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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose ASB17061 | Experimental | Oral administration of low dose ASB17061 taken once daily for 28 consecutive days. |
|
| Middle dose ASB17061 | Experimental | Oral administration of middle dose ASB17061 taken once daily for 28 consecutive days. |
|
| High dose ASB17061 | Experimental | Oral administration of high dose ASB17061 taken once daily for 28 consecutive days. |
|
| Placebo | Placebo Comparator | Oral administration of placebo taken once daily for 28 consecutive days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5 mg ASB17061 | Drug | Oral administration of 5 mg ASB17061 taken once daily for 28 consecutive days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline up to 29 days after initial dose. |
| 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. | Baseline up to 29 days after initial dose. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35233 | United States | |||
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/
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.
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.
Adult male and female subjects with active atopic dermatitis (AD) were enrolled in this study.
A total of 370 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study at 42 clinic sites in the United States of America.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants with atopic dermatitis were randomized to receive a placebo. |
| FG001 | ASB17061 5 mg Low Dose | Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Oral administration of placebo taken once daily for 28 consecutive days. |
|
| 10 mg ASB17061 | Drug | Oral administration of 10 mg ASB17061 taken once daily for 28 consecutive days. |
|
| 20 mg ASB17061 | Drug | Oral administration of 20 mg ASB17061 taken once daily for 28 consecutive days. |
|
| Baseline up to 29 days after initial dose. |
| 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. | Baseline up to 29 days after initial dose. |
| 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. | Baseline up to 29 days after initial dose. |
| 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. | Baseline up to 29 days after initial dose. |
| Plasma Concentrations of ASB17061 and ASB17584 Over Time Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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). |
| 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. | Baseline up to Day 57 follow-up visit post dose. |
| Phoenix |
| Arizona |
| 85018 |
| United States |
| Rogers | Arkansas | 72758 | United States |
| Encino | California | 91436 | United States |
| Fremont | California | 94538 | United States |
| San Diego | California | 92122 | United States |
| Temecula | California | 92592 | United States |
| Denver | Colorado | 80220 | United States |
| Miami | Florida | 33144 | United States |
| Miami | Florida | 33175 | United States |
| Miramar | Florida | 33027 | United States |
| Saint Augustine | Florida | 32086 | United States |
| South Tampa | Florida | 33609 | United States |
| Tampa | Florida | 33609 | United States |
| Tampa | Florida | 33613 | United States |
| Savannah | Georgia | 31405 | United States |
| Boise | Idaho | 83704 | United States |
| Overland Park | Kansas | 66215 | United States |
| Crowley | Louisiana | 70526 | United States |
| Bay City | Michigan | 48706 | United States |
| Clinton Township | Michigan | 48038 | United States |
| Fort Gratiot | Michigan | 48059 | United States |
| Berlin | New Jersey | 08009 | United States |
| Verona | New Jersey | 07044 | United States |
| Stony Brook | New York | 11790 | United States |
| Raleigh | North Carolina | 27612 | United States |
| Sylvania | Ohio | 43560 | United States |
| Lake Oswego | Oregon | 97035 | United States |
| Portland | Oregon | 97239 | United States |
| Johnston | Rhode Island | 02919 | United States |
| Arlington | Texas | 76011 | United States |
| College Station | Texas | 77845 | United States |
| Pflugerville | Texas | 78660 | United States |
| San Antonio | Texas | 78229 | United States |
| Webster | Texas | 77598 | United States |
| Draper | Utah | 84020 | United States |
| West Jordan | Utah | 84088 | United States |
| Henrico | Virginia | 23233 | United States |
| Norfolk | Virginia | 23507 | United States |
| Spokane | Washington | 99204-4880 | United States |
| FG002 | ASB17061 10 mg Middle Dose | Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg). |
| FG003 | ASB17061 20 mg High Dose | Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg). |
| COMPLETED |
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| NOT COMPLETED |
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Baseline characteristics were assessed in the Intent-to-Treat (ITT) population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants with atopic dermatitis were randomized to receive a placebo. |
| BG001 | ASB17061 5 mg Low Dose | Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg). |
| BG002 | ASB17061 10 mg Middle Dose | Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg). |
| BG003 | ASB17061 20 mg High Dose | Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg). |
| BG004 | 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | 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). | The Intent-to-Treat population, last observation carried forward (LOCF) was used to assess IGA. | Posted | Count of Participants | Participants | Baseline up to 29 days after initial dose. |
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| |||||||||||||||||||||||||||||||||||
| Primary | 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. | The Intent-to-Treat population, last observation carried forward (LOCF) was used to assess IGA by subgroup. | Posted | Number | participants | Baseline up to 29 days after initial dose. |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The Intent-to-Treat population, last observation carried forward (LOCF) was used to assess EASI. | Posted | Mean | Standard Deviation | Units on a scale | Baseline up to 29 days after initial dose. |
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| Secondary | 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. | The Intent-to-Treat population, last observation carried forward (LOCF) was used to assess the percent Body Surface Area. | Posted | Mean | Standard Deviation | Percentage of BSA | Baseline up to 29 days after initial dose. |
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| Secondary | 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. | The Intent-to-Treat population, last observation carried forward (LOCF) was used to assess pruritus score. | Posted | Mean | Standard Deviation | Units on a scale | Baseline up to 29 days after initial dose. |
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| Secondary | 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. | The Intent-to-Treat population, last observation carried forward (LOCF) was used to assess the insomnia score. | Posted | Mean | Standard Deviation | Units on a scale | Baseline up to 29 days after initial dose. |
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| Secondary | Plasma Concentrations of ASB17061 and ASB17584 Over Time Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis | The Pharmacokinetic (PK) sample analyses were performed on the PK Population. Only plasma samples from active participants were analyzed for ASB17061 and ASB17584 concentrations. | Posted | Mean | Standard Deviation | ng/ML | 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. |
|
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| Secondary | 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. | The Cmin was assessed in the Efficacy Evaluable (EE) Population. | Posted | Mean | Standard Deviation | ng/ML | 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. |
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| Secondary | 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. | The Cmax was assessed in the Efficacy Evaluable (EE)Population. | Posted | Mean | Standard Deviation | ng/ML | 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. |
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| Secondary | 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. | The Cavg was analyzed in the Efficacy Evaluable Population. | Posted | Mean | Standard Deviation | ng/ML | 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). |
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| Secondary | 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. | Treatment-emergent adverse events (TEAEs) were assessed in the Safety Population. | Posted | Count of Participants | Participants | Baseline up to Day 57 follow-up visit post dose. |
|
Baseline up to 12 weeks after the initial dose.
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.
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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 | Participants with atopic dermatitis were randomized to receive a placebo. | 0 | 92 | 0 | 92 | 44 | 92 |
| EG001 | ASB17061 5 mg Low Dose | Participants with atopic dermatitis were randomized to receive ASB17061 low dose (5 mg). | 0 | 92 | 1 | 92 | 51 | 92 |
| EG002 | ASB17061 10 mg Middle Dose | Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg). | 0 | 93 | 0 | 93 | 54 | 93 |
| EG003 | ASB17061 20 mg High Dose | Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg). | 0 | 93 | 0 | 93 | 45 | 93 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bilateral Clubfoot | Congenital, familial and genetic disorders | MedDRA (15.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| General disorders and administration site conditions | General disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Contact for Clinical Trial Information | Daiichi Sankyo | 908-992-6400 | CTRinfo@dsi.com |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| 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 |
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| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
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| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | ASB17061 10 mg Middle Dose | Participants with atopic dermatitis were randomized to receive ASB17061 medium dose (10 mg). |
| OG003 | ASB17061 20 mg High Dose | Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg). |
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| OG003 | ASB17061 20 mg High Dose | Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg). |
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| ASB17061 20 mg High Dose |
Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg). |
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Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg). |
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Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg). |
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Participants with atopic dermatitis were randomized to receive ASB17061 high dose (20 mg). |
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