Apremilast for Pediatric Plaque Psoriasis

Not currently recruiting at 36 trial locations

Overseen By Amgen Call Center

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Amgen

Must not be taking: Systemic therapies, Biologics

Disqualifiers: Active infection, Malignancy, Psoriasis flare, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the safety and ease of use of apremilast (Otezla) for children and teens with mild to moderate plaque psoriasis. It focuses on those who have had the condition for at least six months and have not found success with creams or ointments. Participants must weigh at least 20 kg (about 44 pounds) and be able to swallow pills. The medicine is taken as a pill twice a day. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment option.

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 there any evidence suggesting that apremilast is likely to be safe for pediatric patients with plaque psoriasis?

A previous study found apremilast safe for children ages 6 to 17 with plaque psoriasis. Over 16 weeks, it effectively reduced psoriasis severity. Another study showed these improvements lasted a full year, with no new safety concerns during that time.

Common side effects of apremilast include diarrhea, nausea, colds, and headaches, occurring in less than 5% of patients. Overall, current research indicates the treatment is generally well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for plaque psoriasis?

Apremilast is unique because it targets plaque psoriasis in a new way by inhibiting an enzyme called phosphodiesterase 4 (PDE4). This approach reduces inflammation and is different from the current standard treatments like topical corticosteroids, vitamin D analogs, or biologics, which primarily modulate the immune system or reduce skin cell production. Additionally, Apremilast is taken orally, offering a non-invasive alternative to injections or topical treatments, which can be more convenient for pediatric patients and their families. Researchers are excited about Apremilast because it offers a promising new option with a potentially favorable safety profile for managing plaque psoriasis in children.

What evidence suggests that apremilast might be an effective treatment for pediatric plaque psoriasis?

Research has shown that apremilast, the treatment under study in this trial, effectively treats plaque psoriasis in children aged 6 to 17. One study found that apremilast reduced psoriasis severity over 16 weeks in these age groups. Another study discovered that these improvements lasted up to 52 weeks. These studies included children with moderate to severe plaque psoriasis, demonstrating that apremilast can significantly help manage the condition. Overall, the evidence supports apremilast as a promising option for pediatric plaque psoriasis. ^{1 2 4 5 6}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Apremilast

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.

How Is the Trial Designed?

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 United States, European Union, Canada, Japan for the following indications:

Approved in United States as Otezla for:

• Psoriatic arthritis
• Plaque psoriasis
• Behçet’s disease

Approved in European Union as Otezla for:

• Psoriatic arthritis
• Plaque psoriasis
• Behçet’s disease

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

Published Research Related to This Trial

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]

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 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40737559/

Efficacy and safety of apremilast in pediatric patients with ... Conclusions: Improvements in clinical outcomes were sustained through 52 weeks with apremilast treatment in pediatric patients with moderate to ...

2. jaad.org jaad.org/article/S0190-9622(24)00108-7/fulltext

Efficacy and safety of apremilast in pediatric patients with ... In this phase 3 study, apremilast was safe and effective in reducing psoriasis severity over 16 weeks in children aged 6-17 years, supporting ...

3. otezlapro.com otezlapro.com/plaque-psoriasis/efficacy/sprout/

SPROUT: Efficacy in Pediatric Patients - Otezla Otezla (apremilast) was evaluated in pediatric patients with moderate to severe plaque psoriasis (n=163) vs placebo (n=82), 6 to 17 years of age.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03701763

NCT03701763 | Efficacy and Safety Study of Apremilast ... Efficacy and safety of apremilast in pediatric patients with moderate to severe plaque psoriasis: 52-week results from the SPROUT randomized controlled trial.

5. academic.oup.com academic.oup.com/bjd/advance-article/doi/10.1093/bjd/ljaf305/8219502

Efficacy and safety of apremilast in pediatric patients with ... Improvements in clinical outcomes were sustained through 52 weeks with apremilast treatment in pediatric patients with moderate to severe ...

6. otezlapro.com otezlapro.com/plaque-psoriasis/safety/

PsO Safety Profile | Otezla® (apremilast) HCP IMPORTANT SAFETY INFORMATION · Plaque Psoriasis: The most common adverse reactions (≥5%) are diarrhea, nausea, upper respiratory tract infection, and headache, ...