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NCT04435600 · ClinicalTrials.gov registry record · Phase 3
A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms
A Phase 3 study of Psoriasis, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 139
- Enrollment target
- 20
- Study locations
NCT04435600: Completed Phase 3 study of Psoriasis, sponsored by AbbVie.
NCT04435600 is a Phase 3 study of Psoriasis that has completed, run by AbbVie. The registered enrollment target is 139 participants, below the 488-participant average among 125 other Psoriasis trials with a reported enrollment target (72% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04435600, a Phase 3 study of Psoriasis, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 139 participants
- Enrollment target
- 20
- Study locations
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
Primary Outcome
The PASI is used to evaluate a participant's overall psoriasis disease state that includes the percent of surface area of skin that is affected and the severity of erythema, induration, and desquamation over four body regions (head, upper extremities, trunk, and lower extremities). Scores range from 0 to 72, with the highest score representing the worst outcome (complete erythroderma of the severest degree). Data are reported for the percentage of participants achieving at least a 75% improvemen
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 |
What the finished NCT04435600 record still lists
NCT04435600 is an interventional study that assigns participants to a tested intervention. The registered 139 participants enrollment target is mid-sized for trials with a published cap, below the 488-participant average among 125 other Psoriasis trials with a reported enrollment target (72% lower).
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.
NCT04435600 names 20 study sites across 12 states, led by Florida, California, Ohio.
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.
What interventions are being tested in trial NCT04435600?
The interventions under investigation include: Ustekinumab (DRUG), Risankizumab (DRUG).
Who is sponsoring clinical trial NCT04435600?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04435600's enrollment target sits among peer trials
139 49th of 125 higher than 77 of 125 other Psoriasis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Psoriasis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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