Risankizumab Long-term Remission Study

May 22, 2026 updated by: Jaehwan Kim

Immune Modification of Psoriasis by Selective IL-23 Blockade Using Risankizumab

Although the newly developed biologics (drugs derived from living cells cultured in a laboratory) are highly effective in controlling psoriasis, all the biologics should be continuously injected to suppress recurrence of the disease. In this regard, the observation in the phase II clinical trial conducted by us (Laboratory for Investigative Dermatology at the Rockefeller University) was groundbreaking that just a single dose of anti-IL-23p19 antibody (risankizumab, trade name: Skyrizi, study drug in this clinical trial) administration produced disease clearance up to 66 weeks in 46% (6 of 13) of patients. However, there is a lack of understanding about immune regulation in human skin induced by anti-IL-23p19 antibody injection, and there is a need to conduct a psoriasis clinical trial for single-cell sequencing immune cells in human psoriasis skin before and after anti-IL-23p19 antibody administration, and to correlate regulatory immune cell alterations with clinical disease progression. The overall objective of the clinical trial is to study regulatory immune cell alterations induced by anti-IL-23p19 antibody administration in psoriasis patients who achieve long-term disease clearance off drugs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Although the newly developed biologics targeting IL-23/Th17 axis are highly effective in controlling psoriasis, all the biologics should be continuously injected to suppress recurrence of the disease. In this regard, the observation in our phase I psoriasis clinical trial was groundbreaking that just a single dose of anti-IL-23p19 antibody administration produced disease clearance up to 66 weeks in 46% (6 of 13) of patients. Since FoxP3 mRNA levels remained high in posttreatment biopsy specimens of these patients, we hypothesized that IL-23p19 inhibition increased regulatory T-cell levels or function in resolved psoriatic skin. However, there is a lack of understanding about regulatory immune cell promotion by IL-23p19 inhibition in human skin.

Our overall objectives of the study, are to (i) identify regulatory immune cell alterations induced by anti-IL-23p19 antibody administration in the skin of patients whose psoriasis is cleared without recurrence and (ii) develop pre-treatment predictive models for psoriasis patients that anticipate disease clearance and recurrence after short-term anti-IL-23p19 antibody injection. The rationale for this project is that molecular evidence of immune tolerance induction by IL-23p19 inhibition in human skin is likely to offer a strong clinical framework whereby new strategies to prevent recurrence of chronic inflammatory diseases can be developed. In this study, subjects with moderate-to-severe psoriasis will receive FDA-approved anti-IL-23p19 antibody (Generic name: Risankizumab, Product name: SKYRIZI™ or risankizumab-rzaa) up to 4 months following the FDA-approved indications, usage, dosage, and administration in the FDA-approved dosage forms and strengths through week 16, after which, dosing stops.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • University of California Davis Medical Center
      • Sacramento, California, United States, 95655
        • VA Northern California Health Care System
    • New York
      • New York, New York, United States, 10065
        • The Rockefeller Univesity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult males or females with a diagnosis of plaque psoriasis for at least 6 months.
  • Baseline Psoriasis Area Severity Index (PASI) score > 12.
  • More than 10% body surface area has plaque psoriasis involvement.
  • Willingness to forgo other available psoriasis therapies, live vaccines, and pregnancy during the trial.
  • Ability and willingness to provide informed consent and comply with study requirements.

Exclusion Criteria:

  • Non-plaque forms of psoriasis.
  • Any previous treatment with agents targeting IL-12 or IL-23, including ustekinumab.
  • Treatment with biologic agents within previous 3 months prior to visit 0, including adalimumab, etanercept, and infliximab.
  • Treatment with immunosuppressive medications, including methotrexate, cyclosporine, oral retinoids, prednisone, or phototherapy within previous 4 weeks prior to visit 0.
  • Topical psoriasis treatment within previous 2 weeks prior to visit 0, including topical corticosteroids, vitamin D analogues, retinoids, calcineurin inhibitors, salicylic acid, and coal tar.
  • Any investigational study medication within previous 6 months prior to visit 0.
  • History of recent or ongoing uncontrolled bacterial, viral, fungal, or other opportunistic infections.
  • Positive QuantiFERON-TB Gold test. PPD tuberculin test may be substituted for QuantiFERON-TB Gold test.
  • Receipt of a live vaccine (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox) in the previous 6 weeks prior to visit 0.
  • Females who are pregnant, lactating, planning on pregnancy during the study period, or unwilling to use a medically acceptable method of birth control.
  • Severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, or neurological disease, or any other medical condition that, in the investigator's opinion, places the participant at risk by participating in this study.
  • Any medical history, including laboratory results, deemed by the investigator to be likely to interfere with their participation in the study, or to interfere with the interpretation of the results, or any social condition that, in the opinion of the Investigator, might pose additional risk to the participant or confound the results of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Psoriasis treatment with risankizumab
Moderate-to-severe psoriasis treatment with risankizumab for 16 weeks
Drug: Risankizumab-Rzaa
Risankizumab at a dose of 150 mg with injections administered at baseline, week 4 and week 16 following FDA-approved dosage and time periods
Other Names:
  • SKYRIZI
Procedure: Punch biopsies of the skin at baseline visit
Two 6 mm punch biopsies of the skin at baseline visit
Procedure: Punch biopsies of the skin at week 28 visit
One 6 mm punch biopsy of the skin at week 28 visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of regulatory immune cell changes induced by risankizumab
Time Frame: week 52
Changes of regulatory immune cell proportions in total immune cells harvested from the skin biopsy tissues of subjects who have a reduction of 90% or more from baseline in the Psoriasis Area and Severity Index (PASI; range from 0 to 72) at week 12 and also maintain the 90% reduction in PASI at week 52.
week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of predictive models that anticipate disease recurrence after risankizumab treatment
Time Frame: week 52
Sensitivity (range from 0 to 100%) and specificity (range from 0 to 100%) of statistical prediction models with single-cell genomic data from the skin biopsy tissues that predict subjects who have a reduction of 90% or more from baseline in the Psoriasis Area and Severity Index (PASI; range from 0 to 72) at week 12 and also maintain the 90% reduction in PASI at week 52.
week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jaehwan Kim

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
AbbVie

Investigators

  • Principal Investigator: Jaehwan Kim, MD, PhD, The Rockefeller University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2021

Primary Completion (Actual)

May 13, 2025

Study Completion (Actual)

May 13, 2025

Study Registration Dates

First Submitted

November 9, 2020

First Submitted That Met QC Criteria

November 13, 2020

First Posted (Actual)

November 16, 2020

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JKI-1011
  • K23AR080043 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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