NCT07190391Not yet recruiting
Phase 4 Multicenter, Open-label Study on Efficacy and Safety of Apremilast in Moderate-to-severe Psoriasis
A Multi-center, Single-arm, Open-label, Phase 4 Clinical Study to Evaluate the Efficacy and Safety of Apremilast in Patients With Moderate-to-severe Psoriasis
Source: ClinicalTrials.gov · Last updated 24 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 425 (estimated)
- First submitted
- 17 Sept 2025
- Start date
- 30 Sept 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Diseases
- Psoriasis
- NCT number
- NCT07190391
What you commit to
- Study type: Observational
- Planned participants: 425
- From 30 Sept 2025 to the primary completion date, 31 Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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.)
Other illness
- Patients with a history of hypersensitivity to apremilast.
- Patients with severe renal impairment requiring hemodialysis or peritoneal dialysis.
- Patients with a history of psychiatric disorders (e.g., substance abuse, depression).
Lab values
- Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
Other
- Pregnant or breastfeeding women.
- Patients who, in the opinion of the investigator, are otherwise considered unsuitable for participation in this study.
Who the study is looking for
- 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.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.