Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis

  • STATUS
    Recruiting
  • End date
    Apr 6, 2023
  • participants needed
    230
  • sponsor
    Amgen
Updated on 7 August 2021
systemic therapy
phototherapy
topical agents
cc-10004
apremilast
plaque psoriasis

Summary

This is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study of the efficacy and safety of apremilast (CC-10004) in pediatric subjects with moderate to severe plaque psoriasis.

At least 230 pediatric subjects (ages 6 through 17 years) will be randomized 2:1 to receive either apremilast or placebo for the first 16 weeks and then all subjects will receive apremilast during the 36 week Extension Phase for a total of 52 weeks. Randomization to apremilast arm or placebo arm will be stratified by age group (6 to 11 years or 12 to 17 years). Subjects will receive apremilast treatment of either 20 mg twice daily (BID) or 30 mg BID, depending on weight. This Phase 3 study is being conducted to evaluate the safety and efficacy of apremilast in the treatment of pediatric subjects.

Description

Treatment will be assigned by weight with subjects 20 kg to < 50 kg receiving apremilast 20 mg BID or placebo BID and subjects 50 kg receiving apremilast 30 mg BID or placebo BID. Total study duration is up to 71 weeks. Subjects completing all 52 weeks of the treatment and extension phase will be able to enter the Long-term study. Subjects not entering the Long-term study will return for 3 observational follow-up visits, 4, 8 and 14 weeks after last dose of study drug.

Details
Condition Psoriasis, Psoriasis and Psoriatic Disorders
Treatment Placebo, Apremilast (CC-10004)
Clinical Study IdentifierNCT03701763
SponsorAmgen
Last Modified on7 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Males or female subjects 6 to 17 years of age, inclusive, at the time the informed consent form is signed by the legal guardian
Subjects must have a weight of 20 kg
Diagnosis of chronic plaque psoriasis for at least 6 months prior to Screening
Has moderate to severe plaque psoriasis at Screening and Baseline as defined by
PASI score 12; and
Body surface area (BSA) 10%; and
sPGA 3 (moderate to severe)
Disease inadequately controlled by or inappropriate for topical therapy for psoriasis
Candidate for systemic therapy or phototherapy

Exclusion Criteria

Guttate, erythrodermic, or pustular psoriasis at Screening and Baseline
Psoriasis flare or rebound within 4 weeks prior to Screening
Prior history of suicide attempt at any time in the subject's lifetime prior to Screening or randomization in the study, or major psychiatric illness requiring hospitalization within 3 years prior to signing the assent and informed consent
Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale during Screening or at Baseline
Current or planned concurrent use of the following therapies that may have a possible effect on psoriasis
Topical therapy within 2 weeks prior to randomization (including but not limited to topical corticosteroids, topical retinoid or vitamin D analog preparations, tacrolimus, pimecrolimus, or anthralin/dithranol)
Exceptions
i. Low potency or weak corticosteroids (please refer to the Investigators'
Manual) will be allowed as background therapy for treatment of the face
axillae and groin in accordance with manufacturer's suggested usage ii
Unmedicated skin moisturizer (eg, Eucerin) will also be permitted for body
lesions
Subjects should not use these topical treatments within 24 hours prior to the clinic visit
b. Conventional systemic therapy for psoriasis within 4 weeks prior to
randomization c. Phototherapy treatment (ie, ultraviolet B [UVB], PUVA) within
weeks prior to randomization d. Biologic therapy within 4 weeks prior to
randomization or 5 PK/PD half-lives (whichever is longer)
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note