal Investigator: Adena Rosenblatt
Phone: 773-702-8621
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Ciudad Autonoma de Buenos Aire, Buenos Aires
Principal Investigator: Ricardo Luis Galimberti
Phone: 541149590392
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Clearwater, Florida 33757
Principal Investigator: Matthew Zook
Phone: 813-849-5566
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Dallas, Texas 75231
Principal Investigator: Jennifer A Cather
Phone: 214-361-2008
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Exton, Pennsylvania 19341
Principal Investigator: Scott L Gottlieb
Phone: 610-594-6660
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725 University Boulevard
Fairborn, Ohio 45324
Principal Investigator: Jeffrey Travers
Phone: 937-245-7500
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17271 Brookhurst Street
Fountain Valley, California 92708
Principal Investigator: Vivian Laquer
Phone: 714-531-2966
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920 North Hamilton Road
Gahanna, Ohio 43230
Principal Investigator: Jessica Kaffenberger
Phone: 614-366-2025
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Jacksonville, Florida
Principal Investigator: Pearl Kwong
Phone: 904-619-8157
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Norfolk, Virginia 23507
Principal Investigator: David M Pariser
Phone: 757-625-0151
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Portland, Oregon 97210
Principal Investigator: Phoebe Rich
Phone: 503-226-3376
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5301 Keystone Court
Rolling Meadows, Illinois 60008
Principal Investigator: Michael Bukhalo
Phone: 847-392-5440
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1465 South Grand Boulevard
Saint Louis, Missouri 63104
Principal Investigator: Elaine Siegfried
Phone: 314-678-3047
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San Antonio, Texas 78218
Principal Investigator: John C. Browning
Phone: 210-852-2779
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Sandy Springs, Georgia 30328
Principal Investigator: Jamie Debra Weisman
Phone: 4049399220
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211 North Eddy St.
South Bend, Indiana 46617
574-234-8161
Principal Investigator: Holly Hake Harris
Phone: 574-204-6432
South Bend Clinic The South Bend Clinic employs a staff of 610 at its five...
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Tampa, Florida 33624
Principal Investigator: Seth B Forman
Phone: 813-264-2155
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Principal Investigator: Kalyani Marathe
Phone: 202-476-3026
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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