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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03451851




Registration number
NCT03451851
Ethics application status
Date submitted
26/02/2018
Date registered
2/03/2018
Date last updated
15/10/2024

Titles & IDs
Public title
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
Scientific 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)
Secondary ID [1] 0 0
2017-003053-42
Secondary ID [2] 0 0
CR108452
Universal Trial Number (UTN)
Trial acronym
PROTOSTAR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Guselkumab
Treatment: Drugs - Placebo for guselkumab
Treatment: Drugs - Etanercept

Experimental: Part 1 Group 1: 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.

Placebo comparator: Part 1 Group 2: 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.

Active comparator: Part 1 Group 3: 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.

Experimental: Part 2: 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.


Treatment: Drugs: Guselkumab
Participants will receive a weight-based dose of guselkumab subcutaneously.

Treatment: Drugs: Placebo for guselkumab
Participants will receive a weight-based dose of placebo for guselkumab subcutaneously.

Treatment: Drugs: Etanercept
Participants will receive a weight-based dose of etanercept (up to 50 mg) subcutaneously.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1)
Timepoint [1] 0 0
Week 16
Primary outcome [2] 0 0
Part 1: Percentage of Participants who Achieve Psoriasis Area and Severity Index (PASI) 75 Response
Timepoint [2] 0 0
Week 16
Secondary outcome [1] 0 0
Part 1: Percentage of Participants who Achieve Psoriasis Area and Severity Index (PASI) 90 Response
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Part 1: Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0)
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Part 1 and 2: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI)
Timepoint [3] 0 0
Baseline, Week 16 (Part 1) and up to Week 52 (Part 2)
Secondary outcome [4] 0 0
Part 1: Percentage of Participants who Achieve PASI 100 Response
Timepoint [4] 0 0
Week 16
Secondary outcome [5] 0 0
Part 1: Percentage of Retreated Participants who Achieve a PASI 90 Response Over Time After Retreatment
Timepoint [5] 0 0
Every 4 weeks after retreatment is initiated, until Week 52
Secondary outcome [6] 0 0
Part 1: Percentage of Retreated Participants who Achieve PASI Responses (PASI 50, 75, 90, and 100) Over Time After Retreatment
Timepoint [6] 0 0
Every 4 weeks after retreatment is initiated, until Week 52
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
Every 4 weeks after retreatment is initiated, until Week 52
Secondary outcome [8] 0 0
Part 1: Time to Loss of 50% of the Week 16 PASI Improvement After Withdrawal
Timepoint [8] 0 0
Week 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [9] 0 0
Part 1: Time to Loss of PASI 90 Response After Withdrawal
Timepoint [9] 0 0
Week 20, 24, 28, 32, 36, 40, 44, 48 and 52
Secondary outcome [10] 0 0
Part 1: Percentage of Participants who Achieve a PASI 50 Response
Timepoint [10] 0 0
Week 16
Secondary outcome [11] 0 0
Part 1: Percentage of Participants who Achieve an IGA Score of Mild or Better (Less Than or Equal to [<=] 2)
Timepoint [11] 0 0
Week 16
Secondary outcome [12] 0 0
Part 1 and 2: Percent Change From Baseline in PASI Over Time
Timepoint [12] 0 0
Baseline, up to Week 16 (Part 1); up to Week 52 (Part 2)
Secondary outcome [13] 0 0
Part 1 and 2: Percentage of Participants with PASI Responses (PASI 50, 75, 90, and 100) Over Time
Timepoint [13] 0 0
Up to Week 16 (Part 1); up to Week 52 (Part 2)
Secondary outcome [14] 0 0
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
Timepoint [14] 0 0
Up to Week 16 (Part 1); up to Week 52 (Part 2)
Secondary outcome [15] 0 0
Part 1 and 2: Percentage of Participants with CDLQI equal to (=) 0 or 1 Among Participants with a Baseline CDLQI Greater Than (>) 1
Timepoint [15] 0 0
At Week 16 (Part 1); up to Week 52 (Part 2)
Secondary outcome [16] 0 0
Part 1 and 2: Percentage of Participants with Family Dermatology Life Quality Index (FDLQI)=0 or 1 Among Participants with a Baseline FDLQI >1
Timepoint [16] 0 0
At Week 16 (Part 1); up to Week 52 (Part 2)
Secondary outcome [17] 0 0
Part 1 and 2: Change From Baseline in FDLQI Score
Timepoint [17] 0 0
Baseline, Week 16 (Part 1); up to Week 52 (Part 2)

Eligibility
Key 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
Minimum age
6 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
18/12/2026
Actual
Sample size
Target
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Eastern Health Research - Box Hill
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 0 0
Veracity Clinical Research - Woolloongabba
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Belgium
State/province [8] 0 0
Brussels
Country [9] 0 0
Belgium
State/province [9] 0 0
Gent
Country [10] 0 0
Belgium
State/province [10] 0 0
Liege
Country [11] 0 0
Canada
State/province [11] 0 0
Alberta
Country [12] 0 0
Canada
State/province [12] 0 0
British Columbia
Country [13] 0 0
Germany
State/province [13] 0 0
Bonn
Country [14] 0 0
Germany
State/province [14] 0 0
Dresden
Country [15] 0 0
Germany
State/province [15] 0 0
Frankfurt
Country [16] 0 0
Germany
State/province [16] 0 0
Kiel
Country [17] 0 0
Germany
State/province [17] 0 0
Langenau
Country [18] 0 0
Germany
State/province [18] 0 0
Selters
Country [19] 0 0
Germany
State/province [19] 0 0
Stuttgart
Country [20] 0 0
Hungary
State/province [20] 0 0
Budapest
Country [21] 0 0
Hungary
State/province [21] 0 0
Debrecen
Country [22] 0 0
Hungary
State/province [22] 0 0
Miskolc
Country [23] 0 0
Hungary
State/province [23] 0 0
Szeged
Country [24] 0 0
Italy
State/province [24] 0 0
Ancona
Country [25] 0 0
Italy
State/province [25] 0 0
Bologna
Country [26] 0 0
Italy
State/province [26] 0 0
Cagliari
Country [27] 0 0
Italy
State/province [27] 0 0
Padova
Country [28] 0 0
Italy
State/province [28] 0 0
Reggio Emilia
Country [29] 0 0
Netherlands
State/province [29] 0 0
Nijmegen
Country [30] 0 0
Poland
State/province [30] 0 0
Lodz
Country [31] 0 0
Poland
State/province [31] 0 0
Warszawa
Country [32] 0 0
Poland
State/province [32] 0 0
Wroclaw

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03451851
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03451851