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Apremilast for Pediatric Plaque Psoriasis

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.

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.

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.

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 below

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I weigh at least 20 kg.

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My psoriasis is mild to moderate, covering 2-15% of my body.

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My psoriasis is not improving with creams or ointments.

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My BMI is within the healthy range for my age and sex according to growth charts.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have guttate, erythrodermic, or pustular psoriasis currently.

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My psoriasis worsened or came back in the last 4 weeks.

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I do not have active TB nor a history of inadequately treated TB.

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I have a history of or currently have cancer or blood disorders.

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I am a woman who can have children and I am not currently pregnant.

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I have a history of getting infections often.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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

viral gastroenteritis

cyst left inner thigh

abscess right hand

right flank pain

irritability

leg cramps

upper respiratory infection

otitis externa

100%

80%

60%

40%

20%

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

0 / 10Eligibility criteria met