Moderate to Severe Plaque Psoriasis MedDRA version: 20.0 Level: LLT Classification code 10071117 Term: Plaque psoriasis System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Otezla (apremilast)
Product Name: Apremilast 20 mg
Product Code: CC-10004
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Apremilast 20 mg
CAS Number: 608141-41-9
Current Spon
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the long-term safety of apremilast in children and adolescents (ages 6 through 17 years) with moderate to severe plaque psoriasis;Secondary Objective: To evaluate maintenance of effect as measured by static Physician Global Assessment (sPGA) ;Primary end point(s): 1. Adverse Events: Type, frequency, severity, and relationship to apremilast from Week 0 (Visit 1) through end of Observational Follow-up 2. Columbia-Suicide Severity Rating Scale (C-SSRS) Questionnaire to monitor depression, suicidal thoughts and behavior 3. Tanner Staging Assessment of sexual maturity 4. Body weight, height and BMI: Monitor growth - Height and body weight are measured at each visit;Timepoint(s) of evaluation of this end point: end points 1 and 2 for the entire the study duration end point 3 at Week 0 (Visit 1) and then every 52 weeks. Also Early Termination visit end point 4 at every study visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): sPGA - Proportion of subjects with an sPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline;Timepoint(s) of evaluation of this end point: at every study visit | — |
Countries
Belgium, Canada, Czech Republic, France, Germany, Israel, Italy, Netherlands, Russian Federation, Spain, United States
Contacts
Public ContactMedical Information
Amgen (EUROPE) GmbH
Outcome results
None listed