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 6 to less than 12 Years of Age
- Conditions
- Moderate to Severe Chronic Plaque PsoriasisMedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000018190Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2016-000121-40-DE
- Lead Sponsor
- Janssen-Cilag International N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 45
- 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
- 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 Score (PASI) From Baseline at Week 12;Timepoint(s) of evaluation of this end point: Week 4, 12, 16, 28, 40 and 52