PsoriasisNCT07190391
Phase 4 Multicenter, Open-label Study on Efficacy and Safety of Apremilast in Moderate-to-severe Psoriasis
An observational study of Psoriasis, run by Daewoong Pharmaceutical Co. LTD..
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Psoriasis
- How many people
- 425 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2025to 31 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In the ESTEEM 1 study of moderate-to-severe psoriasis, 33.1% of patients achieved PASI 75 at Week 16 with apremilast, while 28.8% did so in ESTEEM 2. Based on these results, this trial assumed a Week 16 PASI 75 response rate of ~30%. To estimate this with a 95% confidence interval and ±5% margin of error, a sample size of 340 was calculated. If the observed rate is 30%, the Clopper-Pearson method yields a lower bound of 25.2%. The study aims to present the Week 16 PASI 75 response rate with 95% confidence in a single-arm design, ensuring effect size and precision. Considering ~20% dropout, 425 subjects will be enrolled.
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
About this study
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
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.
Read the 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.
- Conditions
- Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Apsola Tab. | Apsola Tab. 10mg, Apsola Tab. 20mg, Apsola Tab. 30mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who achieved PASI 75
Proportion of patients who achieved PASI 75 at week 16
Measured: 16 weeks
Secondary outcomes (21)
[Investigator-Assessed Endpoints]Proportion of patients who achieved PASI 75
Proportion of patients who achieved PASI 75 at week 32
Measured: 32 weeks
[Investigator-Assessed Endpoints]Proportion of patients who achieved PASI 50
Proportion of patients who achieved PASI 50 at weeks 16
Measured: 16 weeks
[Investigator-Assessed Endpoints]Proportion of patients who achieved PASI 50
Proportion of patients who achieved PASI 50 at weeks 32
Measured: 32 weeks
[Investigator-Assessed Endpoints]Proportion of patients who achieved PASI 90
Proportion of patients who achieved PASI 90 at weeks 16
Measured: 16 weeks
[Investigator-Assessed Endpoints]Proportion of patients who achieved PASI 90
Proportion of patients who achieved PASI 90 at weeks 32
Measured: 32 weeks
[Investigator-Assessed Endpoints]Proportion of patients with an absolute PASI score ≤ 2
Proportion of patients with an absolute PASI score ≤ 2 at weeks 16
Measured: 16 weeks
[Investigator-Assessed Endpoints]Proportion of patients with an absolute PASI score ≤ 2
Proportion of patients with an absolute PASI score ≤ 2 at weeks 32
Measured: 32 weeks
[Investigator-Assessed Endpoints]Percentage improvement in mNAPSI (modified Nail Psoriasis Severity Index)
Percentage improvement in mNAPSI (modified Nail Psoriasis Severity Index) from baseline at weeks 16
Measured: 16 weeks
[Investigator-Assessed Endpoints]Percentage improvement in mNAPSI (modified Nail Psoriasis Severity Index)
Percentage improvement in mNAPSI (modified Nail Psoriasis Severity Index) from baseline at weeks 32
Measured: 32 weeks
[Investigator-Assessed Endpoints]Proportion of patients who achieved ScPGA (Scalp Physician Global Assessment) score of 0 or 1
Proportion of patients who achieved ScPGA (Scalp Physician Global Assessment) score of 0 or 1 at weeks 16
Measured: 16 weeks
[Investigator-Assessed Endpoints]Proportion of patients who achieved ScPGA (Scalp Physician Global Assessment) score of 0 or 1
Proportion of patients who achieved ScPGA (Scalp Physician Global Assessment) score of 0 or 1 at weeks 32
Measured: 32 weeks
[Patient-Reported Endpoints]Change from baseline in DLQI (Dermatology Life Quality Index)
Change from baseline in DLQI (Dermatology Life Quality Index) at weeks 16
Measured: 16 weeks
[Patient-Reported Endpoints]Change from baseline in DLQI (Dermatology Life Quality Index)
Change from baseline in DLQI (Dermatology Life Quality Index) at weeks 32
Measured: 32 weeks
[Patient-Reported Endpoints]Change from baseline in Pruritus NRS (Numeric Rating Scale)
Change from baseline in Pruritus NRS (Numeric Rating Scale) at weeks 16
Measured: 16 weeks
Change from baseline in Pruritus NRS (Numeric Rating Scale)
Change from baseline in Pruritus NRS (Numeric Rating Scale) at weeks 32
Measured: 32 weeks
[Patient-Reported Endpoints]Change from baseline in PaGA (Patient Global Assessment)
Change from baseline in PaGA (Patient Global Assessment) at weeks 16
Measured: 16 weeks
[Patient-Reported Endpoints]Change from baseline in PaGA (Patient Global Assessment)
Change from baseline in PaGA (Patient Global Assessment) at weeks 32
Measured: 32 weeks
[Patient-Reported Endpoints]Shift in distribution of PaGA scores
Shift in distribution of PaGA scores from baseline at weeks 16
Measured: 16 weeks
[Patient-Reported Endpoints]Shift in distribution of PaGA scores
Shift in distribution of PaGA scores from baseline at weeks 32
Measured: 32 weeks
[Patient-Reported Endpoints]Proportion of patients who achieved PaGA score of 0 or 1
Proportion of patients who achieved PaGA score of 0 or 1 at weeks 16
Measured: 16 weeks
[Patient-Reported Endpoints]Proportion of patients who achieved PaGA score of 0 or 1
Proportion of patients who achieved PaGA score of 0 or 1 at weeks 32
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start30 Sep 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 425 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190391
- Sponsor's protocol ID
- DWAPS_P401
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07190391
- Acronym / sponsor ID
- DWAPS_P401
- Conditions
- Psoriasis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 425 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apsola Tab. | – | –Apsola Tab. 10mg, Apsola Tab. 20mg, Apsola Tab. 30mg |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In the ESTEEM 1 study of moderate-to-severe psoriasis, 33.1% of patients achieved PASI 75 at Week 16 with apremilast, while 28.8% did so in ESTEEM 2. Based on these results, this trial assumed a Week 16 PASI 75 response rate of ~30%. To estimate this with a 95% confidence interval and ±5% margin of error, a sample size of 340 was calculated. If the observed rate is 30%, the Clopper-Pearson method yields a lower bound of 25.2%. The study aims to present the Week 16 PASI 75 response rate with 95% confidence in a single-arm design, ensuring effect size and precision. Considering ~20% dropout, 425 subjects will be enrolled.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
- Patients receiving strong CYP3A4 enzyme inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin, St. John's Wort).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients who achieved PASI 75
Time frame: 16 weeks
Proportion of patients who achieved PASI 75 at week 16
21 secondary outcomes
[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
[Patient-Reported Endpoints]Change from baseline in DLQI (Dermatology Life Quality Index)
Time frame: 32 weeks
[Patient-Reported Endpoints]Change from baseline in Pruritus NRS (Numeric Rating Scale)
Time frame: 16 weeks
Change from baseline in Pruritus NRS (Numeric Rating Scale)
Time frame: 32 weeks
[Patient-Reported Endpoints]Change from baseline in PaGA (Patient Global Assessment)
Time frame: 16 weeks
[Patient-Reported Endpoints]Change from baseline in PaGA (Patient Global Assessment)
Time frame: 32 weeks
[Patient-Reported Endpoints]Shift in distribution of PaGA scores
Time frame: 16 weeks
[Patient-Reported Endpoints]Shift in distribution of PaGA scores
Time frame: 32 weeks
[Patient-Reported Endpoints]Proportion of patients who achieved PaGA score of 0 or 1
Time frame: 16 weeks
[Patient-Reported Endpoints]Proportion of patients who achieved PaGA score of 0 or 1
Time frame: 32 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis, run by Daewoong Pharmaceutical Co. LTD..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who achieved PASI 75 (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.