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Compensation: Varies

Number of Visits: Unknown

Duration: 208 weeks

160 Participants Needed

Long-Term Apremilast Use for Psoriasis

Recruiting at 57 trial locations

Overseen ByAmgen 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 GroupAll 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 DataThis treatment has passed at least one previous human trial

Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This study was created to provide subjects who complete Week 52 (end of Apremilast Extension Phase) of study CC-10004-PPSO-003 the option to continue to receive open-label apremilast therapy. The study will consist of up to 208 weeks of long-term treatment followed by an 8-week observational follow-up phase.

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.

What data supports the effectiveness of the drug Apremilast (Otezla) for treating psoriasis?

Research shows that Apremilast (Otezla) effectively reduces the severity of moderate to severe plaque psoriasis, including difficult-to-treat areas like nails and scalp, and improves patient-reported outcomes such as itching and skin discomfort. These benefits were observed as early as two weeks into treatment and were sustained over time.¹ ² ³ ⁴ ⁵

Is Apremilast (Otezla) safe for long-term use in humans?

Apremilast (Otezla) is generally well tolerated in humans, with common side effects including diarrhea and nausea, which usually occur in the first two weeks and resolve within four weeks. It has a favorable safety profile with no need for specific pre-screening or ongoing lab monitoring, although a rare side effect like a pseudotumor of the larynx has been reported.¹ ³ ⁴ ⁵ ⁶

How is the drug Apremilast unique for treating psoriasis?

Apremilast is unique because it is an oral medication that works by inhibiting phosphodiesterase 4 (PDE4), which helps reduce inflammation in psoriasis. Unlike some other treatments, it does not require injections and has a generally well-tolerated side effect profile, making it a convenient option for long-term management.¹ ² ³ ⁴ ⁵

Research Team

Principal Investigator

Amgen

Eligibility Criteria

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.

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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.

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Timeline

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

Treatment Details

Interventions

Apremilast

Trial OverviewThe 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.

Participant Groups

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.

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

Find a Clinic Near You

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

Findings from Research

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 (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]