Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-27 @ 9:17 PM
Study NCT ID:
NCT06055361
Status:
RECRUITING
Last Update Posted:
2025-09-19
First Post:
2023-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Safety, Tolerability, and Efficacy of BxC-I17e Single and Multiple Dose SC Injection in Patients With Moderate to Severe Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2023-09-12', 'studyFirstSubmitQcDate': '2023-09-20', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Baseline to Week 26', 'description': 'Incidence of treatment-emergent adverse events as assessed by CTCAE v5.0'}], 'secondaryOutcomes': [{'measure': 'Incidence, severity and relationship of adverse events(AEs)', 'timeFrame': 'Baseline to Week 26', 'description': 'Incidence, severity and relationship of adverse events as assessed by CTCAE v5.0'}, {'measure': 'Number of abnormalities and change from baseline in Vital signs', 'timeFrame': 'Baseline to Week 26', 'description': 'Supine blood pressure and pulse rate, tympanic temperature, and respiratory rate'}, {'measure': 'Number of abnormalities in 12-lead electrocardiogram (ECG)', 'timeFrame': 'Baseline to Week 26', 'description': "PR interval, QRS interval, RR interval, QT interval and QT interval using Friderica's correction (QTcF)"}, {'measure': 'Number of abnormalities in clinical laboratory parameter', 'timeFrame': 'Baseline to Week 26', 'description': 'Hematology, clinical chemistry, and urinalysis parameters'}, {'measure': 'Frequency and proportion of clinically significant finding of physical examination', 'timeFrame': 'Baseline to Week 26', 'description': 'Assessments of the following body categories : skin, HEENT (head, eye, ears, nose, and throat), cardiovascular, respiratory, gastrointestinal, endocrine/metabolic, genitourinary, psychiatric, hematologic/lymphatics, musculoskeletal, neurologic, hepatic, and allergic/immunologic'}, {'measure': "Proportion of patients who achieved the Investigator's Global Assessment (IGA) score of 0 or 1", 'timeFrame': 'Baseline to Week 8 (single dose) or Week 14 (multiple dose)', 'description': 'The IGA is an assessment instrument used in clinical studies to rate the severity of Atopic dermatitis globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe).'}, {'measure': 'Change and percent change in Body Surface Area (BSA)', 'timeFrame': 'Baseline to Week 8 (single dose) or Week 14 (multiple dose)', 'description': 'The BSA affected by atopic dermatitis will be assessed for each major section of the body (head, trunk, arms, and legs). Extent and intensity of eczema as well as subjective signs (insomnia, etc.) are assessed and scored. Total score ranges from 0 (absent disease) to 103 (severe disease).'}, {'measure': 'Change and percent change in Eczema Area and Severity Index (EASI)', 'timeFrame': 'Baseline to Week 8 (single dose) or Week 14 (multiple dose)', 'description': 'The EASI is a composite index with scores ranging from 0 to 72. Higher scores indicates worse condition.'}, {'measure': 'Change and percent change in Scoring Atopic Dermatitis (SCORAD)', 'timeFrame': 'Baseline to Week 8 (single dose) or Week 14 (multiple dose)', 'description': 'The SCORAD is a clinical tool for assessing the severity of Atopic Dermatitis. Total score ranged from 0 (absent disease) to 103 (severe disease).'}, {'measure': 'Change and percent change in Pruritus Numerical Rating Scale (NRS)', 'timeFrame': 'Baseline to Week 8 (single dose) or Week 14 (multiple dose)', 'description': "The Pruritus NRS is a simple assessment tool used to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being 'no itch' and 10 being the' worst itch imaginable'"}, {'measure': 'Change and percent change in Dermatology Life Quality Index (DLQI)', 'timeFrame': 'Baseline to Week 8 (single dose) or Week 14 (multiple dose)', 'description': 'The DLQI is a validated questionnaire designed to measure the impact of skin disease on the Quality of Life. The higher the score, the greater the impact is on the quality of life'}, {'measure': 'Change and percent change in Patient-Oriented Eczema Measure (POEM)', 'timeFrame': 'Baseline to Week 8 (single dose) or Week 14 (multiple dose)', 'description': 'The POEM is a validated 7-item questionnaire used to assess disease symptoms with a scoring system of 1 to 28. The higher score, the higher morbidity'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atopic dermatitis', 'exosome', 'extracellular vesicles', 'EV'], 'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of a single and multiple SC dose of BxC-I17e in patients with moderate to severe atopic dermatitis (AD)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients (males or females) aged 18 years or older.\n2. Patients have documented history of moderate to severe AD, that has been present for at least 1 year\n3. History of inadequate response to a stable regimen of TCSs or TCIs as treatment for AD\n4. Patients must agree to apply stable doses of additive-free, basic bland emollient lotions twice daily for at least 7 days before the Baseline Visit.\n5. Willingness and ability to comply with clinic visits and study-related procedures.\n6. Patients should be able to read, understand, and be willing to sign the ICF\n\nExclusion Criteria:\n\n1. Presence of any of the following laboratory abnormalities\n\n * Hemoglobin \\< 11 g/dL\n * WBC \\< 3.5 × 103/μL\n * Platelet count \\< 125 × 103/μL\n * Neutrophils \\< 1.75 × 103/μL\n * AST/ALT \\> 1.5 × ULN\n * Total bilirubin \\> ULN\n * Creatinine \\> ULN\n * Creatine phosphokinase \\> ULN\n2. Positive test for hepatitis B surface antigen, and/or hepatitis C antibody\n3. Active dermatologic conditions that may confound the diagnosis of AD\n4. Prior exposure to any investigational systemic treatment or is currently enrolled in another clinical study\n5. Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease, or any other illness or condition that would adversely affect the patient's participation in this study\n6. Treatment with TCS, and/or TCI, within 1 week prior to the Baseline Visit.\n7. Known history of human immunodeficiency virus (HIV) infection\n8. Pregnant or breastfeeding women"}, 'identificationModule': {'nctId': 'NCT06055361', 'briefTitle': 'A Study to Investigate the Safety, Tolerability, and Efficacy of BxC-I17e Single and Multiple Dose SC Injection in Patients With Moderate to Severe Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Brexogen Inc.'}, 'officialTitle': 'A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of BxC-I17e Administered Subcutaneously in Patients With Moderate to Severe Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'BRE-AD01-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BxC-I17e (Single Dose)', 'description': '* Subcutaneous (SC) injection of 25, 50, or 100 ug BxC-I17e\n* Single dose on Day 1', 'interventionNames': ['Drug: BxC-I17e (primed iMSC derived Extracellular vesicles(EV))']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Single Dose)', 'description': '* Subcutaneous (SC) injection of the matching placebo\n* Single dose on Day 1', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BxC-I17e (Multiple Dose)', 'description': '* Subcutaneous (SC) injection of 50, or 100 ug BxC-I17e\n* 4 doses on Day 1, 15, 29, and 43', 'interventionNames': ['Drug: BxC-I17e (primed iMSC derived Extracellular vesicles(EV))']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Multiple Dose)', 'description': '* Subcutaneous (SC) injection of the matching placebo\n* 4 doses on Day 1, 15, 29, and 43', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BxC-I17e (primed iMSC derived Extracellular vesicles(EV))', 'type': 'DRUG', 'description': 'Pharmaceutical form : solution for injection', 'armGroupLabels': ['BxC-I17e (Multiple Dose)', 'BxC-I17e (Single Dose)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Pharmaceutical form : solution for injection', 'armGroupLabels': ['Placebo (Multiple Dose)', 'Placebo (Single Dose)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72117', 'city': 'North Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shawna S Owens', 'role': 'CONTACT'}], 'facility': 'Arkansas Research Trials', 'geoPoint': {'lat': 34.76954, 'lon': -92.26709}}, {'zip': '17011', 'city': 'Camp Hill', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elise Magnine', 'role': 'CONTACT'}], 'facility': 'DermDox Centers for Dermatology', 'geoPoint': {'lat': 40.23981, 'lon': -76.91997}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Paola Santos', 'role': 'CONTACT'}], 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'centralContacts': [{'name': 'Hugh Lee', 'role': 'CONTACT', 'email': 'hughlee@kcrnresearch.com', 'phone': '1-301-540-2600'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brexogen Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}