Phase 2
N=42
A Study of Safety, Tolerability and Pharmacokinetics of Apremilast (CC-10004) in Pediatric Subjects With Moderate to Severe Plaque Psoriasis
Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT02576678 ↗Enrolled (actual)
42
Serious AEs
2.4%
Results posted
Sep 2018
Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 13; 7; 20; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Apremilast (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
13; 7; 20; 11; 6; 17 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Apremilast |
274.272; 410.929; 348.146 | — |
| PRIMARY Time to Maximum Plasma Concentration (Tmax) of Apremilast |
2.467; 3.000; 2.000 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post Dose of Apremilast (AUC0-12) |
1799.717; 2901.795; 2544.874 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration of Apremilast (AUC0-t) |
1794.815; 2900.472; 2367.641 | — |
| PRIMARY Apparent Total Plasma Clearance When Dosed Orally (CL/F) for Apremilast |
11.113; 10.338; 7.859 | — |
| PRIMARY Apparent Total Volume of Distribution When Dosed Orally, Based on Study-State (Vss/F) or in the Terminal Phase (Vz/F) |
86.870; 101.049; 55.126 | — |
| PRIMARY Terminal Phase Elimination Half-Life |
5.418; 6.775; 4.862 | — |
| SECONDARY Taste and Acceptability of Apremilast Tablets Using the Faces Likert Scale |
0; 0; 3; 1; 0; 1 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Subjects must satisfy all of the following criteria to be enrolled in the study:
- Male or female subjects 6 to 17 years of age, inclusive, at the time the informed consent document is signed by the legal guardian
- Group 1 Only: ages 12 to 17 years, inclusive, and weighs ≥ 35 kg
- Group 2 Only: ages 6 to 11 years, inclusive, and weighs ≥ 15 kg
- Subject is able to swallow the apremilast tablet
- Able to sign an assent with a legal guardian who can understand and voluntarily sign an informed consent
- Able to adhere to the study visit schedule and other protocol requirements
- Must agree to withhold vaccinations during the first 2 weeks of dosing. Inactivated vaccines will be allowed during the extension treatment period
- Diagnosis of chronic plaque psoriasis for at least 6 months prior to Screening
- Have moderate to severe plaque psoriasis at Screening and Baseline as defined by:
- Psoriasis Area and Severity Index (PASI) score ≥ 12; and
- Body surface area (BSA) ≥ 10%; and
- Static Physician Global Assessment (sPGA) ≥ 3 (moderate to severe)
- Disease inadequately controlled by or inappropriate for topical therapy for psoriasis
- Candidate for systemic or phototherapy
- Have not been exposed to any or have been exposed to no more than one systemic agent for psoriasis
- At Screening, laboratory values must be within the following ranges:
- White blood cell (WBC) count Age (yrs) Males (x 103 /µL) Females (x 103 /µL) 6-11 3.5 - 13.65 3.5 - 13.65 12-18 3.5 - 13.15 3.5 - 13.15
- Platelet count Age (yrs) Males (x 103 /µL) Females (x 103 /µL) 6-11 117 - 394 117 - 394 12-18 126 - 400 126 - 400
- Hemoglobin (Hb) Age (yrs) Males (g/dL) Females (g/dL) 6-11 10.0 - 15.5 10.0 - 15.5 12-18 11.0 - 18.1 10.0 - 16.4
- Male subjects who engage in activity in which conception is possible must use barrier contraception (male latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) while on apremilast and for at least 28 days after the last dose of apremilast
- All females of childbearing potential (FCBP) must either practice abstinence* from heterosexual contact or use one of the approved contraceptive options as described below while on apremilast and for at least 28 days after dministration of the last dose of apremilast. For the purposes of this study, a female subject is considered of childbearing potential if she is ≥ 12 years old or has reached menarche, whichever occurred first 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 Females of childbearing potential must have a negative pregnancy test at Screening and Baseline. All FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below: Option 1: Any one of the following effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]; PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide * Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
Exclusion Criteria
- The presence of any of the following will exclude a subject from enrollment:
- History of or currently active inflammatory bowel disease
- Major concurrent medical conditions, pregnancy or lactation
- Any condition that confounds
Data sourced from ClinicalTrials.gov (NCT02576678). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.