ong-term Study of Apremilast (CC-10004) in Pediatric Subjects from 6 Through 17 Years of Age with Moderate to Severe Plaque Psoriasis

Phase 1

• Conditions: Moderate to Severe Plaque Psoriasis; MedDRA version: 20.0Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2019-003497-13-FR
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-28
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. Subject is male or female 6 to 17 years of age, inclusive, at the time the informed consent document is signed by the legal guardian.
2. Subject must have a weight of = 20 kg.
3. Subjects must have an age and sex specific BMI value no lower in range than the 5th percentile on the Centers for Disease Control (CDC) growth chart for children and adolescents (CDC, 2000).
4. Subject must have completed Week 52 (Apremilast Extension Phase) of Study CC-10004-PPSO-003.
5. Subject is able to sign an assent with a legal guardian/s who understand/s and voluntarily sign/s an informed consent prior to any study-related assessments/procedures being conducted.
Are the trial subjects under 18? yes
Number of subjects for this age range: 140
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

1. Subject has a condition, including the presence of laboratory abnormalities, or psychiatric illness, that would place the subject at unacceptable risk if he/she were to participate in the study.
2. Subject has a condition that confounds the ability to interpret data from the study.
3. Subject has evidence of skin conditions, other than psoriasis, that would interfere with clinical assessments.
4. Subject is pregnant or breastfeeding.
5. Subject has guttate, erythrodermic, or pustular psoriasis.

Study & Design

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