Back to resultsA 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
Primary Purpose
Plaque Psoriasis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Apremilast
Topical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Plaque Psoriasis
Eligibility Criteria
Inclusion Criteria:
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.
- 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.
Exclusion Criteria:
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).
- 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.
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Motomachi Dermatology Clinic
- Research Site
- Nippon Medical School Hospital
- The University of Tokyo Hospital
- Chitose Dermatology and Plastic, Reconstructive Surgery Clinic
- Research Site
- Kiryu Dermatology Clinic
- Fukuoka University Hospital
- Tomoko Matsuda Dermatology Clinic
- Hino Dermatology Clinic
- Research Site
- Research Site
- Saruwatari Dermatology Clinic
- Noguchi Dermatorogy Clinic
- Research Site
- Japan Community Health-care Organization Kyushu Hospital
- Research Site
- Maruyama Dermatology Clinic
- Research Site
- Mita Dermatology Clinic
- Research Site
- Iwate Medical University Uchimaru Medical Center
- Research Site
- Research Site
- Yoshioka Dermatology Clinic
- Takagi Dermatological Clinic
- Nippon Life Hospital
- Research Site
- Kume Clinic
- Hino Clinic
- Research Site
- Sapporo Skin Clinic
- Fukuzumi Dermatology Clinic
- Kitagou Dermatology Clinic
- Research Site
- Kobayashi Skin Clinic
- Research Site
- Hosui Medical Clinic
- Research Site
- Jichi Medical University Hospital
- Research Site
- NTT Medical Center Tokyo
- Research Site
- Tokyo Medical University Hospital
- Fujita Health University Hospital
- Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Apremilast
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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.
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.
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.
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).
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.
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.
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.
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.
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).
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).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03930186
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 17, 2019 (Actual)
Primary Completion Date
May 8, 2020 (Actual)
Study Completion Date
September 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
152 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Apremilast
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Apremilast
Other Intervention Name(s)
CC-10004, Otezla®
Intervention Description
Tablets for oral administration
Intervention Type
Drug
Intervention Name(s)
Topical Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieved an sPGA Score of Clear (0) or Almost Clear (1) at Week 16
Description
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.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieved an sPGA Score of Clear (0) or Almost Clear (1) at Week 32
Description
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.
Time Frame
Week 32
Title
Percentage of Participants Who Achieved a Scalp Physicians Global Assessment (ScPGA) Score of Clear (0) or Almost Clear (1) at Weeks 16 and 32
Description
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).
Time Frame
Weeks 16 and 32
Title
Change From Baseline in Percentage of BSA Affected by Psoriasis at Weeks 16 and 32
Description
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.
Time Frame
Baseline and weeks 16 and 32
Title
Percent Change From Baseline in Pruritus Visual Analog Scale (VAS) at Weeks 2, 16, and 32
Description
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.
Time Frame
Baseline and weeks 2, 16, and 32
Title
Mean Change From Baseline in Shiratori's Pruritus Severity Score at Weeks 2, 16, and 32
Description
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.
Time Frame
Baseline and weeks 2, 16, and 32
Title
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
Description
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).
Time Frame
Weeks 16 and 32
Title
Change From Baseline in Dermatology Life Quality Index (DLQI) at Weeks 16 and 32
Description
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.
Time Frame
Baseline and weeks 16 and 32
Title
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Weeks 16 and 32
Description
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.
Time Frame
Baseline and weeks 16 and 32
Title
Percentage of Participants Who Achieved ≥ 75% Reduction From Baseline in PASI Score (PASI-75)
Description
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.
Time Frame
Weeks 16 and 32
Title
Percentage of Participants Who Achieved ≥ 50% Reduction From Baseline in PASI Score (PASI-50)
Description
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.
Time Frame
Weeks 16 and 32
Title
Treatment Satisfaction Questionnaire for Medication (TSQM) Sub-domain Scores
Description
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).
Time Frame
Baseline and weeks 16 and 32
Title
Percentage of Participants Who Achieved a Patient Benefit Index (PBI) Score ≥ 1 at Weeks 16 and 32
Description
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).
Time Frame
Weeks 16 and 32
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Description
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.
Time Frame
From first dose of study drug until at least 28 days after last dose; up to 36 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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.
Exclusion Criteria:
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).
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Research Site
City
Fukuoka-shi, Fukuoka
State/Province
Fukuoka
ZIP/Postal Code
813-0044
Country
Japan
Facility Name
Research Site
City
Fukuoka-shi, Fukuoka
State/Province
Fukuoka
ZIP/Postal Code
819-0167
Country
Japan
Facility Name
Research Site
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Research Site
City
Obihiro-shi
State/Province
Hokkaido
ZIP/Postal Code
080-0013
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-0063
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
062-0042
Country
Japan
Facility Name
Research Site
City
Sakai-shi
State/Province
Osaka
ZIP/Postal Code
593-8324
Country
Japan
Facility Name
Research Site
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
Research Site
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
Facility Name
Motomachi Dermatology Clinic
City
Asahikawa-shi, Hokkaido
ZIP/Postal Code
070-0810
Country
Japan
Facility Name
Research Site
City
Asahikawa-shi, Hokkaido
ZIP/Postal Code
070-0810
Country
Japan
Facility Name
Nippon Medical School Hospital
City
Bunkyo-ku
ZIP/Postal Code
113-8602
Country
Japan
Facility Name
The University of Tokyo Hospital
City
Bunkyo-ku
ZIP/Postal Code
113-8655
Country
Japan
Facility Name
Chitose Dermatology and Plastic, Reconstructive Surgery Clinic
City
Chitose
ZIP/Postal Code
066-0021
Country
Japan
Facility Name
Research Site
City
Chitose
ZIP/Postal Code
066-0021
Country
Japan
Facility Name
Kiryu Dermatology Clinic
City
Fukuoka-shi, Fukuoka
ZIP/Postal Code
813-0044
Country
Japan
Facility Name
Fukuoka University Hospital
City
Fukuoka-shi, Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Tomoko Matsuda Dermatology Clinic
City
Fukuoka-shi, Fukuoka
ZIP/Postal Code
819-0167
Country
Japan
Facility Name
Hino Dermatology Clinic
City
Fukutsu
ZIP/Postal Code
811-3217
Country
Japan
Facility Name
Research Site
City
Fukutsu
ZIP/Postal Code
811-3217
Country
Japan
Facility Name
Research Site
City
Kagoshima
ZIP/Postal Code
890-0055
Country
Japan
Facility Name
Saruwatari Dermatology Clinic
City
Kagoshima
ZIP/Postal Code
890-0055
Country
Japan
Facility Name
Noguchi Dermatorogy Clinic
City
Kamimashiki-gun
ZIP/Postal Code
861-3101
Country
Japan
Facility Name
Research Site
City
Kamimashiki-gun
ZIP/Postal Code
861-3101
Country
Japan
Facility Name
Japan Community Health-care Organization Kyushu Hospital
City
Kitakyushu-city
ZIP/Postal Code
806-8501
Country
Japan
Facility Name
Research Site
City
Kitakyushu-city
ZIP/Postal Code
806-8501
Country
Japan
Facility Name
Maruyama Dermatology Clinic
City
Koto-ku, Tokyo
ZIP/Postal Code
136-0074
Country
Japan
Facility Name
Research Site
City
Koto-ku, Tokyo
ZIP/Postal Code
136-0074
Country
Japan
Facility Name
Mita Dermatology Clinic
City
Minato-ku
ZIP/Postal Code
108-0014
Country
Japan
Facility Name
Research Site
City
Minato-ku
ZIP/Postal Code
108-0014
Country
Japan
Facility Name
Iwate Medical University Uchimaru Medical Center
City
Morioka
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Research Site
City
Morioka
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Research Site
City
Neyagawa
ZIP/Postal Code
572-0838
Country
Japan
Facility Name
Yoshioka Dermatology Clinic
City
Neyagawa
ZIP/Postal Code
572-0838
Country
Japan
Facility Name
Takagi Dermatological Clinic
City
Obihiro
ZIP/Postal Code
080-0013
Country
Japan
Facility Name
Nippon Life Hospital
City
Osaka
ZIP/Postal Code
550-0006
Country
Japan
Facility Name
Research Site
City
Osaka
ZIP/Postal Code
550-0006
Country
Japan
Facility Name
Kume Clinic
City
Sakai-shi, Osaka
ZIP/Postal Code
593-8324
Country
Japan
Facility Name
Hino Clinic
City
Sakai
ZIP/Postal Code
599-8272
Country
Japan
Facility Name
Research Site
City
Sakai
ZIP/Postal Code
599-8272
Country
Japan
Facility Name
Sapporo Skin Clinic
City
Sapporo-shi, Hokkaido
ZIP/Postal Code
060-0063
Country
Japan
Facility Name
Fukuzumi Dermatology Clinic
City
Sapporo-shi, Hokkaido
ZIP/Postal Code
062-0042
Country
Japan
Facility Name
Kitagou Dermatology Clinic
City
Sapporo
ZIP/Postal Code
003-0833
Country
Japan
Facility Name
Research Site
City
Sapporo
ZIP/Postal Code
003-0833
Country
Japan
Facility Name
Kobayashi Skin Clinic
City
Sapporo
ZIP/Postal Code
060-0807
Country
Japan
Facility Name
Research Site
City
Sapporo
ZIP/Postal Code
060-0807
Country
Japan
Facility Name
Hosui Medical Clinic
City
Sapporo
ZIP/Postal Code
064-0807
Country
Japan
Facility Name
Research Site
City
Sapporo
ZIP/Postal Code
064-0807
Country
Japan
Facility Name
Jichi Medical University Hospital
City
Shimotsuke
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
Research Site
City
Shimotsuke
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
NTT Medical Center Tokyo
City
Shinagawa-ku, Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Facility Name
Research Site
City
Shinjyuku-ku
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Shinjyuku-ku
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Fujita Health University Hospital
City
Toyoake
ZIP/Postal Code
470-1192
Country
Japan
Facility Name
Research Site
City
Toyoake
ZIP/Postal Code
470-1192
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD Sharing Time Frame
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD Sharing Access Criteria
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
IPD Sharing URL
http://www.amgen.com/datasharing
Citations:
PubMed Identifier
35689737
Citation
Okubo 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.
Results Reference
derived
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
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
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