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Monoclonal Antibodies
Ustekinumab for Psoriasis
Phase 4
Recruiting
Led By Kevin Cooper, MD
Research Sponsored by University Hospitals Cleveland Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Insurance that includes an anti-p40 biologic (ustekinumab/Stelara) and at least one anti-p19 biologic (guselkumab/Tremfya or risankizumab/Skyrizi)
Diagnosed with plaque-type psoriasis defined by a board-certified dermatologist, dermatology nurse practitioner, or skin punch biopsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
Study Summary
This trial is looking to see if researchers can predict which psoriasis drugs will work for individual patients by looking at markers or gene patterns. Participants will try two different drugs for 8 weeks at a time and have their skin monitored for improvement.
Who is the study for?
This trial is for individuals with plaque-type psoriasis covering at least 10% of their body, who have not used certain biologics or other psoriasis treatments recently. Participants must have insurance that covers the study drugs and be able to give informed consent. Those with psoriatic arthritis, recent use of tanning booths, or women who are pregnant or breastfeeding cannot join.Check my eligibility
What is being tested?
The trial aims to personalize psoriasis treatment by predicting responses to FDA-approved drugs Ustekinumab and others using gene patterns. Participants will try two different drugs over periods of 8 weeks while undergoing skin improvement monitoring and providing blood, stool, and skin samples.See study design
What are the potential side effects?
Ustekinumab may cause side effects like infections, allergic reactions, headache, tiredness, joint pain and nausea. The exact side effects from this trial's interventions will depend on individual responses to the medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My insurance covers Stelara and either Tremfya or Skyrizi.
Select...
I have been diagnosed with plaque-type psoriasis by a skin specialist or through a biopsy.
Select...
I have never been treated with ustekinumab, guselkumab, or risankizumab.
Select...
At least 10% of my skin is affected by my condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Identification of a unique differentially expressed gene set in patients with psoriasis that may predict disease response following antagonism to IL-12 and/or IL-23.
Secondary outcome measures
Identification of a cell subset that is a modified and predictive of disease response following antagonism to IL-12 and/or IL-23
Side effects data
From 2018 Phase 4 trial • 43 Patients • NCT0218717250%
Upper respiratory infection
27%
Common cold
9%
Urinary tract infection
9%
Anxiety
9%
Back pain
9%
Dizziness
9%
Fracture
9%
Skin and subcutaneous tissue disorders
5%
Rash/Rash Acneiform/Maculo-Papular
5%
Hypertension
5%
Pain/Pain in extremity
5%
Toothache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ustekinumab (Stelara)
Placebo (RCT Period)
Placebo (Active Treatment Period)
Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Patients will be treated with ustekinumab (90mg at week 0 and week 4 by subcutaneous injection) for 8 weeks followed by treatment with guselkumab (100mg at week 0 and week 4 by subcutaneous injection) or risankizumab (150mg at week 0 and week 4 by subcutaneous injection)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ustekinumab
2013
Completed Phase 4
~4140
Find a Location
Who is running the clinical trial?
University Hospitals Cleveland Medical CenterLead Sponsor
317 Previous Clinical Trials
340,201 Total Patients Enrolled
7 Trials studying Psoriasis
135 Patients Enrolled for Psoriasis
LEO FoundationUNKNOWN
Case Western Reserve UniversityOTHER
299 Previous Clinical Trials
259,964 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My insurance covers Stelara and either Tremfya or Skyrizi.I have been diagnosed with plaque-type psoriasis by a skin specialist or through a biopsy.I have never been treated with ustekinumab, guselkumab, or risankizumab.At least 10% of my skin is affected by my condition.I have psoriatic arthritis or another similar condition like Crohn's disease.You haven't used tanning booths for at least 4 weeks before the study starts.I cannot get ustekinumab, gusekumab, or risankizumab for the trial.I have been using skin treatments like steroids or Vitamin D on my lesions for at least 2 weeks.I have been on systemic or biologic therapy for at least 8 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still openings for participants in this scientific experiment?
"As per the updated data hosted on clinicaltrials.gov, this medical trial is no longer recruiting patients. The study was initially posted in December 1st 2022 and recently modified on October 19th of 2022. Nevertheless, there are 167 other trials looking for participants at this moment."
Answered by AI
Has the U.S. Food and Drug Administration officially certified Ustekinumab for human use?
"There is ample evidence from Phase 4 trials confirming Ustekinumab's safety; accordingly, it was scored 3 out of 3."
Answered by AI
Is the population for this investigation limited to individuals who are under forty years old?
"This research is inviting participants aged between 18 years and 89 years to take part."
Answered by AI
To which individuals is this research open?
"This trial is currently seeking 56 individuals aged 18 to 89 years old with a diagnosis of psoriasis. Candidates must possess an insurance plan that covers anti-P40 and P19 biologics, have not previously used ustekinumab, guselkumab, or risankizumab, present at least 10% body surface area involvement in their condition as seen by board-certified dermatologist/dermatology nurse practitioner/skin punch biopsy, and accept the terms outlined in the informed consent document reviewed by IRB approval procedures."
Answered by AI
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