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

A Phase 2, Multicenter, Open-label Study to Assess the Safety, Tolerability and Pharmacokinetics of Apremilast (CC-10004) in Pediatric Subjects with Moderate to Severe Plaque Psoriasis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003314-24-GB

Enrollment

Registered

2015-11-25

Start date

Unknown

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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:

Interventions

Product Name: Apremilast Product Code: CC-10004 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Apremilast CAS Number: 6081

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to select a paediatric dose of apremilast based on the safety, tolerability, and PK of apremilast in adolescents and children with moderate to severe plaque psoriasis.;Secondary Objective: The secondary objective is to evaluate the taste and acceptability of apremilast tablet using a faces Likert Scale.; Primary end point(s): Safety: a.Adverse events (AEs) b.Complete Physical examinations c.Vital sign measurements d.Height and weight e.Clinical laboratory safety tests f.12-lead electrocardiograms (ECGs) g.Concomitant medications / procedures h.Pregnancy testing for females of child-bearing potential i.Hepatitis B and C testing j.Pharmacokinetics: -Maximum observed plasma concentration (Cmax) - Time to Cmax (tmax) - Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-8) - Area under the plasma concentration-time curve from time zero to 12 hours postdose (AUC0-12) - Area under the plasma concentration-time curve from time zero to the last quantifiable concentration (AUC0-t) - Apparent total plasma clearance when dosed orally (CL/F) - Apparent total volume of distribution when dosed orally, based on steady-state (Vss/F) or the terminal phase (Vz/F) - Terminal-phase elimination half-life (t1/2) - CL/F - Apparent total volume of distribution when dosed orally (V/F) - Absorption rate constant (first-order; Ka) - Lag (if applicable) ; Timepoint(s) of evaluation of this end point: a.After signing ICF and until 28 days after the last dose	—

Measure

Time frame

Main Objective: The primary objective of the study is to select a paediatric dose of apremilast based on the safety, tolerability, and PK of apremilast in adolescents and children with moderate to severe plaque psoriasis.;Secondary Objective: The secondary objective is to evaluate the taste and acceptability of apremilast tablet using a faces Likert Scale.; Primary end point(s): Safety: a.Adverse events (AEs) b.Complete Physical examinations c.Vital sign measurements d.Height and weight e.Clinical laboratory safety tests f.12-lead electrocardiograms (ECGs) g.Concomitant medications / procedures h.Pregnancy testing for females of child-bearing potential i.Hepatitis B and C testing j.Pharmacokinetics: -Maximum observed plasma concentration (Cmax) - Time to Cmax (tmax) - Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-8) - Area under the plasma concentration-time curve from time zero to 12 hours postdose (AUC0-12) - Area under the plasma concentration-time curve from time zero to the last quantifiable concentration (AUC0-t) - Apparent total plasma clearance when dosed orally (CL/F) - Apparent total volume of distribution when dosed orally, based on steady-state (Vss/F) or the terminal phase (Vz/F) - Terminal-phase elimination half-life (t1/2) - CL/F - Apparent total volume of distribution when dosed orally (V/F) - Absorption rate constant (first-order; Ka) - Lag (if applicable) ; Timepoint(s) of evaluation of this end point: a.After signing ICF and until 28 days after the last dose

—

Secondary

Measure	Time frame
Secondary end point(s): Taste and acceptability of apremilast tablet;Timepoint(s) of evaluation of this end point: At Visit 2	—

Countries

Canada, Germany, Spain, United Kingdom, United States

Contacts

Public ContactClinicalTrialDisclosure

Celgene Corporation

ClinicalTrialDisclosure@celgene.com+1888-260-1599

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026