Status:
COMPLETED
A Study to Investigate Efficacy and Safety of Apremilast 30 mg Twice Daily (BID) in Chinese Participants With Moderate to Severe Plaque-type Psoriasis (PsO)
Lead Sponsor:
Amgen
Conditions:
Plaque Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2025
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT06122649
Start Date
November 27 2023
End Date
December 5 2025
Last Update
January 5 2026
Active Locations (21)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
2
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
3
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350000
4
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510091