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)

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06122649
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Amgen
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	MD
Principal Investigator Affiliation	Amgen
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Plaque Psoriasis
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Placebo-controlled Treatment Phas

Participants are randomized in a 1:1 ratio to take either apremilast or placebo BID for 16 weeks.

Experimental: Active Treatment Phase

Participants who received placebo during the placebo-controlled treatment phase will receive apremilast BID for 36 weeks. Participants who took apremilast will continue receiving it BID for 36 weeks.

Interventions

Drug: - apremilast

Oral tablet

Drug: - Placebo

Oral tablet

Contact a Trial Team

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International Sites

Peking University First Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Peking University First Hospital

Beijing, Beijing, 100034

Site Contact

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