A Phase 3 randomized, placebo-controlled, double-blind program to evaluate efficacy and safety of upadacitinib in adult and adolescent subjects with severe alopecia areata

Date Added
February 7th, 2024
PRO Number
Pro00132680
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Skin
Summary

The purpose of this study is to evaluate the efficacy and safety of upadicitinib in adults and adolescents with severe alopecia areata. Participation in this research study will take approximately 168 weeks with 17 visits in that time. This research study includes three phases; a screening phase, treatment phase, and a follow-up phase. The length of the screening period varies from 1 to 35 days, depending on therapies that must be washed out or discontinued before initiation of treatment. Patients who meet all eligibility criteria will be randomized to receive upadicitinib or placebo for the first 24 weeks. At week 24, all patients will receive upadicitinib until week 160. The post-treatment follow-up visit will occur approximately 30 days after the last study drug dose.

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

A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Eltrekibart in Adult Participants with Moderate to Severe Hidradenitis Suppurativa

Date Added
February 15th, 2024
PRO Number
Pro00132756
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

The purpose of this study is to evaluate the efficacy of eltrekibart compared to placebo in adults with moderate to severe HS. The study duration will be up to 67 weeks. This study includes a screening period, a 16-week double-blind, placebo-controlled treatment period, a 36-week double-blind maintenance treatment period, and a 10-week follow-up period.

Institution
MUSC
Recruitment Contact
Tiffany Vereen
843-792-6882
vereent@musc.edu

A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-6194 in Adult Participants with Non Segmental Vitiligo

Date Added
February 20th, 2024
PRO Number
Pro00133486
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

The purpose of this research study is to study if the investigational drug, MK-6194, is safe and effective to treat adults with non-segmental vitiligo. In this study, MK-6194 or placebo administration will occur every two weeks or every four weeks to evaluate how well MK-6194 may treat non-segmental vitiligo. This study can last up to 60 weeks, including up to 4 weeks for screening, up to 52 weeks for treatment, and 14 days for safety follow-up. Eligible participants will be randomized 1:1:1 to receive MK-6194 every two weeks, every four weeks, or receive placebo.

Institution
MUSC
Recruitment Contact
Tiffany Vereen
843-792-6882
vereent@musc.edu

A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, and Tolerability of Upadacitinib in Adult and Adolescent Subjects with Non-Segmental Vitiligo Who Are Eligible for Systemic Therapy

Date Added
March 25th, 2024
PRO Number
Pro00135007
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Skin
Summary

The primary objective of this study is to evaluate the efficacy, safety, and tolerability of upadacitinib for the treatment of adults and adolescents with Non-Segmental Vitiligo who are eligible for systemic therapy. This study is comprised of a 35-day Screening Period; a 48-week placebo-controlled, double-blinded treatment period (Period A); a 112-week open-label extension period (Period B); and a 30-day follow-up period. In Period A, adult and adolescent subjects who meet eligibility criteria will be randomized 2:1 to receive daily oral doses of upadacitinib 15 mg or matching placebo. Subjects who complete Period A will continue into Period B and will receive open-label upadacitinib 15 mg.

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

A Double-Arm, Open Label, Phase III Study to Compare the Efficacy and Safety of SCENESSE® and Narrow-Band Ultraviolet B (NB-UVB) Light versus NB-UVB Light Alone in the Treatment of Vitiligo

Date Added
March 28th, 2024
PRO Number
Pro00135212
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Skin
Summary

This is a double arm, open label, 20-week Phase III study with three and six-month follow up periods, in patients with a documented history of generalised vitiligo.
Up to 200 eligible patients across study sites will be enrolled and randomised in equal numbers to one of the following treatment groups:
• Group A will receive NB-UVB twice weekly from Day 0 (40 treatments in total), and SCENESSE® (one implant administered on Days 0, 21 (±4), 42 (±4), 63 (±4), 84 (±4), 105 (±4) and 126 (±4) (seven implants in total));
• Group B will receive NB-UVB light only (administered twice weekly for 20 weeks, 40 treatments in total).
To determine eligibility for study participation, patients will undergo a screening evaluation within a 28-day period before receiving the first study treatment.

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

A Prospective Observational Study of Patients Receiving Dupilumab for Prurigo Nodularis

Date Added
April 18th, 2024
PRO Number
Pro00129789
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This is a non-interventional, prospective, multinational, post-marketing, observational study designed to describe the real-world effectiveness, safety, and patterns of use of dupilumab in patients with PN. This study will be conducted globally and will collect data available from patients' medical files and other items routinely collected during disease management in clinical practice and PROs related to disease, work productivity, and QoL.

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

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

A MULTICENTER, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, ACTIVE-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB COMPARED TO USTEKINUMAB IN CHILDREN AND ADOLESCENTS FROM 6 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Date Added
June 24th, 2024
PRO Number
Pro00136667
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Skin
Summary

The purpose of this study is to evaluate the efficacy and safety of bimekizumab compared to active control (ustekinumab) in children and adolescents (from 6 to <18 years of age) with moderate to severe plaque PSO. This study will consist of the following periods:
• Screening Period: up to 5 weeks
• Initial Treatment Period: 16 weeks
• Maintenance Period: 32 weeks
• OLE Period: 104 weeks
• SFU Period: 20 weeks after final dose of IMP
After the Screening Period of up to 5 weeks, eligible study participants will be randomized in a 2:1 ratio of bimekizumab to ustekinumab. Study participants will participate in a 16-week double-blinded Initial Treatment Period and continue into a 32-week double-blinded Maintenance Period. After completion of the Maintenance Period, study participants will be offered the opportunity to continue in a 104-week open label extension period and receive bimekizumab.

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

A PHASE 3 RANDOMIZED WITHDRAWAL AND DOSE-UP TITRATION, MULTICENTER EXTENSION STUDY INVESTIGATING THE SAFETY, EFFICACY, AND TOLERABILITY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS WITH NONSEGMENTAL VITILIGO

Date Added
August 13th, 2024
PRO Number
Pro00135139
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This is a Phase 3, 52-week, multi-center, double-blind, parallel-group, randomized withdrawal (RW), dose-up titration (DUT) extension study investigating the safety, tolerability, efficacy and durability of response of ritlecitinib (50 mg QD and 100 mg QD) in adult and adolescent (where permitted) participants with nonsegmental vitiligo following their participation in pivotal Study B7981040. The maximum duration of study participation is approximately 14 months, including a screening period up to 25 days, a 52-week treatment period, and a 4-week follow-up period.

Institution
MUSC
Recruitment Contact
Tiffany Vereen
843-792-6882
vereent@musc.edu



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