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Monoclonal Antibodies
Guselkumab for Plaque Psoriasis (SPECTREM Trial)
Phase 3
Recruiting
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
Participants must meet specific disease severity criteria at screening and at baseline
Participants must be inadequately controlled with or intolerant of at least 1 prior topical therapy for the treatment of psoriasis at both screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 56
Awards & highlights
SPECTREM Trial Summary
This trial will compare a possible psoriasis treatment to an inactive drug to see if it is effective.
Who is the study for?
This trial is for individuals with a diagnosis of moderate plaque psoriasis covering a low area of the body, who haven't responded well to or can't tolerate at least one topical treatment. They should be eligible for light therapy or systemic treatment and have had psoriasis for over six months. People with non-plaque psoriasis, drug-induced psoriasis, certain palmoplantar conditions, previous biologic treatments, or chronic infections cannot participate.Check my eligibility
What is being tested?
The study aims to compare the effectiveness of Guselkumab (a medication) against a placebo (an inactive substance) in treating patients with moderate plaque psoriasis affecting small areas of their body including special sites like palms and soles.See study design
What are the potential side effects?
Guselkumab may cause side effects such as injection site reactions, upper respiratory infections, headache, and possibly serious but rare events like severe allergic reactions.
SPECTREM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition meets the required severity criteria.
Select...
My psoriasis hasn't improved with at least one skin treatment.
SPECTREM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 56
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 56
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
Secondary outcome measures
Change From Baseline in Body Surface Area (BSA) Affected With Psoriasis at Week 16
Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Total Symptom Score at Week 16
Change From Baseline in Total Psoriasis Area and Severity Index (PASI) Score at Week 16
+11 moreSPECTREM Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 1: GuselkumabExperimental Treatment2 Interventions
Participants will receive guselkumab by subcutaneous injection with placebo as needed to maintain the blind.
Group II: Group 2: PlaceboPlacebo Group2 Interventions
Participants will receive placebo by subcutaneous injection then receive guselkumab by subcutaneous injection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guselkumab
2015
Completed Phase 4
~5990
Placebo
1995
Completed Phase 3
~2670
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
Plaque Psoriasis treatments often target specific pathways in the immune system to reduce inflammation and slow down the rapid skin cell turnover characteristic of the disease. Guselkumab, for example, is a monoclonal antibody that targets the IL-23p19 subunit, inhibiting the IL-23 pathway, which is crucial in the inflammatory process of psoriasis.
Other treatments include TNF-alpha inhibitors, which block the tumor necrosis factor-alpha, a cytokine involved in systemic inflammation, and IL-17 inhibitors, which target the IL-17 pathway, another key player in psoriasis-related inflammation. These treatments are significant for patients as they help manage symptoms, reduce flare-ups, and improve quality of life by addressing the underlying inflammatory processes of Plaque Psoriasis.
Guselkumab, an inhibitor of the IL-23p19 subunit, provides sustained improvement in signs and symptoms of active psoriatic arthritis: 1 year results of a phase III randomised study of patients who were biologic-naïve or TNFα inhibitor-experienced.Targeting IL-23 in psoriasis: current perspectives.
Guselkumab, an inhibitor of the IL-23p19 subunit, provides sustained improvement in signs and symptoms of active psoriatic arthritis: 1 year results of a phase III randomised study of patients who were biologic-naïve or TNFα inhibitor-experienced.Targeting IL-23 in psoriasis: current perspectives.
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Who is running the clinical trial?
Janssen Research & Development, LLCLead Sponsor
978 Previous Clinical Trials
6,384,794 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
747 Previous Clinical Trials
3,960,372 Total Patients Enrolled
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