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The goal of this clinical trial is to evaluate ASN008 in people with itch caused by eczema. The main questions it aims to answer are:
Researchers will compare 3 different doses of ASN008 and a matching vehicle group to see which group responds best.
All participants will sign an informed consent form and undergo screening (within 28 days prior to Day 1). During the screening period, all treatments for Atopic Dermatitis (AD) (also known as eczema) and/or itch will be stopped to allow for wash out, as applicable and according to eligibility requirements. Consistent daily or twice daily use of a non-prescription emollient is required at least 7 days prior to Day 1 and throughout the trial until the follow-up (Week 8). No other products, including, but not limited to, topical corticosteroids, calcineurin inhibitors, biologics, or Janus Kinase (JAK) inhibitors (topical or oral) may be used during the trial.
Eligible participants will be randomized in a 1:1:1:1 ratio to receive ASN008 gel 1.25 percent, ASN008 gel 2.5 percent, ASN008 gel 5.0 percent, or matching vehicle twice daily for 4 weeks (28 days), followed by a 4-week (28-day) follow-up period. The first dose of study treatment will be applied on Day 1 and the last dose will be applied on the morning of Day 28.
Participants will be required to participate in 8 scheduled visits: Screening; Randomization (remote visit); Day 1; Week 1 (Day 8); Week 2 (Day 15); Week 3 (Day 22); Week 4 (Day 28); and Week 8 (Day 56)/early termination (ET).
The trial duration per participant is up to 12 weeks (84 days): including up to 4 weeks (28 days) for the screening period, 4 weeks (28 days) for the treatment period, and up to 4 weeks (28 days) for the follow-up period.
A participant is considered to have reached the end of the trial when they have completed their Day 56 (Week 8) or ET visit. The trial will be considered complete when the last participant has completed their last trial visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASN008 1.25% | Experimental | ASN008 1.25% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days) |
|
| ASN008 2.5% | Experimental | ASN008 2.5% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days) |
|
| ASN008 5% | Experimental | ASN008 5% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days) |
|
| ASN008 Matching Vehicle | Placebo Comparator | ASN008 matching vehicle twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASN008 | Drug | ASN008 topical gel applied twice daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Daily Peak Pruritus Numerical Rating Scale (NRS) | Percent change of 7-day average daily peak pruritus NRS from Baseline to Week 4 | Baseline to Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Pruritus Response of ASN008 Topical Gel on Atopic Dermatitis (AD) Assessed by Daily Peak Pruritus NRS | Pruritus response defined as 7-day average of daily peak pruritus NRS reduction greater than or equal to 4 points from Baseline to Week 4 | Baseline to Week 4 |
| Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score |
| Measure | Description | Time Frame |
|---|---|---|
| Inter- and Intra-subject Variability of ASN008 Pharmacokinetics (PK) Characterized by Peak Plasma Concentration (Cmax) | ASN008 PK will be characterized using population-based methods to include Peak Plasma Concentration (Cmax). | Baseline and Week 4 |
| Inter- and Intra-subject Variability of ASN008 Pharmacokinetics Characterized by Area Under the Plasma Concentration Versus Time Curve (AUC) |
Inclusion Criteria:
Exclusion Criteria:
Any female who is breastfeeding, pregnant, or who is planning to become pregnant during the trial.
Active infection requiring treatment, including skin infections (including clinically infected AD).
History of skin disease or presence of a skin condition that, in the opinion of the Investigator, would interfere with trial assessments.
Any clinically significant medical or psychiatric condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the Investigator, put the participant at undue risk or interfere with interpretation of trial results.
Use of any of the following treatments within the indicated washout period before Day 1:
Known hypersensitivity to ASN008 or its excipients.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TrialSpark Investigative Site 0106 | Scottsdale | Arizona | 85255 | United States | ||
| TrialSpark Investigative Site 0118 |
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| ID | Title | Description |
|---|---|---|
| FG000 | ASN008 1.25% | ASN008 1.25% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days) ASN008: ASN008 topical gel applied twice daily. |
| FG001 | ASN008 2.5% |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Randomized |
|
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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 | Jul 5, 2023 | Sep 27, 2024 |
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Eligible participants will be randomized to 1 of 4 cohorts: ASN008 gel 1.25 percent, 2.5 percent, 5 percent, or matching vehicle.
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At all times, treatment and randomization information will be kept confidential and will not be released to the Sponsor's trial team until database lock is completed. Investigators, participants, and clinical staff will remain blinded throughout the trial.
| ASN008 Matching Vehicle | Other | The ASN008 matching vehicle formulation matches the formulation of each ASN008 topical gel dose, but contains no ASN008. |
|
This outcome measure evaluates the change and percent change in the Eczema Area and Severity Index (EASI) score from Baseline to Week 4. The EASI score measures the extent and severity of eczema across four body regions: head/neck, trunk, upper limbs, and lower limbs. Two components are assessed: severity of erythema, edema/papulation, excoriation, and lichenification (each scored 0 to 3, with 0 = none and 3 = severe) and the surface area affected (scored 0 to 6, with 0 = no involvement and 6 = 90%-100% involvement). Subscale scores are combined using weighted multipliers for each region (head/neck 0.1, upper limbs 0.2, trunk 0.3, lower limbs 0.4) to calculate the total score. The EASI is a composite score ranging from 0 (no eczema) to 72 (maximum severity and extent). Scores are summed to account for the severity of lesions and the percentage of body surface area (BSA) affected in each region. |
| Baseline to Week 4 |
| Mean Change From Baseline in Total Body Surface Area (BSA) | Change from Baseline in total BSA at week 4. | Baseline to Week 4 |
| Mean Change From Baseline in the Patient-Oriented Eczema Measure (POEM) | This outcome measure evaluates the change in the the Patient-Oriented Eczema Measure (POEM) score from Baseline to Week 4.The POEM is a self-assessment tool that evaluates eczema severity based on patient-reported symptoms over the previous week. It includes 7 questions addressing common symptoms: itch, sleep disturbance, bleeding, weeping, cracking, flaking, and dryness. Each question is scored on a scale from 0 to 4 based on frequency (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = every day). The scores are summed to generate a total score ranging from 0 to 28. Scores are interpreted as follows: 0-2 = clear or almost clear, 3-7 = mild eczema, 8-16 = moderate eczema, 17-24 = severe eczema, and 25-28 = very severe eczema. Higher scores indicate a greater symptom burden and worse disease severity. | Baseline to Week 4 |
ASN008 PK will be characterized using population-based methods to include area under the plasma concentration versus time curve (AUC) |
| Baseline and Week 4 |
| Number of Treatment Emergent Adverse Events (TEAEs) | Number of participants who experienced a TEAE. | Baseline to Day 56 |
| Number of Investigational Product (IP)-Related TEAEs | Number of participants who experienced an IP-related TEAE. | Baseline to Day 56 |
| Incidence of TEAEs Leading to Treatment Discontinuation | Incidence of TEAEs leading to treatment discontinuation from first dose through completion of follow-up period (up to a maximum of 56 days) | Baseline to Day 56 |
| Hot Springs |
| Arkansas |
| 71913 |
| United States |
| TrialSpark Investigative Site 0123 | Beverly Hills | California | 90212 | United States |
| TrialSpark Investigative Site 0113 | Fremont | California | 94538 | United States |
| TrialSpark Investigative Site 0101 | Los Angeles | California | 90057 | United States |
| TrialSpark Investigative Site 0103 | Miami Lakes | Florida | 33014 | United States |
| TrialSpark Investigative Site 0129 | Miramar | Florida | 33027 | United States |
| TrialSpark Investigative Site 0131 | Clarksville | Indiana | 47129 | United States |
| TrialSpark Investigative Site 0109 | Indianapolis | Indiana | 46250 | United States |
| TrialSpark Investigative Site 0112 | Louisville | Kentucky | 40241 | United States |
| TrialSpark Investigative Site 0108 | Baton Rouge | Louisiana | 70808 | United States |
| TrialSpark Investigative Site 0124 | Monroe | Louisiana | 71201 | United States |
| TrialSpark Investigative Site 0107 | Auburn Hills | Michigan | 48326 | United States |
| TrialSpark Investigative Site 0102 | Saint Joseph | Missouri | 54506 | United States |
| TrialSpark Investigative Site 0115 | Kew Gardens | New York | 11415 | United States |
| TrialSpark Investigative Site 0119 | New York | New York | 10075 | United States |
| TrialSpark Investigative Site 0105 | Wilmington | North Carolina | 28405 | United States |
| TrialSpark Investigative Site 0125 | Mason | Ohio | 45040 | United States |
| TrialSpark Investigative Site 0127 | Oklahoma City | Oklahoma | 73170 | United States |
| TrialSpark Investigative Site 0122 | Philadelphia | Pennsylvania | 19103 | United States |
| TrialSpark Investigative Site 0121 | Houston | Texas | 77056 | United States |
| TrialSpark Investigative Site 0130 | Pflugerville | Texas | 78660 | United States |
| TrialSpark Investigative Site 0114 | San Antonio | Texas | 78213 | United States |
| TrialSpark Investigative Site 0126 | San Antonio | Texas | 78229 | United States |
| TrialSpark Investigative Site 0110 | Springville | Utah | 84663 | United States |
| TrialSpark Investigative Site 0117 | Richmond | Virginia | 23226 | United States |
| TrialSpark Investigative Site 0128 | Spokane | Washington | 99202 | United States |
ASN008 2.5% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days)
ASN008: ASN008 topical gel applied twice daily.
| FG002 | ASN008 5% | ASN008 5% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days) ASN008: ASN008 topical gel applied twice daily. |
| FG003 | ASN008 Matching Vehicle | ASN008 matching vehicle twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days) ASN008 Matching Vehicle: The ASN008 matching vehicle formulation matches the formulation of each ASN008 topical gel dose, but contains no ASN008. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Treatment Period |
|
|
Modified Intent to Treat Population
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| ID | Title | Description |
|---|---|---|
| BG000 | ASN008 1.25% | ASN008 1.25% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days) ASN008: ASN008 topical gel applied twice daily. |
| BG001 | ASN008 2.5% | ASN008 2.5% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days) ASN008: ASN008 topical gel applied twice daily. |
| BG002 | ASN008 5% | ASN008 5% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days) ASN008: ASN008 topical gel applied twice daily. |
| BG003 | ASN008 Matching Vehicle | ASN008 matching vehicle twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days) ASN008 Matching Vehicle: The ASN008 matching vehicle formulation matches the formulation of each ASN008 topical gel dose, but contains no ASN008. |
| 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 | Least Squares Mean | Standard Deviation | years |
| |||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | 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 | Daily Peak Pruritus Numerical Rating Scale (NRS) | Percent change of 7-day average daily peak pruritus NRS from Baseline to Week 4 | Modified Intent to Treat | Posted | Least Squares Mean | Standard Error | percent change | Baseline to Week 4 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pruritus Response of ASN008 Topical Gel on Atopic Dermatitis (AD) Assessed by Daily Peak Pruritus NRS | Pruritus response defined as 7-day average of daily peak pruritus NRS reduction greater than or equal to 4 points from Baseline to Week 4 | Modified Intent to Treat | Posted | Count of Participants | Participants | Baseline to Week 4 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | This outcome measure evaluates the change and percent change in the Eczema Area and Severity Index (EASI) score from Baseline to Week 4. The EASI score measures the extent and severity of eczema across four body regions: head/neck, trunk, upper limbs, and lower limbs. Two components are assessed: severity of erythema, edema/papulation, excoriation, and lichenification (each scored 0 to 3, with 0 = none and 3 = severe) and the surface area affected (scored 0 to 6, with 0 = no involvement and 6 = 90%-100% involvement). Subscale scores are combined using weighted multipliers for each region (head/neck 0.1, upper limbs 0.2, trunk 0.3, lower limbs 0.4) to calculate the total score. The EASI is a composite score ranging from 0 (no eczema) to 72 (maximum severity and extent). Scores are summed to account for the severity of lesions and the percentage of body surface area (BSA) affected in each region. | Modified Intent to Treat | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Week 4 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in Total Body Surface Area (BSA) | Change from Baseline in total BSA at week 4. | Modified Intent to Treat | Posted | Least Squares Mean | Standard Error | Percentage | Baseline to Week 4 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline in the Patient-Oriented Eczema Measure (POEM) | This outcome measure evaluates the change in the the Patient-Oriented Eczema Measure (POEM) score from Baseline to Week 4.The POEM is a self-assessment tool that evaluates eczema severity based on patient-reported symptoms over the previous week. It includes 7 questions addressing common symptoms: itch, sleep disturbance, bleeding, weeping, cracking, flaking, and dryness. Each question is scored on a scale from 0 to 4 based on frequency (0 = no days, 1 = 1-2 days, 2 = 3-4 days, 3 = 5-6 days, 4 = every day). The scores are summed to generate a total score ranging from 0 to 28. Scores are interpreted as follows: 0-2 = clear or almost clear, 3-7 = mild eczema, 8-16 = moderate eczema, 17-24 = severe eczema, and 25-28 = very severe eczema. Higher scores indicate a greater symptom burden and worse disease severity. | Modified Intent to Treat | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline to Week 4 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Inter- and Intra-subject Variability of ASN008 Pharmacokinetics (PK) Characterized by Peak Plasma Concentration (Cmax) | ASN008 PK will be characterized using population-based methods to include Peak Plasma Concentration (Cmax). | Not Posted | Baseline and Week 4 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Inter- and Intra-subject Variability of ASN008 Pharmacokinetics Characterized by Area Under the Plasma Concentration Versus Time Curve (AUC) | ASN008 PK will be characterized using population-based methods to include area under the plasma concentration versus time curve (AUC) | Not Posted | Baseline and Week 4 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Treatment Emergent Adverse Events (TEAEs) | Number of participants who experienced a TEAE. | Safety | Posted | Count of Participants | Participants | Baseline to Day 56 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Investigational Product (IP)-Related TEAEs | Number of participants who experienced an IP-related TEAE. | Safety | Posted | Count of Participants | Participants | Baseline to Day 56 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Incidence of TEAEs Leading to Treatment Discontinuation | Incidence of TEAEs leading to treatment discontinuation from first dose through completion of follow-up period (up to a maximum of 56 days) | Safety | Posted | Count of Participants | Participants | Baseline to Day 56 |
|
Adverse event data were collected beginning after participant enrollment, before treatment, during treatment, and up to 28 days following the cessation of treatment, up to Day 56/Week 8.
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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 | ASN008 1.25% | ASN008 1.25% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days) ASN008: ASN008 topical gel applied twice daily. | 0 | 34 | 0 | 34 | 12 | 34 |
| EG001 | ASN008 2.5% | ASN008 2.5% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days) ASN008: ASN008 topical gel applied twice daily. | 0 | 32 | 0 | 32 | 14 | 32 |
| EG002 | ASN008 5% | ASN008 5% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days) ASN008: ASN008 topical gel applied twice daily. | 0 | 32 | 0 | 32 | 13 | 32 |
| EG003 | ASN008 Matching Vehicle | ASN008 matching vehicle twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days) ASN008 Matching Vehicle: The ASN008 matching vehicle formulation matches the formulation of each ASN008 topical gel dose, but contains no ASN008. | 0 | 33 | 0 | 33 | 9 | 33 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Food Poisoning | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Application Site Pain | General disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Ear Infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Eczema Impetiginous | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Pyuria | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA (26.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Heat Exhaustion | Injury, poisoning and procedural complications | MedDRA (26.0) | Systematic Assessment |
| |
| Blood Creatine Phosphokinase increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Blood Iron Decreased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Protein Urine Present | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Urine Ketone Body Present | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Urine Leukocyte Esterase Positive | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| White Blood Cell Count Increased | Investigations | MedDRA (26.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Micturition Urgency | Renal and urinary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Dermatitis Atopic | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
| |
| Skin Fissures | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Systematic Assessment |
|
This trial included an exploratory evaluation of ASN008 pharmacokinetics (PK) as a secondary endpoint using population-based methods. During the analysis, quantifiable levels of ASN008 were unexpectedly observed in vehicle and pre-dose plasma samples. Follow-up investigation indicated this may have been related to assay limitations, which would confound the population PK analysis. Therefore, the analysis was not pursued.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| TrialSpark | TrialSpark | Please Email | soothe.info@trialspark.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 18, 2024 | Sep 27, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D011537 | Pruritus |
| 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 |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Female |
|
| Ethnicity : Not Hispanic or Latino |
|
| Race: White |
|
| Race: Black or African American |
|
| Race: Asian |
|
| Race: Native Hawaiian or Other Pacific Islander |
|
| Race: Other |
|
| Mean Difference (Final Values) |
| -5.89 |
| 2-Sided |
| Superiority |
| Mixed Models Analysis | 0.8177 | Mean Difference (Final Values) | 1.66 | 2-Sided | Superiority |
ASN008 matching vehicle twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days)
ASN008 Matching Vehicle: The ASN008 matching vehicle formulation matches the formulation of each ASN008 topical gel dose, but contains no ASN008.
|
|
|
| OG002 | ASN008 5% | ASN008 5% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days) ASN008: ASN008 topical gel applied twice daily. |
| OG003 | ASN008 Matching Vehicle | ASN008 matching vehicle twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days) ASN008 Matching Vehicle: The ASN008 matching vehicle formulation matches the formulation of each ASN008 topical gel dose, but contains no ASN008. |
|
|
|
|
|
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| OG002 | ASN008 5% | ASN008 5% twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days) ASN008: ASN008 topical gel applied twice daily. |
| OG003 | ASN008 Matching Vehicle | ASN008 matching vehicle twice daily topical application applied as a thin layer (approximately 2 mg/cm^2) for 4 weeks (28 days) ASN008 Matching Vehicle: The ASN008 matching vehicle formulation matches the formulation of each ASN008 topical gel dose, but contains no ASN008. |
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