A Study of Safety, Tolerability and Pharmacokinetics of Apremilast (CC-10004) in Pediatric Subjects With Moderate to Severe Plaque Psoriasis

Part of paid clinical trials in San Diego, California.

Sponsor
Amgen
Study ID
NCT02576678
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a Phase 2, multicenter, open-label study in subjects with moderate to severe plaque psoriasis aged 6 to 17 years, inclusive, intended to assess the safety, tolerability, and PK of apremilast with 2 weeks of oral apremilast treatment followed by a 48-week extension of apremilast treatment. Moderate to severe plaque psoriasis is defined as Psoriasis Area Severity Index (PASI) ≥ 12, Body Surface Area (BSA) ≥ 10%, and static Physician Global Assessment (sPGA) of ≥ 3. The total study duration for each subject will last for up to a total of 107 weeks which includes screening, treatment (including the PK portion of the study and the extension treatment period), two short-term follow-up periods and a long-term follow-up period.

Key Dates

First listed
Oct 15, 2015
Start date
Oct 13, 2015
Status verified
Apr 2020
Primary completion
Sep 4, 2017
Completion
Jul 29, 2019

Study Design

Enrollment
42 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Open label apremilast
    Apremilast doses of 10-mg, 20-mg or 30-mg tablets have been selected to determine the dose range in adolescents and children with moderate to severe plaque psoriasis. These pediatric dosages are expected to achieve exposures similar to those achieved in adult psoriasis and psoriatic arthritis (PsA) subjects treated with apremilast 30 mg orally twice daily (BID). A staggered, stepwise approach by age range and weight (starting with older and heavier subjects) is considered appropriate for this first-time-in-children study. Doses for younger and lower body weight subjects will be adjusted based on safety and PK data from older and heavier subjects. Subjects will be divided into 2 age groups with at least 16 subjects in each group. Dosing within and between groups will be staggered, based on PK data collected and on a minimum of 2 weeks of safety data.

Primary Outcome Measure

Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: From first dose of apremilast until 28 days after the last dose; up to 29 July 2019; median treatment duration for adolescents apremilast 20 mg and 30 mg was 50.00 and 50.57 weeks respectively and for children was 50.00 weeks. ]

Locations (6)

FacilityCityStateZIPSite coordinators
Rady Children's HospitalSan DiegoCalifornia92123-
Emory UniversityAtlantaGeorgia30322-
Ann & Robert H. Lurie Children's Hospital of Chicago Department of DermatologyChicagoIllinois60611-
Dundee DermatologyWest DundeeIllinois60118-
Mount Sinai, St. Luke'sNew YorkNew York10025-
Texas Dermatology and Laser SpecialistsSan AntonioTexas78218-

Find similar trials in San Diego, CA

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Rady Children's Hospital· San Diego, CAEmory University· Atlanta, GAAnn & Robert H. Lurie Children's Hospital of Chicago Department of Dermatology· Chicago, ILDundee Dermatology· West Dundee, ILMount Sinai, St. Luke's· New York, NYTexas Dermatology and Laser Specialists· San Antonio, TX

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