Trial Outcomes & Findings for A Study of Safety, Tolerability and Pharmacokinetics of Apremilast (CC-10004) in Pediatric Subjects With Moderate to Severe Plaque Psoriasis (NCT NCT02576678)

Last Updated: 2020-05-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

42 participants

Primary outcome timeframe

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.

Results posted on

2020-05-07

Participant Flow

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

Participants were enrolled according to a staggered, stepwise approach by age range and weight starting with older and heavier participants. Dosing within and between groups was staggered based on PK data collected and a minimum of 2 weeks of safety data.

Participant milestones

Participant milestones
Measure	Group 1 Adolescents: Apremilast 20 mg Participants ages 12 to 17 years old, with a weight of ≥ 35 kg to \< 70 kg received apremilast tablets 20 mg twice a day (BID) for 2 weeks followed by a 48-week extension of apremilast treatment.	Group 1 Adolescents: Apremilast 30 mg Participants ages 12 to 17 years old, with a weight of ≥ 70 kg received apremilast 30 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.	Group 2 Children: Apremilast 20 mg Participants ages 6 to 11 years old, with a weight of ≥ 15 kg received apremilast 20 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.
Overall Study STARTED	13	8	21
Overall Study Pharmacokinetic (PK) Population	12	8	18
Overall Study COMPLETED	8	7	16
Overall Study NOT COMPLETED	5	1	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 Adolescents: Apremilast 20 mg Participants ages 12 to 17 years old, with a weight of ≥ 35 kg to \< 70 kg received apremilast tablets 20 mg twice a day (BID) for 2 weeks followed by a 48-week extension of apremilast treatment.	Group 1 Adolescents: Apremilast 30 mg Participants ages 12 to 17 years old, with a weight of ≥ 70 kg received apremilast 30 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.	Group 2 Children: Apremilast 20 mg Participants ages 6 to 11 years old, with a weight of ≥ 15 kg received apremilast 20 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.
Overall Study Adverse Event	0	0	2
Overall Study Withdrawal by Subject	3	1	2
Overall Study Lost to Follow-up	0	0	1
Overall Study Miscellaneous	2	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 Adolescents: Apremilast 20 mg n=13 Participants Participants ages 12 to 17 years old, with a weight of ≥ 35 kg to \< 70 kg received apremilast tablets 20 mg twice a day (BID) for 2 weeks followed by a 48-week extension of apremilast treatment.	Group 1 Adolescents: Apremilast 30 mg n=8 Participants Participants ages 12 to 17 years old, with a weight of ≥ 70 kg received apremilast 30 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.	Group 2 Children: Apremilast 20 mg n=21 Participants Participants ages 6 to 11 years old, with a weight of ≥ 15 kg received apremilast 20 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.	Total n=42 Participants Total of all reporting groups
Age, Continuous	13.8 Years STANDARD_DEVIATION 1.77 • n=5 Participants	14.8 Years STANDARD_DEVIATION 2.05 • n=7 Participants	9.3 Years STANDARD_DEVIATION 1.35 • n=5 Participants	11.8 Years STANDARD_DEVIATION 2.95 • n=4 Participants
Age, Customized 6 to 11 years	0 Participants n=5 Participants	0 Participants n=7 Participants	21 Participants n=5 Participants	21 Participants n=4 Participants
Age, Customized 12 to 17 years	13 Participants n=5 Participants	8 Participants n=7 Participants	0 Participants n=5 Participants	21 Participants n=4 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	1 Participants n=7 Participants	13 Participants n=5 Participants	23 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	19 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	9 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	5 Participants n=7 Participants	16 Participants n=5 Participants	33 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized White or Caucasian	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants	32 Participants n=4 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Baseline Weight Category (kg) < 15 kg	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Baseline Weight Category (kg) ≥ 15 - < 35 kg	0 Participants n=5 Participants	0 Participants n=7 Participants	13 Participants n=5 Participants	13 Participants n=4 Participants
Baseline Weight Category (kg) ≥ 35 - < 50 kg	3 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants
Baseline Weight Category (kg) ≥ 50 - < 70 kg	10 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	14 Participants n=4 Participants
Baseline Weight Category (kg) ≥ 70 kg	0 Participants n=5 Participants	8 Participants n=7 Participants	0 Participants n=5 Participants	8 Participants n=4 Participants
Duration of Plaque Psoriasis	7.41 Years STANDARD_DEVIATION 3.190 • n=5 Participants	6.96 Years STANDARD_DEVIATION 4.057 • n=7 Participants	2.75 Years STANDARD_DEVIATION 2.057 • n=5 Participants	4.99 Years STANDARD_DEVIATION 3.611 • n=4 Participants
Psoriasis Area Severity Index (PASI)	18.78 Units on a scale STANDARD_DEVIATION 11.693 • n=5 Participants	15.65 Units on a scale STANDARD_DEVIATION 3.430 • n=7 Participants	18.09 Units on a scale STANDARD_DEVIATION 6.144 • n=5 Participants	17.84 Units on a scale STANDARD_DEVIATION 7.854 • n=4 Participants
Baseline Body Mass Index (BMI) category Healthy Weight	7 Participants n=5 Participants	1 Participants n=7 Participants	15 Participants n=5 Participants	23 Participants n=4 Participants
Baseline Body Mass Index (BMI) category Overweight	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Baseline Body Mass Index (BMI) category Obesity	4 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	15 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Population: The safety population consisted of all participants who received at least 1 dose of apremilast

Outcome measures

Outcome measures
Measure	Group 1 Adolescents: Apremilast 20 mg n=13 Participants Participants ages 12 to 17 years old, with a weight of ≥ 35 kg to \< 70 kg received apremilast tablets 20 mg twice a day (BID) for 2 weeks followed by a 48-week extension of apremilast treatment.	Group 1 Adolescents: Apremilast 30 mg n=8 Participants Participants ages 12 to 17 years old, with a weight of ≥ 70 kg received apremilast 30 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.	Group 2 Children: Apremilast 20 mg n=21 Participants Participants ages 6 to 11 years old, with a weight of ≥ 15 kg received apremilast 20 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Any TEAE	13 Participants	7 Participants	20 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Any Drug Related TEAE	11 Participants	6 Participants	17 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Any Severe TEAE	1 Participants	0 Participants	1 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Any Serious TEAE	0 Participants	0 Participants	1 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Any Serious Drug-Related TEAE	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Any TEAE Leading to Drug Interruption	1 Participants	0 Participants	4 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Any TEAE Leading to Drug Withdrawal	0 Participants	0 Participants	2 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Any TEAE Leading to Death	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 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.

Population: The PK population included all enrolled participants who received one dose of apremilast and had evaluable PK data. PK data was considered evaluable if there were measurable drug levels of apremilast in plasma from at least 3 time points that extended over a minimal 5-hour period within 12 hours post a dose, eg, predose, 2 and 8 hours post a dose.

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.

Outcome measures

Outcome measures
Measure	Group 1 Adolescents: Apremilast 20 mg n=12 Participants Participants ages 12 to 17 years old, with a weight of ≥ 35 kg to \< 70 kg received apremilast tablets 20 mg twice a day (BID) for 2 weeks followed by a 48-week extension of apremilast treatment.	Group 1 Adolescents: Apremilast 30 mg n=8 Participants Participants ages 12 to 17 years old, with a weight of ≥ 70 kg received apremilast 30 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.	Group 2 Children: Apremilast 20 mg n=18 Participants Participants ages 6 to 11 years old, with a weight of ≥ 15 kg received apremilast 20 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.
Maximum Observed Plasma Concentration (Cmax) of Apremilast	274.272 ng/mL Geometric Coefficient of Variation 34.3	410.929 ng/mL Geometric Coefficient of Variation 39.7	348.146 ng/mL Geometric Coefficient of Variation 47.4

PRIMARY outcome

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.

Outcome measures

Outcome measures
Measure	Group 1 Adolescents: Apremilast 20 mg n=12 Participants Participants ages 12 to 17 years old, with a weight of ≥ 35 kg to \< 70 kg received apremilast tablets 20 mg twice a day (BID) for 2 weeks followed by a 48-week extension of apremilast treatment.	Group 1 Adolescents: Apremilast 30 mg n=8 Participants Participants ages 12 to 17 years old, with a weight of ≥ 70 kg received apremilast 30 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.	Group 2 Children: Apremilast 20 mg n=18 Participants Participants ages 6 to 11 years old, with a weight of ≥ 15 kg received apremilast 20 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.
Time to Maximum Plasma Concentration (Tmax) of Apremilast	2.467 hours Interval 1.0 to 3.0	3.000 hours Interval 1.0 to 5.0	2.000 hours Interval 1.9 to 5.0

PRIMARY outcome

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.

Outcome measures

Outcome measures
Measure	Group 1 Adolescents: Apremilast 20 mg n=12 Participants Participants ages 12 to 17 years old, with a weight of ≥ 35 kg to \< 70 kg received apremilast tablets 20 mg twice a day (BID) for 2 weeks followed by a 48-week extension of apremilast treatment.	Group 1 Adolescents: Apremilast 30 mg n=8 Participants Participants ages 12 to 17 years old, with a weight of ≥ 70 kg received apremilast 30 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.	Group 2 Children: Apremilast 20 mg n=17 Participants Participants ages 6 to 11 years old, with a weight of ≥ 15 kg received apremilast 20 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.
Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post Dose of Apremilast (AUC0-12)	1799.717 ng*h/mL Geometric Coefficient of Variation 36.0	2901.795 ng*h/mL Geometric Coefficient of Variation 41.2	2544.874 ng*h/mL Geometric Coefficient of Variation 40.8

PRIMARY outcome

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.

Outcome measures

Outcome measures
Measure	Group 1 Adolescents: Apremilast 20 mg n=12 Participants Participants ages 12 to 17 years old, with a weight of ≥ 35 kg to \< 70 kg received apremilast tablets 20 mg twice a day (BID) for 2 weeks followed by a 48-week extension of apremilast treatment.	Group 1 Adolescents: Apremilast 30 mg n=8 Participants Participants ages 12 to 17 years old, with a weight of ≥ 70 kg received apremilast 30 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.	Group 2 Children: Apremilast 20 mg n=18 Participants Participants ages 6 to 11 years old, with a weight of ≥ 15 kg received apremilast 20 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration of Apremilast (AUC0-t)	1794.815 ng*h/mL Geometric Coefficient of Variation 35.9	2900.472 ng*h/mL Geometric Coefficient of Variation 41.4	2367.641 ng*h/mL Geometric Coefficient of Variation 50.2

PRIMARY outcome

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.

Outcome measures

Outcome measures
Measure	Group 1 Adolescents: Apremilast 20 mg n=12 Participants Participants ages 12 to 17 years old, with a weight of ≥ 35 kg to \< 70 kg received apremilast tablets 20 mg twice a day (BID) for 2 weeks followed by a 48-week extension of apremilast treatment.	Group 1 Adolescents: Apremilast 30 mg n=8 Participants Participants ages 12 to 17 years old, with a weight of ≥ 70 kg received apremilast 30 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.	Group 2 Children: Apremilast 20 mg n=17 Participants Participants ages 6 to 11 years old, with a weight of ≥ 15 kg received apremilast 20 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.
Apparent Total Plasma Clearance When Dosed Orally (CL/F) for Apremilast	11.113 Liters/hour Geometric Coefficient of Variation 36.0	10.338 Liters/hour Geometric Coefficient of Variation 41.2	7.859 Liters/hour Geometric Coefficient of Variation 40.8

PRIMARY outcome

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.

Outcome measures

Outcome measures
Measure	Group 1 Adolescents: Apremilast 20 mg n=12 Participants Participants ages 12 to 17 years old, with a weight of ≥ 35 kg to \< 70 kg received apremilast tablets 20 mg twice a day (BID) for 2 weeks followed by a 48-week extension of apremilast treatment.	Group 1 Adolescents: Apremilast 30 mg n=8 Participants Participants ages 12 to 17 years old, with a weight of ≥ 70 kg received apremilast 30 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.	Group 2 Children: Apremilast 20 mg n=17 Participants Participants ages 6 to 11 years old, with a weight of ≥ 15 kg received apremilast 20 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.
Apparent Total Volume of Distribution When Dosed Orally, Based on Study-State (Vss/F) or in the Terminal Phase (Vz/F)	86.870 Liters Geometric Coefficient of Variation 56.1	101.049 Liters Geometric Coefficient of Variation 31.6	55.126 Liters Geometric Coefficient of Variation 51.2

PRIMARY outcome

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.

Outcome measures

Outcome measures
Measure	Group 1 Adolescents: Apremilast 20 mg n=12 Participants Participants ages 12 to 17 years old, with a weight of ≥ 35 kg to \< 70 kg received apremilast tablets 20 mg twice a day (BID) for 2 weeks followed by a 48-week extension of apremilast treatment.	Group 1 Adolescents: Apremilast 30 mg n=8 Participants Participants ages 12 to 17 years old, with a weight of ≥ 70 kg received apremilast 30 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.	Group 2 Children: Apremilast 20 mg n=17 Participants Participants ages 6 to 11 years old, with a weight of ≥ 15 kg received apremilast 20 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.
Terminal Phase Elimination Half-Life	5.418 hours Geometric Coefficient of Variation 43.1	6.775 hours Geometric Coefficient of Variation 50.3	4.862 hours Geometric Coefficient of Variation 30.2

SECONDARY outcome

Timeframe: Day 1

Population: The Safety Population consisted of all participants who received at least 1 dose of apremilast.

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).

Outcome measures

Outcome measures
Measure	Group 1 Adolescents: Apremilast 20 mg n=13 Participants Participants ages 12 to 17 years old, with a weight of ≥ 35 kg to \< 70 kg received apremilast tablets 20 mg twice a day (BID) for 2 weeks followed by a 48-week extension of apremilast treatment.	Group 1 Adolescents: Apremilast 30 mg n=8 Participants Participants ages 12 to 17 years old, with a weight of ≥ 70 kg received apremilast 30 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.	Group 2 Children: Apremilast 20 mg n=21 Participants Participants ages 6 to 11 years old, with a weight of ≥ 15 kg received apremilast 20 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.
Taste and Acceptability of Apremilast Tablets Using the Faces Likert Scale 1 (Dislike Very Much)	0 Participants	0 Participants	3 Participants
Taste and Acceptability of Apremilast Tablets Using the Faces Likert Scale 2 (Dislike a Little)	1 Participants	0 Participants	1 Participants
Taste and Acceptability of Apremilast Tablets Using the Faces Likert Scale 3 (Not Sure)	5 Participants	4 Participants	3 Participants
Taste and Acceptability of Apremilast Tablets Using the Faces Likert Scale 4 (Like a Little)	1 Participants	1 Participants	4 Participants
Taste and Acceptability of Apremilast Tablets Using the Faces Likert Scale 5 (Like Very Much)	6 Participants	3 Participants	10 Participants

Adverse Events

Group 1 Adolescents: Apremilast 20 mg

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Group 1 Adolescents: Apremilast 30 mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Group 2 Children: Apremilast 20 mg

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group 1 Adolescents: Apremilast 20 mg n=13 participants at risk Participants ages 12 to 17 years old, with a weight of ≥ 35 kg to \< 70 kg received apremilast tablets 20 mg twice a day (BID) for 2 weeks followed by a 48-week extension of apremilast treatment.	Group 1 Adolescents: Apremilast 30 mg n=8 participants at risk Participants ages 12 to 17 years old, with a weight of ≥ 70 kg received apremilast 30 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.	Group 2 Children: Apremilast 20 mg n=21 participants at risk Participants ages 6 to 11 years old, with a weight of ≥ 15 kg received apremilast 20 mg tablets BID for 2 weeks followed by a 48-week extension of apremilast treatment.
Nervous system disorders Syncope	0.00% 0/13 • 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.	0.00% 0/8 • 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.	4.8% 1/21 • 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.

Other adverse events

Additional Information

Anne McClain, Senior Manager

Celgene Corporation

Phone: 888-260-1599

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Results from a center cannot be submitted for publication before results of multicenter study are published unless it is \> 1 year since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 additional days. Investigator must delete confidential information before submission and defer publication to permit patent applications.
Publication restrictions are in place

Restriction type: OTHER