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A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms
NCT04435600 · View on ClinicalTrials.gov ↗
Study Summary
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, questionnai
Conditions Studied
Interventions
- DRUG Ustekinumab
- DRUG Risankizumab
Study Locations (20)
Florida
- Rybear, Inc /ID# 223164 — Fort Lauderdale
- Solutions Through Adv Rch /ID# 217936 — Jacksonville
- Olympian Clinical Research- St. Petersburg /ID# 217941 — St. Petersburg
- Advanced Clinical Research Institute /ID# 222706 — Tampa
California
- First OC Dermatology /ID# 217733 — Fountain Valley
- Integrative Skin Science and Research /ID# 221741 — Sacramento
- University of California San Diego - Rady Children's Hospital San Diego /ID# 217906 — San Diego
Ohio
- Univ Hosp Cleveland /ID# 228483 — Cleveland
- The Ohio State University /ID# 217808 — Columbus
- Apex Clinical Research Center /ID# 228537 — Mayfield Heights
Illinois
- University Dermatology and Vein Clinic, LLC /ID# 222778 — Darien
- Duplicate_Arlington Dermatology /ID# 217472 — Rolling Meadows
Alabama
- UAB Department of Dermatology /ID# 218834 — Birmingham
Nevada
- Duplicate_Skin Cancer and Dermatology Institute (SCDI) /ID# 221738 — Reno
New York
- Duplicate_Forest Hills Dermatology Group /ID# 227941 — Kew Gardens
Oklahoma
- Vital Prospects Clinical Research Institute, PC /ID# 217960 — Tulsa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2020-07-14 |
| Est. Completion | 2024-10-15 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04435600
The ClinicalTrials.gov registry entry for NCT04435600 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 139 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Psoriasis appearing as the primary indexed condition, and to 2 interventions — of which Ustekinumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04435600 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, California, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04435600 about?
NCT04435600 is a clinical study titled "A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms". 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...
What is the current status of trial NCT04435600?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 139 participants. The study started on 2020-07-14. Estimated completion is 2024-10-15.
What conditions does trial NCT04435600 study?
This clinical trial studies the following conditions: Psoriasis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04435600?
The interventions under investigation include: Ustekinumab (DRUG), Risankizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04435600?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04435600 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Illinois, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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