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 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 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 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 3, Multi-center, Open-label, Single-arm Study to Assess the Safety of Apremilast (AMG 407) in Pediatric Subjects from 6 Through 17 Years of Age With Mild to Moderate Plaque Psoriasis

Date Added
January 31st, 2024
PRO Number
Pro00130368
Researcher
Lara Wine Lee

List of Studies


Keywords
Children's Health, Skin
Summary

This study is being done to learn more about apremilast (AMG 407) in mild to moderate plaque psoriasis in participants (children and adolescents) aged 6 to 17 years. It will see whether it causes any side effects. About 50 people are expected to take part in this study. The duration of the study is approximately 285 days. This includes 3 phases: 35 days of screening phase, 225 days (32 weeks) of treatment phase, and 60 days of observational follow-up phase after the last dose of study drug – this means drug is still being tested to see if it is safe and works.

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

A Phase 3, Multicenter, Double-blind Maintenance Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASCEND)

Date Added
January 17th, 2024
PRO Number
Pro00131403
Researcher
Lara Wine Lee

List of Studies


Keywords
Children's Health, Skin
Summary

The study is being conducted in order to assess the long-term safety of rocatinlimab in adult and adolescent subjects with moderate-to-severe atopic dermatitis (AD). The study population will include subjects who completed an end of treatment duration visit in a parent study and meet eligibility criteria. Subjects will be randomized to receive a dosage of rocatinlimab based on age and their previous dosage from the parent study. The total duration of participation, including the parent study, will be up to 2.5 to 3 years, with a safety follow-up period after the last dose of investigational product at week 104.

Institution
MUSC
Recruitment Contact
Mikayla DiDonato
843-876-2281
didonato@musc.edu

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Participants with Moderate to Severe Plaque Psoriasis with Randomized Withdrawal and Retreatment

Date Added
January 8th, 2024
PRO Number
Pro00132759
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Skin
Summary

The purpose of this study is to evaluate the efficacy of JNJ-77242113 in participants with moderate to severe plaque psoriasis. The total duration of this study for each participant is approximately 165 weeks, which includes a 5-week screening period, a placebo-controlled period through Week 16 and a randomized withdrawal and retreatment period from Week 24 through Week 52. At Week 52, participants will be transitioned to open-label JNJ-77242113 through Week 156 and a 4-week safety follow-up period will be observed for participants who discontinue study intervention during the study or at the end of the treatment period.

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

A 2-part, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate-to-Severe Pruritus in Adult Subjects With Notalgia Paresthetica

Date Added
January 2nd, 2024
PRO Number
Pro00130543
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This is Phase 2, 2-part, placebo-controlled study to evaluate the efficacy of the oral medication Difelikefalin at 3 different dose levels (0.25 mg, 1 mg, 2 mg BID) for Moderate-to-Severe Pruritus in Adult Subjects With Notalgia Paresthetica. Study participants will participate in Part A or Part B of the study. If you are eligible to take part in this study, you will be randomly assigned to one of 4 study treatment arms during Part A of the study.
• Arm 1: Difelikefalin 0.25 mg
• Arm 2: Difelikefalin 1 mg
• Arm 3: Difelikefalin 2 mg
• Arm 4: placebo
Participants enrolling in Part B will be randomized in a 1:1 ratio receiving either Difelikefalin or placebo. The dose of Difelikefalin will be determined by the results of Part A. The duration of Blinded Treatment: Part A: 8 weeks, Part B: 8 weeks. A 52 week Open-label extension (OLE) is available for participants enrolling in Part B. During the OLE, participants. Difelikefalin will be administered in the same dose as Part B.

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

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Baricitinib in Children from 6 Years to Less than 18 Years of Age with Alopecia Areata

Date Added
September 11th, 2023
PRO Number
Pro00126611
Researcher
Lara Wine Lee

List of Studies


Keywords
Pediatrics, Skin
Summary

This is a Phase 3, placebo-controlled, randomized, double-blind research study evaluating the efficacy, safety, and PK of baricitinib in children from 6 years to less than 18 years of age with severe alopecia areata. The study is divided into 4 periods: a 5-week screening period, a 36-week double-blind treatment period, an approximately 2-year long-term extension period, and a 4-week posttreatment follow-up period. If the subject meets all eligibility criteria they will be randomized to receive either baricitinib high dose, baricitinib low dose, or placebo for 36 weeks. Participants will then be transitioned into the long-term extension treatment period. Subjects will attend 18 clinic visits for up to 145 weeks.

Institution
MUSC
Recruitment Contact
Madeline Richmond
8437921436
richmoma@musc.edu

A placebo-controlled trial to evaluate the efficacy and safety of spesolimab in the treatment of patients with Netherton syndrome

Date Added
August 28th, 2023
PRO Number
Pro00128405
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This is a multi-center, randomized, double-blind, placebo-controlled, phase II/III study to evaluate the efficacy and safety of spesolimab compared to placebo in the treatment of Netherton syndrome. This study will last up to 72 weeks with 16 clinic visits. Eligible patients will be randomized 2:1 to receive either spesolimab i.v. loading doses at Week 0 plus spesolimab subcutaneous doses every 4 weeks, or to receive placebo i.v. loading dose at Week 0 plus placebo subcutaneous doses every 4 weeks. At Week 20, all patients will enter the open label period to receive spesolimab subcutaneous dose every 4 weeks up to Week 52. There will be a safety follow up visit 16 weeks after the last dose.

Institution
MUSC
Recruitment Contact
Mikayla DiDonato
843-876-2281
didonato@musc.edu



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