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Monoclonal Antibodies

Skyrizi for Psoriasis

Phase 4
Waitlist Available
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
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

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 below
Select...
Over 10% of my body is covered by plaque psoriasis.
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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 weeks
Treatment ~ Varies
Follow Up ~week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

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

Awards & Highlights

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.

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
502 Previous Clinical Trials
1,089,998 Total Patients Enrolled
9 Trials studying Psoriasis
1,292 Patients Enrolled for Psoriasis
AbbVieIndustry Sponsor
1,040 Previous Clinical Trials
523,559 Total Patients Enrolled
62 Trials studying Psoriasis
125,615 Patients Enrolled for Psoriasis
Jaehwan KimLead Sponsor
Jaehwan Kim, MD, PhDPrincipal InvestigatorThe Rockefeller University

Media Library

Risankizumab-Rzaa (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04630652 — Phase 4
Psoriasis Research Study Groups: Psoriasis treatment with risankizumab
Psoriasis Clinical Trial 2023: Risankizumab-Rzaa Highlights & Side Effects. Trial Name: NCT04630652 — Phase 4
Risankizumab-Rzaa (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04630652 — Phase 4
~5 spots leftby Feb 2026
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