Epidermolysis Bullosa Clinical Characterization and Outcomes Database

Date Added
February 26th, 2026
PRO Number
Pro00142696
Researcher
Lara Wine Lee

List of Studies


Keywords
Pediatrics, Skin
Summary

Epidermolysis Bullosa (EB) is a rare, inherited skin condition that makes the skin extremely fragile, causing painful blisters and wounds from even minor friction or injury. There is currently no cure, and because EB is uncommon, doctors still have limited high-quality data to guide the best treatment and long-term care. This study is part of a large North American effort to collect and organize health information from people with EB into a secure database. By tracking how the disease progresses over time, along with symptoms, complications, and treatments, researchers hope to better understand EB and improve care for future patients. Participation involves consenting to share medical record information and optionally completing brief questionnaires during routine clinic visits or by email. No experimental treatments or extra medical procedures are involved. While there is no direct benefit to participants, the knowledge gained may help improve care and support the development of new treatments in the future.

Institution
MUSC
Recruitment Contact
Lara Wine Lee
843-792-2890
winelee@musc.edu

A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Zasocitinib in Participants with Nonsegmental Vitiligo

Date Added
February 11th, 2026
PRO Number
Pro00146857
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This phase 2, multicenter, randomized, placebo-controlled, double-blind, dose-ranging trial evaluates the efficacy and safety of zasocitinib in participants with nonsegmental vitiligo. The maximum trial duration for an individual participant is approximately 61 weeks (427 days), including a screening period of up to 35 days, a treatment period of up to 52 weeks, and a 4-week safety follow-up period. Participants will be randomly assigned to a blinded treatment with zasocitinib 15 mg QD, 30 mg QD, 75 mg QD, placebo/zasocitinib 30 mg, or placebo/zasocitinib 75 mg QD, via an IRT system.

Institution
MUSC
Recruitment Contact
Devyn Spino
843-876-2281
Spino@musc.edu

A US Phase 3b, Multi-center, Randomized, Double-blind, Double-Dummy Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults with Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-Antihistamines

Date Added
February 10th, 2026
PRO Number
Pro00146309
Researcher
Kelli Williams

List of Studies


Keywords
Allergy, Autoimmune disease, Skin
Summary

This is a randomized, double-blind, multicenter Phase IIIb study comparing remibrutinib tablets with dupilumab injections in adults with chronic spontaneous urticaria (CSU) that is not well controlled by second-generation H1-antihistamines. Participants will receive either remibrutinib or dupilumab for 12 weeks, alongside their usual antihistamine. The goal is to see which treatment works faster and better at reducing symptoms like hives and itching. If remibrutinib is not yet available commercially after the study, participants may continue taking it in an optional extension phase.

Institution
MUSC
Recruitment Contact
Emma McLeod
843-792-8008
mcleodem@musc.edu

A Randomized, Double-Blind, Vehicle-Controlled (Period 1) and Open-Label (Period 2)Phase 3 Study to Investigate the Safety and Efficacy of Tapinarof Cream, 1% in Pediatric Participants Ages 3 Months to < 24 Months with Atopic Dermatitis

Date Added
January 6th, 2026
PRO Number
Pro00148113
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This Phase 3 study evaluates the safety and efficacy of tapinarof cream, 1%, for treating atopic dermatitis (AD) in pediatric participants aged 3 to under 24 months. Previous research, including two Phase 3 pivotal studies and a long-term study, assessed the cream in adults and children as young as 2 years. These studies showed minimal to no systemic exposure in children aged 2 to 17 with extensive AD. The findings support investigating the cream's safety and efficacy in younger participants, specifically infants and toddlers.

Institution
MUSC
Recruitment Contact
Andie Hoskins
843-792-6882
hoskinsa@musc.edu

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF RITLECITINIB IN PEDIATRIC PARTICIPANTS 6 TO LESS THAN 12 YEARS OF AGE WITH SEVERE ALOPECIA AREATA

Date Added
November 25th, 2025
PRO Number
Pro00147963
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

Ritlecitinib has been approved for treating severe alopecia areata (AA) in adults and adolescents aged 12 and older in the US, EU, and other countries, based on a positive benefit/risk assessment. However, there are no approved treatments for AA in children aged 6 to under 12. Study B7981027 is being conducted to evaluate the efficacy and safety of ritlecitinib in this younger group. This study is part of the EU Pediatric Investigation Plan (PIP) and fulfills a post-marketing requirement in the US.

Institution
MUSC
Recruitment Contact
Devyn Spino
843-876-2281
spino@musc.edu

A 16-WEEK, MULTICENTER, INTERVENTIONAL, PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ABROCITINIB IN CHILDREN 6 TO LESS THAN 12 YEARS OF AGE WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS

Date Added
November 12th, 2025
PRO Number
Pro00144604
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of abrocitinib compared to a placebo in participants aged 6 to under 12 years with moderate-to-severe AD. Participants will be screened within 28 days before the first dose to confirm eligibility. Those who meet the criteria at baseline will be randomized 2:1 to receive either abrocitinib oral suspension (at a 100 mg adult equivalent dose once daily) or a matching placebo. Participants will be stratified by their baseline vIGA score (3 or 4). They will receive either abrocitinib or a matching placebo for 16 weeks. Additionally, participants must use emollients daily and follow standardized background medicated topical therapy (e.g., low to medium potency corticosteroids) according to protocol guidelines throughout the study's treatment period.

Institution
MUSC
Recruitment Contact
Andie Hoskins
843-792-6882
hoskinsa@musc.edu

A Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of BLU-808, a Wild Type KIT Inhibitor, in Chronic Inducible Urticaria and Chronic Spontaneous Urticaria

Date Added
October 23rd, 2025
PRO Number
Pro00145633
Researcher
Kelli Williams

List of Studies


Keywords
Allergy, Autoimmune disease, Skin
Summary

The purpose of this study is evaluate safety and effectiveness of an investigational drug in adults diagnosed with chronic urticaria (hives). The investigational drug is known as BLU-808 and will be taken daily orally. Participation in the study is expected to be approximately 18 weeks.

Institution
MUSC
Recruitment Contact
Emma McLeod
843-792-8008
mcleodem@musc.edu

Clinical Characteristics, Treatment Patterns and Outcomes in Patients with Alopecia Areata Following Initiation of Ritlecitinib, Baricitinib or Standard of Care Treatment.

Date Added
October 17th, 2025
PRO Number
Pro00146871
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This study is a non-interventional, multicenter investigation of patient outcomes, combining a retrospective medical chart review with prospective patient questionnaires. It focuses on patients receiving ritlecitinib, baricitinib, or standard of care (SOC) treatment for alopecia areata (AA). Prospective data will be collected over 12 months following the start of treatment. The study aims to enroll 300 adults (aged 18 and older) and 100 adolescents/minors (aged 12-17) from 20-25 sites across the USA. Among the adult participants, 100 will receive ritlecitinib, 100 baricitinib, and 100 SOC. The adolescent/minor group will include 50 receiving ritlecitinib and 50 SOC.

Institution
MUSC
Recruitment Contact
Kenreka Yeadon
843-876-0110
yeadon@musc.edu

A PHASE 3, EXTERNAL AND SYNTHETIC PLACEBO‑CONTROLLED RANDOMIZED STUDY WITH DOSE-UP FOR NON-RESPONDERS TO INVESTIGATE SAFETY AND EFFICACY OF RITLECITINIB 50 MG AND 100 MG ONCE DAILY IN ADULT AND ADOLESCENT PARTICIPANTS 12 YEARS OF AGE AND OLDER WITH ALOPECIA AREATA

Date Added
September 12th, 2025
PRO Number
Pro00143084
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This research study aims to evaluate how effective and safe the 100 mg daily dose of ritlecitinib is for participants. By including the already approved 50 mg daily dose as a reference point, the study seeks to draw direct comparisons between these two dosages. This comparison will help determine if increasing the dosage offers additional benefits or poses any new risks. Participants in this study will be closely monitored to assess both their response to treatment and any potential side effects that may arise. The findings from this investigation are expected to provide valuable insights into optimizing ritlecitinib dosing regimens for better therapeutic outcomes.

Institution
MUSC
Recruitment Contact
Devyn Spino
843-876-2281
spino@musc.edu

A Multicenter, Parallel-group, Double-blind, 2-Arm, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared with Placebo Added to Standard of Care in Adult Participants with Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)

Date Added
September 12th, 2025
PRO Number
Pro00146131
Researcher
Kimberly Hashemi

List of Studies

Keywords
Skin
Summary

This multicenter, randomized, placebo-controlled, double-blind study aims to evaluate the efficacy of anifrolumab subcutaneous (SC) injection compared to a placebo in reducing overall disease activity in participants with moderate to severe idiopathic inflammatory myopathies (IIM), specifically polymyositis (PM) and dermatomyositis (DM), while they receive standard care treatment.

Institution
MUSC
Recruitment Contact
Kennedy McLeod
843-792-491
mcleodke@musc.edu



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