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Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) In Japanese Patients With Moderate-To-Severe Plaque-Type Psoriasis

Primary Purpose

Psoriasis, Psoriatic Arthritis, Psoriasis Arthropatica

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Apremilast
Apremilast
Placebo
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis; Psoriatic Arthritis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female Japanese participants greater than or equal to 20 years of age.
  • Diagnosis of chronic, stable plaque psoriasis for at least 6 months prior to screening as defined by: Psoriasis Area Severity Index (PASI) score ≥ 12 and BSA ≥ 10%.
  • Psoriasis which is considered inappropriate for topical therapy (based on severity of disease and extent of affected area) or has not been adequately controlled or treated by topical therapy in spite of at least 4 weeks of prior therapy with at least one topical medication for psoriasis or per label.
  • In otherwise good health based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry, hematology, immunology, and urinalysis.

Exclusion Criteria:

  • Other than psoriasis, history of any clinically significant and uncontrolled systemic diseases; any condition, including the presence of laboratory abnormalities, which would place the participant at unacceptable risk or confound the ability to interpret the data in the study.

Prior medical history of suicide attempt or major psychiatric illness requiring hospitalization within the last 3 years

  • Pregnant or breastfeeding.
  • History of or ongoing chronic or recurrent infectious disease.
  • Active tuberculosis (TB) or a history of incompletely treated TB.
  • Clinically significant abnormality on 12-lead ECG or on chest radiograph at screening.
  • History of human immunodeficiency virus (HIV) infection or have congenital or acquired immunodeficiencies (eg, Common Variable Immunodeficiency).
  • Hepatitis B surface antigen or hepatitis B core antibody positive at screening; positive for antibodies to hepatitis C at screening.
  • Malignancy or history of malignancy, except for treated (ie, cured) basal cell or squamous cell in situ skin carcinomas or treated (ie, cured) cervical intraepithelial neoplasia or carcinoma in situ (CIN) of the cervix with no evidence of recurrence within previous 5 years.
  • Psoriasis flare within 4 weeks of screening.
  • Topical therapy within 2 weeks prior to randomization or systemic therapy for psoriasis or psoriatic arthritis within 4 weeks prior to randomization.
  • Use of etretinate within 2 years prior to randomization for females of child bearing potential (FCBP) or within 6 months for males, and within 4 weeks prior to randomization for non-FCBP.
  • Use of phototherapy: Ultraviolet light B (UVB), Psoralens and long-wave ultraviolet radiation (PUVA) within 4 weeks prior to randomization or prolonged sun exposure or use of tanning booths or other ultraviolet light sources.
  • Use of adalimumab, etanercept, certolizumab pegol, abatacept, tocilizumab, golimumab or infliximab within 12 weeks prior to randomization; use of ustekinumab, alefacept or briakinumab within 24 weeks prior to randomization.
  • Any investigational drug within 4 weeks prior to randomization.

Sites / Locations

  • Ekihigashi Hifuka Clinic
  • Tsutsui Clinic Dermatology & Plastic Surgery
  • Yano Hifuka Hinyokika Clini
  • Fukuoka University Hospital
  • HATAMOTO Derma Clinic
  • Tomoko Matsuda Dermatological Clinic
  • TASHIRO Dermatological Clinic
  • Okubo Skin Care and Clinic
  • Matsuda Dermatology Clinic For Skin, Hair, Nail Diseases
  • Kyusyu Rosai Hospital
  • Kitakyushu Municipal Medical Center
  • Kyushu Kosei Nenkin Hospital
  • Kurume University Hospital
  • Matsuo Clinic
  • Yame General Hospital
  • Kokubu Medical Office Abashiri Dermatology Clinic
  • Chitose Dermatology Plastic Surgery Clinic
  • Asanuma Dermatology Clinic
  • Kokubu Dermatology
  • Sapporo Skin Clinic
  • Fukuzumi Dermatology Clinic
  • Kobe City Medical Center
  • Hitachi General Hospital
  • Tokyo Medical University Ibaraki Medical Center
  • Kanto Rosai Hospital
  • Kawasaki Saiwai Clinic
  • Teikyo University School of Medicine University Hospital
  • Sagamihara National Hospital
  • Queen's Square Medical Facilities
  • Yokohama City University Hospital
  • Nomura Dermatology Clinic
  • Yokosuka Kyosai Hospital
  • Kumamoto Shinto General Hospital
  • Kosumi lin
  • Kume Derma Clinic
  • SANRUI Dermatology
  • Jichi Medical University Hospital
  • Sugai Dermatologist Park Side Clinic
  • Kayaba Dermatology Clinic
  • Tokai University School of Medicine
  • Inagi Municipal Hospital
  • TSUTSUMI Clinic
  • Koto Hospital
  • Maruyama Dermatology Clinic
  • OIZUMI HANAWA Clinic
  • Kitahara Dermatology Clinic
  • NAOKO Dermatology Clinic
  • Mita Dermatology Clinic
  • NTT Medical Center Tokyo
  • Tokyo Medical University Hospital
  • Taneda Dermatology Clinic
  • Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital
  • Shakaihoken Simonoseki Kosei Hospital
  • Matsuo Clinic
  • AMC Nishiumeda Clinic
  • Tokyo Center Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Apremilast 20mg

Apremilast 30mg

Placebo

Arm Description

Apremilast 20 mg tablets orally twice a day (BID)

Apremilast 30 mg tablets orally BID

Identically-appearing placebo tablets BID for 16 weeks followed by participants being re-randomized in a blinded fasion to apremilast 20 mg or 30mg tablets BID for 52 weeks

Outcomes

Primary Outcome Measures

Percentage of Participants Who Achieved a 75% Improvement (Response) From Baseline in the Psoriasis Area and Severity Index (PASI-75) at Week 16
PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was 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. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing.

Secondary Outcome Measures

Percentage of Participants Who Achieved a Static Physician's Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With at Least 2 Point Reduction From Baseline to Week 16
The sPGA is a measure of psoriasis disease severity at the time of evaluation by the Investigator. It does not compare assessments across visits or rely on investigator recall or prior disease. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examines all of the lesions on the participant and assigns a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equals the overall sPGA score.
Percent Change From Baseline in the Psoriasis Affected Body Surface Area (BSA) at Week 16
BSA is a measurement of involved skin. The overall BSA affected by psoriasis is estimated based on the palm area of the subject's hand (entire palmar surface or "handprint" including the fingers), which equates to approximately 1% of total body surface area.
Percent Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score
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 is a validated instrument that has become standard in clinical trials for psoriasis. The PASI scores range from 0 to 72, with higher scores reflecting a greater disease severity.
Percentage of Participants Who Achieved a 50% Improvement From Baseline (Response) Reduction in the PASI-50 at Week 16
PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was 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. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement is missing.
Change From Baseline in Pruritus Visual Analogue Scale 100-mm (VAS) at Week 16
The pruritus visual analog scale (VAS) was used to measure the amount of itching and discomfort a participant experiences. Participant's assessment of pruritus (Itch) asked: On average, how much itch have you had because of your condition in the past week? Higher scores correspond to more severe symptom or disease. The participant places a vertical line on a 100-mm VAS on which the left-hand boundary represents no itch at all and the right-hand boundary represents the worst itch imaginable. The distance from the vertical line to the left-hand boundary is recorded. VAS scores range from 0 to 100 mm, where higher scores correspond to worse pruritis (itch).
Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16
Dermatology Life Quality Index (DLQI) was developed as a practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains 10 items dealing with the participants skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if "No," then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively). The DLQI total score has a possible range from 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.
Change From Baseline in Mental Component Summary (MCS) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 at Week 16
SF-36 is a 36-item general health status instrument often used in clinical trials and health services research. It consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better quality of life (better functioning)
Number of Participants Who Achieved an American College of Rheumatology Criteria (ACR) 20% Improvement (ACR 20)
The ACR 20 is defined as a 20% improvement in joint tenderness (78 joint count) and joint swelling scores (76 joint count) compared to baseline plus 20% improvements in 3 of the following 5 assessments (compared to baseline): subject global assessment of disease activity (measured on a 100-mm visual analog scale [VAS]); physician global assessment of disease activity (measured on a 100-mm VAS); subject self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI] score); subject assessment of pain (measured on a 100-mm VAS); and CRP level.
Percent Change From Baseline Psoriatic Arthritis Pain Visual Analogue Scale (VAS)
Change from baseline in psoriatic arthritis pain 100-mm VAS; The participant places a vertical line on a 100-mm VAS on which the left-hand boundary represents no pain at all and the right-hand boundary represents the worst possible pain. The distance from the vertical line to the left-hand boundary is recorded.
Percent Change From Baseline in Physical Function Assessment Using the Health Assessment Questionnaire Disability Index (HAQ-DI)
Change from baseline in physical function assessment using HAQ-DI; The HAQ-DI is a 20-question, self-administered instrument that measures the subject's functional ability on a 4-level difficulty scale (0-3, with 0 representing normal or no difficulty; and 3 representing inability to perform). Eight categories of functioning are included: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities.
Number of Participants With Adverse Events (AE) in the Placebo Controlled Phase
An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.
Number of Participants With Adverse Events (AE) in the During the Apremilast-exposure Period
An AE was any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.

Full Information

First Posted
May 24, 2013
Last Updated
April 28, 2020
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT01988103
Brief Title
Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) In Japanese Patients With Moderate-To-Severe Plaque-Type Psoriasis
Official Title
A Phase 2B, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) In Japanese Subjects With Moderate-To-Severe Plaque-Type Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
July 9, 2013 (Actual)
Primary Completion Date
November 20, 2014 (Actual)
Study Completion Date
December 15, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will test the clinical effectiveness and safety of two orally administered doses of apremilast compared to placebo in Japanese patients with moderate-to-severe plaque-type psoriasis.
Detailed Description
This is a phase 2b, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of apremilast 20 mg twice a day (BID), apremilast 30 mg BID, and placebo in Japanese participants with moderate to severe plaque psoriasis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Psoriatic Arthritis, Psoriasis Arthropatica
Keywords
Psoriasis; Psoriatic Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
254 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apremilast 20mg
Arm Type
Experimental
Arm Description
Apremilast 20 mg tablets orally twice a day (BID)
Arm Title
Apremilast 30mg
Arm Type
Experimental
Arm Description
Apremilast 30 mg tablets orally BID
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Identically-appearing placebo tablets BID for 16 weeks followed by participants being re-randomized in a blinded fasion to apremilast 20 mg or 30mg tablets BID for 52 weeks
Intervention Type
Drug
Intervention Name(s)
Apremilast
Other Intervention Name(s)
CC-10004, Otzela
Intervention Description
20 mg tablet BID for 68 weeks
Intervention Type
Drug
Intervention Name(s)
Apremilast
Other Intervention Name(s)
CC-10004, Otzela
Intervention Description
20 mg tablet BID for 68 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet BID for 16 weeks
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieved a 75% Improvement (Response) From Baseline in the Psoriasis Area and Severity Index (PASI-75) at Week 16
Description
PASI-75 response is the percentage of participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was 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. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement was missing.
Time Frame
Baseline to Week 16
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieved a Static Physician's Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) With at Least 2 Point Reduction From Baseline to Week 16
Description
The sPGA is a measure of psoriasis disease severity at the time of evaluation by the Investigator. It does not compare assessments across visits or rely on investigator recall or prior disease. The sPGA is a 6-point scale ranging from 0 (clear, except for residual discoloration) to 5 (severe; majority of plaques have severe thickness, erythema, and scaling). The investigator examines all of the lesions on the participant and assigns a score ranging from 0 to 5 for thickness, erythema and degree of scaling. Scores for thickness, erythema and scaling are then summed and the mean of these 3 scores equals the overall sPGA score.
Time Frame
Baseline to Week 16
Title
Percent Change From Baseline in the Psoriasis Affected Body Surface Area (BSA) at Week 16
Description
BSA is a measurement of involved skin. The overall BSA affected by psoriasis is estimated based on the palm area of the subject's hand (entire palmar surface or "handprint" including the fingers), which equates to approximately 1% of total body surface area.
Time Frame
Baseline to Week 16
Title
Percent Change From Baseline in the Psoriasis Area and Severity Index (PASI) Score
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 is a validated instrument that has become standard in clinical trials for psoriasis. The PASI scores range from 0 to 72, with higher scores reflecting a greater disease severity.
Time Frame
Baseline to Week 16
Title
Percentage of Participants Who Achieved a 50% Improvement From Baseline (Response) Reduction in the PASI-50 at Week 16
Description
PASI-50 response is the percentage of participants who achieved at least a 50% reduction (improvement) from baseline in PASI score at Week 16. The improvement in PASI score was used as a measure of efficacy. The PASI was 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. PASI scores range from 0 to 72, with higher scores reflecting greater disease severity. Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). The PASI score was set to missing if any severity score or degree of involvement is missing.
Time Frame
Baseline to Week 16
Title
Change From Baseline in Pruritus Visual Analogue Scale 100-mm (VAS) at Week 16
Description
The pruritus visual analog scale (VAS) was used to measure the amount of itching and discomfort a participant experiences. Participant's assessment of pruritus (Itch) asked: On average, how much itch have you had because of your condition in the past week? Higher scores correspond to more severe symptom or disease. The participant places a vertical line on a 100-mm VAS on which the left-hand boundary represents no itch at all and the right-hand boundary represents the worst itch imaginable. The distance from the vertical line to the left-hand boundary is recorded. VAS scores range from 0 to 100 mm, where higher scores correspond to worse pruritis (itch).
Time Frame
Baseline to Week 16
Title
Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Week 16
Description
Dermatology Life Quality Index (DLQI) was developed as a practical questionnaire for use in a dermatology clinical setting to assess limitations related to the impact of skin disease. The instrument contains 10 items dealing with the participants skin. With the exception of Item Number 7, the participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). Item Number 7 is a multi-part item, the first part of which ascertains whether the participant's skin prevented them from working or studying (Yes or No, scores 3 or 0 respectively), and if "No," then the participant is asked how much of a problem the skin has been at work or study over the past week, with response alternatives being "A lot," "A little," or "Not at all" (scores 2, 1, or 0 respectively). The DLQI total score has a possible range from 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best.
Time Frame
Baseline to Week 16
Title
Change From Baseline in Mental Component Summary (MCS) Score of the Medical Outcome Study Short Form 36-item (SF-36) Health Survey Version 2.0 at Week 16
Description
SF-36 is a 36-item general health status instrument often used in clinical trials and health services research. It consists of 8 scales: physical function (PF), role limitations-physical (RP), vitality (VT), general health perceptions (GH), bodily pain (BP), social function (SF), role limitations-emotional (RE), and mental health (MH). Scale scores range from 0 to 100, with higher scores indicating better quality of life (better functioning)
Time Frame
Baseline to Week 16
Title
Number of Participants Who Achieved an American College of Rheumatology Criteria (ACR) 20% Improvement (ACR 20)
Description
The ACR 20 is defined as a 20% improvement in joint tenderness (78 joint count) and joint swelling scores (76 joint count) compared to baseline plus 20% improvements in 3 of the following 5 assessments (compared to baseline): subject global assessment of disease activity (measured on a 100-mm visual analog scale [VAS]); physician global assessment of disease activity (measured on a 100-mm VAS); subject self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI] score); subject assessment of pain (measured on a 100-mm VAS); and CRP level.
Time Frame
Baseline to Week 16
Title
Percent Change From Baseline Psoriatic Arthritis Pain Visual Analogue Scale (VAS)
Description
Change from baseline in psoriatic arthritis pain 100-mm VAS; The participant places a vertical line on a 100-mm VAS on which the left-hand boundary represents no pain at all and the right-hand boundary represents the worst possible pain. The distance from the vertical line to the left-hand boundary is recorded.
Time Frame
Baseline to Week 16
Title
Percent Change From Baseline in Physical Function Assessment Using the Health Assessment Questionnaire Disability Index (HAQ-DI)
Description
Change from baseline in physical function assessment using HAQ-DI; The HAQ-DI is a 20-question, self-administered instrument that measures the subject's functional ability on a 4-level difficulty scale (0-3, with 0 representing normal or no difficulty; and 3 representing inability to perform). Eight categories of functioning are included: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities.
Time Frame
Baseline to Week 16
Title
Number of Participants With Adverse Events (AE) in the Placebo Controlled Phase
Description
An AE was any noxious, unintended, or untoward medical occurrence, that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.
Time Frame
Baseline to Week 16
Title
Number of Participants With Adverse Events (AE) in the During the Apremilast-exposure Period
Description
An AE was any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) was considered an AE. A serious AE (SAE) is any untoward adverse event that is fatal, life-threatening, results in persistent or significant disability or incapacity, requires or prolongs existing in-patient hospitalization, is a congenital anomaly or birth defect, or a condition that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above. An AE is a treatment emergent AE if the AE start date is on or after the date of the first dose of study drug and no later than 28 days after the last dose.
Time Frame
From the first dose of apremilast (either Week 0 or Week 16 for participants originally randomized to placebo who were re-randomized at Week 16) until 28 days after the last dose of apremilast.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female Japanese participants greater than or equal to 20 years of age. Diagnosis of chronic, stable plaque psoriasis for at least 6 months prior to screening as defined by: Psoriasis Area Severity Index (PASI) score ≥ 12 and BSA ≥ 10%. Psoriasis which is considered inappropriate for topical therapy (based on severity of disease and extent of affected area) or has not been adequately controlled or treated by topical therapy in spite of at least 4 weeks of prior therapy with at least one topical medication for psoriasis or per label. In otherwise good health based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry, hematology, immunology, and urinalysis. Exclusion Criteria: Other than psoriasis, history of any clinically significant and uncontrolled systemic diseases; any condition, including the presence of laboratory abnormalities, which would place the participant at unacceptable risk or confound the ability to interpret the data in the study. Prior medical history of suicide attempt or major psychiatric illness requiring hospitalization within the last 3 years Pregnant or breastfeeding. History of or ongoing chronic or recurrent infectious disease. Active tuberculosis (TB) or a history of incompletely treated TB. Clinically significant abnormality on 12-lead ECG or on chest radiograph at screening. History of human immunodeficiency virus (HIV) infection or have congenital or acquired immunodeficiencies (eg, Common Variable Immunodeficiency). Hepatitis B surface antigen or hepatitis B core antibody positive at screening; positive for antibodies to hepatitis C at screening. Malignancy or history of malignancy, except for treated (ie, cured) basal cell or squamous cell in situ skin carcinomas or treated (ie, cured) cervical intraepithelial neoplasia or carcinoma in situ (CIN) of the cervix with no evidence of recurrence within previous 5 years. Psoriasis flare within 4 weeks of screening. Topical therapy within 2 weeks prior to randomization or systemic therapy for psoriasis or psoriatic arthritis within 4 weeks prior to randomization. Use of etretinate within 2 years prior to randomization for females of child bearing potential (FCBP) or within 6 months for males, and within 4 weeks prior to randomization for non-FCBP. Use of phototherapy: Ultraviolet light B (UVB), Psoralens and long-wave ultraviolet radiation (PUVA) within 4 weeks prior to randomization or prolonged sun exposure or use of tanning booths or other ultraviolet light sources. Use of adalimumab, etanercept, certolizumab pegol, abatacept, tocilizumab, golimumab or infliximab within 12 weeks prior to randomization; use of ustekinumab, alefacept or briakinumab within 24 weeks prior to randomization. Any investigational drug within 4 weeks prior to randomization.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Ekihigashi Hifuka Clinic
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
812-0013
Country
Japan
Facility Name
Tsutsui Clinic Dermatology & Plastic Surgery
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
813-0042
Country
Japan
Facility Name
Yano Hifuka Hinyokika Clini
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
814-0013
Country
Japan
Facility Name
Fukuoka University Hospital
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
HATAMOTO Derma Clinic
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
815-0075
Country
Japan
Facility Name
Tomoko Matsuda Dermatological Clinic
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
819-0167
Country
Japan
Facility Name
TASHIRO Dermatological Clinic
City
Iizuka-shi
State/Province
Fukuoka
ZIP/Postal Code
820-0040
Country
Japan
Facility Name
Okubo Skin Care and Clinic
City
Itoshima-shi
State/Province
Fukuoka
ZIP/Postal Code
819-1108
Country
Japan
Facility Name
Matsuda Dermatology Clinic For Skin, Hair, Nail Diseases
City
Itoshima-shi
State/Province
Fukuoka
ZIP/Postal Code
819-1116
Country
Japan
Facility Name
Kyusyu Rosai Hospital
City
Kitakyushu-shi
State/Province
Fukuoka
ZIP/Postal Code
800-0296
Country
Japan
Facility Name
Kitakyushu Municipal Medical Center
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
802-0077
Country
Japan
Facility Name
Kyushu Kosei Nenkin Hospital
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
806-8501
Country
Japan
Facility Name
Kurume University Hospital
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Matsuo Clinic
City
Nishi-Ku
State/Province
Fukuoka
ZIP/Postal Code
819-0373
Country
Japan
Facility Name
Yame General Hospital
City
Yame
State/Province
Fukuoka
ZIP/Postal Code
834-0034
Country
Japan
Facility Name
Kokubu Medical Office Abashiri Dermatology Clinic
City
Abashiri-shi
State/Province
Hokkaido
ZIP/Postal Code
093-0016
Country
Japan
Facility Name
Chitose Dermatology Plastic Surgery Clinic
City
Chitose-shi
State/Province
Hokkaido
ZIP/Postal Code
066-0021
Country
Japan
Facility Name
Asanuma Dermatology Clinic
City
Chitose-shi
State/Province
Hokkaido
ZIP/Postal Code
066-0064
Country
Japan
Facility Name
Kokubu Dermatology
City
Kitami-shi
State/Province
Hokkaido
ZIP/Postal Code
090-0832
Country
Japan
Facility Name
Sapporo Skin Clinic
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-0063
Country
Japan
Facility Name
Fukuzumi Dermatology Clinic
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
062-0042
Country
Japan
Facility Name
Kobe City Medical Center
City
Kobe City
State/Province
Hyogo
ZIP/Postal Code
653-0013
Country
Japan
Facility Name
Hitachi General Hospital
City
Hitachi
State/Province
Ibaraki
ZIP/Postal Code
317-0077
Country
Japan
Facility Name
Tokyo Medical University Ibaraki Medical Center
City
Inashiki-gun
State/Province
Ibaraki
ZIP/Postal Code
300-0395
Country
Japan
Facility Name
Kanto Rosai Hospital
City
Kawasaki City
State/Province
Kanagawa
ZIP/Postal Code
211-8510
Country
Japan
Facility Name
Kawasaki Saiwai Clinic
City
Kawasaki-shi
State/Province
Kanagawa
ZIP/Postal Code
212-0016
Country
Japan
Facility Name
Teikyo University School of Medicine University Hospital
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
213-8507
Country
Japan
Facility Name
Sagamihara National Hospital
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
252-0392
Country
Japan
Facility Name
Queen's Square Medical Facilities
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
220-6208
Country
Japan
Facility Name
Yokohama City University Hospital
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
213-8507
Country
Japan
Facility Name
Nomura Dermatology Clinic
City
Yokohoma City
State/Province
Kanagawa
ZIP/Postal Code
221-0825
Country
Japan
Facility Name
Yokosuka Kyosai Hospital
City
Yokosuka
State/Province
Kanagawa
ZIP/Postal Code
238-8558
Country
Japan
Facility Name
Kumamoto Shinto General Hospital
City
Kumamoto City
State/Province
Kumamoto
ZIP/Postal Code
862-0975
Country
Japan
Facility Name
Kosumi lin
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
860-0016
Country
Japan
Facility Name
Kume Derma Clinic
City
Sakai-Shi
State/Province
Osaka
ZIP/Postal Code
593-8324
Country
Japan
Facility Name
SANRUI Dermatology
City
Saitama-shi
State/Province
Saitama
ZIP/Postal Code
330-0854
Country
Japan
Facility Name
Jichi Medical University Hospital
City
Shimotsuke-shi
State/Province
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
Sugai Dermatologist Park Side Clinic
City
Utsunomiya-shi
State/Province
Tochigi
ZIP/Postal Code
321-0954
Country
Japan
Facility Name
Kayaba Dermatology Clinic
City
Cyu-o-ku
State/Province
Tokyo
ZIP/Postal Code
103-0016
Country
Japan
Facility Name
Tokai University School of Medicine
City
Hachioji
State/Province
Tokyo
ZIP/Postal Code
192-0032
Country
Japan
Facility Name
Inagi Municipal Hospital
City
Inagi
State/Province
Tokyo
ZIP/Postal Code
206-2801
Country
Japan
Facility Name
TSUTSUMI Clinic
City
Itabasi-Ku
State/Province
Tokyo
ZIP/Postal Code
174-0071
Country
Japan
Facility Name
Koto Hospital
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
136-0072
Country
Japan
Facility Name
Maruyama Dermatology Clinic
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
136-0074
Country
Japan
Facility Name
OIZUMI HANAWA Clinic
City
Nerima-ku
State/Province
Tokyo
ZIP/Postal Code
178-0063
Country
Japan
Facility Name
Kitahara Dermatology Clinic
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
158-0094
Country
Japan
Facility Name
NAOKO Dermatology Clinic
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
158-0097
Country
Japan
Facility Name
Mita Dermatology Clinic
City
Shiba Minato-k
State/Province
Tokyo
ZIP/Postal Code
108-0014
Country
Japan
Facility Name
NTT Medical Center Tokyo
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Shinjyuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Taneda Dermatology Clinic
City
Suginami-ku
State/Province
Tokyo
ZIP/Postal Code
166-0015
Country
Japan
Facility Name
Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital
City
Tachikawa
State/Province
Tokyo
ZIP/Postal Code
190-8531
Country
Japan
Facility Name
Shakaihoken Simonoseki Kosei Hospital
City
Shimonoseki-shi
State/Province
Yamaguchi
ZIP/Postal Code
750-0061
Country
Japan
Facility Name
Matsuo Clinic
City
Fukuoka
ZIP/Postal Code
719-0373
Country
Japan
Facility Name
AMC Nishiumeda Clinic
City
Osaka
ZIP/Postal Code
530-0001
Country
Japan
Facility Name
Tokyo Center Clinic
City
Tokyo
ZIP/Postal Code
103-0028
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
28391657
Citation
Ohtsuki M, Okubo Y, Komine M, Imafuku S, Day RM, Chen P, Petric R, Maroli A, Nemoto O. Apremilast, an oral phosphodiesterase 4 inhibitor, in the treatment of Japanese patients with moderate to severe plaque psoriasis: Efficacy, safety and tolerability results from a phase 2b randomized controlled trial. J Dermatol. 2017 Aug;44(8):873-884. doi: 10.1111/1346-8138.13829. Epub 2017 Apr 9.
Results Reference
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PubMed Identifier
29905383
Citation
Ohtsuki M, Kubo H, Morishima H, Goto R, Zheng R, Nakagawa H. Guselkumab, an anti-interleukin-23 monoclonal antibody, for the treatment of moderate to severe plaque-type psoriasis in Japanese patients: Efficacy and safety results from a phase 3, randomized, double-blind, placebo-controlled study. J Dermatol. 2018 Sep;45(9):1053-1062. doi: 10.1111/1346-8138.14504. Epub 2018 Jun 15.
Results Reference
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Learn more about this trial

Efficacy and Safety Study of Two Doses of Apremilast (CC-10004) In Japanese Patients With Moderate-To-Severe Plaque-Type Psoriasis

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