Psoriasis
Conditions
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 exclusion criteria, will be assigned a registration number. Participants will receive Apremilast for 32 weeks and visit the study site at three time points: Visit 1 (screening and baseline, Week 0), Visit 2 (Week 16 ± 4), and Visit 3 (Week 32 ± 4). At each visit, demographic information, efficacy assessments, and adverse event evaluations will be conducted according to the study schedule.
Interventions
None listed
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who achieved PASI 75 | 16 weeks | Proportion of patients who achieved PASI 75 at week 16 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| [Investigator-Assessed Endpoints]Proportion of patients who achieved PASI 75 | 32 weeks | Proportion of patients who achieved PASI 75 at week 32 |
| [Investigator-Assessed Endpoints]Proportion of patients who achieved PASI 50 | 16 weeks | Proportion of patients who achieved PASI 50 at weeks 16 |
| [Investigator-Assessed Endpoints]Proportion of patients who achieved PASI 90 | 16 weeks | Proportion of patients who achieved PASI 90 at weeks 16 |
| [Investigator-Assessed Endpoints]Proportion of patients with an absolute PASI score ≤ 2 | 16 weeks | Proportion of patients with an absolute PASI score ≤ 2 at weeks 16 |
| [Investigator-Assessed Endpoints]Percentage improvement in mNAPSI (modified Nail Psoriasis Severity Index) | 16 weeks | Percentage improvement in mNAPSI (modified Nail Psoriasis Severity Index) from baseline at weeks 16 |
| [Investigator-Assessed Endpoints]Proportion of patients who achieved ScPGA (Scalp Physician Global Assessment) score of 0 or 1 | 16 weeks | Proportion of patients who achieved ScPGA (Scalp Physician Global Assessment) score of 0 or 1 at weeks 16 |
| [Patient-Reported Endpoints]Change from baseline in DLQI (Dermatology Life Quality Index) | 16 weeks | Change from baseline in DLQI (Dermatology Life Quality Index) at weeks 16 |
| [Patient-Reported Endpoints]Change from baseline in Pruritus NRS (Numeric Rating Scale) | 16 weeks | Change from baseline in Pruritus NRS (Numeric Rating Scale) at weeks 16 |
| Change from baseline in Pruritus NRS (Numeric Rating Scale) | 32 weeks | Change from baseline in Pruritus NRS (Numeric Rating Scale) at weeks 32 |
| [Patient-Reported Endpoints]Change from baseline in PaGA (Patient Global Assessment) | 16 weeks | Change from baseline in PaGA (Patient Global Assessment) at weeks 16 |
| [Patient-Reported Endpoints]Shift in distribution of PaGA scores | 16 weeks | Shift in distribution of PaGA scores from baseline at weeks 16 |
| [Patient-Reported Endpoints]Proportion of patients who achieved PaGA score of 0 or 1 | 16 weeks | Proportion of patients who achieved PaGA score of 0 or 1 at weeks 16 |
Outcome results
None listed