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)

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

April 4, 2024

Primary Completion Date

March 31, 2026

Study Completion Date

January 31, 2027

Conditions
Generalized Epidermolysis Bullosa Simplex
Interventions
DRUG

AC-203

The investigational product is formulated as 1% topical ointment

DRUG

Vehicle

Vehicle-only control study medication is the same formulation as investigational product without active ingredient

Trial Locations (35)

11790

RECRUITING

Stony Brook Dermatology, Stony Brook

29425

RECRUITING

Medical University of South Carolina, Charleston

33146

RECRUITING

Pediatric Center of Excellence (PCE) - Miami Pediatric Endocrinology, LLC, Miami

45229

RECRUITING

Cincinnati Childrens Hospital, Cincinnati

60611

RECRUITING

Northwestern University - Lurie Childrens's Hospital, Chicago

78218

RECRUITING

Texas Dermatology and Laser Specialists, San Antonio

80045

RECRUITING

Children's Hospital Colorado, Aurora

92688

RECRUITING

Mission dermatology Center, Rancho Santa Margarita

94304

RECRUITING

Stanford University, Stanford

562101

NOT_YET_RECRUITING

Sri Madhusudan Sai Institute of Medical Science, Muddenahalli

Unknown

RECRUITING

Premier Specialists, Kogarah

RECRUITING

Sydney Children's Hospital, Randwick

RECRUITING

Universitaetsklinik fuer Dermatologie und Allergologie, Salzburg

RECRUITING

UZ Leuven, Leuven

RECRUITING

Hopital Necker-Enfants Malades, Paris

RECRUITING

Hospital of Skin and Venereal Diseases of Thessaloniki, Thessaloniki

NOT_YET_RECRUITING

Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh

RECRUITING

Children's Health Ireland, Dublin

RECRUITING

Tel Aviv Sourasky Medical Center, Tel Aviv

RECRUITING

IRCCS, AOUBO, Policlinico Sant'Orsola, Bologna

RECRUITING

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano, Milan

RECRUITING

Università degli Studi di Modena e Reggio Emilia (UNIMORE), Modena

RECRUITING

Istituto Dermopatico dell'Immacolata (IDI) - Istituto di, Rome

RECRUITING

"UOS Centro delle Dermatosi Croniche Complesse e Genodermatosi UOC Dermatologia", Rome

RECRUITING

Hospital Tunku Azizah (Hospital Wanita Dan Kanak-kanak Kuala Lumpur), Kuala Lumpur

RECRUITING

Asian Hospital, City of Muntinlupa

RECRUITING

Iloilo Doctors Hospital, Iloilo City

RECRUITING

Health Cube Medical Clinics, Mandaluyong

RECRUITING

OT.CO Clinic Osipowicz & Turkowski, Warsaw

RECRUITING

Gangnam Severane Hospital, Seoul

RECRUITING

Hospital Universitario La Paz, Madrid

RECRUITING

National Cheng Kung University Hospital, Tainan City

RECRUITING

Sheikh Khalifa Medical City (SKMC), Abu Dhabi

RECRUITING

Great Ormond Street Hospital (GOSH) for Children NHS Foundation Trust - Somers Clinical Research Facility (CRF), London

RECRUITING

University Hospitals Birmingham NHS Foundation Trust (UHB), Solihull

All Listed Sponsors
lead

TWi Biotechnology, Inc.

INDUSTRY