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NCT02576678 · ClinicalTrials.gov registry record · Phase 2
A Study of Safety, Tolerability and Pharmacokinetics of Apremilast (CC-10004) in Pediatric Subjects With Moderate to Severe Plaque Psoriasis
A Phase 2 study of Psoriasis, sponsored by Amgen.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
- 18
- Study locations
NCT02576678: Completed Phase 2 study of Psoriasis, sponsored by Amgen.
NCT02576678 is a Phase 2 study of Psoriasis that has completed, run by Amgen. The registered enrollment target is 42 participants, below the 488-participant average among 125 other Psoriasis trials with a reported enrollment target (91% lower). The trial reports 18 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02576678, a Phase 2 study of Psoriasis, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
- 18
- Study locations
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.
Primary Outcome
A TEAE is an adverse event with a start date on or after the date of the first dose of apremilast and no later than 28 days after the last dose of apremilast. An adverse event 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. A
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 |
What the finished NCT02576678 record still lists
NCT02576678 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 488-participant average among 125 other Psoriasis trials with a reported enrollment target (91% 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.
NCT02576678 lists 18 locations in 9 states (Other, Illinois, California).
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.
What interventions are being tested in trial NCT02576678?
The interventions under investigation include: Apremilast (DRUG).
Who is sponsoring clinical trial NCT02576678?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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.
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 NCT02576678's enrollment target sits among peer trials
42 82nd of 125 higher than 44 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.
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