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

Completed · Phase 3 · Has a placebo group

Conditions studied: Plaque Psoriasis

In brief

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

Key facts

Study ID

NCT03073200

Run by

Eli Lilly and Company

People needed

201

Starts

2017-03-28

Expected to finish

2021-03-23

Last updated by the study team

2021-09-27

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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