Psoriasis
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Psoriasis
CR108452 Enrolling

Youth Chronic Plaque Psoriasis Study


Treatment: Injection Age: 6 Years

Youth 6 to less than 18 years old with chronic plaque psoriasis for at least 6 months, may qualify to participate in this study. Individuals must have plaque psoriasis inadequately controlled with phototherapy and/or topical therapy, as well as moderate to severe disease severity at the time of study entry.

Participants will receive study medication via injection depending on which part they are enrolled in:

  • Part 1: either active investigational medication, placebo or active comparator
  • Part 2: active investigational medication

Study medication and study-related care will be provided at no cost. Reimbursement for study-related expenses may be provided.

Participation will last about 74 weeks and include about 12-16 visits to the study centre. Participants may then be offered the opportunity to participate in a long-term extension of the study.


The following information is from ClinicalTrials.gov

Last Update Posted: November 27, 2022

Official Title

A Phase 3, Multicenter, Randomized, Placebo- and Active Comparator-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Subjects (>=6 To <18 Years of Age)

ClinicalTrials.gov ID

NCT03451851

Sponsor

Janssen Research & Development, LLC

Study Description

  • Brief 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.

  • Condition or Disease:

    Psoriasis

  • Intervention/Treatment:

    Drug: Guselkumab
    Drug: Guselkumab
    Drug: Guselkumab
    Drug: Guselkumab
  • Phase:

    Phase 3

  • Ages Eligible for Study:

    6 Years and 17 Years (Child)

  • Sexes Eligible for Study:

    All

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


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.


Participating Locations

COUNTRY
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Canada

Participating Experts

Dr. Alim Devani

Dermatologist

Dr. Vimal Prajapati

Dermatologist

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