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Phosphodiesterase 4 (PDE4) Inhibitor

Long-Term Apremilast Use for Psoriasis

Phase 3
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Females of childbearing potential must have a negative pregnancy test at each visit. 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 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. NOTE: Option 2 may not be acceptable as a contraception option in all countries per local guidelines/regulations.
All female subjects 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 administration of the last dose of apremilast. For the purpose of this study, a female subject is considered of childbearing potential if she is ≥ 12 years old or has reached menarche, whichever occurred first.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collected every 52 weeks throughout the life of the study - up to 4 years
Awards & highlights

Study Summary

This trial provides the option to continue apremilast treatment for up to 4 years for those who complete an initial 52-week trial. There will be an 8-week observational follow-up phase.

Who is the study for?
This trial is for children aged 6-17 with moderate to severe plaque psoriasis, weighing at least 20 kg and having a BMI within the CDC's growth chart. They must have completed a previous Apremilast study and be willing to follow the new study schedule. Girls who can get pregnant must use birth control or practice abstinence, and cannot participate if they are pregnant or breastfeeding.Check my eligibility
What is being tested?
The trial tests long-term effects of Apremilast in young patients with plaque psoriasis. Participants will receive this medication for up to 208 weeks followed by an observational phase of 8 weeks to monitor its safety and effectiveness over time.See study design
What are the potential side effects?
Apremilast may cause side effects like diarrhea, nausea, upper respiratory tract infections, tension headaches, and potential weight loss. It might also affect mood leading to depression or other mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am using approved birth control methods if I can become pregnant.
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I am using birth control or practicing abstinence as required while on apremilast and for 28 days after.
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I weigh at least 20 kg.
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My BMI is above the 5th percentile for my age and sex according to the CDC chart.
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My BMI is above the 5th percentile for my age and sex according to the CDC chart.
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I weigh at least 20 kg.
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I am between 6 and 17 years old, and my guardian has signed the consent.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collected every 52 weeks throughout the life of the study - up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and collected every 52 weeks throughout the life of the study - up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events (AEs)
Assessment of sexual maturity
Columbia-Suicide Severity Rating Scale (C-SSRS)
+3 more
Secondary outcome measures
Static Physician Global Assessment (sPGA)

Side effects data

From 2018 Phase 4 trial • 20 Patients • NCT03000309
30%
diarrhea
30%
nausea
25%
headache
15%
abdominal cramping
15%
upset stomach, unspecified
10%
heartburn
5%
viral gastroenteritis
5%
right flank pain
5%
abscess right hand
5%
cyst left inner thigh
5%
irritability
5%
leg cramps
5%
upper respiratory infection
5%
otitis externa
100%
80%
60%
40%
20%
0%
Study treatment Arm
Apremilast

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients treated with ApremilastExperimental Treatment1 Intervention
Subjects with a weight between 20 kg to < 50 kg will receive apremilast 20 mg BID and subjects with weight ≥ 50 kg at Visit 1 will receive apremilast 30 mg BID. Subjects that begin the study receiving apremilast 20 mg BID and later record a body weight ≥ 50 kg, will be switched to apremilast 30 mg BID.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apremilast
2017
Completed Phase 4
~2500

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,355 Previous Clinical Trials
1,383,911 Total Patients Enrolled
76 Trials studying Psoriasis
116,350 Patients Enrolled for Psoriasis
MDStudy DirectorAmgen
899 Previous Clinical Trials
921,588 Total Patients Enrolled
64 Trials studying Psoriasis
23,160 Patients Enrolled for Psoriasis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the target number of enrollees for this trial?

"In order to carry out this investigation, 140 individuals that meet the prerequisites will be needed. The sponsor, Amgen, will be conducting the trial from various locations, including Solutions Through Advanced Research Inc in Jacksonville, Florida and Johnson Dermatology Clinic in Fort Smith, Arkansas."

Answered by AI

Are individuals who are younger than 55 years old allowed to participate in this research project?

"In order to meet the requirements to participate in this clinical trial, applicants must be between the ages of 6 and 17. Out of the 200 total clinical trials, 36 are for patients that are under 18 years old and 164 are for patients that are over 65 years old."

Answered by AI

Which patients does this research require?

"This clinical trial is looking for 140 children and adolescents aged 6 to 17 with psoriasis. The following inclusion criteria must be met:- The subject must have a weight of ≥ 20 kg.- The subject must have completed Week 52 (Apremilast Extension Phase) of Study CC-10004-PPSO-003.- The subject is willing and able to adhere to the study visit schedule and other protocol requirements.- The subject's age and sex specific BMI value must be no lower in range than the 5th percentile on the Centers for Disease Control (CDC) growth chart."

Answered by AI

What is the precedent for using Apremilast in medical treatment?

"Attikon Hospital was the first to study apremilast back in 2014. So far, a total of 76 clinical trials have been completed with 14 more currently underway. These active studies are primarily based in Jacksonville, Florida."

Answered by AI

Could you please tell us about Apremilast's safety records?

"There is some evidence indicating that Apremilast is effective, and multiple clinical trials have supported its safety, so it received a score of 3."

Answered by AI

What are the primary conditions that Apremilast treats?

"Apremilast is not only effective in the treatment of ulcers, but also for other chronic inflammatory diseases like psoriasis, behcet's syndrome, and severe plaque psoriasis."

Answered by AI

Could you please provide the total number of hospitals currently participating in this trial?

"Solutions Through Advanced Research Inc in Jacksonville, Florida, Johnson Dermatology Clinic in Fort Smith, Arkansas, Skin care Physicians of Georgia in Macon, Georgia, and 17 other locations are where this research is being conducted."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
What state do they live in?
Indiana
What site did they apply to?
Dawes Fretzin Dermatology Group Inc
How many prior treatments have patients received?
1
3+

Why did patients apply to this trial?

I've tried other drugs that have not worked. I am open to trying other drugs.
PatientReceived no prior treatments
~30 spots leftby Mar 2025