Study to Assess the Long-term Safety, Tolerability, Efficacy of Secukinumab in Pediatric Patients of Age 6 to <18 Years, With Moderate to Severe Plaque Psoriasis
Part of paid clinical trials in Fountain Valley, California.
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT03668613
- Phase
- PHASE3
- Status
- Completed
Conditions
- Moderate to Severe Chronic Plaque-type Psoriasis
Eligibility Criteria
- Sex
- ALL
- Age
- 6 Years - 17 Years
- Healthy Volunteers
- Not accepted
Interventions
- secukinumab low dose — DRUGdose depends on the weight group
- secukinumab high dose — DRUGdose depends on the weight group
Study Details
This was an open-label, parallel-group, two-arm, multicenter study in pediatric subjects aged 6 years to less than 18 years, at randomization, with moderate to severe chronic plaque psoriasis. 84 subjects (most with moderate severity) were enrolled. Subjects were stratified by weight and disease severity.
Key Dates
- Start date
- Aug 29, 2018
- Status verified
- May 2025
- Primary completion
- Sep 19, 2019
- Completion
- Sep 12, 2023
Study Design
- Enrollment
- 84 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: secukinumab low dosesecukinumab low dose
- Experimental: secukinumab high dosesecukinumab high dose
Primary Outcome Measure
Number and Percentage of Participants With PASI 75 Response [ Time Frame: Week 12 ]
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| First OC Dermatology | Fountain Valley | California | 92708 | - |
| Private Practice | Jacksonville | Florida | 32256 | - |
| Novartis Investigative Site | Lebanon | New Hampshire | 03756 | - |
| Texas Derm and Laser Specialists . | San Antonio | Texas | 78218 | - |