Apremilast for Pediatric Plaque Psoriasis

Recruiting at 31 trial locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Amgen

Must not be taking: Systemic therapies, Biologics

Disqualifiers: Active infection, Malignancy, Psoriasis flare, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The primary objective of this post-marketing study is to assess the safety and tolerability of apremilast in pediatric participants (ages 6 through 17 years) with mild to moderate plaque psoriasis.

Will I have to stop taking my current medications?

Yes, if you are currently using certain medications for psoriasis, you will need to stop them before joining the trial. This includes stopping conventional systemic therapies 28 days before, and certain biologic therapies up to 24 weeks before the study starts.

Is Apremilast safe for treating plaque psoriasis in children?

Apremilast (Otezla) is generally well tolerated in adults with psoriasis and psoriatic arthritis, with common side effects including diarrhea and nausea, which usually resolve within a few weeks. It has a favorable safety profile with no need for special monitoring, but there has been a rare report of a laryngeal pseudotumor (a non-cancerous growth in the throat) in an adult treated for plaque psoriasis. ^{1 2 3 4 5}

What makes the drug Apremilast unique for treating pediatric plaque psoriasis?

Apremilast is unique because it is an oral medication that works by inhibiting an enzyme called phosphodiesterase 4 (PDE-4), which helps reduce inflammation. Unlike some other treatments, it does not require pre-screening or ongoing lab monitoring, making it easier to use. ^{1 2 4 5 6}

Research Team

MD

Principal Investigator

Amgen

Eligibility Criteria

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.

Inclusion Criteria

Participant is able to swallow the study medication tablet.

I weigh at least 20 kg.

I have been diagnosed with chronic plaque psoriasis for at least 6 months.

Exclusion Criteria

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

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

I have not had an infection or taken antibiotics in the last 14 days.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Apremilast dosed by body weight, administered twice daily in the form of oral tablets

12 weeks

Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Apremilast (Other)

Trial Overview 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.

Participant Groups

Group I: Apremilast Experimental Treatment 1 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.

Apremilast is already approved in Canada, Japan for the following indications:

Approved in Canada as Otezla for:

• Psoriatic arthritis
• Plaque psoriasis

Approved in Japan as Otezla for:

• Psoriatic arthritis
• Plaque psoriasis

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Findings from Research

Apremilast is an effective oral treatment for plaque psoriasis and psoriatic arthritis, showing proven and durable efficacy in managing these conditions.

It has a favorable safety profile, requiring no specific pre-screening or ongoing laboratory monitoring, making it a convenient option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

▼ Apremilast for psoriasis and psoriatic arthritis. [2015]

In two phase III clinical trials (ESTEEM), apremilast significantly reduced the severity of moderate to severe plaque psoriasis in adults at 16 weeks, with benefits sustained over 52 weeks.

In three PALACE trials, apremilast improved symptoms of psoriatic arthritis (PsA) at 16 weeks, with effects lasting up to 104 weeks, and was generally well tolerated, with common side effects like diarrhea and nausea typically resolving within a month.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apremilast: A Review in Psoriasis and Psoriatic Arthritis. Deeks, ED.[2022]

Apremilast (30 mg twice daily) significantly reduces the severity of moderate to severe plaque psoriasis and improves patient-reported outcomes, with effects noticeable as early as week 2, based on results from the phase 3 ESTEEM trials.

In patients with active psoriatic arthritis, apremilast also shows early efficacy and sustained improvement in symptoms over 208 weeks, while being generally well tolerated and requiring no laboratory monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apremilast: A Review in Psoriasis and Psoriatic Arthritis. Keating, GM.[2022]

Apremilast is an oral medication that inhibits PDE-4, showing efficacy in treating active psoriatic arthritis, and has received its first global approval in the USA for this condition.

The drug is also under review for approval in Canada and Europe for psoriatic arthritis and plaque psoriasis, indicating its potential as a widely used treatment option for these inflammatory conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apremilast: first global approval. Poole, RM., Ballantyne, AD.[2021]

Apremilast (Otezla®) is an effective oral medication for managing psoriasis, psoriatic arthritis, and recently approved for treating oral ulcerations in Behçet's disease, with a favorable side effect profile compared to other DMARDs.

This report highlights a rare case of laryngeal pseudotumor in a patient using apremilast for plaque psoriasis, suggesting the need for awareness of potential uncommon side effects even with well-tolerated medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pseudotumor of the Larynx: A Previously Unreported Side Effect of Apremilast. Ntouniadakis, E., Landström, F.[2021]

Apremilast (Otezla) is an oral medication specifically designed for adults suffering from psoriasis and psoriatic arthritis, providing a new treatment option for these conditions.

Clinical studies have demonstrated that apremilast effectively reduces the severity of psoriasis symptoms and improves joint function in patients with psoriatic arthritis, making it a valuable addition to existing therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apremilast (Otezla): A New Oral Treatment for Adults With Psoriasis and Psoriatic Arthritis. Zerilli, T., Ocheretyaner, E.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

▼ Apremilast for psoriasis and psoriatic arthritis. [2015]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Apremilast: A Review in Psoriasis and Psoriatic Arthritis. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Apremilast: A Review in Psoriasis and Psoriatic Arthritis. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Apremilast: first global approval. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Pseudotumor of the Larynx: A Previously Unreported Side Effect of Apremilast. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Apremilast (Otezla): A New Oral Treatment for Adults With Psoriasis and Psoriatic Arthritis. [2020]