Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2026-02-25 @ 10:05 PM
Study NCT ID:
NCT03798561
Status:
COMPLETED
Last Update Posted:
2023-05-09
First Post:
2019-01-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate ASN008 Topical Gel (TG)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D011537', 'term': 'Pruritus'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Part A: Double blinded, with exception of unblinded dispensing pharmacist Part B: Double blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Phase 1, multicenter, double-blind, vehicle-controlled, randomized ascending doses trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-08', 'studyFirstSubmitDate': '2019-01-04', 'studyFirstSubmitQcDate': '2019-01-09', 'lastUpdatePostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate safety and tolerability of ASN008 topical gel to define a maximum tolerated dose (Part A and B)', 'timeFrame': 'Part A: 14 days; Part B: 22 days', 'description': 'Analyze incidence of treatment-emergent adverse events (TEAE)'}], 'secondaryOutcomes': [{'measure': 'Calculate area under the plasma concentration versus time curve (Part A and B)', 'timeFrame': '7 days and 16 days', 'description': 'A plot of the concentration of ASN008 in plasma over time'}, {'measure': 'Calculate the Pharmacokinetic Half-life (Part A and B)', 'timeFrame': '7 days and 16 days', 'description': 'Derive maximum blood plasma concentration of Time required for ASN008 concentration to decrease by 50%'}, {'measure': 'Calculate the Pharmacokinetic maximum concentration (Part A and B)', 'timeFrame': '7 days and 16 days', 'description': 'Maximum concentration of ASN008 achieved after dosing'}, {'measure': 'Change from baseline in pruritus NRS in AD subjects (Part B)', 'timeFrame': '22 days', 'description': 'Numeric Rating Scale ranging from 0 to 10; 0 indicates no itching; 10 indicates worst possible itching; Rating of pruritis based degree, duration, direction, disability, and distribution'}, {'measure': 'Change from baseline in Eczema Area and Severity Score (EASI) in AD subjects (Part B)', 'timeFrame': '22 days', 'description': 'Measurement of area and severity of atopic dermatitis based on composite score 0 to 72 encompassing degree of erythema, induration, excoriation and lichenification; each scored from 0 to 3 with 0 indicating none and 3 indicating severe'}, {'measure': 'Change from baseline in Investigator Global Assessment Score in AD subjects (Part B)', 'timeFrame': '22 Days', 'description': '5 point morphological assessment of overall disease severity scored from 0 to 4 with 0 indicating clear (no inflammation) and 4 indicating severe (marked erythema)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dermatitis, Atopic', 'Pruritus', 'Dermatitis Eczema']}, 'referencesModule': {'references': [{'pmid': '32616515', 'type': 'DERIVED', 'citation': 'Ramachandran R, Thompson SK, Malkmus S, Mieda T, Lin JH, Gupta S, Yaksh TL. Topical Application of ASN008, a Permanently Charged Sodium Channel Blocker, Shows Robust Efficacy, a Rapid Onset, and Long Duration of Action in a Mouse Model of Pruritus. J Pharmacol Exp Ther. 2020 Sep;374(3):521-528. doi: 10.1124/jpet.120.265074. Epub 2020 Jul 2.'}]}, 'descriptionModule': {'briefSummary': 'This is an ascending dose escalation study to test the safety, tolerability and preliminary efficacy of ASN008 TG in first-in-human subjects', 'detailedDescription': 'This is a two part, randomized, blinded, vehicle-controlled study to determine a safe and tolerable dose of ASN008 TG. Part A will asses a single ascending dose of ASN008 TG in cohorts of healthy volunteers, while Part B will assess multiple ascending doses of TG, to be determined (TBD) based on Part A safety and tolerability, in patients with mild-to-moderate dermatitis. Results from Part A and B will characterize safety, tolerability and pharmacokinetics. Part B patients will be assessed for changes in pruritus based on a numerical rating scale (NRS) of pruritus at baseline and on Day 15.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPart A - Healthy Volunteers:\n\n* Written informed consent obtained prior to any required study-related procedure\n* Healthy female or male subject aged 18 to 65\n* Willing to use medically effective methods of birth control\n* Females of reproductive potential must have a negative serum pregnancy test at screening and negative serum or urine pregnancy test prior to first study drug application on Day 1\n* Non-smoker (no nicotine products for at least 6 months prior to screening)\n* BMI ≥18.5 kg/m2 and ≤32.0 kg/m2 with minimum weight of 60 kg\n\nPart B- Subjects with AD:\n\n* Written informed consent obtained prior to any required study-related procedure\n* Confirmed diagnosis of active atopic dermatitis (AD)\n* History of AD for at least 6 months prior to Day 1 with an investigator global assessment ≥3 and body surface area covered with 1-10% AD\n* Pruritus score (NRS)≥ 5 at screening and NRS ≥7 on Day 1\n\nExclusion Criteria:\n\nBoth Part A and Part B:\n\n* Pregnant or breast-feeding women\n* Skin disease that may interfere with study assessments\n* Febrile illness within 6 days prior to Day 1, history of cancer within 5 years of Day 1, major surgery within 8 weeks prior to Day1, known immunodeficiencies, positive for hepatitis B or C or HIV infection\n* Significant medical/surgical history or condition or current physical/laboratory/ECG/ vitals signs abnormality that might compromise the subject\n* Corrected QT duration ≥450 milliseconds or other significant ECG abnormality\n* Received marketed or investigational biological agent within 12 weeks prior to Day 1 or JAK inhibitor or nonbiological product or device within 4 weeks of Day 1 or within 8 weeks of Day 1 if investigational product used or any drug/ substance that is a strong inhibitor or inducer of CYP3A4 or CYP2D6\n* Suspected hypersensitivity/allergy to lidocaine\n* Significant drug or alcohol abuse or mental illness in 2 years prior to Day 1\n\nPart A Only- Healthy Volunteers:\n\n-Used medications or skin emollients within 2 weeks prior to Day 1 unless approved by investigator and sponsor\n\nPart B Only - Subjects with AD:\n\n* Has infected atopic dermatitis\n* Used dupilumab 12 weeks prior to Day 1\n* Used doxepin, hydroxyzine or diphenhydramine, urea containing topical products within 1 week prior to Day 1\n* Used systemic antibiotics or topical medicated treatment or other systemic treatments that could affect AD 2 weeks prior to Day 1\n* Received any UV-B phototherapy, excimer laser treatment or psoralen-UV-A treatment within 4 weeks prior to Day 1'}, 'identificationModule': {'nctId': 'NCT03798561', 'briefTitle': 'Study to Evaluate ASN008 Topical Gel (TG)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Asana BioSciences'}, 'officialTitle': 'A Phase 1, Randomized, Double-Blind, Vehicle-Controlled Ascending Doses Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ASN008 Topical Gel in Healthy Volunteers and Subjects With Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'ASN008-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '82 µg/cm2 ASN008 TG or Placebo', 'description': 'PART A: ASN008 TG 82 µg/cm2 single application in 7 days or Placebo TG (6 subjects ASN008: 2 subjects placebo) (6:2)', 'interventionNames': ['Drug: ASN008 TG', 'Drug: Placebo TG']}, {'type': 'EXPERIMENTAL', 'label': '164 µg/cm2 ASN008 TG or Placebo', 'description': 'PART A: ASN008 TG 164 µg/cm2 single application in 7 days or Placebo (6:2)', 'interventionNames': ['Drug: ASN008 TG', 'Drug: Placebo TG']}, {'type': 'EXPERIMENTAL', 'label': '328 µg/cm2 ASN008 TG or Placebo', 'description': 'Part A: ASN008 TG 328 µg/cm2 single application in 7 days or Placebo (6:2)', 'interventionNames': ['Drug: ASN008 TG', 'Drug: Placebo TG']}, {'type': 'EXPERIMENTAL', 'label': '492 µg/cm2 ASN008 TG or Placebo', 'description': 'Part A: ASN008 TG 492 µg/cm2 single application in 7 days or Placebo (6:2)', 'interventionNames': ['Drug: ASN008 TG', 'Drug: Placebo TG']}, {'type': 'EXPERIMENTAL', 'label': 'ASN008 TG TBD Cohort 1 or Placebo', 'description': 'Part B: ASN008 TG Cohort 1 daily application for 15 days or Placebo (9 subjects ASN008: 3 subjects Placebo) (9:3)', 'interventionNames': ['Drug: ASN008 TG', 'Drug: Placebo TG']}, {'type': 'EXPERIMENTAL', 'label': 'ASN008 TG TBD Cohort 2 or Placebo', 'description': 'Part B: ASN008 TG Cohort 2 daily application for 15 days or Placebo (9:3)', 'interventionNames': ['Drug: ASN008 TG', 'Drug: Placebo TG']}, {'type': 'EXPERIMENTAL', 'label': 'ASN008 TG TBD Cohort 3 or Placebo', 'description': 'Part B: Placebo TG Cohort 3 daily application for 15 days or Placebo (9:3)', 'interventionNames': ['Drug: ASN008 TG', 'Drug: Placebo TG']}], 'interventions': [{'name': 'ASN008 TG', 'type': 'DRUG', 'description': 'ASN008 TG', 'armGroupLabels': ['164 µg/cm2 ASN008 TG or Placebo', '328 µg/cm2 ASN008 TG or Placebo', '492 µg/cm2 ASN008 TG or Placebo', '82 µg/cm2 ASN008 TG or Placebo', 'ASN008 TG TBD Cohort 1 or Placebo', 'ASN008 TG TBD Cohort 2 or Placebo', 'ASN008 TG TBD Cohort 3 or Placebo']}, {'name': 'Placebo TG', 'type': 'DRUG', 'description': 'Placebo TG', 'armGroupLabels': ['164 µg/cm2 ASN008 TG or Placebo', '328 µg/cm2 ASN008 TG or Placebo', '492 µg/cm2 ASN008 TG or Placebo', '82 µg/cm2 ASN008 TG or Placebo', 'ASN008 TG TBD Cohort 1 or Placebo', 'ASN008 TG TBD Cohort 2 or Placebo', 'ASN008 TG TBD Cohort 3 or Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13045', 'city': 'Cortland', 'state': 'New York', 'country': 'United States', 'facility': 'Certified Research Associates', 'geoPoint': {'lat': 42.60118, 'lon': -76.18048}}, {'zip': '27262', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Dermatology Consulting Services, PLLC', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '78213', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Progressive Clinical Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '53095', 'city': 'West Bend', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Spaulding Research Clinic, Inc', 'geoPoint': {'lat': 43.42528, 'lon': -88.18343}}, {'zip': 'H2K4L5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Innovaderm Recherches Inc', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Niranjan Rao, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Asana BioSciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asana BioSciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}