Plaque Psoriasis
Conditions
Keywords
Apremilast, Dermatology
Brief summary
The study aims to evaluate the clinical efficacy of oral apremilast 30 mg BID compared with placebo in Chinese participants with moderate to severe PsO
Interventions
DRUGapremilast
Oral tablet
DRUGPlacebo
Oral tablet
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chinese participants aged ≥18. * Diagnosis of chronic, stable moderate to severe plaque PsO for ≥ 12 months before screening. The participant must have sPGA score ≥ 3, PASI score ≥ 12, and BSA involvement ≥ 10% at both screening and baseline (week 0). * Participant is a candidate for phototherapy and/or systemic therapy.
Exclusion criteria
* Psoriasis flare within 4 weeks of screening. * Evidence of skin conditions that would interfere with evaluations of the effect of study medication on psoriasis. * Prior medical history of suicide attempt at any time in the participant's lifetime before screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years. * Participant has a malignancy or history of malignancy or myeloproliferative or lymphoproliferative disease within the past 3 years. * Active tuberculosis or a history of incompletely treated tuberculosis. * History of human immunodeficiency virus (HIV) infection. * Prior treatment with apremilast. * Female participants of childbearing potential unwilling to use protocol specified method of contraception. * Female participants who are breastfeeding or who plan to breastfeed. * Female participants planning to become pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Achieving at least a 75% Reduction (Improvement) From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16 | Week 16 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Affected Body Surface Area (BSA) at Week 16 | Baseline and Week 16 | — |
| Number of Participants Achieving a Static Physician's Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) and with ≥ 2-point Reduction From Baseline at Week 16 | Baseline and Week 16 | — |
| Number of Participants Achieving ≥ 4-point Reduction (Improvement) From Baseline in the Whole Body Itch Scale (NRS) Score at Week 16 | Baseline and Week 16 | — |
| Number of Participants with Baseline Scalp Physician's Globa Assesment (ScPGA) of ≥ 2 Achieving a Clear (0) or Almost Clear (1) ScPGA and with ≥ 2-point Reduction From Baseline and at Week 16 | Baseline and Week 16 | — |
| Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 16 | Baseline and Week 16 | — |
| Number of Participants who Have a Baseline Scalp Itch NRS ≥ 4 and Achieving ≥ 4-point Reduction (Improvement) From Baseline in Scalp Itch NRS at Week 16 | Baseline and Week 16 | — |
| Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | Baseline to Week 52 | TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. |
| Plasma Concentration of Apremilast | Baseline to Week 16 | — |
| Percent Change of PASI From Baseline at Week 16 | Baseline and Week 16 | — |
Countries
China
Outcome results
None listed