A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants

Psoriasis Clinical Trial

— PROTOSTAR  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03451851
• Other study ID #: CR108452
• Secondary ID: 2017-003053-42CN
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 11, 2018
• Est. completion date: December 18, 2026

Study information

• Verified date: June 2024
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 18, 2026
• Est. primary completion date: July 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Australia	Eastern Health Research	Box Hill
Australia	Royal North Shore Hospital	St Leonards
Australia	Veracity Clinical Research	Woolloongabba
Belgium	Cliniques Universitaires Saint Luc	Brussels
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman	Liege
Canada	Dermatology Research Institute Inc.	Calgary	Alberta
Canada	Kirk Barber Reseach Inc.	Calgary	Alberta
Canada	Skin Care Centre	Vancouver	British Columbia
Germany	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
Hungary	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
Italy	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
Netherlands	Radboud University Medical Center	Nijmegen
Poland	Dermed Centrum Medyczne Sp z o o	Lodz
Poland	Szpital Dzieciecy im. prof. dr. med. Jana Bogdanowicza w Warszawie	Warszawa
Poland	Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu	Wroclaw
United States	Arlington Center for Dermatology	Arlington	Texas
United States	Dell Children's Medical Center of Central Texas	Austin	Texas
United States	Northwestern University Feinberg School of Medicine Ann & Robert H Lurie Children's Hospital	Chicago	Illinois
United States	Wright State Physicians Health Center	Dayton	Ohio
United States	Windsor Dermatology	East Windsor	New Jersey
United States	Dermatologic Surgery Specialists	Macon	Georgia
United States	Mt. Sinai School of Medicine	New York	New York
United States	Stanford University	Palo Alto	California
United States	Arlington Dermatology	Rolling Meadows	Illinois
United States	University of California, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Germany,  Hungary,  Italy,  Netherlands,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1)	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.	Week 16
Primary	Part 1: Percentage of Participants who Achieve Psoriasis Area and Severity Index (PASI) 75 Response	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.	Week 16
Secondary	Part 1: Percentage of Participants who Achieve Psoriasis Area and Severity Index (PASI) 90 Response	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.	Week 16
Secondary	Part 1: Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0)	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.	Week 16
Secondary	Part 1 and 2: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI)	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.	Baseline, Week 16 (Part 1) and up to Week 52 (Part 2)
Secondary	Part 1: Percentage of Participants who Achieve PASI 100 Response	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).	Week 16
Secondary	Part 1: Percentage of Retreated Participants who Achieve a PASI 90 Response Over Time After Retreatment	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.	Every 4 weeks after retreatment is initiated, until Week 52
Secondary	Part 1: Percentage of Retreated Participants who Achieve PASI Responses (PASI 50, 75, 90, and 100) Over Time After Retreatment	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.	Every 4 weeks after retreatment is initiated, until Week 52
Secondary	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	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.	Every 4 weeks after retreatment is initiated, until Week 52
Secondary	Part 1: Time to Loss of 50% of the Week 16 PASI Improvement After Withdrawal	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.	Week 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary	Part 1: Time to Loss of PASI 90 Response After Withdrawal	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.	Week 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary	Part 1: Percentage of Participants who Achieve a PASI 50 Response	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.	Week 16
Secondary	Part 1: Percentage of Participants who Achieve an IGA Score of Mild or Better (Less Than or Equal to [<=] 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.	Week 16
Secondary	Part 1 and 2: Percent Change From Baseline in PASI Over Time	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.	Baseline, up to Week 16 (Part 1); up to Week 52 (Part 2)
Secondary	Part 1 and 2: Percentage of Participants with PASI Responses (PASI 50, 75, 90, and 100) Over Time	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.	Up to Week 16 (Part 1); up to Week 52 (Part 2)
Secondary	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	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.	Up to Week 16 (Part 1); up to Week 52 (Part 2)
Secondary	Part 1 and 2: Percentage of Participants with CDLQI equal to (=) 0 or 1 Among Participants with a Baseline CDLQI Greater Than (>) 1	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.	At Week 16 (Part 1); up to Week 52 (Part 2)
Secondary	Part 1 and 2: Percentage of Participants with Family Dermatology Life Quality Index (FDLQI)=0 or 1 Among Participants with a Baseline FDLQI >1	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.	At Week 16 (Part 1); up to Week 52 (Part 2)
Secondary	Part 1 and 2: Change From Baseline in FDLQI Score	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.	Baseline, Week 16 (Part 1); up to Week 52 (Part 2)