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Monoclonal Antibodies

Subcutaneous Guselkumab for Psoriasis (PROTOSTAR Trial)

Phase 3
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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) >= 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 younger than 18 years old
Must not have
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
Currently has nonplaque forms of psoriasis (example, erythrodermic, guttate, or pustular)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 20, 24, 28, 32, 36, 40, 44, 48 and 52
Awards & highlights

Summary

This trial is testing a medication called guselkumab to see if it is safe and effective for children and teenagers with chronic plaque psoriasis. The medication aims to reduce inflammation and slow down the rapid growth of skin cells. Guselkumab is the first IL-23 specific inhibitor to be approved for the treatment of plaque psoriasis and has shown excellent safety and efficacy in previous studies.

Who is the study for?
This trial is for children and teens aged 6 to less than 18 with chronic plaque psoriasis. They must have had the condition for at least 6 months, show certain levels of severity, be up-to-date on vaccinations or immune to varicella and MMR, and could benefit from etanercept therapy. Those with a history of lymphoproliferative disease, previous guselkumab or etanercept use, chronic infections, nonplaque psoriasis types, or drug-induced psoriasis cannot join.
What is being tested?
The study tests the effectiveness and safety of Guselkumab administered under the skin in young patients with plaque psoriasis compared to Etanercept (another treatment) and a placebo. The goal is to see how well Guselkumab works in reducing symptoms of this skin condition.
What are the potential side effects?
Potential side effects may include reactions at the injection site like pain or swelling, increased risk of infections due to immune system suppression by Guselkumab or Etanercept, headaches, stomach issues such as nausea or diarrhea. Each patient's experience can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had severe plaque psoriasis for at least 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of chronic or recurrent infections.
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My psoriasis is not the common plaque type.
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I have been treated with guselkumab or etanercept before.
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My psoriasis was triggered or worsened by certain medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 20, 24, 28, 32, 36, 40, 44, 48 and 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 20, 24, 28, 32, 36, 40, 44, 48 and 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part 1: Percentage of Participants who Achieve Psoriasis Area and Severity Index (PASI) 75 Response
Part 1: Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1)
Secondary study objectives
Part 1 and 2: Change From Baseline in Children's Dermatology Life Quality Index (CDLQI)
Part 1 and 2: Change From Baseline in FDLQI Score
Part 1 and 2: Percent Change From Baseline in PASI Over Time
+14 more

Side effects data

From 2020 Phase 4 trial • 1027 Patients • NCT03573323
1%
Nasopharyngitis
1%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ixekizumab Post-Treatment Follow Up
Ixekizumab
Guselkumab
Guselkumab Post-Treatment Follow Up

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Part 2: GuselkumabExperimental Treatment1 Intervention
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.
Group II: Part 1 Group 1: GuselkumabExperimental Treatment2 Interventions
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.
Group III: Part 1 Group 3: EtanerceptActive Control2 Interventions
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.
Group IV: Part 1 Group 2: Placebo for GuselkumabPlacebo Group2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guselkumab
2015
Completed Phase 4
~5990
Placebo for guselkumab
2014
Completed Phase 3
~2710

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Psoriasis treatments often target specific components of the immune system to reduce inflammation and slow down the overproduction of skin cells. Guselkumab, an IL-23 inhibitor, works by blocking the interleukin-23 protein, which plays a crucial role in the inflammatory process of psoriasis. This helps to reduce the symptoms and progression of the disease. Other common treatments include TNF-alpha inhibitors, which block tumor necrosis factor-alpha, a substance involved in systemic inflammation, and IL-17 inhibitors, which target interleukin-17, another key player in the inflammatory response. These treatments are significant for psoriasis patients as they offer targeted therapy options that can lead to better management of symptoms and improved quality of life.

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
987 Previous Clinical Trials
6,385,539 Total Patients Enrolled
22 Trials studying Psoriasis
8,040 Patients Enrolled for Psoriasis
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
753 Previous Clinical Trials
3,961,339 Total Patients Enrolled
18 Trials studying Psoriasis
6,235 Patients Enrolled for Psoriasis

Media Library

Psoriasis Research Study Groups: Part 1 Group 2: Placebo for Guselkumab, Part 1 Group 3: Etanercept, Part 1 Group 1: Guselkumab, Part 2: Guselkumab
~17 spots leftby Sep 2025
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