A study of ixekizumab (LY2439821) in participants from 6 to less than 18 years of age with moderate to severe plaque psoriasis.

Phase 1

Conditions: Moderate-to-Severe Plaque Psoriasis
MedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2016-003331-38-DE

Lead Sponsor: Eli Lilly and Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 201

Inclusion Criteria

Males and females from 6 years to <18 years of age.
Have a diagnosis of moderate-to-severe plaque-type Ps for at least 6 months prior to baseline (Week 0; Visit 2), as determined by the investigator.
Have PASI score =12 and a sPGA =3 and body area involved =10% of whole body surface at screening (Visit 1) and baseline (Week 0; Visit 2).
Are candidates for phototherapy or systemic treatment of Ps (may be either naive or have a prior history of previous treatment) or have Ps considered by the investigator as poorly controlled with topical therapy.
Are the trial subjects under 18? yes
Number of subjects for this age range: 195
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pustular, erythrodermic, and/or guttate forms of Ps or have drug induced psoriasis.
Have used any therapeutic agent targeted at reducing IL-17.
Previously treated with etanercept (Note: criteria applicable to all countries)
Concurrent or recent use of any biologic agent within the following washout periods: 1) Adalimumab and infliximab =60 days, abatacept >90 days, anakinra >7 days, or any other biologic DMARD >5 half-lives prior to baseline
Systemic therapy for Ps and PsA (other than above, eg, MTX, cyclosporine), phototherapy (eg, PUVA) in the previous 4 weeks; 2) Any investigational drugs in the previous 4 weeks or 5 half-lives, whichever is longer; 3) UVA-therapy, UVB-therapy; topical treatments (except in face, scalp, and genital area during screening) in the previous 4 weeks.
Have latent TB, active TB, acute or chronic viral hepatitis, active infection (within 4 weeks of baseline), history of immune deficiency syndrome, history of malignancy, History of major immunologic reaction, history of sepsis or risk of sepsis.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess whether ixekizumab Q4W is superior to placebo at Week 12 (Visit 7) in the treatment of pediatric subjects (children and adolescents) with moderate-to-severe plaque psoriasis, as measured by PASI 75 and by sPGA (0,1);Secondary Objective: To assess whether ixekizumab Q4W is superior to placebo at Week 12 as measured by: PASI 90, sPGA (0), PASI 100, and Itch NRS.<br>;Primary end point(s): Proportion of subjects achieving PASI 75.<br>Proportion of subjects achieving sPGA (0,1). <br>;Timepoint(s) of evaluation of this end point: Week 12.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Proportion of subjects achieving PASI 90.<br>Proportion of subjects achieving sPGA (0).<br>Proportion of subjects achieving PASI 100.<br>Proportion of subjects achieving PASI 75.<br>Proportion of subjects achieving sPGA (0,1).<br>Improvement =4 for subjects who had a baseline Itch NRS score =4.<br>;Timepoint(s) of evaluation of this end point: PASI 75 and sPGA (0,1) are measured at week 2, all others at week 12.

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