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 6 to less than 12 Years of Age
- Conditions
- rashskin disease10014982
- Registration Number
- NL-OMON45724
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1
- 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) greater than or equal to 3, and involved body surface area (BSA)greater than or equal to 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
- Participants who currently have nonplaque forms of psoriasis ;- Have received any systemic immunosuppressants 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Efficacy evaluations chosen for this study are consistent with applicable US<br /><br>and EU regulatory guidance and precedent established in previous studies of<br /><br>therapeutic biologic agents for the treatment of psoriasis. Patient-reported<br /><br>outcomes (PROs) chosen for this study are also consistent with clinically<br /><br>relevant measurements that are accepted in the medical literature for other<br /><br>studies in psoriasis and applicable US/EU regulatory guidance documents.<br /><br>Psoriasis response evaluations include:<br /><br>• Physician*s Global Assessment (PGA)<br /><br>• Psoriasis Area and Severity Index (PASI)<br /><br>• Children*s Dermatology Life Quality Index (CDLQI; PRO)<br /><br>Given the open-label study design, PASI and PGA assessments will be performed<br /><br>by a blinded evaluator.</p><br>
- Secondary Outcome Measures
Name Time Method <p>/</p><br>