Plaque PsoriasisPhase 3NCT03930186
A Phase 3B, Open-label, Single-arm Study of the Efficacy and Safety of Apremilast, in Subjects With Plaque Psoriasis That is Not Adequately Controlled by Topical Therapy
A Phase 3 study testing Apremilast and Topical Therapy in people with Plaque Psoriasis, run by Amgen at 56 sites in 2 countries.
Trial summary
The primary objective of the study is to assess the efficacy and safety of the combination of apremilast plus topical therapies for the treatment of adults with plaque psoriasis who have not achieved an adequate response with topicals alone. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Apremilast and Topical Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 56 sitesin 2 countries
- Study dates
- 17 Jun 2019to 25 Sep 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must satisfy the following criteria to be enrolled in the study:
- Subject is ≥ 20 years of age at the time of signing the informed consent form (ICF) with plaque psoriasis.
- Subject has understood and voluntarily signed an informed consent document prior to any study related assessments/procedures being conducted.
- Subject is able to adhere to the study visit schedule and other protocol requirements.
- Subject has chronic plaque psoriasis based on a diagnosis for at least 6 months prior to Baseline.
- Subject has psoriasis with sPGA = 2 or 3 at screening and baseline.
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- Subject is currently treated for psoriasis with topical therapies only for at least 4 weeks prior to Baseline.
- Subject has inadequate response to current topical therapy as per Investigator's discretion.
- Subject is naïve to all biologic therapies for psoriasis vulgaris.
- Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination, and clinical laboratories.
- (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).
- Subjects that are females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational product, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below:
- Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device; tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom (latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.
Who cannot join
- The presence of any of the following will exclude a subject from enrollment:
- Subject has any condition, including other inflammatory diseases or dermatologic conditions, which confounds the ability to interpret data from the study, including other types of psoriasis (ie, pustular, inverse, erythrodermic, or guttate), other than plaque psoriasis.
- Subject has psoriatic arthritis that requires systemic therapy.
- Subject has history of drug-induced psoriasis.
- Subject has had prior treatment with biologic therapies for psoriasis.
- Subject has used phototherapy or conventional systemic therapy for psoriasis within 8 weeks prior to baseline and during the study (including but not limited to cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, sulfasalazine, azathioprine).
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- Subject has worsening of psoriasis indicated by an increase in sPGA of ≥ 1 from Screening to Baseline.
- Subject cannot avoid excessive sun exposure or use of tanning booths for at least 8 weeks prior to Baseline and during the study.
- Subject is currently enrolled in any other clinical trial involving an investigational product.
- Subject has other than psoriasis, any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled.
- Subject has malignancy or history of malignancy or myeloproliferative or lymphoproliferative disease within the past 3 years, except for treated (ie, cured) basal cell or squamous cell in situ skin carcinomas.
- Subject has received a live vaccine within 3 months of baseline or plans to do so during study.
- Subject is pregnant or breastfeeding (lactating) women.
- Subject has bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening. Any treatment for such infections must have been completed and the infection cured, at least 4 weeks prior to Screening and no new or recurrent infections prior to the Baseline Visit.
- Subject is hepatitis B surface antigen positive or hepatitis B core antibody positive at screening.
- Subject is positive for antibodies to hepatitis C at screening.
- Subject has any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study.
- Subject has prior history of suicide attempt at any time in the subject's life time prior to signing the informed consent and enrollment, or major psychiatric illness requiring hospitalization within the last 3 years prior to signing the informed consent.
- Subject has active substance abuse or a history of substance abuse within 6 months prior to signing the informed consent.
- Subject has prior treatment with apremilast or participation in a clinical study involving apremilast.
Trial locations and contacts
56 sites in 2 countries.
56 sites in 2 countries
Japan55 sites
Motomachi Dermatology Clinic
Asahikawa-shi, Hokkaido, 070-0810
Research Site
Asahikawa-shi, Hokkaido, 070-0810
Nippon Medical School Hospital
Bunkyō City, 113-8602
The University of Tokyo Hospital
Bunkyō City, 113-8655
Research Site
Bunkyo-ku, Tokyo, 113-8603
Research Site
Bunkyo-ku, Tokyo, 113-8655
Chitose Dermatology and Plastic, Reconstructive Surgery Clinic
Chitose, 066-0021
Research Site
Chitose, 066-0021
Research Site
Fukuoka, Fukuoka, 814-0180
Research Site
Fukuoka-shi, Fukuoka, Fukuoka, 813-0044
Research Site
Fukuoka-shi, Fukuoka, Fukuoka, 819-0167
Kiryu Dermatology Clinic
Fukuoka-shi, Fukuoka, 813-0044
Fukuoka University Hospital
Fukuoka-shi, Fukuoka, 814-0180
Tomoko Matsuda Dermatology Clinic
Fukuoka-shi, Fukuoka, 819-0167
Hino Dermatology Clinic
Fukutsu, 811-3217
Research Site
Fukutsu, 811-3217
Research Site
Kagoshima, 890-0055
Saruwatari Dermatology Clinic
Kagoshima, 890-0055
Noguchi Dermatorogy Clinic
Kamimashiki-gun, 861-3101
Research Site
Kamimashiki-gun, 861-3101
Japan Community Health-care Organization Kyushu Hospital
Kitakyushu, 806-8501
Research Site
Kitakyushu, 806-8501
Maruyama Dermatology Clinic
Koto-ku, Tokyo, 136-0074
Research Site
Koto-ku, Tokyo, 136-0074
Mita Dermatology Clinic
Minatoku, 108-0014
Research Site
Minatoku, 108-0014
Iwate Medical University Uchimaru Medical Center
Morioka, 020-8505
Research Site
Morioka, 020-8505
Research Site
Neyagawa, 572-0838
Yoshioka Dermatology Clinic
Neyagawa, 572-0838
Takagi Dermatological Clinic
Obihiro, 080-0013
Research Site
Obihiro-shi, Hokkaido, 080-0013
Nippon Life Hospital
Osaka, 550-0006
Research Site
Osaka, 550-0006
Hino Clinic
Sakai, 599-8272
Research Site
Sakai, 599-8272
Research Site
Sakai-shi, Osaka, 593-8324
Kume Clinic
Sakai-shi, Osaka, 593-8324
Research Site
Sapporo, Hokkaido, 060-0063
Research Site
Sapporo, Hokkaido, 062-0042
Kitagou Dermatology Clinic
Sapporo, 003-0833
Research Site
Sapporo, 003-0833
Kobayashi Skin Clinic
Sapporo, 060-0807
Research Site
Sapporo, 060-0807
Hosui Medical Clinic
Sapporo, 064-0807
Research Site
Sapporo, 064-0807
Sapporo Skin Clinic
Sapporo-shi, Hokkaido, 060-0063
Fukuzumi Dermatology Clinic
Sapporo-shi, Hokkaido, 062-0042
Jichi Medical University Hospital
Shimotsuke, 329-0498
Research Site
Shimotsuke, 329-0498
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo, 141-8625
Research Site
Shinjyuku-ku, 160-0023
Tokyo Medical University Hospital
Shinjyuku-ku, 160-0023
Fujita Health University Hospital
Toyoake, 470-1192
Research Site
Toyoake, 470-1192
About this study
Official title: A Phase 3b, Open-label, Single-arm Study of the Efficacy and Safety of Apremilast, in Subjects With Plaque Psoriasis That is Not Adequately Controlled by Topical Therapy
The primary objective of the study is to assess the efficacy and safety of the combination of apremilast plus topical therapies for the treatment of adults with plaque psoriasis who have not achieved an adequate response with topicals alone.
Read the detailed description
Participants will be enrolled at 28 sites in Japan. The study consists of 4 phases: a screening phase (4 weeks), an open-label combination therapy phase (16 weeks), an open-label combination therapy phase with optional topical reduction (16 weeks), and a post-treatment observational follow-up phase (4 weeks).
- Conditions
- Plaque Psoriasis
- Being tested
- Apremilast, Topical Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApremilastDrug
Also called CC-10004, Otezla®
Tablets for oral administration
Topical TherapyDrug
Participants continued to use their existing topical treatment for psoriasis for the first 16 weeks. After 16 weeks, participants could decrease the use of topical therapy at their discretion under the direction of their physician.
| Study group | Role | What they receive |
|---|---|---|
| Apremilast | Experimental | After a 5-day titration, participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16 participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician. Receives: Drug: Apremilast; Drug: Topical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Achieved an sPGA Score of Clear (0) or Almost Clear (1) at Week 16
The sPGA is an assessment by the Investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale, ranging from 0 (clear) to 4 (severe).
The National Psoriasis Foundation Psoriasis Score version of a static PGA is calculated by averaging the total body erythema, induration, and desquamation scores. The overall scores are as follows:
0 = Clear;
- = Almost Clear;
- = Mild;
- = Moderate;
- = Severe.
The percentage of participants with a sPGA response was estimated using a multiple imputation method from 100 imputed data sets.
Measured: Week 16
Secondary outcomes (13)
Percentage of Participants Who Achieved an sPGA Score of Clear (0) or Almost Clear (1) at Week 32
The sPGA is an assessment by the Investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale, ranging from 0 (clear) to 4 (severe).
The National Psoriasis Foundation Psoriasis Score version of a static PGA is calculated by averaging the total body erythema, induration, and desquamation scores. The overall scores are as follows:
0 = Clear;
- = Almost Clear;
- = Mild;
- = Moderate;
- = Severe.
Measured: Week 32
Percentage of Participants Who Achieved a Scalp Physicians Global Assessment (ScPGA) Score of Clear (0) or Almost Clear (1) at Weeks 16 and 32
The ScPGA assesses scalp involvement of psoriasis based on scalp plaque elevation, scaling, and erythema. The 5-point ScPGA scale ranges from 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), to 4 (severe).
Measured: Weeks 16 and 32
Change From Baseline in Percentage of BSA Affected by Psoriasis at Weeks 16 and 32
The overall body surface area affected by psoriasis was estimated based on the palm area of the participant's hand, which equates to approximately 1% of total body surface area. BSA affected by psoriasis is expressed as a percentage of total body surface area.
A negative change from baseline indicates improvement.
Measured: Baseline and weeks 16 and 32
Percent Change From Baseline in Pruritus Visual Analog Scale (VAS) at Weeks 2, 16, and 32
Participants were asked to indicate how much itch they have had due to psoriasis in the past week by placing a vertical stroke on a 100 mm line on which the left-hand boundary (0 mm) represented no itch, and the right-hand boundary (100 mm) represented worst itch imaginable. The distance from the mark to the left-hand boundary was recorded. A negative change from baseline indicates improvement.
Measured: Baseline and weeks 2, 16, and 32
Mean Change From Baseline in Shiratori's Pruritus Severity Score at Weeks 2, 16, and 32
Shiratori's Pruritus Severity Score is a pruritus (itchiness) severity assessment tool used in Japan. Daytime and nighttime pruritus were evaluated and scored separately. Daytime pruritus was rated on a five-grade scale: 0 (absent), 1 (endurable without scratching; minimal), 2 (subsides with slight scratching; mild), 3 (subsides with considerable scratching; moderate), or 4 (not subsiding with scratching, which prompts repeated scratching; severe).
Nighttime pruritus was rated on a five-grade scale: 0 (absent), 1 (slight itching at bedtime but not causing intentional scratching; no difficulty sleeping because of pruritus), 2 (slight itching that subsides with scratching; no difficulty sleeping because of pruritus), 3 (difficulty sleeping because of pruritus that resolves with scratching; unconscious scratching occurs during sleep), or 4 (severe difficulty sleeping due to pruritus; frequent scratching that worsens pruritus).
A negative change from baseline indicates improvement.
Measured: Baseline and weeks 2, 16, and 32
Percentage of Participants Who Achieved a ≥ 50% Reduction From Baseline in NAPSI Score (NAPSI-50) at Weeks 16 and 32 Among Participants With NAPSI ≥ 1 at Baseline
One target thumb nail or fingernail representing the worst nail psoriasis involvement was selected for assessment at Baseline.
The nail matrix was assessed for presence of any of the nail matrix features (pitting, leukonychia red spots in the lunula, crumbling) graded on a scale of 0 (none) to 4 (present in all 4 quadrants).
The nail bed was assessed for the presence of any nail bed features (onycholysis, splinter hemorrhages, subungual hyperkeratosis, "oil drop" (salmon patch dyschroma) on a scale from 0 (none) to 4 (present in all quadrants).
The sum of the nail matrix and nail bed scores is the total score and ranges from 0 to 8 (worst).
Measured: Weeks 16 and 32
Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 16 and 32
The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment related feelings. Participants answer 10 questions on a scale from 0 (not at all) to 3 (very much), except for Question 7, which first asks whether the participant's skin prevented them from working or studying (Yes (score = 3) or No (score = 0), then If "No", the participant is asked how much their skin was a problem at work or studying over the last week, with responses from 0 (not at all), 1 (a little), or 2 (a lot).
The DLQI total score ranges from 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best. A negative change from baseline indicates improvement.
Measured: Baseline and weeks 16 and 32
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Weeks 16 and 32
The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. The PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. A negative change from baseline indicates improvement.
Measured: Baseline and weeks 16 and 32
Percentage of Participants Who Achieved ≥ 75% Reduction From Baseline in PASI Score (PASI-75)
The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. The PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.
Measured: Weeks 16 and 32
Percentage of Participants Who Achieved ≥ 50% Reduction From Baseline in PASI Score (PASI-50)
The PASI is a measure of psoriatic disease severity taking into account qualitative lesion characteristics (erythema, thickness, and scaling) and degree of skin surface area involvement on defined anatomical regions. The PASI scores range from 0 to 72, with higher scores reflecting greater disease severity.
Measured: Weeks 16 and 32
Treatment Satisfaction Questionnaire for Medication (TSQM) Sub-domain Scores
The Treatment Satisfaction Questionnaire for Medication (TSQM) version II is a self-administered instrument to understand a participant's satisfaction on current therapy. The TSQM comprises 11 items across 4 domains focusing on effectiveness (Item 1 and 2), side effects (Item 4 to 6), convenience (Item 7 to 9), and global satisfaction (Item 10 and 11). With the exception of Item 3 (experience any side effects; yes or no), all items have five or seven responses. Item scores are summed to give four domain scores, which are in turn transformed to a scale from 0 (extremely dissatisfied) to 100 (extremely satisfied).
Measured: Baseline and weeks 16 and 32
Percentage of Participants Who Achieved a Patient Benefit Index (PBI) Score ≥ 1 at Weeks 16 and 32
The Patient Benefit Index (PBI) is used to assess patient-relevant benefits of psoriasis treatment as a function of the most important needs identified by the participant before the start of treatment.
Participants were asked to assess the benefits of treatment by completing the Patient Benefit Questionnaire (PBQ), which consists of 25 treatment goal statements scored from 0 (not at all) to 4 (very).
The PBI is calculated for each participant by weighing the achievement values of each statement by their importance to the individual patient as assessed prior to the start of treatment. The PBI ranges from 0 (no benefit) to 4 (maximum benefit).
Measured: Weeks 16 and 32
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
The Investigator assessed the severity/intensity of each adverse event as:
Mild (asymptomatic or mild symptoms; intervention not indicated; activities of daily life (ADLs) minimally or not affected); Moderate (symptom(s) cause moderate discomfort; local or noninvasive intervention indicated; more than minimal interference with ADLs but able to carry out daily social and functional activities; drug therapy may be required); Severe (symptoms causing severe discomfort/pain; symptoms requiring medical/surgical attention/intervention; interference with ADLs including inability to perform daily social and functional activities; drug therapy required).
A serious adverse event is any AE occurring at any dose that:
- Resulted in death;
- Was life-threatening;
- Required inpatient hospitalization or prolongation of existing hospitalization;
- Resulted in persistent or significant disability/incapacity;
- Was a congenital anomaly/birth defect;
- Constituted an important medical event.
Measured: From first dose of study drug until at least 28 days after last dose; up to 36 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start17 Jun 2019
- Primary completion8 May 2020
- Study completion25 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 152 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
- NCT03930186
- Sponsor's protocol ID
- CC-10004-PSOR-023
- Other IDs
- U1111-1230-7468, 20200062
- Status last verified
- Dec 2021
- First submitted
- 25 Apr 2019
- Last updated
- 20 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Publications
Strober B, Lebwohl M, van de Kerkhof P, Gold LS, Merola JF, Okubo Y, Gisondi P, Zhou Z, Chaudhari S, Deignan C, Mrowietz U. Efficacy of Apremilast in Patients with Psoriasis with Limited Skin Involvement, Including High-Impact Site Involvement: A Pooled Analysis of Six Trials. Dermatol Ther (Heidelb). 2026 Oct 2. doi: 10.1007/s13555-026-01921-9. Online ahead of print.
PubMed 42825996Abe M, Okubo Y, Takahashi H, Endo K, Chaudhari S, Deignan C, Amouzadeh H, Hino R. Consistent Efficacy of Apremilast in Patients with Psoriasis Regardless of Baseline Disease Severity or Special Area Involvement: Subgroup Analysis from PROMINENT. Dermatol Ther (Heidelb). 2024 Jun;14(6):1587-1597. doi: 10.1007/s13555-024-01179-z. Epub 2024 May 27.
PubMed 38801606Okubo Y, Takahashi H, Hino R, Endo K, Kikuchi S, Ozeki Y, Nakamura T, Paris M, Abe M. Efficacy and Safety of Apremilast in the Treatment of Patients with Mild-to-Moderate Psoriasis in Japan: Results from PROMINENT, A Phase 3b, Open-Label, Single-Arm Study. Dermatol Ther (Heidelb). 2022 Jun;12(6):1469-1480. doi: 10.1007/s13555-022-00747-5. Epub 2022 Jun 11.
PubMed 35689737
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, Open-label, Single-arm Study of the Efficacy and Safety of Apremilast, in Subjects With Plaque Psoriasis That is Not Adequately Controlled by Topical Therapy
- ClinicalTrials.gov ID
- NCT03930186
- Acronym / sponsor ID
- CC-10004-PSOR-023
- Conditions
- Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 8 May 2020 (actual)
- Study completion
- 25 Sep 2020 (actual)
- First posted
- 29 Apr 2019 (actual)
- Results
- Posted 20 Jan 2022
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 the study is to assess the efficacy and safety of the combination of apremilast plus topical therapies for the treatment of adults with plaque psoriasis who have not achieved an adequate response with topicals alone.
Detailed description
Participants will be enrolled at 28 sites in Japan. The study consists of 4 phases: a screening phase (4 weeks), an open-label combination therapy phase (16 weeks), an open-label combination therapy phase with optional topical reduction (16 weeks), and a post-treatment observational follow-up phase (4 weeks).
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: Apremilast, Drug: Topical TherapyAfter a 5-day titration, participants received 30 mg apremilast tablets orally twice daily (BID) for up to 32 weeks in addition to their existing topical therapy. At week 16 participants were permitted to decrease their use of topical therapy at their own discretion under the direction of their physician. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subject is ≥ 20 years of age at the time of signing the informed consent form (ICF) with plaque psoriasis.
- Subject has understood and voluntarily signed an informed consent document prior to any study related assessments/procedures being conducted.
- Subject is able to adhere to the study visit schedule and other protocol requirements.
- Subject has chronic plaque psoriasis based on a diagnosis for at least 6 months prior to Baseline.
- Subject has psoriasis with sPGA = 2 or 3 at screening and baseline.
Key exclusion criteria (20 listed)
- Subject has any condition, including other inflammatory diseases or dermatologic conditions, which confounds the ability to interpret data from the study, including other types of psoriasis (ie, pustular, inverse, erythrodermic, or guttate), other than plaque psoriasis.
- Subject has psoriatic arthritis that requires systemic therapy.
- Subject has history of drug-induced psoriasis.
- Subject has had prior treatment with biologic therapies for psoriasis.
- Subject has used phototherapy or conventional systemic therapy for psoriasis within 8 weeks prior to baseline and during the study (including but not limited to cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, sulfasalazine, azathioprine).
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: CC-10004, Otezla®Tablets for oral administration | Drug | Apremilast |
| Topical TherapyParticipants continued to use their existing topical treatment for psoriasis for the first 16 weeks. After 16 weeks, participants could decrease the use of topical therapy at their discretion under the direction of their physician. | Drug | Apremilast |
Primary outcome
Percentage of Participants Who Achieved an sPGA Score of Clear (0) or Almost Clear (1) at Week 16
Time frame: Week 16
The sPGA is an assessment by the Investigator of the overall disease severity at the time of evaluation. Erythema (E), induration (I), and desquamation (D) are scored on a 5-point scale, ranging from 0 (clear) to 4 (severe). The National Psoriasis Foundation Psoriasis Score version of a static PGA is calculated by averaging the total body erythema, induration, and desquamation scores. The overall scores are as follows: 0 = Clear; 1. = Almost Clear; 2. = Mild; 3. = Moderate; 4. = Severe. The percentage of participants with a sPGA response was estimated using a multiple imputation method from 100 imputed data sets.
13 secondary outcomes
Percentage of Participants Who Achieved an sPGA Score of Clear (0) or Almost Clear (1) at Week 32
Time frame: Week 32
Percentage of Participants Who Achieved a Scalp Physicians Global Assessment (ScPGA) Score of Clear (0) or Almost Clear (1) at Weeks 16 and 32
Time frame: Weeks 16 and 32
Change From Baseline in Percentage of BSA Affected by Psoriasis at Weeks 16 and 32
Time frame: Baseline and weeks 16 and 32
Percent Change From Baseline in Pruritus Visual Analog Scale (VAS) at Weeks 2, 16, and 32
Time frame: Baseline and weeks 2, 16, and 32
Mean Change From Baseline in Shiratori's Pruritus Severity Score at Weeks 2, 16, and 32
Time frame: Baseline and weeks 2, 16, and 32
Percentage of Participants Who Achieved a ≥ 50% Reduction From Baseline in NAPSI Score (NAPSI-50) at Weeks 16 and 32 Among Participants With NAPSI ≥ 1 at Baseline
Time frame: Weeks 16 and 32
Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 16 and 32
Time frame: Baseline and weeks 16 and 32
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Weeks 16 and 32
Time frame: Baseline and weeks 16 and 32
Percentage of Participants Who Achieved ≥ 75% Reduction From Baseline in PASI Score (PASI-75)
Time frame: Weeks 16 and 32
Percentage of Participants Who Achieved ≥ 50% Reduction From Baseline in PASI Score (PASI-50)
Time frame: Weeks 16 and 32
Treatment Satisfaction Questionnaire for Medication (TSQM) Sub-domain Scores
Time frame: Baseline and weeks 16 and 32
Percentage of Participants Who Achieved a Patient Benefit Index (PBI) Score ≥ 1 at Weeks 16 and 32
Time frame: Weeks 16 and 32
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From first dose of study drug until at least 28 days after last dose; up to 36 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42825996Strober B, Lebwohl M, van de Kerkhof P, Gold LS, Merola JF, Okubo Y, Gisondi P, Zhou Z, Chaudhari S, Deignan C, Mrowietz U. Efficacy of Apremilast in Patients with Psoriasis with Limited Skin Involvement, Including High-Impact Site Involvement: A Pooled Analysis of Six Trials. Dermatol Ther (Heidelb). 2026 Oct 2. doi: 10.1007/s13555-026-01921-9. Online ahead of print.
- Derived from this study: PubMed 38801606Abe M, Okubo Y, Takahashi H, Endo K, Chaudhari S, Deignan C, Amouzadeh H, Hino R. Consistent Efficacy of Apremilast in Patients with Psoriasis Regardless of Baseline Disease Severity or Special Area Involvement: Subgroup Analysis from PROMINENT. Dermatol Ther (Heidelb). 2024 Jun;14(6):1587-1597. doi: 10.1007/s13555-024-01179-z. Epub 2024 May 27.
- Derived from this study: PubMed 35689737Okubo Y, Takahashi H, Hino R, Endo K, Kikuchi S, Ozeki Y, Nakamura T, Paris M, Abe M. Efficacy and Safety of Apremilast in the Treatment of Patients with Mild-to-Moderate Psoriasis in Japan: Results from PROMINENT, A Phase 3b, Open-Label, Single-Arm Study. Dermatol Ther (Heidelb). 2022 Jun;12(6):1469-1480. doi: 10.1007/s13555-022-00747-5. Epub 2022 Jun 11.
- 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
56 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apremilast and Topical Therapy in people with Plaque Psoriasis, run by Amgen at 56 sites in 2 countries.
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 13 inclusion and 20 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 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in Japan, Germany. 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?
Yes. Results are posted in the registry (first posted 20 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Who Achieved an sPGA Score of Clear (0) or Almost Clear (1) 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?
On the ClinicalTrials.gov record for NCT03930186, which also lists 3 linked publications.
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 20 Jan 2022.