CompletedNCT02576678Updated May 7, 2020Results posted

A Study of Safety, Tolerability and Pharmacokinetics of Apremilast (CC-10004) in Pediatric Subjects With Moderate to Severe Plaque Psoriasis

A Phase 2 interventional study of Apremilast in Psoriasis, sponsored by Amgen. Completed at 18 sites in 4 countries. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2020-05-07.

Sponsored by Amgen · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 42
Allocation: Not applicable
Ages: 6 Years to 17 Years
Sex: All

Study summary

This is a Phase 2, multicenter, open-label study in subjects with moderate to severe plaque psoriasis aged 6 to 17 years, inclusive, intended to assess the safety, tolerability, and PK of apremilast with 2 weeks of oral apremilast treatment followed by a 48-week extension of apremilast treatment. Moderate to severe plaque psoriasis is defined as Psoriasis Area Severity Index (PASI) ≥ 12, Body Surface Area (BSA) ≥ 10%, and static Physician Global Assessment (sPGA) of ≥ 3. The total study duration for each subject will last for up to a total of 107 weeks which includes screening, treatment (including the PK portion of the study and the extension treatment period), two short-term follow-up periods and a long-term follow-up period.

Read the detailed description

Each subject will undergo a screening period of up to 5 weeks, a treatment period of 2 weeks with PK sample collection, and an extension treatment period of 48 weeks, to allow subjects access to apremilast treatment if medically appropriate (following the completion of the 2 week PK portion). Regardless of when they stop treatment, subjects should complete two post treatment follow-up visits at approximately 4 and 8 weeks after the last dose. All subjects should complete the final follow-up visit at Week 102 or at a timepoint 52 weeks after the last dose of apremilast was taken in subjects who have withdrawn at any time prior to Week 50. At least 32 subjects will be enrolled into this study to provide an adequate PK profile and safety assessment in subjects of different ages and body weight ranges. Subjects will be divided into 2 age groups (adolescents [ages 12 to 17 years, inclusive] and children [ages 6 to 11 years, inclusive]), with at least 16 subjects in each group. Apremilast treatment will start in older and heavier subjects.

Group 1 (ages 12 to 17 years, inclusive; weight ≥ 35 kg)

The data collected from the first 8 subjects will be reviewed by an independent data monitoring committee (DMC) to determine if it is appropriate to proceed with dosing the balance of Group 1 subjects and to proceed with dosing in the Group 2 subjects.

and an evaluation of these data by the DMC has been completed.

Group 2 (ages 6 to 11 years, inclusive; weight ≥ 15 kg)

The dose regimens (dose strength and/or dose frequency) for these first 8 subjects will be based upon the PK and safety assessments from the first 8 subjects in Group 1.
For the remaining subjects in Group 2, the dose (dose strength and/or dose frequency) will be based upon the subject weight as determined by the PK and safety assessments. The dose strength and/or dose frequency will be adjusted for any safety concerns or for unexpected changes in exposure. In the event of a dose regimen adjustment after the second PK and safety assessment, the first 8 subjects in Group 2 will return to the site for the appropriate dosing adjustment.

Conditions studied

Psoriasis

Browse trials for

Psoriasis 1,899

Keywords

Psoriasis
Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
CC-10004
Apremilast
Pharmacokinetics
Open-label
Safety
Pediatric

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 42 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Years to 17 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Subjects must satisfy all of the following criteria to be enrolled in the study:

Male or female subjects 6 to 17 years of age, inclusive, at the time the informed consent document is signed by the legal guardian
Group 1 Only: ages 12 to 17 years, inclusive, and weighs ≥ 35 kg
Group 2 Only: ages 6 to 11 years, inclusive, and weighs ≥ 15 kg
Subject is able to swallow the apremilast tablet
Able to sign an assent with a legal guardian who can understand and voluntarily sign an informed consent
Able to adhere to the study visit schedule and other protocol requirements
Must agree to withhold vaccinations during the first 2 weeks of dosing. Inactivated vaccines will be allowed during the extension treatment period
Diagnosis of chronic plaque psoriasis for at least 6 months prior to Screening
Have moderate to severe plaque psoriasis at Screening and Baseline as defined by:
- Psoriasis Area and Severity Index (PASI) score ≥ 12; and
- Body surface area (BSA) ≥ 10%; and
- Static Physician Global Assessment (sPGA) ≥ 3 (moderate to severe)
Disease inadequately controlled by or inappropriate for topical therapy for psoriasis
Candidate for systemic or phototherapy
Have not been exposed to any or have been exposed to no more than one systemic agent for psoriasis
At Screening, laboratory values must be within the following ranges:
- White blood cell (WBC) count Age (yrs) Males (x 103 /µL) Females (x 103 /µL) 6-11 3.5 - 13.65 3.5 - 13.65 12-18 3.5 - 13.15 3.5 - 13.15
- Platelet count Age (yrs) Males (x 103 /µL) Females (x 103 /µL) 6-11 117 - 394 117 - 394 12-18 126 - 400 126 - 400
- Hemoglobin (Hb) Age (yrs) Males (g/dL) Females (g/dL) 6-11 10.0 - 15.5 10.0 - 15.5 12-18 11.0 - 18.1 10.0 - 16.4
Male subjects who engage in activity in which conception is possible must use barrier contraception (male latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) while on apremilast and for at least 28 days after the last dose of apremilast
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 for at least 28 days after dministration of the last dose of apremilast. For the purposes of this study, 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 effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]; PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide * Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.

Exclusion criteria

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:
1. History of or currently active inflammatory bowel disease
2. Major concurrent medical conditions, pregnancy or lactation
3. Any condition that confounds the ability to interpret data from the study
4. Guttate, erythrodermic, or pustular psoriasis
5. Psoriasis flare or rebound within 4 weeks prior to Screening
6. Evidence of skin conditions that would interfere with clinical assessments
7. History of human immunodeficiency virus infection, or positive result to hepatitis B surface antigen or hepatitis C antibodies at Screening
8. Clinically significant abnormality on 12-Lead ECG at Screening
9. History of active mycobacterial infection with any species (including Mycobacterium tuberculosis) within 3 years of the Screening Visit and without documentation of successful treatment
10. Congenital and acquired immunodeficiencies (eg, Common Variable Immunodeficiency),immunoglobulin A deficiency
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 15 cP, titanium dioxide, polydextrose FCC, talc, maltodextrin, medium chain triglycerides, iron oxide red, iron oxide yellow, and iron oxide black.
15. Deficiencies in lactose metabolism, ie, galactose-1-phosphate uridylyltransferase, UDPglactose 4-epimerase, galactokinase or Fanconi Bickel syndrome, including congenital lactase deficiencies, and glucose-galactose malabsorption.
16. Any other 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
17. Prior history of suicide attempt at any time in the subject's lifetime prior to screening or enrollment in the study or major psychiatric illness requiring hospitalization within 3 years
18. Answering '"Yes'" to any question on the Columbia-Suicide Severity Rating Scale during screening or at baseline
19. Having received biologic therapy within 5 terminal half-lives, including but not limited to the following time periods:
  - Four weeks prior to baseline for etanercept
  - Ten weeks prior to baseline for adalimumab
  - Twenty-four weeks prior to baseline for ustekinumab
20. Topical therapy within 2 weeks of baseline (including but not limited to topical corticosteroids, topical retinoid or vitamin D analog preparations, tacrolimus, pimecrolimus, or anthralin/dithranol)
  - Exceptions: low-potency corticosteroids (please refer to the Investigators' Manual) will be allowed as background therapy for treatment of the face, axillae, and groin in accordance with the manufacturers' suggested usage during the course of the study
  - Subjects with scalp psoriasis will be permitted to use coal tar shampoo and/or salicylic acid scalp preparations on scalp lesions
  - An unmedicated skin moisturizer (eg, Eucerin®) will be also permitted for body lesions only. Subjects should not use these topical treatments within 24 hours prior to the clinic visit
21. Systemic therapy for psoriasis within 4 weeks prior to baseline (including but not limited to cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, sulfasalazine, azathioprine, and fumaric acid esters)
22. Use of phototherapy (ie, UVB, PUVA)within 4 weeks prior to baseline
23. Use of any investigational drug within 4 weeks prior to baseline, or 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer)
24. Children in Care: a child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation
25. Prior treatment with apremilast

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 42 participants (actual)

Study arms

Experimental
Open label apremilast
Apremilast doses of 10-mg, 20-mg or 30-mg tablets have been selected to determine the dose range in adolescents and children with moderate to severe plaque psoriasis. These pediatric dosages are expected to achieve exposures similar to those achieved in adult psoriasis and psoriatic arthritis (PsA) subjects treated with apremilast 30 mg orally twice daily (BID). A staggered, stepwise approach by age range and weight (starting with older and heavier subjects) is considered appropriate for this first-time-in-children study. Doses for younger and lower body weight subjects will be adjusted based on safety and PK data from older and heavier subjects. Subjects will be divided into 2 age groups with at least 16 subjects in each group. Dosing within and between groups will be staggered, based on PK data collected and on a minimum of 2 weeks of safety data.
Drug: Apremilast

Interventions

DrugApremilast
Also known as: CC-10004

What researchers measure

Primary outcomes

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
A TEAE is an adverse event with a start date on or after the date of the first dose of apremilast and no later than 28 days after the last dose of apremilast. An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. A serious AE is any untoward AE that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization or in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect or constitutes an important medical event. The investigator assessment of severity/intensity of an event was defined as mild, moderate or severe.
Time frame: From first dose of apremilast until 28 days after the last dose; up to 29 July 2019; median treatment duration for adolescents apremilast 20 mg and 30 mg was 50.00 and 50.57 weeks respectively and for children was 50.00 weeks.
Maximum Observed Plasma Concentration (Cmax) of Apremilast
Maximum observed plasma concentration (Cmax) of apremilast. PK parameters were calculated using non-compartmental methods, plasma concentrations and actual blood sampling times from the intensive sampling schedule.
Time frame: For adolescents, a pre-dose sample prior to morning dose and on Day 14 as well as at hours 1, 2, 3, 5, 8 and 12 post dose; for the children, samples were collected 2 hours at predose (prior to morning dose) and at 2, 5 and 12 hours post morning dose.
Time to Maximum Plasma Concentration (Tmax) of Apremilast
Time to maximum observed plasma concentration obtained directly from the observed concentration versus time data. PK parameters were calculated using non-compartmental methods, plasma concentrations and actual blood sampling times from the intensive sampling schedule.
Time frame: For adolescents, a pre-dose sample prior to morning dose and on Day 14 as well as at hours 1, 2, 3, 5, 8 and 12 post dose; for the children, samples were collected 2 hours at predose (prior to morning dose) and at 2, 5 and 12 hours post morning dose.
Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post Dose of Apremilast (AUC0-12)
Area under the plasma concentration-time curve from time zero to the 12 hours post dose was calculated using non-compartmental methods, plasma concentrations and actual blood sampling times from the intensive sampling schedule.
Time frame: For adolescents, a pre-dose sample prior to morning dose and on Day 14 as well as at hours 1, 2, 3, 5, 8 and 12 post dose; for the children, samples were collected 2 hours at predose (prior to morning dose) and at 2, 5 and 12 hours post morning dose.
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration of Apremilast (AUC0-t)
Area under the plasma concentration-time curve from time zero to the last quantifiable time point and was calculated using non-compartmental methods, plasma concentrations and actual blood sampling times from the intensive sampling schedule.
Time frame: For adolescents, a pre-dose sample prior to morning dose and on Day 14 as well as at hours 1, 2, 3, 5, 8 and 12 post dose; for the children, samples were collected 2 hours at predose (prior to morning dose) and at 2, 5 and 12 hours post morning dose.
Apparent Total Plasma Clearance When Dosed Orally (CL/F) for Apremilast
Apparent total plasma clearance (CL/F) of apremilast was calculated using non-compartmental methods, plasma concentrations and actual blood sampling times from the intensive sampling schedule.
Time frame: For adolescents, a pre-dose sample prior to morning dose and on Day 14 as well as at hours 1, 2, 3, 5, 8 and 12 post dose; for the children, samples were collected 2 hours at predose (prior to morning dose) and at 2, 5 and 12 hours post morning dose.
Apparent Total Volume of Distribution When Dosed Orally, Based on Study-State (Vss/F) or in the Terminal Phase (Vz/F)
Apparent total volume of distribution when dosed orally, based on study-state (Vss/F) or in the terminal phase (Vz/F). Pharmacokinetic parameters were calculated using non-compartmental methods, plasma concentrations and actual blood sampling times from the intensive sampling schedule.
Time frame: For adolescents, a pre-dose sample prior to morning dose and on Day 14 as well as at hours 1, 2, 3, 5, 8 and 12 post dose; for the children, samples were collected 2 hours at predose (prior to morning dose) and at 2, 5 and 12 hours post morning dose.
Terminal Phase Elimination Half-Life
Terminal-phase elimination half-life (t ½). PK parameters were calculated using non-compartmental methods, plasma concentrations and actual blood sampling times from the intensive sampling schedule.
Time frame: For adolescents, a pre-dose sample prior to morning dose and on Day 14 as well as at hours 1, 2, 3, 5, 8 and 12 post dose; for the children, samples were collected 2 hours at predose (prior to morning dose) and at 2, 5 and 12 hours post morning dose.

Secondary outcomes

Taste and Acceptability of Apremilast Tablets Using the Faces Likert Scale
Taste and acceptability of the apremilast tablet was assessed using a faces Likert Scale on Day 1, initial dosing. The scale consists of options from 1 (dislike very much, illustrated by a frowning face) to 5 (like very much, illustrated by a smiling face).
Time frame: Day 1

Results

Posted Sep 27, 2018

Participant flow

The study was conducted at 11 study centers in 4 countries, including the United States, Canada, Germany and Spain.

Participant flow — Overall Study
Milestone	Group 1 Adolescents: Apremilast 20 mg	Group 1 Adolescents: Apremilast 30 mg	Group 2 Children: Apremilast 20 mg
Started	13	8	21
Pharmacokinetic (pk) population	12	8	18
Completed	8	7	16
Not completed	5	1	5
Withdrew: Adverse event	0	0	2
Withdrew: Withdrawal by subject	3	1	2
Withdrew: Lost to follow-up	0	0	1
Withdrew: Miscellaneous	2	0	0

Outcome measures

PrimaryNumber of Participants With Treatment Emergent Adverse Events (TEAEs)

A TEAE is an adverse event with a start date on or after the date of the first dose of apremilast and no later than 28 days after the last dose of apremilast. An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. A serious AE is any untoward AE that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization or in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect or constitutes an important medical event. The investigator assessment of severity/intensity of an event was defined as mild, moderate or severe.

Time frame:: From first dose of apremilast until 28 days after the last dose; up to 29 July 2019; median treatment duration for adolescents apremilast 20 mg and 30 mg was 50.00 and 50.57 weeks respectively and for children was 50.00 weeks.
Reported as:: Count of participants · Participants

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Participants	Group 1 Adolescents: Apremilast 20 mg	Group 1 Adolescents: Apremilast 30 mg	Group 2 Children: Apremilast 20 mg
Any TEAE	13	7	20
Any Drug Related TEAE	11	6	17
Any Severe TEAE	1	0	1
Any Serious TEAE	0	0	1
Any Serious Drug-Related TEAE	0	0	0
Any TEAE Leading to Drug Interruption	1	0	4
Any TEAE Leading to Drug Withdrawal	0	0	2
Any TEAE Leading to Death	0	0	0

PrimaryMaximum Observed Plasma Concentration (Cmax) of Apremilast

Maximum observed plasma concentration (Cmax) of apremilast. PK parameters were calculated using non-compartmental methods, plasma concentrations and actual blood sampling times from the intensive sampling schedule.

Time frame:: For adolescents, a pre-dose sample prior to morning dose and on Day 14 as well as at hours 1, 2, 3, 5, 8 and 12 post dose; for the children, samples were collected 2 hours at predose (prior to morning dose) and at 2, 5 and 12 hours post morning dose.
Reported as:: Geometric mean · ng/mL

Maximum Observed Plasma Concentration (Cmax) of Apremilast
ng/mL	Group 1 Adolescents: Apremilast 20 mg	Group 1 Adolescents: Apremilast 30 mg	Group 2 Children: Apremilast 20 mg
Maximum Observed Plasma Concentration (Cmax) of Apremilast	274.272 ± 34.3	410.929 ± 39.7	348.146 ± 47.4

PrimaryTime to Maximum Plasma Concentration (Tmax) of Apremilast

Time to maximum observed plasma concentration obtained directly from the observed concentration versus time data. PK parameters were calculated using non-compartmental methods, plasma concentrations and actual blood sampling times from the intensive sampling schedule.

Time frame:: For adolescents, a pre-dose sample prior to morning dose and on Day 14 as well as at hours 1, 2, 3, 5, 8 and 12 post dose; for the children, samples were collected 2 hours at predose (prior to morning dose) and at 2, 5 and 12 hours post morning dose.
Reported as:: Median · hours

Time to Maximum Plasma Concentration (Tmax) of Apremilast
hours	Group 1 Adolescents: Apremilast 20 mg	Group 1 Adolescents: Apremilast 30 mg	Group 2 Children: Apremilast 20 mg
Time to Maximum Plasma Concentration (Tmax) of Apremilast	2.467 (1.00 to 3.00)	3.000 (1.00 to 5.00)	2.000 (1.90 to 5.00)

PrimaryArea Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post Dose of Apremilast (AUC0-12)

Area under the plasma concentration-time curve from time zero to the 12 hours post dose was calculated using non-compartmental methods, plasma concentrations and actual blood sampling times from the intensive sampling schedule.

Time frame:: For adolescents, a pre-dose sample prior to morning dose and on Day 14 as well as at hours 1, 2, 3, 5, 8 and 12 post dose; for the children, samples were collected 2 hours at predose (prior to morning dose) and at 2, 5 and 12 hours post morning dose.
Reported as:: Geometric mean · ng*h/mL

Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post Dose of Apremilast (AUC0-12)
ng*h/mL	Group 1 Adolescents: Apremilast 20 mg	Group 1 Adolescents: Apremilast 30 mg	Group 2 Children: Apremilast 20 mg
Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post Dose of Apremilast (AUC0-12)	1799.717 ± 36.0	2901.795 ± 41.2	2544.874 ± 40.8

PrimaryArea Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration of Apremilast (AUC0-t)

Area under the plasma concentration-time curve from time zero to the last quantifiable time point and was calculated using non-compartmental methods, plasma concentrations and actual blood sampling times from the intensive sampling schedule.

Time frame:: For adolescents, a pre-dose sample prior to morning dose and on Day 14 as well as at hours 1, 2, 3, 5, 8 and 12 post dose; for the children, samples were collected 2 hours at predose (prior to morning dose) and at 2, 5 and 12 hours post morning dose.
Reported as:: Geometric mean · ng*h/mL

Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration of Apremilast (AUC0-t)
ng*h/mL	Group 1 Adolescents: Apremilast 20 mg	Group 1 Adolescents: Apremilast 30 mg	Group 2 Children: Apremilast 20 mg
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration of Apremilast (AUC0-t)	1794.815 ± 35.9	2900.472 ± 41.4	2367.641 ± 50.2

PrimaryApparent Total Plasma Clearance When Dosed Orally (CL/F) for Apremilast

Apparent total plasma clearance (CL/F) of apremilast was calculated using non-compartmental methods, plasma concentrations and actual blood sampling times from the intensive sampling schedule.

Time frame:: For adolescents, a pre-dose sample prior to morning dose and on Day 14 as well as at hours 1, 2, 3, 5, 8 and 12 post dose; for the children, samples were collected 2 hours at predose (prior to morning dose) and at 2, 5 and 12 hours post morning dose.
Reported as:: Geometric mean · Liters/hour

Apparent Total Plasma Clearance When Dosed Orally (CL/F) for Apremilast
Liters/hour	Group 1 Adolescents: Apremilast 20 mg	Group 1 Adolescents: Apremilast 30 mg	Group 2 Children: Apremilast 20 mg
Apparent Total Plasma Clearance When Dosed Orally (CL/F) for Apremilast	11.113 ± 36.0	10.338 ± 41.2	7.859 ± 40.8

PrimaryApparent Total Volume of Distribution When Dosed Orally, Based on Study-State (Vss/F) or in the Terminal Phase (Vz/F)

Apparent total volume of distribution when dosed orally, based on study-state (Vss/F) or in the terminal phase (Vz/F). Pharmacokinetic parameters were calculated using non-compartmental methods, plasma concentrations and actual blood sampling times from the intensive sampling schedule.

Time frame:: For adolescents, a pre-dose sample prior to morning dose and on Day 14 as well as at hours 1, 2, 3, 5, 8 and 12 post dose; for the children, samples were collected 2 hours at predose (prior to morning dose) and at 2, 5 and 12 hours post morning dose.
Reported as:: Geometric mean · Liters

Apparent Total Volume of Distribution When Dosed Orally, Based on Study-State (Vss/F) or in the Terminal Phase (Vz/F)
Liters	Group 1 Adolescents: Apremilast 20 mg	Group 1 Adolescents: Apremilast 30 mg	Group 2 Children: Apremilast 20 mg
Apparent Total Volume of Distribution When Dosed Orally, Based on Study-State (Vss/F) or in the Terminal Phase (Vz/F)	86.870 ± 56.1	101.049 ± 31.6	55.126 ± 51.2

SecondaryTaste and Acceptability of Apremilast Tablets Using the Faces Likert Scale

Taste and acceptability of the apremilast tablet was assessed using a faces Likert Scale on Day 1, initial dosing. The scale consists of options from 1 (dislike very much, illustrated by a frowning face) to 5 (like very much, illustrated by a smiling face).

Time frame:: Day 1
Reported as:: Count of participants · Participants

Taste and Acceptability of Apremilast Tablets Using the Faces Likert Scale
Participants	Group 1 Adolescents: Apremilast 20 mg	Group 1 Adolescents: Apremilast 30 mg	Group 2 Children: Apremilast 20 mg
1 (Dislike Very Much)	0	0	3
2 (Dislike a Little)	1	0	1
3 (Not Sure)	5	4	3
4 (Like a Little)	1	1	4
5 (Like Very Much)	6	3	10

PrimaryTerminal Phase Elimination Half-Life

Terminal-phase elimination half-life (t ½). PK parameters were calculated using non-compartmental methods, plasma concentrations and actual blood sampling times from the intensive sampling schedule.

Time frame:: For adolescents, a pre-dose sample prior to morning dose and on Day 14 as well as at hours 1, 2, 3, 5, 8 and 12 post dose; for the children, samples were collected 2 hours at predose (prior to morning dose) and at 2, 5 and 12 hours post morning dose.
Reported as:: Geometric mean · hours

Terminal Phase Elimination Half-Life
hours	Group 1 Adolescents: Apremilast 20 mg	Group 1 Adolescents: Apremilast 30 mg	Group 2 Children: Apremilast 20 mg
Terminal Phase Elimination Half-Life	5.418 ± 43.1	6.775 ± 50.3	4.862 ± 30.2

Adverse events

Collected over From first dose of apremilast until 28 days after the last dose; up to 198 weeks; median treatment duration for adolescents apremilast 20 mg and 30 mg was 50.00 and 50.57 weeks respectively and for children was 50.00 weeks.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Group 1 Adolescents: Apremilast 20 mg	0/13 (0%)	0/13 (0%)	13/13 (100%)
Group 1 Adolescents: Apremilast 30 mg	0/8 (0%)	0/8 (0%)	7/8 (87.5%)
Group 2 Children: Apremilast 20 mg	0/21 (0%)	1/21 (4.8%)	19/21 (90.5%)

Most frequent serious events

Most frequent serious events
Event	Group 1 Adolescents: Apremilast 20 mg	Group 1 Adolescents: Apremilast 30 mg	Group 2 Children: Apremilast 20 mg
SyncopeNervous system disorders	0/13	0/8	1/21

Most frequent other events

Showing 10 of 60

Most frequent other events
Event	Group 1 Adolescents: Apremilast 20 mg	Group 1 Adolescents: Apremilast 30 mg	Group 2 Children: Apremilast 20 mg
NauseaGastrointestinal disorders	8/13	4/8	10/21
HeadacheNervous system disorders	7/13	1/8	11/21
Abdominal painGastrointestinal disorders	6/13	1/8	11/21
DiarrhoeaGastrointestinal disorders	6/13	4/8	5/21
NasopharyngitisInfections and infestations	6/13	3/8	7/21
VomitingGastrointestinal disorders	4/13	1/8	8/21
Urinary tract infectionInfections and infestations	1/13	2/8	0/21
GastroenteritisInfections and infestations	2/13	1/8	5/21
CoughRespiratory, thoracic and mediastinal disorders	3/13	1/8	2/21
Abdominal pain upperGastrointestinal disorders	2/13	1/8	4/21

Baseline characteristics

The Safety Population consisted of all participants who were enrolled and received at least 1 dose of apremilast.

Age, Continuous
Age, Continuous(Years)	Group 1 Adolescents: Apremilast 20 mg	Group 1 Adolescents: Apremilast 30 mg	Group 2 Children: Apremilast 20 mg	Total
Mean	13.8 ± 1.77	14.8 ± 2.05	9.3 ± 1.35	11.8 ± 2.95

Age, Customized
Age, Customized(Participants)	Group 1 Adolescents: Apremilast 20 mg	Group 1 Adolescents: Apremilast 30 mg	Group 2 Children: Apremilast 20 mg	Total
6 to 11 years	0	0	21	21
12 to 17 years	13	8	0	21

Sex: Female, Male
Sex: Female, Male(Participants)	Group 1 Adolescents: Apremilast 20 mg	Group 1 Adolescents: Apremilast 30 mg	Group 2 Children: Apremilast 20 mg	Total
Female	9	1	13	23
Male	4	7	8	19

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Group 1 Adolescents: Apremilast 20 mg	Group 1 Adolescents: Apremilast 30 mg	Group 2 Children: Apremilast 20 mg	Total
Hispanic or Latino	1	3	5	9
Not Hispanic or Latino	12	5	16	33
Unknown or Not Reported	0	0	0	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Group 1 Adolescents: Apremilast 20 mg	Group 1 Adolescents: Apremilast 30 mg	Group 2 Children: Apremilast 20 mg	Total
American Indian or Alaska Native	0	0	0	0
Asian	2	0	2	4
Black or African American	0	0	2	2
Native Hawaiian or other Pacific Islander	0	1	0	1
White or Caucasian	10	6	16	32
Other	1	1	1	3

Baseline Weight Category (kg)
Baseline Weight Category (kg)(Participants)	Group 1 Adolescents: Apremilast 20 mg	Group 1 Adolescents: Apremilast 30 mg	Group 2 Children: Apremilast 20 mg	Total
< 15 kg	0	0	0	0
≥ 15 - < 35 kg	0	0	13	13
≥ 35 - < 50 kg	3	0	4	7
≥ 50 - < 70 kg	10	0	4	14
≥ 70 kg	0	8	0	8

Duration of Plaque Psoriasis
Duration of Plaque Psoriasis(Years)	Group 1 Adolescents: Apremilast 20 mg	Group 1 Adolescents: Apremilast 30 mg	Group 2 Children: Apremilast 20 mg	Total
Mean	7.41 ± 3.190	6.96 ± 4.057	2.75 ± 2.057	4.99 ± 3.611

Psoriasis Area Severity Index (PASI)
Psoriasis Area Severity Index (PASI)(Units on a scale)	Group 1 Adolescents: Apremilast 20 mg	Group 1 Adolescents: Apremilast 30 mg	Group 2 Children: Apremilast 20 mg	Total
Mean	18.78 ± 11.693	15.65 ± 3.430	18.09 ± 6.144	17.84 ± 7.854

1 further baseline measures are reported on the registry.

Study locations

18 sites

Rady Children's Hospital
San Diego, California 92123, United States
Emory University
Atlanta, Georgia 30322, United States
Ann & Robert H. Lurie Children's Hospital of Chicago Department of Dermatology
Chicago, Illinois 60611, United States
Dundee Dermatology
West Dundee, Illinois 60118, United States
Mount Sinai, St. Luke's
New York, New York 10025, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas 78218, United States
Stollery Children's Hospital
Edmonton, Alberta T6G 2B7, Canada
Nexus Clinical Research
St John's, Newfoundland and Labrador A1A 5E8, Canada
CHU Saint-Justine
Montreal, Quebec H3T 1C5, Canada
Rheinische Friedrich-Wilhelms-Universitaet Bonn - Universitaetsklinikum Bonn
Bonn, 53127, Germany
Universitatsklinikum Essen
Essen, 45147, Germany
Universitatsklinikum Klinikum Frankfurt Main
Frankfurt, 60590, Germany
Kinderkrankenhaus Wilhelmstift, Dermatologie
Hamburg, 22149, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131, Germany
Muenster University Hospital (Universitätsklinikum Muenster)
Munster, 48149, Germany
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041, Spain
Hospital Sant Joan de Deu
Esplugues de Llobregat, 08950, Spain
Hospital La Paz
Madrid, 28046, Spain

References and documents

Publications

Paller AS, Hong Y, Becker EM, de Lucas R, Paris M, Zhang W, Zhang Z, Barcellona C, Maes P, Fiorillo L. Pharmacokinetics and safety of apremilast in pediatric patients with moderate to severe plaque psoriasis: Results from a phase 2 open-label study. J Am Acad Dermatol. 2020 Feb;82(2):389-397. doi: 10.1016/j.jaad.2019.08.019. Epub 2019 Aug 10. PubMed 31408686 ↗

Study documents

Study protocol · Apr 29, 2016
Statistical analysis plan · Mar 15, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Supporting information: Study protocol, Sap, Icf, Csr

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02576678
Lead sponsor: Amgen
Responsible party: Sponsor
First posted: Oct 15, 2015
Start date: Oct 13, 2015
Primary completion: Sep 4, 2017
Completion: Jul 29, 2019
Results posted: Sep 27, 2018
Last update: May 7, 2020

Study contacts

study director · Amgen

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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