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Monoclonal Antibodies
Skyrizi for Psoriasis
Phase 4
Recruiting
Led By Jaehwan Kim, MD, PhD
Research Sponsored by Jaehwan Kim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
More than 10% body surface area has plaque psoriasis involvement.
Adult males or females with a diagnosis of plaque psoriasis for at least 6 months.
Must not have
History of recent or ongoing uncontrolled bacterial, viral, fungal, or other opportunistic infections
Treatment with biologic agents within previous 3 months prior to visit 0, including adalimumab, etanercept, and infliximab
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights
Summary
This trial is testing a new drug, Skyrizi, to see if it produces long-term disease clearance in psoriasis patients.
Who is the study for?
Adults with plaque psoriasis for at least 6 months, a PASI score over 12, and more than 10% body surface area affected. Participants must not use other psoriasis treatments or live vaccines during the trial and cannot be pregnant.
What is being tested?
The study tests Risankizumab's ability to maintain long-term remission in psoriasis patients. It involves comparing skin biopsies before and after treatment to understand immune changes correlating with disease progression.
What are the potential side effects?
Potential side effects of Risankizumab may include reactions at the injection site, increased risk of infections due to immune system suppression, headaches, fatigue, and possible gastrointestinal issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
Over 10% of my body is covered by plaque psoriasis.
Select...
I have been diagnosed with plaque psoriasis for at least 6 months.
Select...
I agree not to use other psoriasis treatments, live vaccines, or become pregnant during the trial.
Select...
Over 10% of my body is covered by psoriasis plaques.
Select...
I agree not to use other psoriasis treatments, live vaccines, or become pregnant during the trial.
Select...
I have been diagnosed with plaque psoriasis for at least 6 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I currently have or recently had a serious infection that is not under control.
Select...
I haven't taken drugs like adalimumab in the last 3 months.
Select...
My psoriasis is not the plaque type.
Select...
I have been treated with medications targeting IL-12 or IL-23.
Select...
I am not pregnant, breastfeeding, planning to become pregnant, and I agree to use birth control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Determination of regulatory immune cell changes induced by risankizumab
Secondary study objectives
Validation of predictive models that anticipate disease recurrence after risankizumab treatment
Trial Design
1Treatment groups
Experimental Treatment
Group I: Psoriasis treatment with risankizumabExperimental Treatment3 Interventions
Moderate-to-severe psoriasis treatment with risankizumab for 16 weeks
Find a Location
Who is running the clinical trial?
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
493 Previous Clinical Trials
1,089,410 Total Patients Enrolled
9 Trials studying Psoriasis
1,292 Patients Enrolled for Psoriasis
AbbVieIndustry Sponsor
1,004 Previous Clinical Trials
513,758 Total Patients Enrolled
62 Trials studying Psoriasis
125,592 Patients Enrolled for Psoriasis
Jaehwan KimLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Over 10% of my body is covered by plaque psoriasis.I have been diagnosed with plaque psoriasis for at least 6 months.I haven't taken immunosuppressive drugs in the last 4 weeks.I currently have or recently had a serious infection that is not under control.Your Psoriasis Area Severity Index (PASI) score is higher than 12 before starting the trial.I have not received a live vaccine in the last 6 weeks.I agree not to use other psoriasis treatments, live vaccines, or become pregnant during the trial.I have used psoriasis cream or ointment in the last 2 weeks.I haven't taken drugs like adalimumab in the last 3 months.Your Psoriasis Area Severity Index (PASI) score is higher than 12 before starting the study.Over 10% of my body is covered by psoriasis plaques.My psoriasis is not the plaque type.I agree not to use other psoriasis treatments, live vaccines, or become pregnant during the trial.I do not have any severe health conditions that could worsen by joining this study.I have been treated with medications targeting IL-12 or IL-23.I am not pregnant, breastfeeding, planning to become pregnant, and I agree to use birth control.You have tested positive for tuberculosis.I have been diagnosed with plaque psoriasis for at least 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Psoriasis treatment with risankizumab
Awards:
This trial has 3 awards, including:- 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.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
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