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 10 mg
Product Code: CC-10004
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Apremilast 10 mg
CAS Number: 608141-41-9
Current Spo
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject must satisfy the following criteria to be enrolled in the study: 1. Males or female subjects 6 to 17 years of age, inclusive, at the time the informed consent form is signed by the legal guardian 2. Subjects must have a weight of = 20 kg 3. Subject must have 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. 4. Subject is able to swallow the study medication tablet 5. Able to sign an age-appropriate 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. 6. Be willing and able to adhere to the study visit schedule and other protocol requirements. 7. Diagnosis of chronic plaque psoriasis for at least 6 months prior to screening. 8. Has moderate to severe plaque psoriasis at screening and baseline as defined by: • PASI score = 12; and • Body surface area (BSA) = 10%; and • sPGA = 3 (moderate to severe) 9. Disease inadequately controlled by or inappropriate for topical therapy for psoriasis. 10. Candidate for systemic therapy or phototherapy. 11. At screening, laboratory values must be within the following ranges •White blood cell (WBC) count Age (years) Males (x 103 /µL) Females (x 103 /µL) 6-11 3.5 – 13.5 3.5 – 13.5 12-18 3.5 – 13.5 3.5 – 13.5 •Platelet count Age (years) Males (x 103 /µL) Females (x 103 /µL) 6-11 125 – 500 125 – 500 12-18 125 – 500 125 – 500 •Serum creatinine = 1.2 x upper-limit of normal (ULN) for age and gender. Please see reference ranges of the central laboratory •Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) = 1.5 x ULN for age and gender. If initial test of ALT or AST is > 1.5 x ULN, one repeat test is allowed during Screening. Please see the reference ranges of the central laboratory •Total bilirubin = 2 mg/dL (= 34 µmol/L). If initial test result is > 2 mg/dL, one repeat test is allowed during the Screening period •Hemoglobin (Hb) Age (years) Males (g/dL) Females (g/dL) 6-11 10.0 – 15.0 10.0 – 15.0 12-18 11.0 – 16.5 10.5 – 15.5 12. All females of childbearing potential (FCBP) must either practice abstinence* from heterosexual contact or use one of the approved contraceptive options as described below while on apremilast and during any dose interruption, and for at least 28 days after administration of the last dose of apremilast. For the purpose of thisstudy, a female subject is considered of childbearing potential if she is = 12 years old or has reached menarche, whichever occurred first. At the time of study entry, and at any time during the study when a female subject of childbearing potential's contraceptive measures or ability to become pregnant changes, the Investigator will educate the subject regarding abstinence or contraception options and the correct and consistent use of effective contraceptive methods in order to successfully prevent pregnancy. Females of childbearing potential must have a negative pregnancy test at Screening and Baseline. All FCBP who engage in activity in which conception is possible must use one of the approved contraceptive+ options described below: Option 1: Any one of the following highly effective methods: hormonal contraception (for example, birth control pills, intr
Exclusion criteria
Exclusion criteria: The presence of any of the following will exclude a subject from enrollment: 1. Other than psoriasis, history of any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease. 2. Any 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 3. Any condition that confounds the ability to interpret data from the study. 4. Evidence of skin conditions, other than psoriasis, that would interfere with clinical assessments 5. Pregnant or breastfeeding 6. Guttate, erythrodermic, or pustular psoriasis at Screening and Baseline 7. Psoriasis flare or rebound within 4 weeks prior to Screening 8. Positive Hepatitis B surface antigen, or anti-hepatitis C antibody, at Screening 9. History of positive human immunodeficiency virus infection (HIV), congenital and acquired immunodeficiencies (eg, common variable immunodeficiency, immunoglobulin A deficiency) 10. Active tuberculosis (TB) or a history of incompletely treated TB 11. History of recurrent significant infections 12. Active infection or infection treated with antibiotic treatment within 2 weeks of first dose 13. Any history of or active malignancy 14. History of allergy/intolerance to any component of the investigational product, ie, apremilast, lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose 15cP, titanium dioxide, polydextrose food chemical color, talc, maltodextrine, medium chain triglycerides, iron oxide red, iron oxide yellow, and iron oxide black. 15. Deficiencies in lactose metabolism, ie, galactose-1-phosphate uridylyltransferase, UDP-galactose 4-epimerase, galactokinase or Fanconi Bickel syndrome, including congenital lactase deficiencies, and glucose-galactose malabsorption. 16. Prior history of suicide attempt at any time in the subject's lifetime prior to Screening or randomization in the study, or major psychiatric illness requiring hospitalization within 3 years prior to signing the assent and informed consent 17. Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale during Screening or at Baseline 18. Current or planned concurrent use of the following therapies that may have a possible effect on psoriasis a. Topical therapy within 2 weeks prior to randomization (including but not limited to topical corticosteroids, topical retinoid or vitamin D analog preparations, tacrolimus, pimecrolimus, or anthralin/dithranol) Exceptions*: i. Low potency or weak corticosteroids (please refer to the Investigators' Manual) will be allowed as background therapy for treatment of the face, axillae and groin in accordance with manufacturer's suggested usage ii. Unmedicated skin moisturizer (eg, Eucerin®) will also be permitted for body lesions *Subjects should not use these topical treatments within 24 hours prior to the clinic visit. b. Conventional systemic therapy for psoriasis within 4 weeks prior to randomization (including but not limited to cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, sulfasalazine, azathioprine, and fumaric acid esters) c. Phototherapy treatment (ie, ultraviolet B [UVB], PUVA) within 4 weeks prior to randomization d. Biologic therapy: i. Etanercept (or biosimilar) t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the clinical efficacy of apremilast compared with placebo in children and adolescents (ages 6 through 17 years) with moderate to severe plaque psoriasis.;Secondary Objective: The secondary objectives are: •To evaluate the safety and tolerability of apremilast compared with placebo, in children and adolescents (ages 6 through 17 years) with moderate to severe plaque psoriasis •To evaluate the effect of apremilast compared with placebo on health-related quality of life (HRQoL);Primary end point(s): Static Physician Global Assessment (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: Primary endpoint will be evaluated at the end of Week 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Psoriasis Area Severity Index-75 (PASI-75) - Proportion of subjects who achieve at least a 75% reduction in PASI (PASI-75) from baseline 2. PASI-50 - Proportion of subjects who achieve at least a 75% reduction in PASI (PASI-75) from baseline 3. PASI - Percent change from baseline in total PASI score 4. Children's Dermatological Life Quality Index (CDLQI) - Change from baseline in CDLQI score 5. CDLQI (0/1) - Proportion of subjects who achieve CDLQI (0/1) 6. Body Surface Area (BSA) - Percent change from baseline in affected BSA;Timepoint(s) of evaluation of this end point: All secondary endpoints will be evaluated at the end of Week 16. | — |
Countries
Belgium, Canada, Czechia, Czech Republic, France, Hungary, Israel, Italy, Netherlands, Poland, Russian Federation, Spain, United States
Contacts
Public ContactMedical Information
Amgen (EUROPE) GmbH
Outcome results
None listed