A clinical trial to evaluate if apremilast is safe in children and adolescents with moderate to severe plaque psoriasis as well as assessing how apremilast is processed by the body, and to determine the appropriate dose for them
Phase 1
- Conditions
- Moderate to severe plaque psoriasis in adolescents (ages 12 to 17 years, inclusive) and in children (ages 6 to 11 years, inclusive).Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]MedDRA version: 18.1 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disordersMedDRA version: 18.1 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
- Registration Number
- EUCTR2015-003314-24-ES
- Lead Sponsor
- Celgene Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 32
Inclusion Criteria
Male or female 6 to 17 years of age with diagnosis of chronic plaque psoriasis
Are the trial subjects under 18? yes
Number of subjects for this age range: 32
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study or which places subject at unacceptable riskif he/she were to participate in the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method