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A study to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with moderate to severe atopic dermatitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apremilast 40 mg | Experimental | Apremilast 40 mg administered orally twice daily (BID) for 12 weeks (following dose titration) during the placebo controlled phase followed by 40 mg Apremilast tablets orally administered BID for an additional 12 weeks in the active treatment phase |
|
| Apremilast 30 mg | Experimental | Apremilast 30 mg administered orally BID for 12 weeks (following dose titration) during the placebo controlled phase followed by 30 mg Apremilast tablets orally administered BID for an additional 12 weeks in the active treatment phase |
|
| Placebo + Apremilast 40 mg | Experimental | Placebo administered orally BID for 12 weeks, during the placebo controlled phase followed by 40 mg Apremilast tablets orally BID for an additional 12 weeks in the active treatment phase |
|
| Placebo + Apremilast 30 mg | Experimental | Placebo administered orally BID for 12 weeks, during the placebo controlled phase followed by 30 mg Apremilast tablets orally BID for an additional 12 weeks in the active treatment phase |
|
| Placebo | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apremilast | Drug | Orally twice a day (BID) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 12. | EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). A representative lesion is selected for each of the four body regions for assessing the intensity of each of the four signs (erythema, induration /papulation, excoriation, and lichenification). Symptoms (eg, pruritus) and secondary signs (eg, xerosis, scaling) are excluded from the assessment. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved a Score of 0 (Cleared) or 1 (Almost Cleared) and at Least a 2-point Reduction From Baseline in a Static Physician's Global Assessment of Acute Signs (sPGA-A) at Week 12. | The sPGA-A is intended to assess the global severities (ie, a "visual average" integrating all areas of AD) of key acute clinical signs of AD, including erythema, induration/papulation, oozing/crusting (lichenification excluded) based on a 5-point scale of cleared (0), almost cleared (1), mild (2), moderate (3) and severe (4). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Research Center | Phoenix | Arizona | 85023 | United States | ||
| Bakersfield Dermatology and Skin Cancer Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30528828 | Derived | Simpson EL, Imafuku S, Poulin Y, Ungar B, Zhou L, Malik K, Wen HC, Xu H, Estrada YD, Peng X, Chen M, Shah N, Suarez-Farinas M, Pavel AB, Nograles K, Guttman-Yassky E. A Phase 2 Randomized Trial of Apremilast in Patients with Atopic Dermatitis. J Invest Dermatol. 2019 May;139(5):1063-1072. doi: 10.1016/j.jid.2018.10.043. Epub 2018 Dec 5. |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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.
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.
Treatment assignment was stratified by geographic region and within each region, by the Eczema Area and Severity Index (EASI) score (≤ 20 or > 20). Six participants were excluded from analysis due to unsigned case books; a total of 185 participants were included in the final analyses.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12) |
| FG001 | Apremilast 30 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Placebo-Controlled Phase Week 0-12 |
|
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Oral Placebo tablets administered twice daily (BID) for 12 weeks during the placebo-controlled phase. |
|
| Apremilast | Drug | Orally twice a day (BID) |
|
|
| Placebo | Drug | Orally twice a day (BID) |
|
| Placebo | Drug | Orally twice a day (BID) |
|
| Baseline to Week 12 |
| Percentage of Participants Who Achieved at Least a 50% Reduction From Baseline in the EASI Score (EASI 50) at Week 12 | The EASI 50 reduction (defined as ≥ 50% reduction from baseline in EASI score) was selected to serve as the key responder endpoint. A ≥ 50% improvement is clinically meaningful for this population. | Baseline to Week 12 |
| The Percentage Change From Baseline in the Average Weekly Pruritus Numerical Rating Scale (NRS) Score at Week 4 | The participant completed a daily diary recording the average intensity of pruritus they experienced during the preceding 24 hrs. The intensity of pruritus was assessed using a validated 11-point NRS, ranging from 0 ("no pruritus") to 10 ("the worst pruritus imaginable"). It should be noted that this NRS is distinct from the pruritus, Visual Analogue Scale (VAS) in the Modified SCORAD Index with respect to recall period (three days for the VAS). The weekly NRS score was calculated as the average of the NRS scores over 7 days within the specified week. A higher score indicated worse disease status, and a negative change from baseline indicated improvement. | Baseline to Week 4 |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Period | A TEAE is an adverse event with a start date on or after the date of the first dose of IP and no later than 28 days after the last dose of IP for participants who discontinued early. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a 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 pre existing condition) should be considered an AE. A serious AE is any which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event. | Baseline to Week 12 |
| Number of Participants With TEAEs During the Apremilast Exposure Period | A TEAE is an adverse event with a start date on or after the date of the first dose of investigational product (IP) and no later than 28 days after the last dose of IP. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a 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 pre existing condition) should be considered an AE. A serious AE is any which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event. | Baseline to Week 24; median duration of apremilast 30 mg was 23.3 weeks and 22.4 weeks for apremilast 40 mg |
| Bakersfield |
| California |
| 93309 |
| United States |
| Dermatology Research Associates | Los Angeles | California | 90045 | United States |
| Renstar Medical Research | Ocala | Florida | 34471 | United States |
| Emory Clinic | Atlanta | Georgia | 30322 | United States |
| Advanced Medical Research | Atlanta | Georgia | 30342 | United States |
| Northwestern University Northwestern Medical Faculty Foundation | Chicago | Illinois | 60611 | United States |
| Northwestern Medicine Lake Forest Hospital | Lake Forest | Illinois | 60045 | United States |
| Dermatology Specialists, PSC | Louisville | Kentucky | 40202 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| NYU Department of Dermatology | New York | New York | 10016 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| PMG Research of Winston-Salem LLC | Winston-Salem | North Carolina | 27103-3914 | United States |
| Oregon Health and Science University | Portland | Oregon | 97201-3098 | United States |
| Virginia Clinical Research Inc | Norfolk | Virginia | 23507 | United States |
| Chih-Ho Hong Medical, Inc. | Surrey | British Columbia | V3R 6A7 | Canada |
| Eastern Canada Cutaneous Research Associates Ltd | Halifax | Nova Scotia | B3H 1Z2 | Canada |
| Ultranova Skincare | Barrie | Ontario | L4M 6L2 | Canada |
| K. Papp Clinical Research | Waterloo | Ontario | N2J 1C4 | Canada |
| Innovaderm Research | Montreal | Quebec | H2K 4L5 | Canada |
| Centre Dermatologique du Quebec Metropolitain | Ste-Foy | Quebec | G1V 4X7 | Canada |
| Kokubu Abashiri Dermatology Clinic | Abashiri-shi, Hokkaido | 093-0016 | Japan |
| Asanuma Dermatology Clinic | Chitose-shi, Hokkaido | 066-0064 | Japan |
| Fukuoka University Hospital Dermatology | Fukuoka-shi, Fukuoka | 814-0180 | Japan |
| Hatamoto Dermatology Clinic | Fukuoka-shi, Fukuoka | 815-0075 | Japan |
| Tashiro Clinic | Iizuka-shi, Fukuoka | 820-0040 | Japan |
| Kokubu Dermatology | Kitami-shi, Hokkaido | 090-0832 | Japan |
| University Hospital, Kyoto Prefectural University of Medicine | Kyoto | 602-8566 | Japan |
| Kyoto University Hospital | Kyoto | 606-8507 | Japan |
| Sapporo Skin Clinic | Sapporo-shi, Hokkaido | 060-0063 | Japan |
| NTT Medical Center Tokyo | Shinagawa-ku, Tokyo | 141-8625 | Japan |
Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase and continued to receive 30 mg apremilast tablets twice daily (BID) for up to Week 24 in the active treatment phase
| FG002 | Apremilast 40 mg | Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase and continued to receive 40 mg apremilast tablets twice daily (BID) for up to Week 24 in the active treatment phase. |
| FG003 | Placebo/Apremilast 30 mg | Participants initially randomized to identically matching placebo tablets twice daily and were re-randomized at Week 12 to 30 mg apremilast for 12 weeks, up to week 24. |
| FG004 | Placebo/Apremilast 40 mg | Participants initially randomized to identically matching placebo tablets twice daily and were re-randomized at Week 12 to 40 mg apremilast for 12 weeks, up to week 24. |
| Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Active Treatment Phase Week 12-24 |
|
|
| Observational Follow-up Phase Week 24-30 |
|
Intent to Treat (ITT) includes all participants who were randomized as specified in the protocol and received at least one dose of Investigational product (IP)
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16) |
| BG001 | Apremilast 30 mg | Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase. |
| BG002 | Apremilast 40 mg | Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage Change From Baseline in the Eczema Area and Severity Index (EASI) Score at Week 12. | EASI is a validated composite scoring system integrating the proportion of the body region (area) involved and the intensity of key signs of atopic dermatitis (AD). A representative lesion is selected for each of the four body regions for assessing the intensity of each of the four signs (erythema, induration /papulation, excoriation, and lichenification). Symptoms (eg, pruritus) and secondary signs (eg, xerosis, scaling) are excluded from the assessment. The total EASI score ranges from 0 to 72. A higher score indicated worse disease status, and a negative change from baseline indicated improvement. | All participants who were randomized as specified per protocol and who received at least one dose of IP with a baseline and at least 1 post baseline value at or before week 12; A missing value at Week 12 was imputed by last observation carried forward (LOCF), including the value obtained at the Early Termination Visit prior to Week 12. | Posted | Least Squares Mean | Standard Error | percent change | Baseline to Week 12 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved a Score of 0 (Cleared) or 1 (Almost Cleared) and at Least a 2-point Reduction From Baseline in a Static Physician's Global Assessment of Acute Signs (sPGA-A) at Week 12. | The sPGA-A is intended to assess the global severities (ie, a "visual average" integrating all areas of AD) of key acute clinical signs of AD, including erythema, induration/papulation, oozing/crusting (lichenification excluded) based on a 5-point scale of cleared (0), almost cleared (1), mild (2), moderate (3) and severe (4). | ITT includes all participants who were randomized as specified per protocol and received at least one dose of IP. LOCF for missing data handling. | Posted | Number | percentage of participants | Baseline to Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved at Least a 50% Reduction From Baseline in the EASI Score (EASI 50) at Week 12 | The EASI 50 reduction (defined as ≥ 50% reduction from baseline in EASI score) was selected to serve as the key responder endpoint. A ≥ 50% improvement is clinically meaningful for this population. | ITT includes all participants who were randomized as specified in the protocol and received at least one dose of IP. LOCF. | Posted | Number | percentage of participants | Baseline to Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Percentage Change From Baseline in the Average Weekly Pruritus Numerical Rating Scale (NRS) Score at Week 4 | The participant completed a daily diary recording the average intensity of pruritus they experienced during the preceding 24 hrs. The intensity of pruritus was assessed using a validated 11-point NRS, ranging from 0 ("no pruritus") to 10 ("the worst pruritus imaginable"). It should be noted that this NRS is distinct from the pruritus, Visual Analogue Scale (VAS) in the Modified SCORAD Index with respect to recall period (three days for the VAS). The weekly NRS score was calculated as the average of the NRS scores over 7 days within the specified week. A higher score indicated worse disease status, and a negative change from baseline indicated improvement. | All participants who were randomized as specified in the protocol and who received at least one dose of IP with a baseline and at least 1 postbaseline value at or before Week 4 were included. LOCF. | Posted | Least Squares Mean | Standard Error | percent change | Baseline to Week 4 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Placebo Controlled Period | A TEAE is an adverse event with a start date on or after the date of the first dose of IP and no later than 28 days after the last dose of IP for participants who discontinued early. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a 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 pre existing condition) should be considered an AE. A serious AE is any which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event. | Safety population includes all participants who received at least one dose of IP. | Posted | Number | participants | Baseline to Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With TEAEs During the Apremilast Exposure Period | A TEAE is an adverse event with a start date on or after the date of the first dose of investigational product (IP) and no later than 28 days after the last dose of IP. An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a 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 pre existing condition) should be considered an AE. A serious AE is any which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect; constitutes an important medical event. | Safety population includes all participants who received at least one dose of IP. These were Apremilast participants as treated. | Posted | Number | participants | Baseline to Week 24; median duration of apremilast 30 mg was 23.3 weeks and 22.4 weeks for apremilast 40 mg |
|
Adverse Events are reported for the 12-week placebo-controlled phase and up to 24 weeks for all participants who received apremilast at any time during the study. All TEAEs were recorded by the investigator from the time the participant received the first dose of study drug to no later than 28 days after the last dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (Weeks 0-12) | Participants initially randomized to identically matching PBO tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12) | 0 | 64 | 14 | 64 | ||
| EG001 | Apremilast 30 mg (Weeks 0-12) | Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase. | 1 | 58 | 22 | 58 | ||
| EG002 | Apremilast 40 mg (Weeks 0-12) | Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase. | 2 | 63 | 30 | 63 | ||
| EG003 | Apremilast 30 mg (Apremilast Exposure Period) 0-24 | Participants who received 30 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 12 up until Week 24. | 2 | 82 | 30 | 82 | ||
| EG004 | Apremilast 40 mg (Apremilast Exposure Period) 0-24 | Participants who received 40 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 12 up until Week 24. | 3 | 86 | 45 | 86 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Squamous Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Glomerulonephritis | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
Results from a center cannot be submitted for publication before results of multicenter study are published unless it is > 12 months since study completion. Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to 90 days. Investigator must delete confidential information before submission or defer publication to permit patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne McClain, Senior Manager, Clinical Trial Disclosure | CelgeneCorp | 1-888-260-1599 | amcclain@celgene.com |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C505730 | apremilast |
Not provided
Not provided
Not provided
| Lack of Efficacy |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Other-Unspecified |
|
| Male |
|
| ANCOVA |
| 0.0347 |
Based on an analysis of covariance model with the percentage change from Baseline as the response variable and the treatment group and Baseline EASI score stratification (≤ 20, > 20) as factors. |
| LS Mean Difference |
| -20.60 |
| 2-Sided |
| 95 |
| -39.70 |
| -1.50 |
| Superiority or Other (legacy) |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
| OG002 |
| Apremilast 40 mg |
Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase. |
|
|
|
| OG002 | Apremilast 40 mg | Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase. |
|
|
| OG001 | Apremilast 40 mg | Participants initially randomized to 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase and continued receiving 40 mg apremilast tablets twice daily (BID) up to Week 24 in the active treatment phase, and for participants who were initially randomized to placebo and at week 12 subsequently randomized to 40 mg apremilast tablets twice daily in the active treatment phase. |
|
|