E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pediatric psoriasis(PsO) Juvenile psoriatic arthritis (jPsA) |
|
E.1.1.1 | Medical condition in easily understood language |
Pediatric psoriasis(PsO) Juvenile psoriatic arthritis (jPsA) |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10076674 |
E.1.2 | Term | Juvenile psoriatic arthritis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
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 |
Evaluate pharmacokinetics (PK) of ustekinumab in juvenile psoriatic arthritis (jPsA) and pediatric psoriasis(PsO) |
|
E.2.2 | Secondary objectives of the trial |
Evaluate the safety of ustekinumab |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age and Disease Characteristics 1. ≥5 to <18 years of age, inclusive, with a diagnosis of jPsA (ie, ILAR or Vancouver criteria) by qualified HCP. AND / OR ≥6 to <18 years of age, inclusive, with a diagnosis of pediatric PsO by a qualified HCP. Type of Participant 2. Initiated ustekinumab treatment ≥16 weeks prior to enrollment and received 3 or more doses of ustekinumab prior to enrollment. Informed Consent 3. Parent(s) (preferably both if available or as per local requirements) (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. Assent is also required of children capable of understanding the nature of the study.
|
|
E.4 | Principal exclusion criteria |
Any potential participant who meets any of the following criteria will be excluded from participating in the study. 1. Has poor tolerability of venipuncture or lack of adequate venous access for required blood sampling. 2. Has any condition that, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. 3. If currently enrolled in an investigational study, contact the Study Responsible Physician to discuss eligibility for inclusion in study. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Observed serum ustekinumab concentrations. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Cumulative samples from visits 1-4 |
|
E.5.2 | Secondary end point(s) |
The occurrences and type of adverse events (AEs) and all serious adverse events (SAEs).
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
From signing of ICF through 3 days after completion of the participant's last study-related procedure. |
|
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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
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) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
|
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | No |
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 end of study is considered to be after the last completed PK blood sample draw and final AE evaluation for the last participant in the study. |
|
E.8.9 Initial estimate of the duration of the trial |
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 | 20 |