CorEvitas International Adolescent Alopecia Areata (AA) Drug Safety and Effectiveness Registry

Date Added
May 29th, 2025
PRO Number
Pro00139971
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

An international research registry called the CorEvitas International Adolescent Alopecia Areata (AA) Registry (the "CorEvitas Registry"). This observational registry studies adolescent patients with AA between 12-17 years of age under the care of a dermatology provider diagnosed with moderate to severe alopecia areata.

Institution
MUSC
Recruitment Contact
Mary Tyler Lillich
843-876-9302
lillich@musc.edu

CorEvitas International Adolescent Atopic Dermatitis (AD) Drug Safety and Effectiveness Registry

Date Added
May 21st, 2025
PRO Number
Pro00140864
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

An international research registry called the CorEvitas International Adolescent Atopic Dermatitis (AD) Registry (the "CorEvitas Registry"). This observational registry studies adolescent patients with AA between 12-17 years of age under the care of a dermatology provider diagnosed with moderate to severe atopic dermatitis.

Institution
MUSC
Recruitment Contact
Mary Tyler Lillich
843-876-9302
lillich@musc.edu

A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects with Moderate to Severe Hidradenitis Suppurativa Who Have Failed Anti-TNF Therapy

Date Added
March 28th, 2025
PRO Number
Pro00141998
Researcher
Kimberly Hashemi

List of Studies

Keywords
Skin
Summary

This Phase 3, randomized, placebo-controlled, double-blind study evaluates the efficacy and safety of Upadacitinib in adults and adolescents with moderate to severe hidradenitis suppurativa who have failed anti-TNF therapy. The study includes a 35-day screening period, a 16-week placebo-controlled, double-blind treatment period (Period 1), a 20-week re-randomized extension treatment period (Period 2), a 68-week long-term extension treatment period (Period 3), and a 30-day follow-up period.

Institution
MUSC
Recruitment Contact
Neharika Talasila
843-792-6882
talasila@musc.edu

A Phase 3, Randomized, Double-Blind, Safety, and Efficacy Study of Ruxolitinib Cream in Pediatric Participants With Nonsegmental Vitiligo

Date Added
March 7th, 2025
PRO Number
Pro00140123
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This study aims to evaluate the effectiveness of ruxolitinib cream compared to a placebo (vehicle) cream in treating vitiligo in children aged 2 to 12 years. The vehicle cream looks identical to the ruxolitinib cream but contains no active medication. By comparing these two treatments, researchers hope to determine whether ruxolitinib is more effective than the placebo in improving facial and body vitiligo symptoms. This study could provide important insights into new treatment options for young children affected by this condition.

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

An open-label, single-arm study to evaluate the pharmacokinetics and safety of subcutaneous sonelokimab in adolescents aged ≥12 to ≤17 years at the time of study inclusion with active moderate to severe hidradenitis suppurativa.

Date Added
February 13th, 2025
PRO Number
Pro00141590
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

M1095-HS-304 is a Phase 3, open-label, single-arm design that assesses the safety and tolerability of sonelokimab in adolescent patients with HS. The study population will comprise adolescent participants (aged ≥12 to ≤17 years) with moderate to severe HS.

Institution
MUSC
Recruitment Contact
Kenreka Yeadon
8438760110
yeadon@musc.edu

A randomized, double-blind, double-dummy, placebo-controlled, multicenter, Phase 3 study assessing the efficacy, safety, and tolerability of 2 doses of remibrutinib over a 68-week treatment period in adult patients with moderate to severe hidradenitis suppurativa

Date Added
January 10th, 2025
PRO Number
Pro00141359
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

The research study determines if remibrutinib (study treatment) with two doses, dose A (10 mg b.i.d.) and dose B (25 mg b.i.d)., is safe and effective and can help adult patients with moderate to severe hidradenitis suppurativa (HS).

Institution
MUSC
Recruitment Contact
Neharika Talasila
843-792-6882
talasila@musc.edu

A Phase 3, randomized, double-blind, placebo-controlled, parallel-group, 3-arm, multinational, multicenter study to evaluate the efficacy and safety of amlitelimab by subcutaneous injection in participants aged 12 years and older with moderate to-severe atopic dermatitis (AD) who are on background topical corticosteroids and have had an inadequate response to prior biologic therapy or oral Janus Kinase (JAK) inhibitor treatment

Date Added
November 21st, 2024
PRO Number
Pro00138920
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Pediatrics, Skin
Summary

This is a Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 3-arm, multiple dose level study to investigate the efficacy and safety of subcutaneous injections of amlitelimab in participants aged 12 years and older with moderate-to-severe AD who are on background topical corticosteroids or calcineurin inhibitors and have had an inadequate response to prior biologic or oral JAKi therapy. There will be up to 13 visits including up to a 4-week screening period, a 36 week treatment period, and a post-treatment safety follow up period or a long-term Safety Study for 16 weeks. Subjects will be randomized in a 1:1:1 ratio to the following study arms: amlitelimab Q4W, amlitelimab Q12W, and placebo Q4W.

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

A Phase 3, Open-label, Efficacy-Assessor-Blinded Study, Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Children from 2 to Less than 12 Years of Age with Moderate to Severe Atopic Dermatitis (START UP)

Date Added
October 9th, 2024
PRO Number
Pro00138750
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This study is being conducted at approximately 150 research centers worldwide and is expected to enroll approximately 675 pediatric subjects in total with moderately to severely AD. This study will have 2 cohorts, a Randomized Cohort, and a Dupilumab-Inadequate Responder / Dupilumab Medically Inadvisable Cohort. The study comprises a 35-day Screening Period; a 16-week, open-label, efficacy assessor blinded study treatment period for the subjects in the randomized cohort; an open-label period up to Week 160 for subjects in the upadacitinib study treatment arms across both cohorts (Randomized Cohort and Dupi-IR/Dupilumab Medically Inadvisable Cohort); an open label period up to Week 52 for subjects in the dupilumab arm; and a 30-day Follow up Visit/call after the last dose is administered for upadacitinib or dupilumab.

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

A Phase 3b/4 Randomized, Open-label, Efficacy Assessor-Blinded Study, to Evaluate the Efficacy and Safety of Upadacitinib for the Treatment of Adult Subjects with Moderate to Severe Atopic Dermatitis and Inadequate Response to Dupilumab (SWITCH-UP)

Date Added
June 12th, 2024
PRO Number
Pro00137232
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This is a global, Phase 3b/4, randomized, open-label, efficacy assessor-blinded, multi-center study that will evaluate upadacitinib compared to dupilumab in adult subjects with moderate to severe AD and inadequate response to dupilumab after at least 6 months of current use. The study consists of a 35-day Screening Period; an 8-week randomized, open-label, efficacy assessor blinded treatment period for all participants (Period 1); a 24-week open-label, efficacy assessor-blinded extension period for all participants who finish Period 1 (Period 2) (total duration of Period 1 and Period 2 is 32 weeks); and a 30-day Follow-up visit.

Institution
MUSC
Recruitment Contact
Alyson Winter
843-876-3209
wintera@musc.edu

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)

Date Added
May 2nd, 2024
PRO Number
Pro00135115
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Children's Health, Skin
Summary

This is a randomized, double-blind, parallel group, vehicle-controlled phase to evaluate the efficacy and safety of diacerein 1% ointment applied topically once daily for 8 weeks for the treatment of adult and pediatric (age ≥ 6 months) patients with generalized EBS. The duration of study participation is anticipated to be approximately ~16 to 20 weeks per patient consisting of a Screening Period of up to 4 weeks, a Treatment Period of 8 weeks and a No Treatment Follow-up Period of 8 weeks. Patients that complete this portion of the study will be eligible to participate in an open-label, 24-week extension phase to evaluate the long-term safety of diacerein 1% ointment for the treatment of generalized EBS.

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



-- OR --