A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms
Public ClinicalTrials.gov record NCT04435600. 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 Randomized, Active-Controlled, Efficacy Assessor-Blinded Study to Evaluate Pharmacokinetics, Safety and Efficacy of Risankizumab in Patients From 6 to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin. There is an unmet medical need for effective treatment in pediatric patients and this study is being done to evaluate risankizumab in pediatric participants with moderate to severe plaque psoriasis. This study will assess the change in disease symptoms. Risankizumab is a drug being studied for the treatment for plaque psoriasis in pediatric participants. This study has 4 parts. Part 1: Participants aged 12 \< 18 will receive a fixed dose of risankizumab. Part 2: Participants aged 12 \< 18 will receive; * Period A: Risankizumab or ustekinumab based on body weight followed by; * Period B: Risankizumab or no treatment. * Period C: Re-treatment with risankizumab (if needed). Part 3: Participants aged 6 \< 12 will receive risankizumab based on body weight. Part 4: Participants aged 6 \< 12 will receive risankizumab based on body weight (Japan only: Participants aged 12 \> 18 will receive risankizumab based on body weight). Around 132 participants will be enrolled in approximately 50 sites worldwide. Risankizumab and ustekinumab are given as a subcutaneous (under the skin) injection. Parts 1, 3, and 4: Risankizumab for 40 weeks with a follow-up call 20 weeks later for a study duration of approximately 65 weeks. Part 2: * Period A: Risankizumab or ustekinumab for 16 weeks. * Period B: Risankizumab or no treatment for 36 weeks. * Period C: Re-treatment with risankizumab for 16 weeks. Follow-up call 20 weeks later for a study duration of approximately 81 weeks. Participants from each Part who meet eligibility criteria for an open-label extension (OLE) study may continue on risankizumab for 216 additional weeks. There may be a higher burden for study participants compared to standard treatment. Participants will attend monthly visits and medical assessments will check the effect of treatment through blood tests, questionnaires, and checking for side effects.
Study identification
- NCT ID
- NCT04435600
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 139 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Years to 17 Years
- 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
- Jul 14, 2020 (Actual)
- Primary completion
- Feb 12, 2024 (Actual)
- Completion
- Oct 15, 2024 (Actual)
- Last update posted
- May 20, 2025
2020 – 2024
United States locations
- U.S. sites
- 21
- U.S. states
- 12
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UAB Department of Dermatology /ID# 218834 | Birmingham | Alabama | 35233 | — |
| First OC Dermatology /ID# 217733 | Fountain Valley | California | 92708 | — |
| Integrative Skin Science and Research /ID# 221741 | Sacramento | California | 95815 | — |
| University of California San Diego - Rady Children's Hospital San Diego /ID# 217906 | San Diego | California | 92123 | — |
| Rybear, Inc /ID# 223164 | Fort Lauderdale | Florida | 33316-1952 | — |
| Solutions Through Adv Rch /ID# 217936 | Jacksonville | Florida | 32256 | — |
| Olympian Clinical Research- St. Petersburg /ID# 217941 | St. Petersburg | Florida | 33709-1405 | — |
| Advanced Clinical Research Institute /ID# 222706 | Tampa | Florida | 33607 | — |
| University Dermatology and Vein Clinic, LLC /ID# 222778 | Darien | Illinois | 60561 | — |
| Duplicate_Arlington Dermatology /ID# 217472 | Rolling Meadows | Illinois | 60008 | — |
| Duplicate_Skin Cancer and Dermatology Institute (SCDI) /ID# 221738 | Reno | Nevada | 89052 | — |
| Duplicate_Forest Hills Dermatology Group /ID# 227941 | Kew Gardens | New York | 11415 | — |
| Univ Hosp Cleveland /ID# 228483 | Cleveland | Ohio | 44106 | — |
| The Ohio State University /ID# 217808 | Columbus | Ohio | 43210 | — |
| Apex Clinical Research Center /ID# 228537 | Mayfield Heights | Ohio | 44124 | — |
| Vital Prospects Clinical Research Institute, PC /ID# 217960 | Tulsa | Oklahoma | 74136-7049 | — |
| Medical University of South Carolina /ID# 217735 | Charleston | South Carolina | 29425 | — |
| Arlington Research Center, Inc /ID# 217471 | Arlington | Texas | 76011 | — |
| West Virginia University Hospitals /ID# 228352 | Morgantown | West Virginia | 26506 | — |
| Clinical Investigation Specialist, Inc - Kenosha /ID# 223161 | Kenosha | Wisconsin | 53144-1782 | — |
| Wisconsin Medical Center /ID# 240005 | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 32 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04435600, 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 May 20, 2025 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04435600 live on ClinicalTrials.gov.