E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate-to-Severe Plaque Psoriasis |
|
E.1.1.1 | Medical condition in easily understood language |
A Study of Ixekizumab (LY2439821) in Participants From 6 to Less Than 18 Years of Age With Moderate-to-Severe Plaque Psoriasis. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10071117 |
E.1.2 | Term | Plaque psoriasis |
E.1.2 | System Organ Class | 100000004858 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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) |
|
E.2.2 | Secondary objectives of the trial |
To assess whether ixekizumab Q4W is superior to placebo at Week 12 as measured by: PASI 90, sPGA (0), PASI 100, and Itch NRS.
|
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Protocol Addendum I1F-MC-RHCD(1): 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. Version date: 30Nov2016. Objective: Describes additional PK sampling for a subgroup of subjects, which will be used to help define the PK of ixekizumab in pediatric subjects.
Protocol Addendum I1F-MC-RHCD(2): 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. Version Date: 30Nov2016. Objectives: States that in countries where etanercept is approved for severe pediatric Ps treatment only (emerging markets and European countries), subjects may be randomized to etanercept. This addendum contains an active-controlled reference group (etanercept) during the Double-Blind Treatment Period (Period 2). Additionally, subjects from EU countries who meet the response criterion (defined as sPGA [0,1]) at Week 60 will be re-randomized to ixekizumab or placebo (1:1 ratio) during a 48-Week Double-Blind, Randomized Withdrawal Period. |
|
E.3 | Principal 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. |
|
E.4 | Principal 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. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects achieving PASI 75.
Proportion of subjects achieving sPGA (0,1).
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
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.
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
PASI 75 and sPGA 0,1 are measured at Week 2. All the others at Week 12. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 32 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Canada |
Czech Republic |
France |
Germany |
Hungary |
Mexico |
Netherlands |
Poland |
Russian Federation |
Spain |
United States |
|
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 9 |