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

Lilly

Status and phase: Completed; Phase 3

Conditions: Plaque Psoriasis

Treatments: Drug: Placebo; Drug: Ixekizumab; Drug: Etanercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT03073200

I1F-MC-RHCD (Other Identifier)

16367

2016-003331-38 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 201 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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201 participants in 3 patient groups, including a placebo group

Ixekizumab

Experimental group

Description:

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

Treatment:

Drug: Ixekizumab

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Open-Label Etanercept

Experimental group

Description:

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.

Treatment:

Drug: Etanercept