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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 up to approximately 285 days

Awards & highlights

Study 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.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 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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 up to approximately 285 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 up to approximately 285 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to approximately 285 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With Treatment-emergent Adverse Events

Secondary outcome measures

Columbia-Suicide Severity rating Scale (C-SSRS)

Growth and Development as Assessed by Body Mass Index (BMI)

Growth and Development as Assessed by Height

+7 more

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

right flank pain

abscess right hand

cyst left inner thigh

irritability

leg cramps

upper respiratory infection

otitis externa

100%

80%

60%

40%

20%

Study treatment Arm

Apremilast

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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor

1,371 Previous Clinical Trials

1,378,168 Total Patients Enrolled

MDStudy DirectorAmgen

915 Previous Clinical Trials

924,680 Total Patients Enrolled

Frequently Asked Questions

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

How many participants have been enrolled in this experiment?

"To conduct this experiment, 50 eligible individuals are required. Potential subjects may join the study at either Dermatology Research Center of Oklahoma in Tulsa or Studies in Dermatology found in Cypress."

Answered by AI

What potential side effects may be associated with Apremilast use?

"Our team at Power assigned Apremilast a score of 3 based on its Phase 3 status, which demonstrates the drug's efficacy and multiple safety confirmations."

Answered by AI

Is the inclusion age for this research endeavor above eighty-five?

"This medical trial necessitates that participants are between the ages of 6 and 17, in accordance with its eligibility criteria."

Answered by AI

Are there numerous locations within the United States where this experiment is being conducted?

"Currently, there are 9 different locations across the US where this study is being conducted. Tulsa, Cypress and Sugar Land are three of these sites; a full list can be found online to determine the closest centre for prospective participants."

Answered by AI

Are any new patients being accepted into this experimental protocol?

"Indeed, the information on clinicaltrials.gov confirms that this trial is presently looking for participants and has been since October 24th 2023. The posting was most recently amended on November 10th 2023, with 50 people needed at 9 sites."

Answered by AI

Who are the ideal candidates for enrolment in this experiment?

"A current clinical trial is searching for 50 young participants with plaque psoriasis, aged between 6 and 17. To be eligible, the candidate must meet a variety of criteria including: Psoriasis Area Severity Index score ranging from 2 to 15; Body surface area up to 15%; Weight over 20 kg; Age-and sex-specific BMI no lower than the fifth percentile on growth chart for children/adolescents; Ability to swallow study medication tablets; Diagnosis of chronic plaque psoriasis at least half a year before screening begins with Static Physician Global Assessment score evaluating as mild or moderate. Moreover, this medical trial requires that"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis

2023. "A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06088199.

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