Study to Assess the Safety and Efficacy of Subcutaneously Injected Risankizumab in Adult Participants With Genital or Scalp Psoriasis
Public ClinicalTrials.gov record NCT05969223. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 4 Multicenter, Randomized, Double-Blind Study of Risankizumab for the Treatment of Adult Subjects With Moderate to Severe Genital Psoriasis or Moderate to Severe Scalp Psoriasis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Psoriasis (PsO) is a chronic disease characterized by marked inflammation of the skin that results in thick, red, scaly plaques. This study will assess how safe and effective risankizumab is in adult participants with moderate to severe genital psoriasis or moderate to severe scalp psoriasis. Adverse events and change in disease signs and symptoms will be monitored. Risankizumab (Skyrizi) is a drug being studied for the treatment of moderate to severe genital psoriasis or moderate to severe scalp psoriasis. Approximately 200 participants with moderate to severe genital psoriasis or moderate to severe scalp psoriasis will be enrolled across approximately 45 sites globally. The study will be broken up into 2 studies by disease location, participants with moderate to severe genital psoriasis (Study-G) and moderate to severe scalp psoriasis (Study-S). In both studies participants will receive subcutaneous (SC) injections of risankizumab during the 52 week treatment period, or SC injections of placebo risankizumab during the 16 week treatment period followed by SC injections of risankizumab during the 36 week treatment period, with an 8-week follow-up period after the 52 week treatment period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Study identification
- NCT ID
- NCT05969223
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 214 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 10, 2023 (Actual)
- Primary completion
- Jan 22, 2025 (Actual)
- Completion
- Nov 28, 2025 (Actual)
- Last update posted
- Feb 24, 2026
2023 – 2025
United States locations
- U.S. sites
- 38
- U.S. states
- 19
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Medical Dermatology Specialists /ID# 262915 | Phoenix | Arizona | 85006 | — |
| Alliance Dermatology and Mohs Center /ID# 255846 | Phoenix | Arizona | 85032 | — |
| Banner University Medicine Dermatology /ID# 255845 | Tucson | Arizona | 85718-1407 | — |
| Private Practice - Dr. Tooraj Raoof /ID# 255334 | Encino | California | 91436 | — |
| Dermatology Research Associates /ID# 255347 | Los Angeles | California | 90045 | — |
| Clinical Trials Research Institute /ID# 264555 | Thousand Oaks | California | 91320-2130 | — |
| Florida Academic Dermatology Center /ID# 264065 | Coral Gables | Florida | 33134-5755 | — |
| Skin Care Research - Hollywood /ID# 255394 | Hollywood | Florida | 33021-6748 | — |
| GSI Clinical Research, LLC /ID# 255472 | Margate | Florida | 33063 | — |
| Skin and Cancer Associates, LLP /ID# 255506 | Miami | Florida | 33137-3254 | — |
| Sullivan Dermatology /ID# 264067 | Miami | Florida | 33162 | — |
| Renstar Medical Research /ID# 255339 | Ocala | Florida | 34470 | — |
| Hamilton Research, LLC /ID# 255409 | Alpharetta | Georgia | 30022 | — |
| Treasure Valley Medical Research /ID# 255671 | Boise | Idaho | 83706 | — |
| DeNova Research /ID# 264063 | Chicago | Illinois | 60610 | — |
| Arlington Dermatology /ID# 255330 | Rolling Meadows | Illinois | 60008 | — |
| The Indiana Clinical Trials Center /ID# 255333 | Plainfield | Indiana | 46168 | — |
| Dermatology Partners of Leawood /ID# 263244 | Leawood | Kansas | 66211 | — |
| DermAssociates - Rockville /ID# 263252 | Rockville | Maryland | 20850 | — |
| Skin Specialists /ID# 262929 | Omaha | Nebraska | 68144 | — |
| Skin Cancer and Dermatology Institute (SCDI) /ID# 264570 | Sparks | Nevada | 89436 | — |
| Care Access - Hoboken /ID# 264066 | Hoboken | New Jersey | 07030 | — |
| Forest Hills Dermatology Group @ Union Turnpike /ID# 255346 | Kew Gardens | New York | 11415 | — |
| Schweiger Dermatology, P.C. /ID# 255336 | New York | New York | 07044-2946 | — |
| Darst Dermatology /ID# 255848 | Charlotte | North Carolina | 28277 | — |
| Wright State Physicians Health Center /ID# 255395 | Fairborn | Ohio | 45324 | — |
| Apex Clinical Research Center /ID# 263432 | Mayfield Heights | Ohio | 44124 | — |
| Oregon Dermatology and Research Center /ID# 255670 | Portland | Oregon | 97210 | — |
| Oregon Medical Research Center /ID# 255332 | Portland | Oregon | 97239 | — |
| Studies in Dermatology LLC /ID# 262989 | Cypress | Texas | 77429 | — |
| Modern Research Associates /ID# 263234 | Dallas | Texas | 75231 | — |
| Center for Clinical Studies - Houston (Binz) /ID# 255396 | Houston | Texas | 77004-8097 | — |
| U.S. Dermatology Partners Longview /ID# 266325 | Longview | Texas | 75601 | — |
| Progressive Clinical Research - San Antonio /ID# 263255 | San Antonio | Texas | 78229 | — |
| Center for Clinical Studies Webster TX /ID# 255518 | Webster | Texas | 77598 | — |
| Care Access - Danville /ID# 266300 | Danville | Virginia | 24541 | — |
| Center for Excellence in Dermatology /ID# 264647 | Kennewick | Washington | 99336 | — |
| North Sound Dermatology /ID# 264565 | Mill Creek | Washington | 98012 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05969223, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 24, 2026 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05969223 live on ClinicalTrials.gov.