Safety and Efficacy of Apremilast in Children 6 through 17 Years with Moderate to Severe Plaque Psoriasis

Phase 1

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

• Registration Number: EUCTR2018-002918-12-HU
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-18
• Last Update Posted: 1 February 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 230

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

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

Study & Design

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