Plaque PsoriasisPhase 3NCT05565560
A Study to Assess the Efficacy and Safety of Apremilast in Japanese Pediatric Participants With Moderate to Severe Plaque Psoriasis
A Phase 3 study testing Apremilast in people with Plaque Psoriasis, run by Amgen at 29 sites in Japan.
Trial summary
The primary objective of this study is to evaluate the efficacy of apremilast in children and adolescents (ages 6 through 17 years) with moderate to severe plaque psoriasis. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Apremilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 29 sitesJapan
- Study dates
- 25 Jan 2023to 3 Sep 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 9Show fewer
- sPGA ≥ 3 (moderate to severe)
- Disease inadequately controlled by or contraindicated for ≥ 1 topical therapy for psoriasis
- Candidate for systemic therapy or phototherapy
Who cannot join
- 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
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
Japan29 sites
St Lukes International Hospital
Chuo-ku, Tokyo, 104-8560
Fukuoka University Hospital
Fukuoka, Fukuoka, 814-0180
Fukushima Medical University Hospital
Fukushima, Fukushima, 960-1295
Gifu University Hospital
Gifu, Gifu, 501-1194
University of the Ryukyus Hospital
Ginowan-shi, Okinawa, 901-2725
Kansai Medical University Hospital
Hirakata-shi, Osaka, 573-1191
Tokai University Hospital
Isehara-shi, Kanagawa, 259-1193
Saruwatari Dermatology Clinic
Kagoshima, Kagoshima-ken, 890-0046
Kanazawa Medical University Hospital
Kahoku-gun, Ishikawa-ken, 920-0293
St Marianna University Hospital
Kawasaki-shi, Kanagawa, 216-8511
Hospital of the University of Occupational and Environmental Health, Japan
Kitakyushu-shi, Fukuoka, 807-8556
Kurume University Hospital
Kurume-shi, Fukuoka, 830-0011
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-8566
Gunma University Hospital
Maebashi, Gunma, 371-8511
Takeoka Dermatology Clinic
Marugame-shi, Kagawa-ken, 763-0074
Shinshu University Hospital
Matsumoto-shi, Nagano, 390-8621
Mita Dermatology Clinic
Minato-ku, Tokyo, 108-0014
Nagasaki University Hospital
Nagasaki, Nagasaki, 852-8501
Nagoya City University Hospital
Nagoya, Aichi-ken, 467-8602
Takagi Dermatological Clinic
Obihiro-shi, Hokkaido, 080-0013
Nippon Life Hospital
Osaka, Osaka, 550-0006
Kindai University Hospital
Osakasayama-shi, Osaka, 589-8511
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
Dokkyo Medical University Hospital
Shimotsuga-gun, Tochigi, 321-0293
Seibo International Catholic Hospital
Shinjuku-ku, Tokyo, 161-8521
Tokyo Medical University Hospital
Shinjyuku-ku, 160-0023
Teikyo University Hospital
tabashi City, Tokyo, 173-8606
Takamatsu Red Cross Hospital
Takamatsu, Kagawa-ken, 760-0017
Sugai Dermatology Park Side Clinic
Utsunomiya, Tochigi, 321-0954
About this study
Official title: A Phase 3, Multicenter, Open-label, Single-arm Study to Assess the Efficacy and Safety of Apremilast (AMG 407) in Japanese Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis
The primary objective of this study is to evaluate the efficacy of apremilast in children and adolescents (ages 6 through 17 years) with moderate to severe plaque psoriasis.
- Conditions
- Plaque Psoriasis
- Being tested
- Apremilast
- Keywords
- Plaque Psoriasis, Apremilast, AMG 407, Moderate to Severe Plaque Psoriasis, Pediatric Plaque Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApremilastDrug
Also called AMG 407, Otezla
Oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Apremilast | Experimental | Participants with a weight between ≥ 15 kg to < 50 kg will receive apremilast 20 mg twice daily (BID) tablet. Participants weighing ≥ 50 kg will receive apremilast 30 mg BID tablet. Receives: Drug: Apremilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of a static Physician Global Assessment (sPGA) score of clear (0) or almost clear (1) with at least 2 points reduction from baseline at Week 16
Measured: Week 16
Secondary outcomes (9)
Achievement of at least 75% reduction in Psoriasis Area and Severity Index (PASI) score (PASI-75) from baseline at Week 16
Measured: Baseline, Week 16
Achievement of at least a 50% reduction in PASI score (PASI-50) from baseline at Week 16
Measured: Baseline, Week 16
Percent change from baseline in total PASI score at Week 16
Measured: Baseline, Week 16
Percent change from baseline in affected body surface area (BSA) at Week 16
Measured: Baseline, Week 16
Achievement of Children Dermatology Life Quality Index (CDLQI) (0/1) at Week 16
Measured: Week 16
Change from baseline in CDLQI score at Week 16
Measured: Baseline, Week 16
Number of participants with treatment-emergent adverse events
Measured: Approximately 52 weeks
Number of participants with clinically significant changes in vital signs
Measured: Approximately 62 weeks
Number of participants with clinically significant changes in laboratory abnormalities
Measured: Approximately 62 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start25 Jan 2023
- Primary completion20 Nov 2025
- Study completion3 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- More trials run by AmgenThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565560
- Sponsor's protocol ID
- 20200346
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2022
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Open-label, Single-arm Study to Assess the Efficacy and Safety of Apremilast (AMG 407) in Japanese Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT05565560
- Acronym / sponsor ID
- 20200346
- Conditions
- Plaque Psoriasis
- Keywords
- Plaque Psoriasis, Apremilast, AMG 407, Moderate to Severe Plaque Psoriasis, Pediatric Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 3 Sep 2026 (actual)
- First posted
- 4 Oct 2022 (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.
The primary objective of this study is to evaluate the efficacy of apremilast in children and adolescents (ages 6 through 17 years) with moderate to severe plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apremilast | Experimental | Drug: ApremilastParticipants with a weight between ≥ 15 kg to < 50 kg will receive apremilast 20 mg twice daily (BID) tablet. Participants weighing ≥ 50 kg will receive apremilast 30 mg BID tablet. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApremilastAlso: AMG 407, OtezlaOral tablets | Drug | Apremilast |
Primary outcome
Achievement of a static Physician Global Assessment (sPGA) score of clear (0) or almost clear (1) with at least 2 points reduction from baseline at Week 16
Time frame: Week 16
9 secondary outcomes
Achievement of at least 75% reduction in Psoriasis Area and Severity Index (PASI) score (PASI-75) from baseline at Week 16
Time frame: Baseline, Week 16
Achievement of at least a 50% reduction in PASI score (PASI-50) from baseline at Week 16
Time frame: Baseline, Week 16
Percent change from baseline in total PASI score at Week 16
Time frame: Baseline, Week 16
Percent change from baseline in affected body surface area (BSA) at Week 16
Time frame: Baseline, Week 16
Achievement of Children Dermatology Life Quality Index (CDLQI) (0/1) at Week 16
Time frame: Week 16
Change from baseline in CDLQI score at Week 16
Time frame: Baseline, Week 16
Number of participants with treatment-emergent adverse events
Time frame: Approximately 52 weeks
Number of participants with clinically significant changes in vital signs
Time frame: Approximately 62 weeks
Number of participants with clinically significant changes in laboratory abnormalities
Time frame: Approximately 62 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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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. This study is not recruiting at the moment.
MD study director
Amgen
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apremilast in people with Plaque Psoriasis, run by Amgen at 29 sites in Japan.
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 9 inclusion and 5 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: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Achievement of a static Physician Global Assessment (sPGA) score of clear (0) or almost clear (1) with at least 2 points reduction from baseline at Week 16 (time frame: Week 16). 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 1 Oct 2026.