E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to Severe Plaque-type Psoriasis |
|
E.1.1.1 | Medical condition in easily understood language |
Moderate to Severe 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 | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10037153 |
E.1.2 | Term | Psoriasis |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
|
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 |
The primary objectives of this study are to evaluate the efficacy and safety of 2 SC dosing tiers of ustekinumab in the treatment of dolescent subjects 12 to 18 years of age with moderate to severe chronic plaque psoriasis. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are to:
1. Evaluate the impact of ustekinumab on physical, social, emotional, and academic functioning as well as dermatologic symptom impact on health-related quality of life in adolescent subjects with moderate to severe chronic plaque psoriasis.
2. Evaluate the pharmacokinetics and immunogenicity of ustekinumab in adolescent subjects with moderate to severe chronic plaque psoriasis. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Have a diagnosis of plaque-type psoriasis with or without psoriatic arthritis (PsA) for at least 6 months; Are candidates for phototherapy or systemic treatment of psoriasis; Have screening laboratory test results within the study parameters |
|
E.4 | Principal exclusion criteria |
Currently have nonplaque forms of psoriasis; Have used any therapeutic agent targeted at reducing interleukin-12 (IL-12) or interleukin-23 (IL-23), including but not limited to ustekinumab and briakinumab; Received conventional systemic therapies or phototherapy within the last 4 weeks; Received biologic therapies within the last 3 months |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients who achieve a Physician's Global Assessment (PGA) score of cleared or minimal disease |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Proportion of patients that achieve Psoriasis Area and Severity Index (PASI) 75 response
Change from baseline in Children's Dermatology Life Quality Index (CDLQI)
The proportion of patients who achieve a Psoriasis Area and Severity Index (PASI) 90 response |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
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 |
|
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
|
The study will end when the last subject completes the Week 60 visit. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |