Back to resultsStudy to Evaluate the Efficacy, Safety and Pharmacokinetics of ASB17061 Capsules in Adult Subjects With Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
5 mg ASB17061
Placebo
10 mg ASB17061
20 mg ASB17061
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic Dermatitis, eczema
Eligibility Criteria
Inclusion Criteria:
- Adult subjects ages 18 to 65 years
- A diagnosis of atopic dermatitis (AD)
- An Investigator's Global Assessment (IGA) score of 2 or higher and AD affecting at least 5% of total Body Surface Area (BSA)
- Other than active AD, in good health with no medical condition that may jeopardize the safety of the subject or impact the validity of the study results
- Subjects must be practicing acceptable birth control methods
Exclusion Criteria:
- Taking systemic immunosuppressive therapy within 3 months prior to screening or systemic (cortico) steroid therapy within 4 weeks prior to screening
- Use of phototherapy or tanning beds within 6 weeks of screening
- Presence of a clinically significant disorder involving gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition, which will jeopardize the safety of the subject or impact the validity of the study results
- Female subjects who are pregnant or breastfeeding
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Low dose ASB17061
Middle dose ASB17061
High dose ASB17061
Placebo
Arm Description
Oral administration of low dose ASB17061 taken once daily for 28 consecutive days.
Oral administration of middle dose ASB17061 taken once daily for 28 consecutive days.
Oral administration of high dose ASB17061 taken once daily for 28 consecutive days.
Oral administration of placebo taken once daily for 28 consecutive days.
Outcomes
Primary Outcome Measures
Number of Investigator's Global Assessment (IGA) Responders at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis
Participants with an IGA score of 0 or 1 were considered IGA responders. The investigator provided an overall assessment of disease severity using the IGA, which consists of a 6-point scale from a minimum of 0 and a maximum of 6. Higher scores indicate a worse outcome and lower scores indicate a better outcome. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease).
Number of Investigator's Global Assessment (IGA) Responders By Subgroup at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis
Participants with an IGA score of 0 or 1 were considered IGA responders. The investigator provided an overall assessment of disease severity using the IGA which consists of a 6-point scale from the minimum of 0 to a maximum of 6. Higher scores indicate increasing severity.. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease) and an overall assessment of the disease severity of the entire body using the Eczema Area and Severity Index (EASI). A composite index, the EASI has a minimum score of 0 (clear) and a maximum score of 72 (very severe); A value less than 15 indicates less severe, and 15 or greater indicates more severe. Lichenification was evaluated on a scale of 0 (none) as the minimum to 3 (severe) as the maximum, and the score of each body region was summed (0 to 12). A percent body surface area (BSA) involved less than 15 is less severe and 15 or greater more severe.
Secondary Outcome Measures
Mean Change From Baseline in Eczema Area and Severity Index Score (EASI) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29
The investigator provided an overall assessment of the disease severity of the entire body using the EASI. A composite index, the EASI has a minimum score of 0 (clear) and a maximum score of 72 (very severe); with a negative value indicating decreasing severity of eczema compared to baseline and a decreasing change in the EASI score. A negative value is an indication of a decrease in individual scores.
Mean Change From Baseline in The Percentage of Body Surface Area (BSA) Involved Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29
Participants' body surface area affected by atopic dermatitis was assessed for the change in percentage after treatment. A negative value indicates a decrease in the percent of body surface area (BSA) involved. A negative value is an indication of a decrease in individual scores.
Mean Change From Baseline in Pruritus Score Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29
Participants assessed the overall intensity of pruritus using a 4-point scale with 0 as the minimum and 3 as the maximum. (0 = absent; 1 = mild; 2 = moderate; and 3 = severe) A negative value indicates a decreasing change in the pruritus score. A negative value is an indication of a decrease in individual scores.
Mean Change From Baseline in Insomnia Score Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29
Participants assessed the extent of their insomnia using an 11-point scale ranging from the minimum, 0 (no insomnia) to the maximum, 10 (severe insomnia). A negative value indicates a decreasing change in the insomnia score. A negative value is an indication of a decrease in individual scores.
Plasma Concentrations of ASB17061 and ASB17584 Over Time Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis
Minimum Observed Plasma Concentration (Cmin) of ASB17061 and ASB17584 Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis
The minimum observed plasma drug concentration (Cmin) of ASB17061 and ASB17584 in the 4-week Treatment Period were estimated from the actual dosing records.
Maximum Observed Plasma Concentration (Cmax) of ASB17061 and ASB17584 Following Treatment With ASB17061 Capsules in Adult Subjects With Atopic Dermatitis
Pharmacokinetic (PK) metrics of ASB17061 and ASB17584 maximum observed plasma drug concentration (Cmax) in the 4-week Treatment Period were estimated from the individual PK parameters and the actual dosing records.
Average Plasma Concentration (Cavg) of ASB17061 and ASB17584 Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis
The average plasma drug concentration (Cmin) of ASB17061 and ASB17584 in the 4-week Treatment Period were estimated from the actual dosing records.
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
Full Information
NCT ID
NCT01756898
First Posted
November 9, 2012
Last Updated
January 29, 2021
Sponsor
Daiichi Sankyo, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01756898
Brief Title
Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ASB17061 Capsules in Adult Subjects With Atopic Dermatitis
Official Title
A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ASB17061 Capsules in Adult Subjects With Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 28, 2012 (Actual)
Primary Completion Date
January 14, 2014 (Actual)
Study Completion Date
January 14, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research study is to gather scientific information about the effectiveness of the study drug, ASB17061 capsules, when compared to placebo in adult subjects with atopic dermatitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic Dermatitis, eczema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
370 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low dose ASB17061
Arm Type
Experimental
Arm Description
Oral administration of low dose ASB17061 taken once daily for 28 consecutive days.
Arm Title
Middle dose ASB17061
Arm Type
Experimental
Arm Description
Oral administration of middle dose ASB17061 taken once daily for 28 consecutive days.
Arm Title
High dose ASB17061
Arm Type
Experimental
Arm Description
Oral administration of high dose ASB17061 taken once daily for 28 consecutive days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral administration of placebo taken once daily for 28 consecutive days.
Intervention Type
Drug
Intervention Name(s)
5 mg ASB17061
Intervention Description
Oral administration of 5 mg ASB17061 taken once daily for 28 consecutive days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral administration of placebo taken once daily for 28 consecutive days.
Intervention Type
Drug
Intervention Name(s)
10 mg ASB17061
Intervention Description
Oral administration of 10 mg ASB17061 taken once daily for 28 consecutive days.
Intervention Type
Drug
Intervention Name(s)
20 mg ASB17061
Intervention Description
Oral administration of 20 mg ASB17061 taken once daily for 28 consecutive days.
Primary Outcome Measure Information:
Title
Number of Investigator's Global Assessment (IGA) Responders at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis
Description
Participants with an IGA score of 0 or 1 were considered IGA responders. The investigator provided an overall assessment of disease severity using the IGA, which consists of a 6-point scale from a minimum of 0 and a maximum of 6. Higher scores indicate a worse outcome and lower scores indicate a better outcome. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease).
Time Frame
Baseline up to 29 days after initial dose.
Title
Number of Investigator's Global Assessment (IGA) Responders By Subgroup at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis
Description
Participants with an IGA score of 0 or 1 were considered IGA responders. The investigator provided an overall assessment of disease severity using the IGA which consists of a 6-point scale from the minimum of 0 to a maximum of 6. Higher scores indicate increasing severity.. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease) and an overall assessment of the disease severity of the entire body using the Eczema Area and Severity Index (EASI). A composite index, the EASI has a minimum score of 0 (clear) and a maximum score of 72 (very severe); A value less than 15 indicates less severe, and 15 or greater indicates more severe. Lichenification was evaluated on a scale of 0 (none) as the minimum to 3 (severe) as the maximum, and the score of each body region was summed (0 to 12). A percent body surface area (BSA) involved less than 15 is less severe and 15 or greater more severe.
Time Frame
Baseline up to 29 days after initial dose.
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Eczema Area and Severity Index Score (EASI) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29
Description
The investigator provided an overall assessment of the disease severity of the entire body using the EASI. A composite index, the EASI has a minimum score of 0 (clear) and a maximum score of 72 (very severe); with a negative value indicating decreasing severity of eczema compared to baseline and a decreasing change in the EASI score. A negative value is an indication of a decrease in individual scores.
Time Frame
Baseline up to 29 days after initial dose.
Title
Mean Change From Baseline in The Percentage of Body Surface Area (BSA) Involved Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29
Description
Participants' body surface area affected by atopic dermatitis was assessed for the change in percentage after treatment. A negative value indicates a decrease in the percent of body surface area (BSA) involved. A negative value is an indication of a decrease in individual scores.
Time Frame
Baseline up to 29 days after initial dose.
Title
Mean Change From Baseline in Pruritus Score Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29
Description
Participants assessed the overall intensity of pruritus using a 4-point scale with 0 as the minimum and 3 as the maximum. (0 = absent; 1 = mild; 2 = moderate; and 3 = severe) A negative value indicates a decreasing change in the pruritus score. A negative value is an indication of a decrease in individual scores.
Time Frame
Baseline up to 29 days after initial dose.
Title
Mean Change From Baseline in Insomnia Score Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29
Description
Participants assessed the extent of their insomnia using an 11-point scale ranging from the minimum, 0 (no insomnia) to the maximum, 10 (severe insomnia). A negative value indicates a decreasing change in the insomnia score. A negative value is an indication of a decrease in individual scores.
Time Frame
Baseline up to 29 days after initial dose.
Title
Plasma Concentrations of ASB17061 and ASB17584 Over Time Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis
Time Frame
Baseline (Day 1 Predose) up to Day 8, Day 15, and Day 22 at 0 to 2.5 hours, 2.5 to 5 hours, 5 to 10 hours, up to Day 29 at 24-32 hours postdose.
Title
Minimum Observed Plasma Concentration (Cmin) of ASB17061 and ASB17584 Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis
Description
The minimum observed plasma drug concentration (Cmin) of ASB17061 and ASB17584 in the 4-week Treatment Period were estimated from the actual dosing records.
Time Frame
Baseline (Day 1 Predose) up to Day 8, Day 15, and Day 22 at 0 to 2.5 hours, 2.5 to 5 hours, 5 to 10 hours, up to Day 29 at 24-32 hours postdose.
Title
Maximum Observed Plasma Concentration (Cmax) of ASB17061 and ASB17584 Following Treatment With ASB17061 Capsules in Adult Subjects With Atopic Dermatitis
Description
Pharmacokinetic (PK) metrics of ASB17061 and ASB17584 maximum observed plasma drug concentration (Cmax) in the 4-week Treatment Period were estimated from the individual PK parameters and the actual dosing records.
Time Frame
Baseline (Day 1 Predose) up to Day 8, Day 15, and Day 22 at 0 to 2.5 hours, 2.5 to 5 hours, 5 to 10 hours, up to Day 29 at 24-32 hours postdose.
Title
Average Plasma Concentration (Cavg) of ASB17061 and ASB17584 Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis
Description
The average plasma drug concentration (Cmin) of ASB17061 and ASB17584 in the 4-week Treatment Period were estimated from the actual dosing records.
Time Frame
Baseline up to Predose, up to 0 to 2.5 hours, up to 2.5 to 5 hours, up to 5 to 10 hours, up to Day 29 (24-32 hours).
Title
Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis
Description
A treatment-emergent adverse event (TEAE) was defined as an AE that emerges during treatment, having been absent at pre-treatment; or reemerges during treatment, having been present at baseline but stopped prior to treatment; or worsens in severity during treatment after initiating the study drug.
Time Frame
Baseline up to Day 57 follow-up visit post dose.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult subjects ages 18 to 65 years
A diagnosis of atopic dermatitis (AD)
An Investigator's Global Assessment (IGA) score of 2 or higher and AD affecting at least 5% of total Body Surface Area (BSA)
Other than active AD, in good health with no medical condition that may jeopardize the safety of the subject or impact the validity of the study results
Subjects must be practicing acceptable birth control methods
Exclusion Criteria:
Taking systemic immunosuppressive therapy within 3 months prior to screening or systemic (cortico) steroid therapy within 4 weeks prior to screening
Use of phototherapy or tanning beds within 6 weeks of screening
Presence of a clinically significant disorder involving gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition, which will jeopardize the safety of the subject or impact the validity of the study results
Female subjects who are pregnant or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92122
Country
United States
City
Temecula
State/Province
California
ZIP/Postal Code
92592
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
City
Saint Augustine
State/Province
Florida
ZIP/Postal Code
32086
Country
United States
City
South Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
City
Crowley
State/Province
Louisiana
ZIP/Postal Code
70526
Country
United States
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
City
Fort Gratiot
State/Province
Michigan
ZIP/Postal Code
48059
Country
United States
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
City
Verona
State/Province
New Jersey
ZIP/Postal Code
07044
Country
United States
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
City
Henrico
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204-4880
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD Sharing Time Frame
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD Sharing Access Criteria
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
IPD Sharing URL
https://vivli.org/ourmember/daiichi-sankyo/
Learn more about this trial
Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ASB17061 Capsules in Adult Subjects With Atopic Dermatitis
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