Clinical Trials List
2016-05-01 - 2019-12-31
Phase III
Terminated3
ICD-10L40.0
Psoriasis vulgaris
ICD-9696.8
Other psoriasis and similar disorders
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 ≥6 to
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Trial Applicant
Johnson & Johnson
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Sponsor
Janssen Research & Development, LLC
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Chih-Hung Lee Division of Dermatology
- 鄭裕文 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Taiwan National PI
Co-Principal Investigator
- Chung-Yao Hsu Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Co-Principal Investigator
- Chih-Chieh Chan Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
The proportion of subjects with a PGA of cleared (0) or minimal (1) at Week 12.
Major Secondary Endpoints
Serum ustekinumab concentrations will be summarized over time to assess the PK of ustekinumab.
The proportions of subjects who achieve a ≥75% improvement in PASI from baseline at Week 12.
The change in CDLQI from baseline at Week 12.
The proportions of subjects who achieve a ≥90% improvement in PASI from baseline at Week 12.
Other Endpoints
In addition to the primary and major secondary endpoint analyses, the following efficacy endpoints will
be summarized:
The proportions of subjects achieving a PGA score of cleared (0), the proportion of subjects
achieving a PGA score of cleared (0) or minimal (1), and the proportion of subjects achieving a PGA
score of mild or better (≤2) over time.
The proportions of subjects who achieve PASI 50, PASI 75, PASI 90, and PASI 100 responses over
time.
The percent improvement from baseline in PASI over time.
The change from baseline in CDLQI over time.
The proportion of subjects with CDLQI = 0 or 1 over time.
Inclution 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
The Estimated Number of Participants
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Taiwan
3 participants
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Global
40 participants
