{ "data": { "asOf": "2026-10-30T22:27:00.467Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT06073132", "title": "An International, Multicenter, Randomized, Double-Blind, Parallel Group, Vehicle-Controlled, Phase 2/3 Study With Open-Label Extension Evaluating the Efficacy and Safety of Diacerein 1% Ointment for the Treatment of Generalized Epidermolysis Bullosa Simplex (EBS)", "scientificTitle": "An International, Multicenter, Randomized, Double-Blind, Parallel Group, Vehicle-Controlled, Phase 2/3 Study With Open-Label Extension Evaluating the Efficacy and Safety of Diacerein 1% Ointment for the Treatment of Generalized Epidermolysis Bullosa Simplex (EBS) [EBShield Study]", "status": "active", "studyType": "interventional", "phase": [ "PHASE2", "PHASE3" ], "conditions": [ "Generalized Epidermolysis Bullosa Simplex" ], "interventions": [ { "name": "AC-203", "type": "DRUG", "description": "The investigational product is formulated as 1% topical ointment" }, { "name": "Vehicle", "type": "DRUG", "description": "Vehicle-only control study medication is the same formulation as investigational product without active ingredient" } ], "sponsor": { "name": "TWi Biotechnology, Inc.", "type": "INDUSTRY" }, "locations": [ { "city": "Rancho Santa Margarita", "country": "United States", "facility": "Mission dermatology Center" }, { "city": "Stanford", "country": "United States", "facility": "Stanford University" }, { "city": "Aurora", "country": "United States", "facility": "Children's Hospital Colorado" }, { "city": "Chicago", "country": "United States", "facility": "Northwestern University - Lurie Childrens's Hospital" }, { "city": "Cincinnati", "country": "United States", "facility": "Cincinnati Childrens Hospital" }, { "city": "Charleston", "country": "United States", "facility": "Medical University of South Carolina" }, { "city": "San Antonio", "country": "United States", "facility": "Texas Dermatology and Laser Specialists" }, { "city": "Kogarah", "country": "Australia", "facility": "Premier Specialists" }, { "city": "Randwick", "country": "Australia", "facility": "Sydney Children's Hospital" }, { "city": "Salzburg", "country": "Austria", "facility": "Universitaetsklinik fuer Dermatologie und Allergologie" }, { "city": "Leuven", "country": "Belgium", "facility": "UZ Leuven" }, { "city": "Guangzhou", "country": "China", "facility": "Dermatology Hospital of Southern Medical University" }, { "city": "Thessaloniki", "country": "Greece", "facility": "Hospital of Skin and Venereal Diseases of Thessaloniki" }, { "city": "Chandigarh", "country": "India", "facility": "Postgraduate Institute of Medical Education and Research (PGIMER)" }, { "city": "Dublin", "country": "Ireland", "facility": "Children's Health Ireland" }, { "city": "Tel Aviv", "country": "Israel", "facility": "Tel Aviv Sourasky Medical Center" }, { "city": "Milan", "country": "Italy", "facility": "Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano" }, { "city": "Modena", "country": "Italy", "facility": "Università degli Studi di Modena e Reggio Emilia (UNIMORE)" }, { "city": "Rome", "country": "Italy", "facility": "Istituto Dermopatico dell'Immacolata (IDI) - Istituto di" }, { "city": "Rome", "country": "Italy", "facility": "UOS \"Centro delle Dermatosi Croniche Complesse e Genodermatosi\" UOC Dermatologia" }, { "city": "Kuala Lumpur", "country": "Malaysia", "facility": "Hospital Tunku Azizah (Hospital Wanita Dan Kanak-kanak Kuala Lumpur)" }, { "city": "City of Muntinlupa", "country": "Philippines", "facility": "Asian Hospital" }, { "city": "Iloilo City", "country": "Philippines", "facility": "Iloilo Doctors Hospital" }, { "city": "Mandaluyong", "country": "Philippines", "facility": "Health Cube Medical Clinics" }, { "city": "Warsaw", "country": "Poland", "facility": "OT.CO Clinic Osipowicz & Turkowski" }, { "city": "Seoul", "country": "South Korea", "facility": "Gangnam Severane Hospital" }, { "city": "Madrid", "country": "Spain", "facility": "Hospital Universitario La Paz" }, { "city": "Tainan", "country": "Taiwan", "facility": "National Cheng Kung University Hospital" }, { "city": "Abu Dhabi", "country": "United Arab Emirates", "facility": "Sheikh Khalifa Medical City (SKMC)" }, { "city": "London", "country": "United Kingdom", "facility": "Great Ormond Street Hospital (GOSH) for Children NHS Foundation Trust - Somers Clinical Research Facility (CRF)" } ], "outcomes": { "other": [], "primary": [ "Proportion of patients achieving treatment success on the IGA of the Treatment Area, in which treatment success is defined as a score of 0 or 1 with at least a 2-point reduction" ], "secondary": [ "Change in % BSA of EBS lesions in the Treatment Area", "Change in pain intensity score", "Change in pruritus intensity score", "Change in EBDASI score (skin activity)", "Change in the QOLEB score" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n1. Patient is at least 6 months old at Visit 2 (Day 1/Baseline A).\n2. Patients has been clinically diagnosed with severe EBS or intermediate EBS, confirmed by documented genetic diagnosis to have autosomal dominant mutations in KRT5 or KRT14 gene.\n3. Patient with ≥ 3% BSA of EBS lesions excluding palms and soles at Visit 2 (Day 1/Baseline A).\n4. Patient's EBS lesions within the Treatment Area have an IGA score of ≥3 at Visit 2 (Day 1/Baseline A).\n5. Patient/caregiver agrees to follow study medication application instructions.\n6. Patient (and caregiver/legal guardian) agrees to report use of all prescription and over-the-counter medications, including topical therapies applied to the body, e.g., medical cleansers, bleach cleansers, bleach baths, topical antiseptics, topical disinfectants, etc. for the duration of the study.\n7. Patient (and caregiver/legal guardian) is willing and able to comply with all study visits and all the protocol requirements, including completing questionnaires.\n8. Patient (and caregiver/legal guardian) is able to provide written informed consent; assent based on age.\n9. Female patient of childbearing potential must have a negative pregnancy test prior to randomization.\n10. Female patient of childbearing potential is willing to practice highly effective contraception (i.e., pregnancy prevention method with a failure rate of \\< 1% per year) from Screening throughout the end of the study.\n\nExclusion Criteria:\n\n1. Patient has a clinically significant skin disease other than EBS (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.), or a vascular disorder associated with cutaneous erosions/ulcerations, that may confound assessments of efficacy or safety.\n2. Patient has a clinically significant underlying medical condition, psychiatric condition (such as major depressive or psychotic disorder, severe intellectual disability, or alcohol or drug use disorder), or requires concomitant medication that based on the investigator's judgement may impair evaluation of the Treatment Area or exposes the patient to an unacceptable risk by study participation.\n3. Patient has used any diacerein-containing product within 6 months prior to Visit 2 (Day 1/Baseline A).\n4. Patient has had a cutaneous infection in the Treatment Area or use systemic antibiotics within 7 days prior to Visit 2 (Day 1/Baseline A).\n5. Patient has uncontrolled diabetes mellitus (HbA1c ≥ 6.5%), hepatic enzyme abnormalities (alanine aminotransferase or aspartate aminotransferase \\>2.5 the upper limit of normal (ULN), or total bilirubin \\>2.0x ULN), or renal abnormalities (estimated glomerular filtration rate \\[eGFR\\]\\< 30 ml/min/1.73 m2) during the Screening period.\n6. Patient has a current malignancy, or a history of treatment for a malignancy within 5 years (with the exception of treated non-melanoma cutaneous malignancy e.g., surgically resected with clear margins) prior to Visit 2 (Day 1/Baseline A).\n7. Patient is treated with protocol-excluded topical therapies other than steroids within 2 weeks prior to Visit 2 (Day 1/Baseline A) that might influence the assessment of the Treatment Area throughout the study period.\n8. Patient has been treated with topical steroids on the EBS lesions within 2 weeks or systemic steroids within 4 weeks. prior to Visit 2 (Day 1/Baseline A). (Note: inhaled and ophthalmic products containing steroids are allowed.)\n9. Patient has been treated with: (a) an approved biologic anti-inflammatory therapy (such as monoclonal antibodies that target to modulate the immune responses) and (b) other immunosuppressive/immunomodulatory therapies or chemotherapy within 8 weeks prior to Visit 2 (Day 1/Baseline A).\n10. Patient has been treated with any investigational drug or device within 30 days or 5 half-lives, whichever is longer, prior to Visit 2 (Day 1/Baseline A).\n11. Patient has a history of allergy or hypersensitivity to any component of study medications, including diacerein or rhein.\n12. Patient is pregnant or breastfeeding/lactating.\n13. Patient has a planned or anticipated major surgical procedure or other activity that would interfere with their ability to comply with protocol requirements.", "minimumAge": "6 Months", "healthyVolunteers": false }, "enrollment": { "type": "ESTIMATED", "count": 80 }, "startDate": "2024-04-04", "completionDate": "2027-03-01", "lastUpdated": "2026-07-09T00:00:00.000Z", "firstPosted": "2023-10-10T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT06073132" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT06073132", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT06073132", "sourceUrl": "https://clinicaltrials.gov/study/NCT06073132", "sourceStatus": "ACTIVE_NOT_RECRUITING", "retrievedAt": "2026-09-21T04:32:28.281Z", "payloadSha256": "bce13218c96a8b9d25ee17f9923bffc0c18fc9b460e923f2fe1ab3f3c34f8559", "piiRedacted": true } ], "citation": { "canonicalId": "NCT06073132", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT06073132", "verifyAt": "https://clinicaltrials.gov/study/NCT06073132", "retrievedAt": "2026-09-21T04:32:28.281Z", "payloadSha256": "bce13218c96a8b9d25ee17f9923bffc0c18fc9b460e923f2fe1ab3f3c34f8559", "text": "ClinicalTrials.gov, record NCT06073132 (https://clinicaltrials.gov/study/NCT06073132), retrieved 2026-09-21, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT06073132, registered in ClinicalTrials.gov, retrieved 2026-09-21. 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