Status:
NOT_YET_RECRUITING
Phase 4 Multicenter, Open-label Study on Efficacy and Safety of Apremilast in Moderate-to-severe Psoriasis
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Psoriasis
Eligibility:
All Genders
19+ years
Brief Summary
This study aims to evaluate the efficacy and safety of Apremilast tablets in patients with psoriasis over 32 weeks, through a multicenter, single-arm, open-label, phase 4 clinical trial.
Detailed Description
In this clinical trial, patients with psoriasis will be informed about study participation and written informed consent will be obtained voluntarily. Eligible participants, based on inclusion and excl...
Eligibility Criteria
Inclusion
- Male or female patients aged ≥19 years at the time of enrollment.
- Patients with moderate to severe psoriasis persisting for ≥6 months.
- Patients with a PASI (Psoriasis Area and Severity Index) score between 5 and 10, requiring pharmacological treatment.
- Patients who have been fully informed about the study, have understood the explanation, and have voluntarily signed the informed consent form.
- Patients who are considered cooperative and able to participate until the end of the study.
Exclusion
- Patients with a history of hypersensitivity to apremilast.
- Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- Pregnant or breastfeeding women.
- Patients (or their spouse/partner) who do not agree to use medically acceptable and appropriate methods of contraception\* during the study period.
- \* Medically acceptable and appropriate methods of contraception include: hormonal contraception (implants, injectables, oral contraceptives, etc.), intrauterine devices (copper IUD, hormone-releasing intrauterine system), salpingectomy, tubal ligation, hysterectomy, vasectomy, dual barrier methods (male condom and female condom, cervical cap, diaphragm, contraceptive sponge used in combination), or single barrier method combined with spermicide.
- Patients receiving strong CYP3A4 enzyme inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin, St. John's Wort).
- Patients with severe renal impairment requiring hemodialysis or peritoneal dialysis.
- Patients who have previously received Apremilast (ApsoLla®) prior to enrollment, or those currently participating in another clinical trial involving an investigational medicinal product or medical device.
- (However, patients enrolled in non-interventional studies or who have completed participation in another clinical trial are eligible.)
- Patients with a history of psychiatric disorders (e.g., substance abuse, depression).
- Patients who, in the opinion of the investigator, are otherwise considered unsuitable for participation in this study.
Key Trial Info
Start Date :
September 30 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
425 Patients enrolled
Trial Details
Trial ID
NCT07190391
Start Date
September 30 2025
End Date
October 31 2027
Last Update
September 24 2025
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