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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 below
Select...
My condition meets the required severity criteria.
Select...
My psoriasis hasn't improved with at least one skin treatment.

SPECTREM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 56
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 56 for reporting.

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 more

SPECTREM 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

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
976 Previous Clinical Trials
6,384,392 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
746 Previous Clinical Trials
3,959,978 Total Patients Enrolled

Frequently Asked Questions

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

Has the United States Food and Drug Administration (FDA) given its endorsement to Guselkumab for Group 1?

"Guselkumab's safety is well-documented due to its Phase 3 status, thus earning an assessment of 3 on the 1-3 scale."

Answered by AI

How many participants have enrolled in this experiment?

"Correct. Clinicaltrials.gov confirms that this medical study, initially posted on August 24th 2023 is currently recruiting patients from four clinical centres with a goal of 300 participants total."

Answered by AI

Is there a call for participants in this experiment presently?

"Affirmative. According to information present on clinicaltrials.gov, this medical experiment is actively seeking out participants with an initial post date of August 24th 2023 and an updated edit made September 9th 2023. The study aims to enlist 300 patients from 4 distinct sites."

Answered by AI

Who else is applying?

What site did they apply to?
Tennessee Clinical Research Center
Therapeutics Clinical Research
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque Psoriasis
2023. "Study of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque Psoriasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06039189.
All > Psoriasis > Plaque Psoriasis
~180 spots leftby Apr 2025
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