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This is a randomized double-blind/placebo study evaluate the efficacy of ASN002 in subjects with moderate to severe atopic dermatitis (AD).
This is a placebo controlled study where subjects with moderate to severe atopic dermatitis will be randomized (1:1:1:1) to receive ASN002 at 40 mg, 60 mg, or 80 mg, or placebo once daily for 12 weeks. Eligible subjects will get the opportunity to enroll in the 24 month open-label extension study (OLE). There will be a 4-week follow up period for subjects not participating in the OLE study. This study will also characterize the pharmacokinetics and pharmacodynamics of ASN002 through blood sampling and three or four biopsies from subjects who consent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASN002 40 mg | Experimental | 40 mg ASN002 |
|
| ASN002 60 mg | Experimental | 60 mg ASN002 |
|
| ASN002 80 mg | Experimental | 80 mg ASN002 |
|
| Placebo Oral Tablet | Experimental | Matching placebo for ASN002 doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASN002 | Drug | Daily dose of ASN002 for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Eczema Area and Severity Index (EASI) at Week 12 | The Eczema Area and Severity Index (EASI) is a composite score ranging from 0 to 72, the higher the value the worse the disease, that takes into account the degree of erythema, induration/infiltration (papules), excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the percentage of BSA involved for each body region and for the proportion of the body region to the whole body. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participant With at Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI75) | Percent of participants with at least a 75% reduction from baseline in EASI (EASI75) at Week 12 | Week 12 |
| Change From Baseline in 5-D Pruritus (Itching) Scale |
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Inclusion Criteria:
Written informed consent obtained prior to any study-related procedure being performed;
Exclusion Criteria:
Clinically infected atopic dermatitis.
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| Name | Affiliation | Role |
|---|---|---|
| David Zammit, Ph.D. | Asana BioSciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group, LLC | Anniston | Alabama | 36207 | United States | ||
| Total Skin and Dermatology Center, PC. |
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First Patient Enrolled July 5, 2018 Last Patient Out August 14, 2019
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| ID | Title | Description |
|---|---|---|
| FG000 | ASN002 40 mg | 40 mg ASN002 ASN002: Daily dose of ASN002 for 12 weeks |
| FG001 | ASN002 60 mg | 60 mg ASN002 ASN002: Daily dose of ASN002 for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 7, 2019 | Apr 13, 2023 |
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| Placebo Oral Tablet | Drug | Placebo of ASN002 for 12 weeks |
|
The 5-D Pruritus Scale is a 1-page, 5-question, validated questionnaire used in clinical trials to assess 5 dimensions of background itch: degree, duration, direction, disability, and distribution. Each question corresponds to 1 of the 5 dimensions of itch; subjects rated their symptoms over the preceding 2-week period as "present" or on a 1 to 5 scale, with 5 being the most affected. The total score of 5-D pruritus is a sum of the 5 scores to provide a total score range from 5 (best) to 25 (worst). |
| Week 12 |
| Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) | In the SCORAD grading system, six items (erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness) evaluate the Atopic Dermatitis severity. The overall body surface area affected by atopic dermatitis was evaluated (from 0% to 100%) and included in the SCORAD scores. Loss of sleep and pruritus were evaluated by subjects on a visual analog scale (0-10) and were based on the average of the last three days/nights. The sum of these measures represented the SCORAD, which could range from 0 to 103. The higher the score the more severe the disease. | Week 12 |
| Percentage of Participants With a Response of Investigator's Global Assessment (IGA) 0 or 1 | The IGA is a global assessment of the current state of the disease. It is a 5-point (0-4) morphological assessment of overall disease severity. The 0 is the least severe and 4 is the most severe. | Week 12 |
| Change From Baseline in Patient-Oriented Eczema Measure (POEM) | The Patient-Oriented Eczema Measure (POEM) is a self-assessment of disease severity by the subject. The POEM has a maximum value of 28 based on the subject's response to seven questions scored from 0 to 4. The higher the value the more severe the disease is. | Week 12 |
| Change From Baseline in Dermatology Life Quality Index (DLQI) | Dermatology Life Quality Index Questionnaire (DLQI) is a simple 10-question validated questionnaire that has been used in more than 40 different skin conditions. The DLQI total score is defined as the sum of the 10 item scales, ranging from 0 to 30. The higher the value, the more severe the disease is. | Week 12 |
| Change From Baseline in Body Surface Area (BSA) | The overall body surface area (BSA) affected by atopic dermatitis is evaluated (from 0% to 100%). | Week 12 |
| Birmingham |
| Alabama |
| 35205 |
| United States |
| Center for Dermatology Clinical Research, Inc. | Fremont | California | 94538 | United States |
| L.A. Universal Research Center, Inc. | Los Angeles | California | 89148 | United States |
| Dermatology Research Associates | Los Angeles | California | 90045 | United States |
| Revival Research | Doral | Florida | 33122 | United States |
| Clinical Physiology Associates | Fort Myers | Florida | 33912 | United States |
| Leavitt Medical Associates of Florida | Ormond Beach | Florida | 32174 | United States |
| Dermatology Consulting Services | Tampa | Florida | 33625 | United States |
| Forward Clinical Trials | Tampa | Florida | 33625 | United States |
| Dawes Fretzin Clinical Research Group | Indianapolis | Indiana | 46256 | United States |
| Dermatology Center of Indiana, PC | Plainfield | Indiana | 46168 | United States |
| The Indiana Clinical Trials Center | Plainfield | Indiana | 46168 | United States |
| Central Kentucky Research Associates, LLC | Lexington | Kentucky | 40509 | United States |
| Dermatology Specialists Research | Louisville | Kentucky | 40241 | United States |
| ActivMed Practices and Research, Inc. | Portsmouth | New Hampshire | 03801 | United States |
| Corning Center for Clinical Research | Corning | New York | 14830 | United States |
| Mt. Sinai Hospital | New York | New York | 10029 | United States |
| Wake Research Associates, LLC | Raleigh | North Carolina | 27612 | United States |
| Dermatologists of Greater Colombus | Bexley | Ohio | 43209 | United States |
| Wright State Physicians | Fairborn | Ohio | 45324 | United States |
| Unity Clinical Research | Oklahoma City | Oklahoma | 73118 | United States |
| Vital Prospects Clinical Research Institute | Tulsa | Oklahoma | 74136 | United States |
| DermDox Centers for Dermatology | Hazleton | Pennsylvania | 18201 | United States |
| Synexus | Greer | South Carolina | 29651 | United States |
| Dermatology Treatment and Research Center | Dallas | Texas | 75320 | United States |
| Innovate Research, LLC | Fort Worth | Texas | 76244 | United States |
| The Center for Skin Research | Houston | Texas | 77056 | United States |
| Progressive Clinical Research | San Antonio | Texas | 78213 | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23502 | United States |
| Institute of Skin Advancement Medical, Surgical, Costmetic & Laser Dermatology | Calgary | T3A2N1 | Canada |
| Innovaderm Research, Inc. | Montreal | H2K4L5 | Canada |
| Ontario Inc. | Ottawa | K2C3N2 | Canada |
| York Regional Dermatology | Richmond Hill | L4C9M7 | Canada |
| NewLab Clinical Research, Inc. | St. John's | A1C2H5 | Canada |
| AvantDerm | Toronto | M5A3R6 | Canada |
| SkinWISE Dermatology | Winnipeg | ABR3M3Z4 | Canada |
| Fachklinik Bad Bentheim | Bad Bentheim | Germany |
| Charité - Universitätsmedizin Berlin | Berlin | Germany |
| Universitätsklinikum Bonn AöR | Bonn | Germany |
| Universitätsklinikum Dresden | Dresden | Germany |
| Universitätsklinikum Frankfurt | Frankfurt | Germany |
| SRH Wald-Klinikum Gera GmbH | Gera | Germany |
| MENSINGDERMA research GmbH | Hamburg | Germany |
| Medizinische Hochschule Hannover | Hanover | Germany |
| Universitätsklinikum Schleswig-Holstein | Lübeck | Germany |
| Universitätshautklinik Münster | Münster | Germany |
| FG002 | ASN002 80 mg | 80 mg ASN002 ASN002: Daily dose of ASN002 for 12 weeks |
| FG003 | Placebo Oral Tablet | Matching placebo for ASN002 doses Placebo Oral Tablet: Placebo of ASN002 for 12 weeks |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ASN002 40 mg | 40 mg ASN002 ASN002: Daily dose of ASN002 for 12 weeks |
| BG001 | ASN002 60 mg | 60 mg ASN002 ASN002: Daily dose of ASN002 for 12 weeks |
| BG002 | ASN002 80 mg | 80 mg ASN002 ASN002: Daily dose of ASN002 for 12 weeks |
| BG003 | Placebo Oral Tablet | Matching placebo for ASN002 doses Placebo Oral Tablet: Placebo of ASN002 for 12 weeks |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (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 | Change From Baseline in Eczema Area and Severity Index (EASI) at Week 12 | The Eczema Area and Severity Index (EASI) is a composite score ranging from 0 to 72, the higher the value the worse the disease, that takes into account the degree of erythema, induration/infiltration (papules), excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the percentage of BSA involved for each body region and for the proportion of the body region to the whole body. | mITT | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percent of Participant With at Least a 75% Reduction From Baseline in Eczema Area and Severity Index (EASI75) | Percent of participants with at least a 75% reduction from baseline in EASI (EASI75) at Week 12 | mITT (compared to PP all participants qualified for mITT were included but missing data were not imputed and not included in the percentages calculations) | Posted | Number | percentage of patients | Week 12 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in 5-D Pruritus (Itching) Scale | The 5-D Pruritus Scale is a 1-page, 5-question, validated questionnaire used in clinical trials to assess 5 dimensions of background itch: degree, duration, direction, disability, and distribution. Each question corresponds to 1 of the 5 dimensions of itch; subjects rated their symptoms over the preceding 2-week period as "present" or on a 1 to 5 scale, with 5 being the most affected. The total score of 5-D pruritus is a sum of the 5 scores to provide a total score range from 5 (best) to 25 (worst). | mITT (MMRM model was used) | Posted | Mean | Standard Deviation | change in score on a scale | Week 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) | In the SCORAD grading system, six items (erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness) evaluate the Atopic Dermatitis severity. The overall body surface area affected by atopic dermatitis was evaluated (from 0% to 100%) and included in the SCORAD scores. Loss of sleep and pruritus were evaluated by subjects on a visual analog scale (0-10) and were based on the average of the last three days/nights. The sum of these measures represented the SCORAD, which could range from 0 to 103. The higher the score the more severe the disease. | mITT (MMRM model was used to analyze the data) | Posted | Mean | Standard Deviation | percentage change from baseline | Week 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Response of Investigator's Global Assessment (IGA) 0 or 1 | The IGA is a global assessment of the current state of the disease. It is a 5-point (0-4) morphological assessment of overall disease severity. The 0 is the least severe and 4 is the most severe. | All patients with evaluable data at Week 12. | Posted | Number | percentage of patients | Week 12 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Patient-Oriented Eczema Measure (POEM) | The Patient-Oriented Eczema Measure (POEM) is a self-assessment of disease severity by the subject. The POEM has a maximum value of 28 based on the subject's response to seven questions scored from 0 to 4. The higher the value the more severe the disease is. | Change from baseline at Week 12 | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) | Dermatology Life Quality Index Questionnaire (DLQI) is a simple 10-question validated questionnaire that has been used in more than 40 different skin conditions. The DLQI total score is defined as the sum of the 10 item scales, ranging from 0 to 30. The higher the value, the more severe the disease is. | All patients with available data at Week 12 | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Body Surface Area (BSA) | The overall body surface area (BSA) affected by atopic dermatitis is evaluated (from 0% to 100%). | All patients with available data at Week 12 | Posted | Mean | Standard Deviation | percentage change from baseline | Week 12 |
|
|
1 year, 1 month
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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 | ASN002 40 mg | 40 mg ASN002 ASN002: Daily dose of ASN002 for 12 weeks | 0 | 61 | 4 | 61 | 20 | 61 |
| EG001 | ASN002 60 mg | 60 mg ASN002 ASN002: Daily dose of ASN002 for 12 weeks | 0 | 59 | 0 | 59 | 19 | 59 |
| EG002 | ASN002 80 mg | 80 mg ASN002 ASN002: Daily dose of ASN002 for 12 weeks | 0 | 63 | 2 | 63 | 24 | 63 |
| EG003 | Placebo Oral Tablet | Matching placebo for ASN002 doses Placebo Oral Tablet: Placebo of ASN002 for 12 weeks | 0 | 60 | 0 | 60 | 9 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| pyrexia | General disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| dysarthria | Nervous system disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| seizure | Nervous system disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| staphylococcal bacteremia | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Renal and urinary disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pablo Jimenez | Asana BioSciencxes, LLC | 9086980782 | pablo.jimenez@asanabio.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 12, 2019 | Apr 13, 2023 | SAP_003.pdf |
Not provided
| 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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| ID | Term |
|---|---|
| C000707471 | gusacitinib |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| United States |
|
| Germany |
|
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Matching placebo for ASN002 doses Placebo Oral Tablet: Placebo of ASN002 for 12 weeks |
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