E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to Severe Chronic Plaque Psoriasis |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
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 evaluate the efficacy and safety of ustekinumab in pediatric subjects aged ≥6 through <12 years with moderate to severe chronic plaque psoriasis. |
|
E.2.2 | Secondary objectives of the trial |
- To evaluate the pharmacokinetics of ustekinumab in pediatric subjects aged ≥6 through <12 years with moderate to severe chronic plaque psoriasis.
- To evaluate the effect of ustekinumab on the dermatologic health-related quality of life in pediatric subjects aged ≥6 through <12 years with moderate to severe chronic plaque psoriasis.
- To evaluate the immunogenicity of ustekinumab in pediatric subjects aged ≥6 through <12 years with moderate to severe chronic plaque psoriasis. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Participants who have a diagnosis of plaque-type psoriasis with or without psoriatic arthritis (PsA) for at least 6 months prior to first administration
of study drug, with widespread lesions defined by Psoriasis Area and
Severity Index score (PASI) greater than or equal to (>=) 12, Physician's Global
Assessment (PGA) >=3, and involved body surface area (BSA) >=10 percent (%)
- Participants who are candidates for phototherapy or systemic treatment of
psoriasis (either naive or history of previous treatment) or have psoriasis
considered by the investigator as poorly controlled with topical therapy
after an adequate dose and duration of therapy
- Participants who are considered eligible according to the protocol defined tuberculosis (TB) screening criteria
- Participants must have positive protective antibody titers to varicella
and measles prior to the first administration of study drug. In the
absence of positive protective antibody titers, the participant must have
documentation of age-appropriate vaccination for varicella and/or
measles (that includes both doses of each vaccine) or verification of past
varicella and/or measles infection documented by a health care provider
- Participants must agree not to receive a live virus or live bacterial
vaccination at least 2 weeks (or longer as indicated in the package insert
of the relevant vaccine) prior to the first administration of study drug,
during the study, or within 15 weeks after the last administration of study drug
- Participants must agree not to receive a Bacille Calmette-Guerin (BCG)
vaccination within 12 months of screening, during the study, or within
12 months after the last administration of study drug |
|
E.4 | Principal exclusion criteria |
- Participants who currently have nonplaque forms of psoriasis (example,
erythrodermic, guttate, or pustular)
- Have received any systemic immunosuppressants (example methotrexate [MTX], azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, and tacrolimus) within 4 weeks of the first administration of study drug
- Have received any biologic agent (example ENBREL, HUMIRA) within the
previous 3 months or 5 times the t1/2 of the agent, whichever is longer
- Have a history of chronic or recurrent infectious disease
- Have a history of latent or active granulomatous infection
- Have any known malignancy or have a history of malignancy
- Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of Participants with a Physician's Global Assessment (PGA) of Cleared (0) or Minimal (1) at Week 12 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- Serum Ustekinumab Concentrations
- Percentage of Participants who Achieve a Greater Than or Equal to (>=75) Percent (%) Improvement in Psoriasis Area and Severity Index
Score (PASI) From Baseline at Week 12 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 4, 12, 16, 28, 40 and 52 |
|
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 | Yes |
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) | 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 | 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 | 1 |
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 | 25 |
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 |
Belgium |
Canada |
France |
Germany |
Hungary |
Korea, Republic of |
Poland |
Taiwan |
United Kingdom |
|
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
|
|
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 | 4 |
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 | 4 |