Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis
Public ClinicalTrials.gov record NCT03701763. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN PEDIATRIC SUBJECTS FROM 6 THROUGH 17 YEARS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in pediatric subjects with moderate to severe plaque psoriasis. At least 230 pediatric subjects (ages 6 through 17 years) will be randomized 2:1 to receive either apremilast or placebo for the first 16 weeks and then all subjects will receive apremilast during the 36 week Extension Phase for a total of 52 weeks. Randomization to apremilast arm or placebo arm will be stratified by age group (6 to 11 years or 12 to 17 years). Subjects will receive apremilast treatment of either 20 mg twice daily (BID) or 30 mg BID, depending on weight. This Phase 3 study is being conducted to evaluate the safety and efficacy of apremilast in the treatment of pediatric subjects.
Study identification
- NCT ID
- NCT03701763
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 245 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 18, 2018
- Primary completion
- Apr 24, 2022
- Completion
- Mar 26, 2023
- Last update posted
- Dec 15, 2024
2018 – 2023
United States locations
- U.S. sites
- 39
- U.S. states
- 21
- U.S. cities
- 38
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35233 | — |
| Phoenix Childrens Hospital | Phoenix | Arizona | 85016 | — |
| Johnson Dermatology Clinic | Fort Smith | Arkansas | 72916 | — |
| Zenith Research Inc. | Beverly Hills | California | 90212 | — |
| First OC Dermatology | Fountain Valley | California | 92708 | — |
| Avance Clinical Trials | Laguna Niguel | California | 92677 | — |
| Stanford University | Palo Alto | California | 94304 | — |
| Coastal Family Dermatology | San Luis Obispo | California | 93401 | — |
| University of California Los Angeles | Santa Monica | California | 90404 | — |
| California Dermatology Institute | Thousand Oaks | California | 91320 | — |
| Solutions Through Advanced Research Inc | Jacksonville | Florida | 32256 | — |
| Glick Skin Institute Clinical Research | Margate | Florida | 33063 | — |
| University of Miami Hospital | Miami | Florida | 33136 | — |
| Ciocca Dermatology | Miami | Florida | 33173 | — |
| University of South Florida Health Morsani Center for Advanced Healthcare | Tampa | Florida | 33612-4742 | — |
| Skin Care Physicians of Georgia | Macon | Georgia | 31217 | — |
| Treasure Valley Medical Research | Meridian | Idaho | 83646 | — |
| DeNova Research | Chicago | Illinois | 60602 | — |
| Dawes Fretzin Dermatology Group Inc | Indianapolis | Indiana | 46256 | — |
| Epiphany Dermatology of Kansas, LLC | Overland Park | Kansas | 66210 | — |
| ActivMed Practices and Research Inc | Beverly | Massachusetts | 01915 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| J Woodson Dermatology and Associates Ltd | Henderson | Nevada | 89052 | — |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03766 | — |
| Forest Hills Dermatology Group | Forest Hills | New York | 11375 | — |
| SUNY Downstate Medical Center | Manhasset | New York | 11030 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Cincinnati Childrens Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Wright State Physicians | Fairborn | Ohio | 45324 | — |
| Essential Medical Research, LLC | Tulsa | Oklahoma | 74137 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Arlington Research Center | Arlington | Texas | 76011 | — |
| Driscoll Childrens Hospital | Corpus Christi | Texas | 78411 | — |
| Modern Research Associates PLLC | Dallas | Texas | 75231 | — |
| Mosaic Dermatology | Houston | Texas | 77065 | — |
| Texas Dermatology and Laser Specialists | San Antonio | Texas | 78218 | — |
| Jordan Valley Dermatology Center | West Jordan | Utah | 84088 | — |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53715 | — |
| Childrens Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 60 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03701763, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 15, 2024 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03701763 live on ClinicalTrials.gov.