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NCT04175613 · ClinicalTrials.gov registry record · Phase 3
A Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis
A Phase 3 study of Psoriasis, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 160
- Enrollment target
- 20
- Study locations
NCT04175613: Completed Phase 3 study of Psoriasis, sponsored by Amgen.
NCT04175613 is a Phase 3 study of Psoriasis that has completed, run by Amgen. The registered enrollment target is 160 participants, below the 487-participant average among 125 other Psoriasis trials with a reported enrollment target (67% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04175613, a Phase 3 study of Psoriasis, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 160 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study was created to provide subjects who complete Week 52 (end of Apremilast Extension Phase) of study CC-10004-PPSO-003 the option to continue to receive open-label apremilast therapy. The study will consist of up to 208 weeks of long-term treatment followed by an 8-week observational follow-up phase.
Primary Outcome
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
Conditions Studied
Interventions
- DRUG Apremilast
Study Locations (20)
California
- First OC Dermatology - Irvine
- Stanford University School of Medicine - Palo Alto
- California Dermatology Institute - Thousand Oaks
Other
- Centre Hospitalier Universitaire Saint Pierre - Brussels
- Cliniques Universitaires Saint Luc - Brussels
- Universitair Ziekenhuis Gent - Ghent
Florida
- Solutions Through Advanced Research Inc - Jacksonville
- Ciocca Dermatology - Miami
Arizona
- Phoenix Childrens Hospital - Phoenix
Arkansas
- Johnson Dermatology Clinic - Fort Smith
Georgia
- Skin Care Physicians of Georgia - Macon
Indiana
- Dawes Fretzin Dermatology Group Inc - Indianapolis
Ohio
- Wright State Physicians - Fairborn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2019-12-20 |
| Est. Completion | 2025-12-12 |
| Phase | Phase 3 |
What the finished NCT04175613 record still lists
NCT04175613 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 487-participant average among 125 other Psoriasis trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Psoriasis appearing as the primary indexed condition, and to 1 intervention - of which Apremilast is the first listed.
NCT04175613 names 20 study sites across 15 states, led by California, Other, Florida.
Frequently Asked Questions
What is clinical trial NCT04175613 about?
NCT04175613 is a clinical study titled "A Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis". This study was created to provide subjects who complete Week 52 (end of Apremilast Extension Phase) of study CC-10004-PPSO-003 the option to continue to receive open-label apremilast therapy. The study will consist of up to 208 weeks of long-term treatment followed by an 8-week observational follow...
What is the current status of trial NCT04175613?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 160 participants. The study started on 2019-12-20. Estimated completion is 2025-12-12.
What conditions does trial NCT04175613 study?
This clinical trial studies the following conditions: Psoriasis.
What interventions are being tested in trial NCT04175613?
The interventions under investigation include: Apremilast (DRUG).
Who is sponsoring clinical trial NCT04175613?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04175613 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Psoriasis
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 NCT04175613's enrollment target sits among peer trials
160 45th of 125 higher than 81 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
-
Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 6 and 17 Years With Moderate to Severe Plaque Psoriasis Treated With Subcutaneous (SC) Injection of Risankizumab Who Have Completed Participation in Study M19-977
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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
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