Psoriasis breakthrough? single shot may keep skin clear for over a year
NCT ID NCT04630652
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at 24 adults with moderate-to-severe plaque psoriasis to understand how a single injection of risankizumab (Skyrizi) changes immune cells in the skin. The goal was to learn why some patients stay clear of psoriasis for up to 66 weeks without further treatment. Researchers took skin biopsies before and after the drug to track immune cell changes and build models that might predict who can achieve long-term remission.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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24 people
The number who actually took part.
- Started
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Apr 2021
- Finished
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May 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The Rockefeller Univesity
New York, New York, 10065, United States
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University of California Davis Medical Center
Sacramento, California, 95817, United States
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VA Northern California Health Care System
Sacramento, California, 95655, United States
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