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 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 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

The Impact of Skin Disease on Self-Reported Quality of Life and Psychosocial Health in Youth with Cutaneous Lupus Erythematosus

Date Added
September 9th, 2025
PRO Number
Pro00142882
Researcher
Lara Wine Lee

List of Studies


Keywords
Children's Health, Lupus, Pediatrics, Skin
Summary

Cutaneous lupus is a common manifestation of childhood-onset Systemic Lupus Erythematosus (cSLE), affecting up to 85% of patients. Skin involvement can cause irritation, scarring, hair loss, changes in skin color and appearance, which may negatively impact quality of life and mental health. This study aims to assess the impact of cutaneous lupus on quality of life and mental health in diverse pediatric populations, with the goal of identifying disparities and improving individualized care. We will use validated surveys to assess disease burden on quality of life.

Institution
MUSC
Recruitment Contact
Courtney Rowley
843-792-9784
rowle@musc.edu

A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa: Topical Ruxolitinib Evaluation in Hidradenitis Suppurativa (TRuE-HS1)

Date Added
August 21st, 2025
PRO Number
Pro00144283
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

The primary purpose of this study is to assess the efficacy and safety of ruxolitinib 1.5% cream applied twice daily in participants with mild to moderate HS (Hurley Stage I or II) without draining tunnels.

Institution
MUSC
Recruitment Contact
Kennedy McLeod
8437924091
mcleodke@musc.edu



-- OR --