A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
- Conditions
- Psoriasis
- Interventions
- Registration Number
- NCT03451851
- Lead Sponsor
- Janssen Research & Development, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1 Group 2: Placebo for Guselkumab Placebo for guselkumab Participants in Part 1a (age \>= 12 - \<18 years) will receive placebo for guselkumab administered SC at Weeks 0, 4, and 12. Participants who are PASI 90 responders at Week 16 will not receive any additional doses of study intervention until they lose \>=50% of their Week 16 PASI response, at which time they will receive a weight-based guselkumab SC dose, followed by a dose 4 weeks later, and q8w thereafter through Week 52. Participants who are PASI 90 non-responders at Week 16 will receive a weight-based guselkumab dose at Weeks 16 and 20, followed by q8w dosing thereafter through Week 52. Participants who are eligible and willing to continue guselkumab treatment, may enter the LTE phase of the study. Part 1b (age \>= 6 - \<12 years) will follow the same dosing and commence after Part 1a data review. Part 1 Group 1: Guselkumab Placebo for guselkumab Participants in Part 1a (age greater than or equal to (\>=) 12 - less than (\<) 18 years) will receive a weight-based dose of guselkumab subcutaneously (SC) at Weeks 0, 4, and 12. Participants who are PASI 90 responders at Week 16 will not receive any additional doses of guselkumab until they lose \>=50% of their Week 16 PASI response, then they receive 1 dose guselkumab, followed by a dose 4 weeks later, and every 8 weeks (q8w) thereafter through Week 52. Participants who are PASI 90 non-responders at Week 16 will receive a placebo injection at Week 16 and continue to receive guselkumab q8w from Week 20 through Week 52. Participants who are eligible and willing to continue guselkumab may enter the Long Term Extension (LTE) Phase of the study. Part 1b (age \>= 6 - \<12 years) will follow the same dosing and commence after Part 1a data review. Part 1 Group 1: Guselkumab Guselkumab Participants in Part 1a (age greater than or equal to (\>=) 12 - less than (\<) 18 years) will receive a weight-based dose of guselkumab subcutaneously (SC) at Weeks 0, 4, and 12. Participants who are PASI 90 responders at Week 16 will not receive any additional doses of guselkumab until they lose \>=50% of their Week 16 PASI response, then they receive 1 dose guselkumab, followed by a dose 4 weeks later, and every 8 weeks (q8w) thereafter through Week 52. Participants who are PASI 90 non-responders at Week 16 will receive a placebo injection at Week 16 and continue to receive guselkumab q8w from Week 20 through Week 52. Participants who are eligible and willing to continue guselkumab may enter the Long Term Extension (LTE) Phase of the study. Part 1b (age \>= 6 - \<12 years) will follow the same dosing and commence after Part 1a data review. Part 1 Group 2: Placebo for Guselkumab Guselkumab Participants in Part 1a (age \>= 12 - \<18 years) will receive placebo for guselkumab administered SC at Weeks 0, 4, and 12. Participants who are PASI 90 responders at Week 16 will not receive any additional doses of study intervention until they lose \>=50% of their Week 16 PASI response, at which time they will receive a weight-based guselkumab SC dose, followed by a dose 4 weeks later, and q8w thereafter through Week 52. Participants who are PASI 90 non-responders at Week 16 will receive a weight-based guselkumab dose at Weeks 16 and 20, followed by q8w dosing thereafter through Week 52. Participants who are eligible and willing to continue guselkumab treatment, may enter the LTE phase of the study. Part 1b (age \>= 6 - \<12 years) will follow the same dosing and commence after Part 1a data review. Part 1 Group 3: Etanercept Guselkumab Participants in Part 1a (age \>= 12 - \<18 years) will receive weight-based etanercept dose up to 50 milligram SC weekly through Week 15. Participants who elect to continue in the study will receive a weight-based guselkumab dose at Weeks 20 and 24, followed by q8w dosing thereafter through Week 48. Participants who are eligible and willing to continue guselkumab treatment, may enter the LTE phase of the study. Part 1b (age \>= 6 - \<12 years) will follow the same dosing and commence after Part 1a data review. Part 2: Guselkumab Guselkumab Participants will receive a weight-based dose of open-label guselkumab SC at Weeks 0, 4 and q8w thereafter through Week 52. Participants who are eligible and willing to continue guselkumab treatment, may enter the LTE of the study and continue to receive guselkumab at Week 52 and q8w thereafter. Part 1 Group 3: Etanercept Etanercept Participants in Part 1a (age \>= 12 - \<18 years) will receive weight-based etanercept dose up to 50 milligram SC weekly through Week 15. Participants who elect to continue in the study will receive a weight-based guselkumab dose at Weeks 20 and 24, followed by q8w dosing thereafter through Week 48. Participants who are eligible and willing to continue guselkumab treatment, may enter the LTE phase of the study. Part 1b (age \>= 6 - \<12 years) will follow the same dosing and commence after Part 1a data review.
- Primary Outcome Measures
Name Time Method Part 1: Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) Week 16 The IGA documents the investigator's assessment of the participants' plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' plaque psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicates more severe disease.
Part 1: Percentage of Participants who Achieve Psoriasis Area and Severity Index (PASI) 75 Response Week 16 The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas are 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 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 75 response represents at least a 75% improvement from baseline in the PASI score.
- Secondary Outcome Measures
Name Time Method Part 1: Percentage of Participants who Achieve Psoriasis Area and Severity Index (PASI) 90 Response Week 16 The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is 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 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 90 response represents at least a 90% improvement from baseline in the PASI score.
Part 1: Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) Week 16 The IGA documents the investigator's assessment of the participants' plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' plaque psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicates more severe disease.
Part 1 and 2: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Baseline, Week 16 (Part 1) and up to Week 52 (Part 2) The CDLQI is a dermatology-specific quality of life (QoL) instrument designed to assess the impact of the disease on a child's QoL. The CDLQI, a 10-item questionnaire has 4-item response options and a recall period of 1 week. The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0; the higher the score, the greater the impairment in QoL.
Part 1: Percentage of Participants who Achieve PASI 100 Response Week 16 The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these area 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% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 100 response represents 100% improvement from baseline in the PASI score (i.e., a PASI score of 0).
Part 1: Percentage of Retreated Participants who Achieve a PASI 90 Response Over Time After Retreatment Every 4 weeks after retreatment is initiated, until Week 52 Participants randomized to guselkumab who are PASI 90 responders at Week 16 will be withdrawn from treatment and upon loss of \>=50% of the improvement in PASI achieved at Week 16, they will be retreated with guselkumab. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is 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% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 90 response represents at least a 90% improvement from baseline in the PASI score.
Part 1: Percentage of Retreated Participants who Achieve PASI Responses (PASI 50, 75, 90, and 100) Over Time After Retreatment Every 4 weeks after retreatment is initiated, until Week 52 Participants randomized to guselkumab who are PASI 90 responders at Week 16 will be withdrawn from treatment and upon loss of \>=50% of the improvement in PASI achieved at Week 16, they will be retreated with guselkumab. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is 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%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 50, 75, 90 and 100 response represents at least 50, 75, 90 and 100% improvement from baseline respectively, in the PASI score.
Part 1: Percentage of Retreated Participants who Achieve IGA Responses (IGA of Cleared [0], Minimal [1], or Mild [2], IGA of Cleared [0] or Minimal [1], and IGA of Cleared [0]) Over Time After Retreatment Every 4 weeks after retreatment is initiated, until Week 52 Participants randomized to guselkumab who are PASI 90 responders at Week 16 will be withdrawn from treatment and upon loss of \>=50% of the improvement in PASI achieved at Week 16, these participants will be retreated with guselkumab. The IGA documents the investigator's assessment of the participants' plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' plaque psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicates more severe disease.
Part 1: Time to Loss of 50% of the Week 16 PASI Improvement After Withdrawal Week 20, 24, 28, 32, 36, 40, 44, 48 and 52 Loss of 50% of PASI improvement is defined as a loss of \>=50% of the improvement in PASI at Week 16 after treatment is withdrawn. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is 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% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
Part 1: Time to Loss of PASI 90 Response After Withdrawal Week 20, 24, 28, 32, 36, 40, 44, 48 and 52 Loss of PASI 90 Response is defined as \<90% improvement in PASI from baseline after Week 16 in a participant who had achieved \>=90% improvement in PASI from baseline at Week 16. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is 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% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 90 response represents at least a 90% improvement from baseline in the PASI score.
Part 1: Percentage of Participants who Achieve a PASI 50 Response Week 16 The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is 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% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. A PASI 50 response represents at least a 50% improvement from baseline in the PASI score.
Part 1: Percentage of Participants who Achieve an IGA Score of Mild or Better (Less Than or Equal to [<=] 2) Week 16 The IGA documents the investigator's assessment of the participants' plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' plaque psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicates more severe disease.
Part 1 and 2: Percent Change From Baseline in PASI Over Time Baseline, up to Week 16 (Part 1); up to Week 52 (Part 2) The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is 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% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
Part 1 and 2: Percentage of Participants with PASI Responses (PASI 50, 75, 90, and 100) Over Time Up to Week 16 (Part 1); up to Week 52 (Part 2) The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is 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% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicates more severe disease. PASI 50, 75, 90, and 100 responses represents at least 50%, 75%, 90%, and 100% improvement from baseline respectively, in the PASI score.
Part 1 and 2: Percentage of Participants with IGA Responses (IGA of Cleared [0], Minimal [1], or Mild [2], IGA of Cleared [0] or Minimal [1], and IGA of Cleared [0]) Over Time Up to Week 16 (Part 1); up to Week 52 (Part 2) The IGA documents the investigator's assessment of the participants' plaque psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' plaque psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicates more severe disease.
Part 1 and 2: Percentage of Participants with CDLQI equal to (=) 0 or 1 Among Participants with a Baseline CDLQI Greater Than (>) 1 At Week 16 (Part 1); up to Week 52 (Part 2) The CDLQI is a dermatology-specific QoL instrument designed to assess the impact of the disease on a child's QoL. The CDLQI, a 10-item questionnaire has 4 item response options and a recall period of 1 week. The CDLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0; the higher the score, the greater impairment in QoL.
Part 1 and 2: Percentage of Participants with Family Dermatology Life Quality Index (FDLQI)=0 or 1 Among Participants with a Baseline FDLQI >1 At Week 16 (Part 1); up to Week 52 (Part 2) The FDLQI is a 10-item questionnaire that examine the impact of participant's skin disease on different aspects of their QoL (example, emotional, physical well-being, relationships, social life, leisure activities, burden of care, job/study, housework and expenditure) over the last 1 month, as assessed by a family member. Each item has a four-point response option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The scores of individual items (0-3) are added to give a total scale score that ranges from 0 to 30; a higher score indicates greater impairment of QoL. This instrument should be completed by a participant's primary care-giver.
Part 1 and 2: Change From Baseline in FDLQI Score Baseline, Week 16 (Part 1); up to Week 52 (Part 2) The FDLQI is a 10-item questionnaire that examine the impact of participant's skin disease on different aspects of their QoL (example, emotional, physical well-being, relationships, social life, leisure activities, burden of care, job/study, housework and expenditure) over the last 1 month, as assessed by a family member. Each item has a four-point response option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The scores of individual items (0-3) are added to give a total scale score that ranges from 0 to 30; a higher score indicates greater impairment of QoL. This instrument should be completed by a participant's primary care-giver.
Trial Locations
- Locations (39)
Universitatsklinikum Carl Gustav Carcus Dresden
🇩🇪Dresden, Germany
Universitatsklinikum Frankfurt
🇩🇪Frankfurt, Germany
Kirk Barber Reseach Inc.
🇨🇦Calgary, Alberta, Canada
Skin Care Centre
🇨🇦Vancouver, British Columbia, Canada
Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman
🇧🇪Liege, Belgium
Ospedali Riuniti Di Ancona
🇮🇹Ancona, Italy
Obudai Egeszsegugyi Centrum Kft
🇭🇺Budapest, Hungary
Debreceni Egyetem
🇭🇺Debrecen, Hungary
Universitatsklinikum Schleswig Holstein Kiel
🇩🇪Kiel, Germany
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Company for Medical Study & Service Selters
🇩🇪Selters, Germany
Eastern Health Research
🇦🇺Box Hill, Australia
Veracity Clinical Research
🇦🇺Woolloongabba, Australia
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
🇵🇱Wroclaw, Poland
Arcispedale Santa Maria Nuova - IRCCS
🇮🇹Reggio Emilia, Italy
Dermatology Research Institute Inc.
🇨🇦Calgary, Alberta, Canada
Royal North Shore Hospital
🇦🇺St Leonards, Australia
Universitatsklinikum Bonn
🇩🇪Bonn, Germany
Szegedi Tudomanyegyetem
🇭🇺Szeged, Hungary
Dermed Centrum Medyczne Sp z o o
🇵🇱Lodz, Poland
Szpital Dzieciecy im. prof. dr. med. Jana Bogdanowicza w Warszawie
🇵🇱Warszawa, Poland
Azienda Ospedaliera Policlinico S. Orsola-Malpighi
🇮🇹Bologna, Italy
Arlington Center for Dermatology
🇺🇸Arlington, Texas, United States
Radboud University Medical Center
🇳🇱Nijmegen, Netherlands
AOU di Cagliari
🇮🇹Cagliari, Italy
Stanford University
🇺🇸Palo Alto, California, United States
University of California, San Diego
🇺🇸San Diego, California, United States
Dermatologic Surgery Specialists
🇺🇸Macon, Georgia, United States
Arlington Dermatology
🇺🇸Rolling Meadows, Illinois, United States
Northwestern University Feinberg School of Medicine Ann & Robert H Lurie Children's Hospital
🇺🇸Chicago, Illinois, United States
Windsor Dermatology
🇺🇸East Windsor, New Jersey, United States
Wright State Physicians Health Center
🇺🇸Dayton, Ohio, United States
Mt. Sinai School of Medicine
🇺🇸New York, New York, United States
Cliniques Universitaires Saint Luc
🇧🇪Brussels, Belgium
Borsod Abauj Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktato Korhaz
🇭🇺Miskolc, Hungary
Hautarztpraxis Dr. Leitz & Kollegen
🇩🇪Stuttgart, Germany
Praxis Dr. med. Beate Schwarz - Germany
🇩🇪Langenau, Germany
Azienda Ospedaliera di Padova
🇮🇹Padova, Italy
Dell Children's Medical Center of Central Texas
🇺🇸Austin, Texas, United States
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