Phase 2, randomized, parallel-group, double-blind, placebo-controlled study of sonelokimab in patients with active moderate to severe hidradenitis suppurativa

Date Added
September 26th, 2022
PRO Number
Pro00121055
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This is a Phase II, randomized, parallel-group, double-blind, placebo-controlled study of sonelokimab in participants with active moderate to severe HS. This study aims to evaluate the safety and efficacy of 2 different doses of sonelokimab in treating HS, in comparison to the placebo. The study includes a screening period of up to 28 days, a 24-week treatment period and a 4-week safety follow-up period. For the first 12 weeks, adalimumab will be used as a reference treatment.

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

The ASCEND Trial: A Multicenter, Double Blinded Vehicle Controlled Study of TMB-001, a Proprietary Isotretinoin Ointment, in the Treatment of RXLI (X-linked) or ARCI (Lamellar) Ichthyosis; Preceded by a Voluntary Maximal Use Study; Both Studies in Subjects 6 Years of Age and Above

Date Added
August 10th, 2022
PRO Number
Pro00120937
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Drug Studies, Pediatrics, Skin
Summary

This study aims to evaluate the safety and efficacy of isotretinoin ointment (TMB-001 0.05%) in treating subjects > or = to 6 years of age with lamellar ichthyosis, and aims to assess the bodily absorption of the cream across application frequencies. Subjects with ARCI/RXLI will be randomized 2:1, to either receive the TMB-001 0.05% isotretinoin ointment or a vehicle ointment - applied daily - for 3 weeks. Subsequently, dosing will be increased to twice daily for 9 weeks. If significant improvement is observed at the end of the 9 weeks, subjects will be randomized 1:1 to receive the TMB-001 0.05% ointment, either applied daily or twice-daily, for 12 weeks. Prior to the Phase III trial, subjects will have the option to participate in a 14 day treatment period with TMB-001 0.05% - twice daily - followed by continued treatment with TMB-001 0.05% twice daily for 10 weeks.

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

A randomized, subject and investigator blinded, placebo-controlled and multi-center platform study, to assess efficacy and safety of different investigational drugs in patients with moderate to severe hidradenitis suppurativa

Date Added
April 28th, 2022
PRO Number
Pro00116044
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This study is designed to assess the efficacy, safety and tolerability of selected systemic investigational treatments for 16 weeks in moderate to severe hidradenitis suppurativa (HS) subjects. Data from this study will enable determination of whether the clinical profile of these investigational treatments support further clinical development in moderate to severe HS.

Institution
MUSC
Recruitment Contact
Caroline Porter
843-876-0110
portecar@musc.edu

A PHASE 3, OPEN-LABEL, PARALLEL GROUP, MULTICENTER, EXTENSION STUDY EVALUATING THE LONG-TERM TREATMENT OF BIMEKIZUMAB IN STUDY PARTICIPANTS WITH MODERATE TO SEVERE HIDRADENITIS SUPPURATIVA

Date Added
April 7th, 2022
PRO Number
Pro00119754
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

The purpose of this open-label extension study is to help us understand how safe and effective a new investigational drug called bimekizumab is for long-term use in treating hidradenitis suppurativa. This study will involve approximately 830 study participants across approximately 200 centers. Participants will either receive 320mg bimekizumab once every two weeks or 320mg bimekizumab once every four weeks. The total duration of the study will be up to 118 weeks. This study includes a total of 52 study visits.

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

Open-label Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Ustekinumab in Pediatric Participants

Date Added
March 21st, 2022
PRO Number
Pro00118773
Researcher
Lara Wine Lee

List of Studies


Keywords
Pediatrics, Skin
Summary

The purpose of this study is to find out how long ustekinumab stays in and acts in participant's who are diagnosed with pediatric psoriasis and juvenile psoriatic arthritis. This is measured by blood tests. Another purpose is to find out if ustekinumab can cause side effects, which are unexpected or unwanted reactions from taking a drug. About 75 children will take part in this study worldwide. Participants will be in the study for a maximum of about 16 weeks.

Institution
MUSC
Recruitment Contact
Wounmee Yaka
8437924091
yaka@musc.edu

Daily Topical Rapamycin Therapy for the Treatment of Vitiligo

Date Added
March 1st, 2022
PRO Number
Pro00115924
Researcher
Ahmad Aleisa

List of Studies

Keywords
Adolescents, Autoimmune disease, Pediatrics, Skin
Summary

In current Dermatology practice, options for vitiligo remain limited. The purpose of this study is to determine if once daily dosed topical rapamycin is effective for the treatment of patients with vitiligo. Participants will apply either 0.1% topical rapamcyin or 0.001% topical rapamycin for six months to a lesion on one side of the body, and topical placebo to a corresponding lesion on the opposite side of the body. The study also aims to evaluate patient satisfaction and identify any adverse effects on these dosing regimens.

Institution
MUSC
Recruitment Contact
Chelsea Shope
8437549577
shopec@musc.edu

A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PRA023 in Subjects with Systemic Sclerosis Associated with Interstitial Lung Disease (SSc-ILD)

Date Added
February 22nd, 2022
PRO Number
Pro00117883
Researcher
Richard Silver

List of Studies


Keywords
Autoimmune disease, Drug Studies, Rare Diseases, Scleroderma, Skin
Summary

The purpose of this study is to test whether a drug called PRA023 (the study drug) is a good treatment for patients with Systemic Sclerosis associated with Interstitial Lung Disease (SSc-ILD). The study drug PRA023 is an investigational drug that is given by infusion every 4 weeks. An investigational drug is not approved by The US Food and Drug Administration. It can only be used in a research study like this one. In this study, PRA023 will be compared with a placebo (dummy drug). The placebo will be a saline solution that does not have any study drug in it. The comparison with the placebo helps to determine whether the effects seen in your body is because of the PRA023 or not. This is a randomized study meaning that you will be assigned by chance (like flipping a coin) to receive either the study drug or placebo. This will be done with the help of a computer-based program and you will have 50% chance of receiving either the study drug or placebo. The study is double-blinded study and 50 weeks long, meaning you and your study doctor will not know what you are receiving, the study drug or placebo.

The study is sponsored by Prometheus Biosciences, Inc. The study is being done at approximately 25 sites across the United States. The main portion of the study will require 15 visits to the MUSC main campus and will have the following procedures completed over the course of your participation: blood draw, physician-led assessments of your disease (for example physical exam and skin thickness testing), tests to assess your pulmonary function and health (Pulmonary Function Test (PFT) and High Resolution Computed Tomography (HRCT)), electrocardiogram, as well as asked to complete surveys. Compensation is available for participation.

Institution
MUSC
Recruitment Contact
Brittany Frasier
843-792-8613
frasibri@musc.edu

Multicenter Phenotype-Genotype Analysis of Vascular Anomalies and Related Syndromes

Date Added
December 24th, 2021
PRO Number
Pro00116848
Researcher
Lara Wine Lee

List of Studies


Keywords
Genetics, Pediatrics, Skin, Vascular
Summary

The purpose of this research study is to develop a better understanding of the cause and natural history of vascular anomalies and related syndromes. This study is being done in order to develop a better understanding of the cause of vascular anomalies in order to to improve care for people who are affected by these anomalies and related syndromes.

This study is being done at the University of Wisconsin-Madison (UW-Madison) and other sites in North America and Europe. A total of about 1000 people will participate in this study. About 20 – 30 people will take part in the study here at the Medical University of South Carolina.

Institution
MUSC
Recruitment Contact
Chelsea Shope
8437549577
shopec@musc.edu

A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Children (Ages ≥ 2 Years to < 12 Years) With Atopic Dermatitis

Date Added
November 16th, 2021
PRO Number
Pro00115393
Researcher
Lara Wine Lee

List of Studies


Keywords
Children's Health, Skin
Summary

The purpose of this research study is to determine if an investigational cream, ruxolitinib cream (0.75% and 1.5% strengths), is safe and effective to treat Atopic Dermatitis. In this study, ruxolitinib cream will be compared to a "vehicle cream." The vehicle cream looks like the ruxolitinib cream but contains no ruxolitinib. This study can last up to 55 weeks. For the first 8 weeks participants will be randomly assigned to receive either the ruxolitinib cream or vehicle cream. For the following 44 weeks participants will receive the ruxolitinib cream.

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Non-Segmental Vitiligo

Date Added
September 21st, 2021
PRO Number
Pro00111604
Researcher
Lara Wine Lee

List of Studies


Keywords
Drug Studies, Skin
Summary

The purpose of this study is to test and compare the effects of an investigational drug called Upadacitinib versus placebo in adults aged 18 to 65 with a diagnosis of non-segmented vitiligo. Participants that meet eligibility criteria will be randomized into 1 of 5 treatments groups for a period of 24 weeks. At week 24, participants who were randomized to placebo will be switched to either 22 or 11 mg upadacitinib in a blinded fashion, while those receiving the drug will remain in their randomized treatment at week 24. This will be a 28 week blinded long-term extension.

Institution
MUSC
Recruitment Contact
Lauren Parsons
8437921436
parsonla@musc.edu



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