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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 20, 24, 28, 32, 36, 40, 44, 48 and 52
Awards & highlights

PROTOSTAR Trial Summary

This trial will test whether the drug guselkumab is effective and safe for treating plaque psoriasis in children aged 6 to 17.

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.Check my eligibility
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.See study design
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.

PROTOSTAR Trial Eligibility Criteria

Inclusion Criteria

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

PROTOSTAR Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
9%
Injection site reaction
8%
Upper respiratory tract infection
7%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ixekizumab
Guselkumab
Ixekizumab Post-Treatment Follow Up
Guselkumab Post-Treatment Follow Up

PROTOSTAR 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

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,188 Total Patients Enrolled
23 Trials studying Psoriasis
8,558 Patients Enrolled for Psoriasis
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,785 Total Patients Enrolled
18 Trials studying Psoriasis
6,113 Patients Enrolled for Psoriasis

Media Library

Psoriasis Research Study Groups: Part 1 Group 2: Placebo for Guselkumab, Part 1 Group 1: Guselkumab, Part 1 Group 3: Etanercept, Part 2: Guselkumab

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are the participants in this experiment only those over 45 years of age?

"The age requirement to participate in this trial is between 6 and 17 years old."

Answered by AI

Are we still looking for volunteers for this experiment?

"Yes, that is correct. The trial was originally posted on July 11th, 2018 and is currently recruiting 125 patients from 9 locations, as stated on clinicaltrials.gov"

Answered by AI

Can Guselkumab create serious health complications for patients?

"Guselkumab has been studied in multiple clinical trials and found to be safe for use. It received a score of 3 on our team's safety scale."

Answered by AI

What is the primary condition that Guselkumab is used to address?

"Guselkumab is often used to manage moderate to severe symptoms. However, it has also been effective in treating other illnesses such as psoriasis, Crohn's disease, and rheumatoid arthritis."

Answered by AI

What goals does this research project hope to realize?

"The primary objective of this study, which will be measured over a 16-week period, is to determine the percentage of participants who achieve an Investigator's Global Assessment (IGA) score of cleared (0) or minimal (1). Additionally, the study will evaluate secondary outcomes including the percentage of participants who achieve Psoriasis Area and Severity Index (PASI) 90 response, defined as at least a 90% improvement from baseline in the PASI score; PASI responses (PASI 50, 75, 90, and 100) over time; and the percentage of participants who achieve an IGA score"

Answered by AI

Who meets the eligibility requirements for this research?

"This study is looking for 125 people with psoriasis between the ages of 6 and 17. Most importantly, patients should meet the following 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"

Answered by AI

What other scientific literature is available on Guselkumab?

"Presently, 55 clinical trials are underway to study Guselkumab. Of these, 16 have reached Phase 3. The majority of these trials originate from Xi'an, Shaanxi; however, there are over 3000 other locations running similar studies."

Answered by AI

Could you inform me as to how many locations are currently conducting this experiment?

"Currently, 9 hospitals are participating in this clinical study. They are situated in Calgary, Chicago, Austin and 6 other cities. To limit travel-related obstacles, patients should choose the location nearest to them."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants
2018. "A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03451851.
All > Psoriasis > Plaque Psoriasis
~18 spots leftby Apr 2025
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