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

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 - I1F-MC-RHCD

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45268

Enrollment

Registered

2017-08-02

Start date

2017-11-23

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque Psoriasis

Interventions

The intervention differs per indication and weight of the patient: patients with moderate psoriasis will enter the 2:1 (ixekizumab vs placebo) arms. They will receive : based on the weight of the

Ixekizumab

Moderate-to-Severe Plaque Psoriasis

Patients from 6 to Less than 18 Years

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: - Males and females from 6 years to

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Proportion of subjects achieving PASI 75. Proportion of subjects achieving sPGA (0,1).	—

Secondary

Measure	Time frame
Proportion of subjects achieving PASI 90. Proportion of subjects achieving sPGA (0). Proportion of subjects achieving PASI 100. Proportion of subjects achieving PASI 75. Proportion of subjects achieving sPGA (0,1). Improvement 4 for subjects who had a baseline Itch NRS score 4.	—

Countries

Argentina, Brazil, Canada, Czechia, France, Germany, Hungary, Mexico, Netherlands, Poland, Russian Federation, Spain, United Kingdom, United States of America

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)