Not provided
Not provided
Not provided
Not provided
Not provided
Phase 2 study results
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized open label study to evaluate the long term safety of ASN002 in subjects with moderate to severe atopic dermatitis (AD).
This is a randomized open label study where subjects with moderate to severe atopic dermatitis will roll over from the Phase 1 ASN002AD-101 (NCT03139981) and ASN002AD-201 (NCT03531957) Ph2b study and be randomized to receive ASN002 at 40mg, 60mg, or 80mg once daily for up to 24 months. This study will also characterize the pharmacokinetics of ASN002 through blood sampling from subjects who consent.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASN002 40 mg | Experimental | ASN002 40 mg |
|
| ASN002 60 mg | Experimental | ASN002 60 mg |
|
| ASN002 80 mg | Experimental | ASN002 80 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASN002 | Drug | Daily dose of ASN002 for up to 110 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Eczema Area Severity Index (EASI) Score | 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. Due to early termination of the study, all efficacy analyses were descriptive in nature | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Achieving an Investigator Global Assessment (IGA) Scale of Clear (0) or Almost Clear (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 IGA is selected using descriptors that best describe the overall appearance of the lesions at any given point. Signs like inflammation, redness, oozing, and crusting are evaluated. The 0 is the least severe and 4 is the most severe. Due to early termination of the study, all efficacy analyses were descriptive in nature. |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
Those participants that received placebo in ASN002AD-201 or were enrolled in ASN002-101 were allocated as starting treatment, and those that received ASN002 in ASN002AD-201 trial are allocated as continuing treatment.
Participants from ASN002AD-101 and ASN002AD-201 were eligible to enter the OLE study if they (1) had participated in ASN002AD-101 study OR (2) had participated in ASN002AD 201 study, had completed at least the first 4 weeks without the use of prohibited treatments for AD, and had completed the study visits up to Week 12. Participants who had received the placebo in the other preceding studies were allowed to be enrolled in the OLE study except those who were responders at Week 12 based on EASI75
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ASN002 40 mg | ASN002 40 mg ASN002: Daily dose of ASN002 for up to 110 weeks |
| FG001 | ASN002 60 mg | ASN002 60 mg ASN002: Daily dose of ASN002 for up to 110 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| 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 12, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 3 months |
| Change From Baseline in 5-D Pruritus (Itch) Scale | The 5-D Pruritus Scale is a validated questionnaire used in clinical trials to assess the degree, duration, direction, disability, and distribution of the itch to rate the their symptoms over the preceding 2-week period. Each symptoms is scored on a scale of 1 to 5, 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). Due to early termination of the study, all efficacy analyses were descriptive in nature | 3 months |
| Change From Baseline in Pruritus (Itch) Numeric Rating Scale (NRS) | Intensity of itch will be measured using an NRS to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable" Due to early termination of the study, all efficacy analyses were descriptive in nature | 3 months |
| Change From Baseline in Patient-Oriented Eczema Measure (POEM) | POEM developed by Charman et al. is a self-assessment of disease severity by the participant. The POEM includes 7 questions to evaluate the number of days the signs and symptoms of eczema over the last week. The answer to each question is categorized by the frequency of the sign or symptom from no days to 7 days. Each question is scored from 0 to 4 and the sum of the questions if the POEM score. The score ranges from 0 to 28 with 0 being the least frequency and 28 showing that all the signs and symptoms occur every day. Therefore, the higher the score, the more severe the eczema. Due to early termination of the study, all efficacy analyses were descriptive in nature | 3 months |
| 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 |
| Tufts Medical Center | Boston | Massachusetts | 02111 | 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 |
| FG002 | ASN002 80 mg | ASN002 80 mg ASN002: Daily dose of ASN002 for up to 110 weeks |
| New Start of Treatment |
|
| Continued Treatment | Continued treatment from parent study |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ASN002 40 mg | ASN002 40 mg ASN002: Daily dose of ASN002 for up to 110 weeks |
| BG001 | ASN002 60 mg | ASN002 60 mg ASN002: Daily dose of ASN002 for up to 110 weeks |
| BG002 | ASN002 80 mg | ASN002 80 mg ASN002: Daily dose of ASN002 for up to 110 weeks |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | 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 | Change From Baseline in Eczema Area Severity Index (EASI) Score | 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. Due to early termination of the study, all efficacy analyses were descriptive in nature | The number of participants analyzed includes those that had a 3 months time point assessed before early termination of the study. Therefore, the numbers analyzed are not the same as those that started or completed the study. | Posted | Mean | Standard Deviation | Change in score on a scale | 3 Months |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants Achieving an Investigator Global Assessment (IGA) Scale of Clear (0) or Almost Clear (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 IGA is selected using descriptors that best describe the overall appearance of the lesions at any given point. Signs like inflammation, redness, oozing, and crusting are evaluated. The 0 is the least severe and 4 is the most severe. Due to early termination of the study, all efficacy analyses were descriptive in nature. | The number of participants analyzed includes those that had a 3 months time point assessed before early termination of the study. Therefore, the numbers analyzed are not the same as those that started or completed the study. | Posted | Count of Participants | Participants | 3 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in 5-D Pruritus (Itch) Scale | The 5-D Pruritus Scale is a validated questionnaire used in clinical trials to assess the degree, duration, direction, disability, and distribution of the itch to rate the their symptoms over the preceding 2-week period. Each symptoms is scored on a scale of 1 to 5, 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). Due to early termination of the study, all efficacy analyses were descriptive in nature | The number of participants analyzed includes those that had a 3 months time point assessed before early termination of the study. Therefore, the numbers analyzed are not the same as those that started or completed the study. | Posted | Mean | Standard Deviation | change in score on a scale | 3 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Pruritus (Itch) Numeric Rating Scale (NRS) | Intensity of itch will be measured using an NRS to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable" Due to early termination of the study, all efficacy analyses were descriptive in nature | The number of participants analyzed includes those that had a 3 months time point assessed before early termination of the study. Therefore, the numbers analyzed are not the same as those that started or completed the study. | Posted | Mean | Standard Deviation | change in score on a scale | 3 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Patient-Oriented Eczema Measure (POEM) | POEM developed by Charman et al. is a self-assessment of disease severity by the participant. The POEM includes 7 questions to evaluate the number of days the signs and symptoms of eczema over the last week. The answer to each question is categorized by the frequency of the sign or symptom from no days to 7 days. Each question is scored from 0 to 4 and the sum of the questions if the POEM score. The score ranges from 0 to 28 with 0 being the least frequency and 28 showing that all the signs and symptoms occur every day. Therefore, the higher the score, the more severe the eczema. Due to early termination of the study, all efficacy analyses were descriptive in nature | The number of participants analyzed includes those that had a 3 months time point assessed before early termination of the study. Therefore, the numbers analyzed are not the same as those that started or completed the study. | Posted | Mean | Standard Deviation | change in score on a scale | 3 months |
|
Participants were to receive ASN002 once daily for up to 24 months. However, the study was early terminated approximately 12 months after initiation. The mean study treatment exposure ranged between 111.5 and 145.7 days, and the median ranged between 87.5 and 116.0 days
Not provided
Not provided
| 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 | ASN002 40 mg Daily dose of ASN002 | 0 | 45 | 0 | 45 | 2 | 45 |
| EG001 | ASN002 60 mg | ASN002 60 mg Daily dose of ASN002 | 0 | 41 | 0 | 41 | 3 | 41 |
| EG002 | ASN002 80 mg | ASN002 80 mg Daily dose of ASN002 | 0 | 76 | 1 | 76 | 6 | 76 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Niranjan Rao | Libertas BioSciences | 908-872-1133 | niranjan@libertasbiosciences.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 25, 2020 | Apr 12, 2023 | SAP_001.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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000707471 | gusacitinib |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
ASN002 80 mg
ASN002: Daily dose of ASN002 for up to 110 weeks
|
|