A Study to Investigate Efficacy and Safety of Apremilast 30 mg Twice Daily (BID) in Chinese Parti… (NCT06122649) | Clinical Trial Compass
CompletedPhase 3
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)
China203 participantsStarted 2023-11-27
Plain-language 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
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Number of Participants Achieving at least a 75% Reduction (Improvement) From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16