An Efficacy, Safety, and Pharmacokinetics Study of Subcutaneously AdministeredUstekinumab in the Treatment of Moderate to Severe Chronic PlaquePsoriasis in Pediatric Participants greater than 6 to less than 12 Years of Age

Phase 1

Conditions: Moderate to Severe Chronic Plaque Psoriasis
MedDRA version: 18.1Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2016-000121-40-BE

Lead Sponsor: Janssen-Cilag International N.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

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
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy and safety of ustekinumab in pediatric subjects aged =6 through <12 years with moderate to severe chronic plaque psoriasis.;Secondary Objective: - To evaluate the pharmacokinetics of ustekinumab in pediatric subjects aged =6 through <12 years with moderate to severe chronic plaque psoriasis.<br>- 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.<br>- To evaluate the immunogenicity of ustekinumab in pediatric subjects aged =6 through <12 years with moderate to severe chronic plaque psoriasis.;Primary end point(s): Percentage of Participants with a Physician's Global Assessment (PGA) of Cleared (0) or Minimal (1) at Week 12;Timepoint(s) of evaluation of this end point: Week 12

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Serum Ustekinumab Concentrations<br>- Percentage of Participants who Achieve a Greater Than or Equal to (>=75) Percent (%) Improvement in Psoriasis Area and Severity Index<br>Score (PASI) From Baseline at Week 12;Timepoint(s) of evaluation of this end point: Week 4, 12, 16, 28, 40 and 52

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