Phase 4 Multicenter, Open-label Study on Efficacy and Safety of Apremilast in Moderate-to-severe Psoriasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Psoriasis. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Primary outcome measures
- Proportion of patients who achieved PASI 75 [Time frame: 16 weeks]
Secondary outcome measures (12)
- [Investigator-Assessed Endpoints]Proportion of patients who achieved PASI 75 [Time frame: 32 weeks]
- [Investigator-Assessed Endpoints]Proportion of patients who achieved PASI 50 [Time frame: 16 weeks]
- [Investigator-Assessed Endpoints]Proportion of patients who achieved PASI 50 [Time frame: 32 weeks]
- [Investigator-Assessed Endpoints]Proportion of patients who achieved PASI 90 [Time frame: 16 weeks]
- [Investigator-Assessed Endpoints]Proportion of patients who achieved PASI 90 [Time frame: 32 weeks]
- [Investigator-Assessed Endpoints]Proportion of patients with an absolute PASI score ≤ 2 [Time frame: 16 weeks]
- [Investigator-Assessed Endpoints]Proportion of patients with an absolute PASI score ≤ 2 [Time frame: 32 weeks]
- [Investigator-Assessed Endpoints]Percentage improvement in mNAPSI (modified Nail Psoriasis Severity Index) [Time frame: 16 weeks]
- [Investigator-Assessed Endpoints]Percentage improvement in mNAPSI (modified Nail Psoriasis Severity Index) [Time frame: 32 weeks]
- [Investigator-Assessed Endpoints]Proportion of patients who achieved ScPGA (Scalp Physician Global Assessment) score of 0 or 1 [Time frame: 16 weeks]
- [Investigator-Assessed Endpoints]Proportion of patients who achieved ScPGA (Scalp Physician Global Assessment) score of 0 or 1 [Time frame: 32 weeks]
- [Patient-Reported Endpoints]Change from baseline in DLQI (Dermatology Life Quality Index) [Time frame: 16 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07190391 · DWAPS_P401