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).; MedDRA version: 18.1 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders; MedDRA version: 18.1 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2015-003314-24-GB
• Lead Sponsor: Celgene Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-25
• Last Update Posted: 16 December 2019

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 the subject at unacceptable risk if he/she were to participate in the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified