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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
NCT04175613 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04175613
The ClinicalTrials.gov registry entry for NCT04175613 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 160 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 266 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 1 intervention — of which Apremilast 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: NCT04175613 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Other, Florida. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04175613?
The interventions under investigation include: Apremilast (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04175613?
This trial is sponsored by Amgen, which has 266 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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