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New hope for kids with psoriasis: oral drug apremilast under study

NCT ID NCT05565560

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times

Summary

This phase 3 trial is testing whether apremilast (Otezla) can safely and effectively treat moderate to severe plaque psoriasis in Japanese children and adolescents aged 6 to 17. The study involves 17 participants who take oral tablets for 16 weeks. The main goal is to see if their skin clears or nearly clears, as measured by a doctor's assessment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
apremilast (Otezla)
What this could lead to
If successful, this could provide a new oral treatment option for children and teens with moderate to severe plaque psoriasis that is not controlled by topical therapies.
What could go wrong
This is a small, single-arm study with only 17 participants, so results may not apply broadly. Apremilast can cause side effects like nausea, diarrhea, and mood changes.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

17 people

The number who actually took part.

Started

Jan 2023

Expected to finish

Sep 2026

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.

Ages

6 to 17 years

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: * Japanese participants aged 6 to 17 years at screening * Participants must have a weight of ≥ 15 kg * Diagnosis of chronic plaque psoriasis for at least 3 months prior to screening * Has moderate to severe plaque psoriasis at screening and baseline as defined by: * PASI score ≥ 12; and * BSA ≥ 10; and * sPGA ≥ 3 (moderate to severe) * Disease inadequately controlled by or contraindicated for ≥ 1 topical therapy for psoriasis * Candidate for systemic therapy or phototherapy Exclusion Criteria: * Psoriasis flare or rebound within 4 weeks prior to screening * Evidence of skin conditions, other than psoriasis, that would interfere with clinical assessments * Other than psoriasis, history of any clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease * Prior history of suicide attempt at any time in the participant's lifetime prior to screening or baseline in the study, or major psychiatric illness requiring hospitalization within 3 years prior to signing the assent and informed consent * Guttate, erythrodermic, or pustular psoriasis at screening and baseline

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Conditions

The condition(s) this trial relates to.

psoriasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Plaque psoriasis

Contacts and locations

Locations

  • Dokkyo Medical University Hospital

    Shimotsuga-gun, Tochigi, 321-0293, Japan

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180, Japan

  • Fukushima Medical University Hospital

    Fukushima, Fukushima, 960-1295, Japan

  • Gifu University Hospital

    Gifu, Gifu, 501-1194, Japan

  • Gunma University Hospital

    Maebashi, Gunma, 371-8511, Japan

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648, Japan

  • Hospital of the University of Occupational and Environmental Health, Japan

    Kitakyushu-shi, Fukuoka, 807-8556, Japan

  • Kanazawa Medical University Hospital

    Kahoku-gun, Ishikawa-ken, 920-0293, Japan

  • Kansai Medical University Hospital

    Hirakata-shi, Osaka, 573-1191, Japan

  • Kindai University Hospital

    Osakasayama-shi, Osaka, 589-8511, Japan

  • Kurume University Hospital

    Kurume-shi, Fukuoka, 830-0011, Japan

  • Mita Dermatology Clinic

    Minato-ku, Tokyo, 108-0014, Japan

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 852-8501, Japan

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602, Japan

  • Nippon Life Hospital

    Osaka, Osaka, 550-0006, Japan

  • Saruwatari Dermatology Clinic

    Kagoshima, Kagoshima-ken, 890-0046, Japan

  • Seibo International Catholic Hospital

    Shinjuku-ku, Tokyo, 161-8521, Japan

  • Shinshu University Hospital

    Matsumoto-shi, Nagano, 390-8621, Japan

  • St Lukes International Hospital

    Chuo-ku, Tokyo, 104-8560, Japan

  • St Marianna University Hospital

    Kawasaki-shi, Kanagawa, 216-8511, Japan

  • Sugai Dermatology Park Side Clinic

    Utsunomiya, Tochigi, 321-0954, Japan

  • Takagi Dermatological Clinic

    Obihiro-shi, Hokkaido, 080-0013, Japan

  • Takamatsu Red Cross Hospital

    Takamatsu, Kagawa-ken, 760-0017, Japan

  • Takeoka Dermatology Clinic

    Marugame-shi, Kagawa-ken, 763-0074, Japan

  • Teikyo University Hospital

    Itabashi-ku, Tokyo, 173-8606, Japan

  • Tokai University Hospital

    Isehara-shi, Kanagawa, 259-1193, Japan

  • Tokyo Medical University Hospital

    Shinjyuku-ku, 160-0023, Japan

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, Kyoto, 602-8566, Japan

  • University of the Ryukyus Hospital

    Ginowan-shi, Okinawa, 901-2725, Japan

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