← Back to Search
Other
Apremilast for Pediatric Plaque Psoriasis
Bay City, MI
Phase 3
Recruiting
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have a weight of ≥ 20 kg.
Has mild to moderate plaque psoriasis at screening and Study Visit 1 as defined by: Psoriasis Area Severity Index score 2-15, Body surface area 2-15%, and Static Physician Global Assessment score of 2-3 (mild to moderate)
Must not have
Guttate, erythrodermic, or pustular psoriasis at screening and Study Day 1.
Psoriasis flare or rebound within 4 weeks prior to screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial looks at how safe and tolerable a drug called apremilast is for kids (ages 6-17) with mild-moderate psoriasis.
See full description
Who is the study for?
This trial is for children aged 6-17 with mild to moderate plaque psoriasis, who are above the fifth percentile in BMI for their age and sex, weigh at least 20 kg, and can swallow tablets. They should have had psoriasis for at least six months but not severe enough to require systemic or biologic therapies recently.Check my eligibility
What is being tested?
The study tests the safety and tolerability of a medication called Apremilast in young patients with plaque psoriasis. It's designed to see how well kids handle this drug that's already used by adults.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. The severity of these side effects will be closely monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I weigh at least 20 kg.
show original
Select...
My psoriasis is mild to moderate, covering 2-15% of my body.
show original
Select...
My psoriasis is not improving with creams or ointments.
show original
Select...
My BMI is within the healthy range for my age and sex according to growth charts.
show original
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have guttate, erythrodermic, or pustular psoriasis currently.
show original
Select...
My psoriasis worsened or came back in the last 4 weeks.
show original
Select...
I do not have active TB nor a history of inadequately treated TB.
show original
Select...
I have a history of or currently have cancer or blood disorders.
show original
Select...
I am a woman who can have children and I am not currently pregnant.
show original
Select...
I have a history of getting infections often.
show original
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2018 Phase 4 trial • 20 Patients • NCT0300030930%
diarrhea
30%
nausea
25%
headache
15%
abdominal cramping
15%
upset stomach, unspecified
10%
heartburn
5%
abscess right hand
5%
right flank pain
5%
cyst left inner thigh
5%
viral gastroenteritis
5%
irritability
5%
leg cramps
5%
upper respiratory infection
5%
otitis externa
100%
80%
60%
40%
20%
0%
Study treatment Arm
Apremilast
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ApremilastExperimental Treatment1 Intervention
Apremilast will be dosed by participant's body weight and administered twice daily (BID) in the form of oral tablets, approximately 12 hours apart, without restriction of food or drink.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Apremilast
2017
Completed Phase 4
~2300
Find a Location
Closest Location:Dawes Fretzin Clinical Research Group, LLC· Indianapolis, IN· 163 miles
Who is running the clinical trial?
AmgenLead Sponsor
1,504 Previous Clinical Trials
1,431,004 Total Patients Enrolled
MDStudy DirectorAmgen
1,019 Previous Clinical Trials
951,697 Total Patients Enrolled