Long-Term Apremilast Use for Psoriasis

Not currently recruiting at 76 trial locations

Overseen By Amgen Call Center

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Amgen

Must be taking: Apremilast

Must not be taking: Conventional systemic, Biologic therapy

Disqualifiers: Pregnancy, Active TB, Other psoriasis, 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: 208 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the long-term use of apremilast, a medication designed to manage psoriasis, a skin condition that causes itchy, scaly patches. The study targets children and teens aged 6-17 who have completed a previous phase of apremilast treatment and are willing to continue with the treatment and attend regular follow-up visits. The goal is to assess the effectiveness and safety of apremilast over an extended period. 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 for psoriasis.

Will I have to stop taking my current medications?

The trial requires that you do not use certain medications that might affect psoriasis, such as conventional systemic therapies or biologic therapies. If you are on any of these, you may need to stop them to participate in the study.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that apremilast is generally safe for long-term use. In studies, participants took apremilast twice daily for up to five years, and it was well-tolerated without new safety concerns. Participants did not experience unexpected side effects, indicating that the treatment remains safe over time.

Other studies support these findings, demonstrating that apremilast maintains a good safety record for more than three years. Overall, the treatment appears safe, with no serious issues reported. ^{1 2 3 4 5}

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

Apremilast is unique because it targets psoriasis by inhibiting an enzyme called phosphodiesterase 4 (PDE4), which reduces inflammation differently than traditional treatments like biologics or topical therapies. Unlike many standard psoriasis treatments that may involve injections or topical applications, apremilast is taken orally, making it more convenient for some patients. Researchers are excited about apremilast because it offers a novel mechanism of action with a potentially favorable side effect profile, providing another option for patients who may not respond well to existing therapies.

What is the effectiveness track record for Apremilast in treating psoriasis?

Research has shown that apremilast effectively treats moderate to severe plaque psoriasis. Patients taking apremilast have experienced significant skin clearance and symptom improvement. In one study, 22% of participants achieved skin that was clear or almost clear. Additionally, apremilast proved safe and effective for up to 52 weeks of use, suggesting it could help manage psoriasis symptoms over the long term. ^{6 7 8 9 10}

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 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.

Inclusion Criteria

At the time of study entry, and at any time during the study when a female subject of childbearing potential's contraceptive measures or ability to become pregnant changes, the Investigator will educate the subject regarding abstinence or contraception options and the correct and consistent use of effective contraceptive methods in order to successfully prevent pregnancy.

I am using birth control or practicing abstinence as required while on apremilast and for 28 days after.

Subject is able to sign an assent with a legal guardian/s who understand/s and voluntarily sign/s an informed consent prior to any study-related assessments/procedures being conducted.

Exclusion Criteria

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

I have had long periods of sun exposure or used tanning booths.

Children in Care: a child who has been placed under the control or protection of an agency, organization, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive open-label apremilast therapy for up to 208 weeks

208 weeks

Visits at regular intervals throughout the study

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Observational visits

What Are the Treatments Tested in This Trial?

Interventions

• Apremilast

Trial Overview 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.

How Is the Trial Designed?

Group I: Patients treated with Apremilast Experimental Treatment 1 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.

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

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 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]

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 (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 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 (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]

Citations

1. otezlapro.com otezlapro.com/plaque-psoriasis/efficacy/

otezla® (apremilast) efficacy in plaque psoriasis Plaque Psoriasis: Body weight loss of 5-10% occurred in 12% (96/784) of adult patients with moderate to severe plaque psoriasis treated with Otezla and in 5% ( ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4517531/

Apremilast (Otezla): A New Oral Treatment for Adults With ... Likewise, during the psoriasis trials, 12% of patients in the apremilast group experienced 5% to 10% weight loss versus 5% in the placebo group. As a result, ...

3. jaad.org jaad.org/article/S0190-9622(23)03022-0/fulltext

Efficacy and safety of apremilast in patients with moderate ... Apremilast demonstrated statistically and clinically meaningful genital Physician Global Assessment responses and improvement of signs, symptoms ...

4. otezlapro.com otezlapro.com/plaque-psoriasis/efficacy/real-world/

Real-World PsO Data | Otezla® (apremilast) HCP Primary Endpoint: 22% of patients taking Otezla 30 mg BID (n=297) achieved an sPGA score of 0 (clear) or 1 (almost clear) and a ≥2-point reduction from baseline ...

5. link.springer.com link.springer.com/article/10.1007/s13555-025-01389-z

Efficacy and Safety of Apremilast Over 52 Weeks in ... Apremilast was safe and effective through week 52 in European patients with chronic plaque psoriasis in at least one high-impact area, limited ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37316690/

Apremilast Long-Term Safety Up to 5 Years from 15 Pooled ... Methods: We analyzed longer-term safety and tolerability of apremilast 30 mg twice daily across three indications for up to 5 years, focusing on ...

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

PsO Safety Profile | Otezla® (apremilast) HCP Long-term exposure includes apremilast Phase 3 data pool in the apremilast exposure period from week 0 through 5 years. §Estimates of patients treated ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10266699/

Apremilast Long-Term Safety Up to 5 Years from 15 Pooled ... This analysis further demonstrates that apremilast is a safe, oral treatment option for long-term use up to 5 years in patients with psoriasis, ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0190962217301469

Long-term safety and tolerability of apremilast in patients ... Apremilast, an oral PDE4 inhibitor, demonstrated an acceptable safety profile and was generally well tolerated for ≥156 weeks. No new safety concerns were ...

10. jrheum.org jrheum.org/content/42/3/479

Longterm (52-week) Results of a Phase III Randomized ... Continuous apremilast treatment resulted in sustained improvements in PsA for up to 52 weeks. Apremilast had an acceptable safety profile and was generally ...