An Efficacy, Safety, and Pharmacokinetics Study of Subcutaneously Administered Ustekinumab in the Treatment of Moderate to Severe Chronic Plaque Psoriasis in Pediatric Participants Greater Than or Equal to 6 to Less Than 12 Years of Age



Status:Active, not recruiting
Conditions:Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:6 - 11
Updated:3/30/2019
Start Date:June 2016
End Date:December 2020

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A Phase 3 Open-label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Ustekinumab in the Treatment of Moderate to Severe Chronic Plaque Psoriasis in Pediatric Subjects Greater Than or Equal to 6 to Less Than 12 Years of Age

The purpose of this study is to evaluate the efficacy and safety of ustekinumab in pediatric
participants aged greater than or equal to (>=) 6 through less than (<) 12 years with
moderate to severe chronic plaque psoriasis

This is an open label (identity of study drug will be known to participant and study staff)
and multicenter (when more than one hospital or medical school team work on a medical
research study) study. The participant population will be comprised of boys and girls who
have had a diagnosis of plaque psoriasis for at least 6 months prior to first study drug
administration and who have moderate to severe disease defined by Psoriasis Area and Severity
Index score (PASI) >=12, Physician's Global Assessment (PGA) >=3, and Body Surface Area (BSA)
>=10 percent (%). The study consists of Screening Phase (up to 10 weeks before administration
of the study drug), Treatment Period (Week 0 up to Week 52) and Safety follow up (Week 56).
Participants will be primarily evaluated for efficacy, pharmacokinetics (PK) and safety.
Following completion of the Week 52 visit, participants who have had a beneficial response
from ustekinumab treatment as determined by the investigator, and who have not yet reached
the age of 12 years or older in countries where marketing authorization for ustekinumab has
been granted for the treatment of psoriasis in adolescent participants (12-17 years), and are
willing to continue ustekinumab treatment, may enter the long-term extension period (from
Week 56 through Week 264) of the study.

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

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
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