New study tests apremilast for psoriasis relief

NCT ID NCT07190391

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 425 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

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

19 years and older

Sex

Anyone

Healthy volunteers

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

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

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  1. 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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  2. A doctor treating you

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