Long-Term Apremilast Use for Psoriasis

Recruiting in Palo Alto (17 mi)

+57 other locations

Age: < 18

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Amgen

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 jurisdictions

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.

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

I weigh at least 20 kg.

My BMI is above the 5th percentile for my age and sex according to the CDC chart.

I am between 6 and 17 years old, and my guardian has signed the consent.

Exclusion Criteria

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

I have a specific type of psoriasis (guttate, erythrodermic, or pustular).

I have skin conditions, other than psoriasis, that could affect skin assessments.

Participant Groups

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.

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: