Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||6 Years - 17 Years|
Inclusion Criteria:1. Males or female subjects 6 to 17 years of age, inclusive, at the time the informed consent form is signed by the legal guardian. 2. Subjects must have a weight of ≥ 20 kg. 3. Diagnosis of chronic plaque psoriasis for at least 6 months prior to Screening. 4. 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) 5.
Exclusion Criteria:1. Guttate, erythrodermic, or pustular psoriasis at Screening and Baseline. 2. Psoriasis flare or rebound within 4 weeks prior to Screening. 3. 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. 4. Answer "Yes" to any question on the Columbia-Suicide Severity Rating Scale during Screening or at Baseline. 5. Current or planned concurrent use of the following therapies that may have a possible effect on psoriasis. a. 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 4 weeks prior to randomization d. Biologic therapy within 4 weeks prior to randomization or 5 PK/PD half-lives (whichever is longer).
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||Amgen|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Belgium, Canada, Czechia, France, Israel, Italy, Netherlands, Russian Federation, Spain, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Study Website:||View Trial Website|
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.
Experimental: Administration of Apremilast (CC-10004) - 20mg
Apremilast 20mg Twice Daily (BID)
Experimental: Administration of Apremilast (CC-10004) - 30mg
Apremilast 30mg Twice Daily (BID)
Placebo Comparator: Administration of Placebo
Placebo tablet Twice Daily (BID)
Drug: - Apremilast (CC-10004)
Other: - Placebo
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.