Active, not recruiting
Phase 3
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
Condition(s) studied
Psoriasis
Investigational drug(s) / intervention(s)
GuselkumabPlacebo for guselkumabEtanercept
Guselkumab: Participants will receive a weight-based dose of guselkumab subcutaneously.
Placebo for guselkumab: Participants will receive a weight-based dose of placebo for guselkumab subcutaneously.
Etanercept: Participants will receive a weight-based dose of etanercept (up to 50 mg) subcutaneously.
Study summary
The purpose of this study is to evaluate the efficacy and safety of guselkumab in pediatric participants aged greater than or equal to 6 through less than 18 years with chronic plaque psoriasis.
Eligibility
Inclusion Criteria:
* Have a diagnosis of chronic plaque-type psoriasis for at least 6 months (with or without psoriatic arthritis \[PsA\]), prior to first administration of study intervention, defined as having at screening and baseline, Investigator Global Assessment (IGA) greater than or equal to (\>=) 3, Psoriasis Area and Severity Index (PASI) \>=12, \>=10% body surface area (BSA) involvement and at least one of the following: very thick lesions, clinically relevant facial, genital, or hand/ foot involvement, PASI\>=20, \>20% BSA involvement, or IGA=4
* Be a candidate for phototherapy or systemic treatment of plaque psoriasis (either naive or history of previous treatment)
* Have plaque psoriasis considered by the investigator as inadequately controlled with phototherapy and/or topical therapy after an adequate dose and duration of therapy
* Be considered, in the opinion of the investigator, a suitable candidate for etanercept therapy, according to their country's approved Enbrel product labeling
* Be otherwise healthy on the basis of physical examination, medical history, and vital signs performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator
* Must have acceptable evidence of immunity to varicella and measles, mumps, and rubella (MMR), which includes any one of the following: documentation of age-appropriate vaccination that includes both doses of each vaccine (unless local guidelines specify otherwise) or documentation of past infection by a healthcare provider or in the absence of previous 2 criteria, participants must have positive protective antibody titers to these infection prior to the first administration of study intervention. For participants who have not completed the recommended vaccination schedule for varicella and MMR, and the subsequent vaccination falls within the next 4 years, an accelerated vaccination schedule must be completed prior to study enrollment if available and required or strongly recommended for the location. If varicella or MMR vaccines are utilized, it is necessary for 2 weeks to elapse between the vaccination and receipt of study intervention
Exclusion Criteria:
* Currently has nonplaque forms of psoriasis (example, erythrodermic, guttate, or pustular)
* Has current drug-induced psoriasis (example, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
* Has previously received guselkumab or etanercept
* Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (example, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers
* Has a known history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance (MGUS); or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly
Primary outcome measure(s)
- Part 1: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16 — At Week 16
The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, \>1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.
- Part 1: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response at Week 16 — At Week 16
The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 75 response represented participants who achieved at least a 75 % improvement from baseline in the PASI score.
Trial sites (39)
| Facility | City | Region | Status |
| Stanford University |
Palo Alto |
California |
|
| University of California, San Diego |
San Diego |
California |
|
| Dermatologic Surgery Specialists |
Macon |
Georgia |
|
| Northwestern University Feinberg School of Medicine Ann & Robert H Lurie Children's Hospital |
Chicago |
Illinois |
|
| Arlington Dermatology |
Rolling Meadows |
Illinois |
|
| Windsor Dermatology |
East Windsor |
New Jersey |
|
| Mt. Sinai School of Medicine |
New York |
New York |
|
| Wright State Physicians Health Center |
Dayton |
Ohio |
|
| Arlington Center for Dermatology |
Arlington |
Texas |
|
| Dell Children's Medical Center of Central Texas |
Austin |
Texas |
|
| Eastern Health Research |
Box Hill |
Australia |
|
| Royal North Shore Hospital |
St Leonards |
Australia |
|
| Veracity Clinical Research |
Woolloongabba |
Australia |
|
| Cliniques Universitaires Saint Luc |
Brussels |
Belgium |
|
| Universitair Ziekenhuis Gent |
Ghent |
Belgium |
|
| Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman |
Liège |
Belgium |
|
| Kirk Barber Reseach Inc. |
Calgary |
Alberta |
|
| Dermatology Research Institute Inc |
Calgary |
Alberta |
|
| Skin Care Centre |
Vancouver |
British Columbia |
|
| Universitatsklinikum Bonn |
Bonn |
Germany |
|
| Universitatsklinikum Carl Gustav Carcus Dresden |
Dresden |
Germany |
|
| Universitatsklinikum Frankfurt |
Frankfurt |
Germany |
|
| Universitatsklinikum Schleswig Holstein Kiel |
Kiel |
Germany |
|
| Praxis Dr. med. Beate Schwarz - Germany |
Langenau |
Germany |
|
| Company for Medical Study & Service Selters |
Selters |
Germany |
|
| Hautarztpraxis Dr. Leitz & Kollegen |
Stuttgart |
Germany |
|
| Obudai Egeszsegugyi Centrum Kft |
Budapest |
Hungary |
|
| Debreceni Egyetem |
Debrecen |
Hungary |
|
| Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz |
Miskolc |
Hungary |
|
| Szegedi Tudomanyegyetem |
Szeged |
Hungary |
|
| Ospedali Riuniti Di Ancona |
Ancona |
Italy |
|
| Azienda Ospedaliera Policlinico S. Orsola-Malpighi |
Bologna |
Italy |
|
| AOU di Cagliari |
Cagliari |
Italy |
|
| Azienda Ospedaliera di Padova |
Padova |
Italy |
|
| Arcispedale Santa Maria Nuova - IRCCS |
Reggio Emilia |
Italy |
|
| Radboud University Medical Center |
Nijmegen |
Netherlands |
|
| Dermed Centrum Medyczne Sp z o o |
Lodz |
Poland |
|
| Szpital Dzieciecy im. prof. dr. med. Jana Bogdanowicza w Warszawie |
Warsaw |
Poland |
|
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu |
Wroclaw |
Poland |
|
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