J2T-MC-B002 (ADjoy): A Prospective Observational Cohort Study Evaluating Lebrikizumab Therapy in the Management of Adult and Pediatric Participants 12 Years of Age and Older with Moderate-to-Severe Atopic Dermatitis in North America

Date Added
July 16th, 2025
PRO Number
Pro00142075
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

J2T-MC-B002 (B002) examines the effectiveness of lebrikizumab in treating moderate-to-severe atopic dermatitis (AD). This study involves adult and adolescent patients suffering from eczema, which is characterized by inflammation, redness, and irritation of the skin. Participants will complete symptom assessments during their visits and will schedule appointments within specific timeframes. The study will also observe skin lesions using clinical measures. Participants will remain in the study for up to two years, even if their therapies change, to track disease progression with or without lebrikizumab. This observational study aims to record real-world treatment outcomes for the analysis of lebrikizumab in AD therapy.

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

A Phase 2, Open-Label, 4-Week Safety Study of Roflumilast Cream 0.05% Administered Once Daily in Infants Aged 3 Months to Less Than 2 Years with Atopic Dermatitis

Date Added
June 6th, 2025
PRO Number
Pro00144456
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This study aims to evaluate the safety and tolerability of ARQ-151 cream 0.05% in infants with mild to moderate eczema after daily application for four weeks. ARQ-151 contains the active ingredient roflumilast, which reduces the activity of the enzyme PDE-4 involved in inflammation. Since eczema is an inflammatory skin disease, ARQ-151 could potentially help treat this condition.

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

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, 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

A PHASE 3 RANDOMIZED, DOUBLE-BLIND, 52-WEEK PLACEBOCONTROLLED MULTI-CENTER STUDY WITH A DOUBLE-BLIND 52-WEEK EXTENSION PERIOD WITH RANDOMIZED DOSE UP/DOSE DOWN TITRATION INVESTIGATING THE EFFICACY, SAFETY, AND TOLERABILITY OF RITLECITINIB IN ADULT PARTICIPANTS WITH NONSEGMENTAL VITILIGO

Date Added
February 13th, 2025
PRO Number
Pro00138891
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

Ritlecitinib (PF 06651600) is an investigational drug (referred to as "study drug" from here on) and is being developed as possible study treatment for participants with non segmental vitiligo (both active and stable vitiligo). The study drug will be compared with a placebo to find out if the study drug is better than the placebo for the study treatment of vitiligo. After a screening period of up to 30 days, approximately 1000 eligible participants (Part Ia) will be randomized in a 3:1:1 ratio to ritlecitinib 100 mg QD (600 participants), ritlecitinib 50mg QD (200 participants), and placebo (200 participants) in the 52-week placebo-controlled treatment period. At Week 52, based how patients respond to the study drug will enter the 52 week extension period.

Institution
MUSC
Recruitment Contact
Courtney Rowley
843-792-9784
rowle@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, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of subcutaneous sonelokimab in adult participants with moderate to severe hidradenitis suppurativa

Date Added
October 24th, 2024
PRO Number
Pro00137663
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This is a Phase 3, multicenter, randomized, parallel-group, double-blind, placebo-controlled study to evaluate the efficacy and safety of sonelokimab in adults with moderate to severe HS. Following a Screening Period of up to 28 days, each participant will enter a Placebo-controlled Period of 16 weeks (Part A) and subsequently a Crossover/Maintenance Period of 36 weeks (Part B). In Part A subjects will be randomly assigned in a 2:1 ratio to sonelokimab 120 mg or placebo. In Part B, participants who were initially randomized to placebo will cross over to sonelokimab and will receive this treatment for the remainder of the study. An End of Treatment (EOT) Visit will be performed at Week 52. After the EOT Visit, all participants who complete Week 52 will be offered the opportunity to enter an optional long-term open label extension (OLE) study under a separate protocol. For participants who do not progress to the OLE study, a Safety Follow-up Visit will be required 8 weeks after the last dose of study treatment.

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



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