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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

Subject must have a weight of ≥ 20 kg.

Subjects must have an age and sex specific BMI value no lower in range than the 5th percentile on the Centers for Disease Control (CDC) growth chart for children and adolescents.

Must not have

Subject has active tuberculosis (TB) or a history of incompletely treated TB.

Subject has guttate, erythrodermic, or pustular psoriasis.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up collected every 52 weeks throughout the life of the study - up to 4 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

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.

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.

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 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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I am between 6 and 17 years old, and my guardian has signed the consent.

Exclusion Criteria

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

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I have active TB or was not fully treated for TB in the past.

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I have a specific type of psoriasis (guttate, erythrodermic, or pustular).

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I have skin conditions, other than psoriasis, that could affect skin assessments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ collected every 52 weeks throughout the life of the study - up to 4 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events (AEs)

Assessment of sexual maturity

Columbia-Suicide Severity Rating Scale (C-SSRS)

+3 more

Secondary study objectives

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

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

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~2300

0 / 6Eligibility criteria met