NCT04630652CompletedPhase 4
Risankizumab Long-term Remission Study
Immune Modification of Psoriasis by Selective IL-23 Blockade Using Risankizumab
Source: ClinicalTrials.gov · Last updated 27 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 9 Nov 2020
- Start date
- 7 Apr 2021
- Primary completion date
- 13 May 2025
- Lead sponsor
- Jaehwan Kim
- Diseases
- Psoriasis
- NCT number
- NCT04630652
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 24
- From 7 Apr 2021 to the primary completion date, 13 May 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- History of recent or ongoing uncontrolled bacterial, viral, fungal, or other opportunistic infections.
- 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.
Lab values
- 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.
Other
- Non-plaque forms of psoriasis.
- Positive QuantiFERON-TB Gold test. PPD tuberculin test may be substituted for QuantiFERON-TB Gold test.
- Females who are pregnant, lactating, planning on pregnancy during the study period, or unwilling to use a medically acceptable method of birth control.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Rockefeller Univesity Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of California, Davis Medical Center Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| VA Northern California Health Care System Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.