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-CZ
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-26
• Last Update Posted: 10 May 2021

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