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A Study of Safety, Tolerability and Pharmacokinetics of Apremilast (CC-10004) in Pediatric Subjects With Moderate to Severe Plaque Psoriasis
NCT02576678 · View on ClinicalTrials.gov ↗
Study Summary
This is a Phase 2, multicenter, open-label study in subjects with moderate to severe plaque psoriasis aged 6 to 17 years, inclusive, intended to assess the safety, tolerability, and PK of apremilast with 2 weeks of oral apremilast treatment followed by a 48-week extension of apremilast treatment. Moderate to severe plaque psoriasis is defined as Psoriasis Area Severity Index (PASI) ≥ 12, Body Surface Area (BSA) ≥ 10%, and static Physician Global Assessment (sPGA) of ≥ 3. The total study duration for each subject will last for up to a total of 107 weeks which includes screening, treatment (including the PK portion of the study and the extension treatment period), two short-term follow-up periods and a long-term follow-up period.
Conditions Studied
Interventions
- DRUG Apremilast
Study Locations (18)
Other
- Rheinische Friedrich-Wilhelms-Universitaet Bonn - Universitaetsklinikum Bonn — Bonn
- Universitatsklinikum Essen — Essen
- Universitatsklinikum Klinikum Frankfurt Main — Frankfurt
- Kinderkrankenhaus Wilhelmstift, Dermatologie — Hamburg
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz — Mainz
- Muenster University Hospital (Universitätsklinikum Muenster) — Münster
- Hospital de la Santa Creu i Sant Pau — Barcelona
- Hospital Sant Joan de Deu — Esplugues de Llobregat
- Hospital La Paz — Madrid
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago Department of Dermatology — Chicago
- Dundee Dermatology — West Dundee
California
- Rady Children's Hospital — San Diego
Georgia
- Emory University — Atlanta
New York
- Mount Sinai, St. Luke's — New York
Texas
- Texas Dermatology and Laser Specialists — San Antonio
Alberta
- Stollery Children's Hospital — Edmonton
Newfoundland and Labrador
- Nexus Clinical Research — St. John's
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2015-10-13 |
| Est. Completion | 2019-07-29 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02576678
The ClinicalTrials.gov registry entry for NCT02576678 describes a study currently listed as completed. It is categorized as Phase 2, 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 42 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: NCT02576678 reports 18 study locations spanning 9 distinct geographic areas — top geographies include Other, Illinois, California. 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 NCT02576678 about?
NCT02576678 is a clinical study titled "A Study of Safety, Tolerability and Pharmacokinetics of Apremilast (CC-10004) in Pediatric Subjects With Moderate to Severe Plaque Psoriasis". This is a Phase 2, multicenter, open-label study in subjects with moderate to severe plaque psoriasis aged 6 to 17 years, inclusive, intended to assess the safety, tolerability, and PK of apremilast with 2 weeks of oral apremilast treatment followed by a 48-week extension of apremilast treatment. Mo...
What is the current status of trial NCT02576678?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2015-10-13. Estimated completion is 2019-07-29.
What conditions does trial NCT02576678 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 NCT02576678?
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 NCT02576678?
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 NCT02576678 being conducted?
This trial has 18 study locations across California, Georgia, Illinois, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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