A long-term non-interventional study to assess the incidence of skin malignancies in patients with dystrophic and junctional epidermolysis bullosa receiving treatment with Filsuvez (FOSTER)

Date Added
March 26th, 2026
PRO Number
Pro00149282
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This observational, multi-country cohort study examines the long-term safety of Filsuvez in real-world clinical practice. Researchers will collect both primary data and use existing patient registry data to gather information on Filsuvez exposure, skin malignancies, medical history, and other clinical characteristics. The study will include patients with confirmed diagnoses of DEB and JEB, regardless of whether they use Filsuvez, as long as they meet the approved indication. Patients previously exposed to Filsuvez through clinical trials, early access programs, or compassionate use programs may also participate. The study does not require any protocol-mandated visits or procedures, and the frequency of patient visits will follow local standard practice and individual patient needs.

Institution
MUSC
Recruitment Contact
Emma Edwards
8438769302
edwaremm@musc.edu

A LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF APG777 IN PATIENTS WITH ATOPIC DERMATITIS PREVIOUSLY TREATED WITH APG777

Date Added
March 4th, 2026
PRO Number
Pro00149283
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This research study will evaluate the long-term safety and effectiveness of APG777 in patients with moderate-to-severe atopic dermatitis (AD) who have already completed treatment in a previous APG777 study. The study is multicenter and double-blind, and participants will continue with the same dose and injection schedule as in their prior study. The study includes three periods: a screening visit, an extended treatment period of about 92 weeks, and a post-treatment follow-up of up to 52 weeks. Patients who met certain improvement criteria in the previous study will continue their maintenance regimen, while others will enter an open-label Escape Arm with a different dosing schedule. The study aims to determine whether long-term use of APG777 is safe and effective for patients who may benefit from continued treatment.

Institution
MUSC
Recruitment Contact
Madeline Richmond
843-792-1436
richmoma@musc.edu

A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults with Lichen Planopilaris

Date Added
March 3rd, 2026
PRO Number
Pro00149812
Researcher
Kimberly Hashemi

List of Studies

Keywords
Skin
Summary

The purpose of this clinical research study is to learn more about the use of an investigational medicine, called brepocitinib, for the treatment of Lichen Planopilaris (LPP). The study will also look at how safe and effective brepocitinib is and will monitor the long-term safety of brepocitinib when taken for a period up to 52 weeks.

Institution
MUSC
Recruitment Contact
Kennedy McLeod
843-792-4091
mcleodke@musc.edu

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 LONG-TERM, DOUBLE-BLIND EXTENSION STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF RITLECITINIB IN PARTICIPANTS WITH SEVERE ALOPECIA AREATA WHO PREVIOUSLY COMPLETED STUDIES B7981027 OR B7981031

Date Added
February 18th, 2026
PRO Number
Pro00139005
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

Study B7981028 is a Phase 3 long-term, double-blind extension study aimed at evaluating the safety and efficacy of ritlecitinib in participants with severe alopecia areata (AA). This study includes individuals who have completed previous ritlecitinib studies, B7981031 or B7981027, and are eligible to enroll in the B7981028 study. The research seeks to gather more comprehensive data on the treatment's effects over an extended period.

Institution
MUSC
Recruitment Contact
Devyn Spino
843-876-2281
spino@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 Phase 3, multicenter, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous sonelokimab in participants with moderate to severe hidradenitis suppurativa.

Date Added
January 22nd, 2026
PRO Number
Pro00145394
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

M1095-HS-303 is a Phase 3, multicenter, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of sonelokimab in participants with moderate to severe HS who were previously enrolled in a parental study.
Rollover to this OLE study will occur at the time of the End-of-Treatment (EOT) visit of the parental study. Upon enrollment into this study, each participant can continue to receive sonelokimab 120 mg every 4 weeks (Q4W) for up to 2 years, with a safety follow-up (SFU). Visit 8 weeks after the last dose of study treatment. Following successful training and supervision, sonelokimab will be self-administered by the participant (or caregiver if required) at home and at the study center.

Institution
MUSC
Recruitment Contact
Kennedy McLeod
843-792-4091
mcleodke@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



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