New study tests apremilast for psoriasis relief
NCT ID NCT07190391
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This phase 4 trial will test the drug apremilast in 425 adults with moderate-to-severe psoriasis. Over 32 weeks, researchers will measure how well the drug clears skin patches and monitor for side effects. The goal is to confirm apremilast's effectiveness and safety in a real-world setting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- apremilast (tablet)
- What this could lead to
- If successful, this could confirm apremilast as a safe and effective option for controlling moderate-to-severe psoriasis symptoms.
- What could go wrong
- This is a single-arm, open-label study, so results may be less reliable than a blinded trial. Apremilast can cause side effects like nausea, diarrhea, and headache.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 425 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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