Evaluation of Upadacitinib in Adult Subjects with Hidradenitis Suppurativa

Date Added
November 18th, 2020
PRO Number
Pro00103132
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

The purpose of this study is to assess the safety and efficacy of upadacitinib compared to placebo (which looks like upadacitinib but contains no active substance) for the treatment of signs and symptoms of moderate to severe Hidradenitis Suppurativa. This study is being conducted in approximately 28 research centers in 3 countries and is expected to enroll approximately 60 subjects.

During the first study treatment period, which lasts for 12 weeks, all subjects will be divided into two groups. One group will receive the study drug (upadacitinib), the other group will receive a placebo. The study drug and placebo are both to be taken as one tablet per day. You will have 5 study visits during this period. During the second study treatment period, which lasts 36 weeks, all subjects will receive the study drug. There are 5 scheduled study visits during this period. A final follow up call/visit will take place approximately 30 days after your last dose of study drug.

This is a double-blinded study, which means neither you nor your study doctor will know to which study group (which study treatment) you were assigned to receive. In case of an emergency, your study doctor can find out this information.

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

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Bimekizumab in Study Participants with Moderate to Severe Hidradenitis Suppurativa

Date Added
November 17th, 2020
PRO Number
Pro00102631
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

The purpose of this study is to help us understand how safe and effective a new drug called bimekizumab is for long-term use in treating hidradenitis suppurativa. Bimekizumab is a new drug that may eventually be used in the treatment of hidradenitis suppurativa. It is investigational, which means that is it still being tested, and has not yet been approved for treatment by the health authorities, such as the US Food and Drug Administration (FDA). Bimekizumab acts on the immune system to help reduce inflammation and other symptoms. In this study, bimekizumab is administered in three different dosing regimens. Among 490 study participants, 420 of them will be receiving bimekizumab (140 study participants under each dose of bimekizumab) and 70 of them will be receiving placebo for the first 16 weeks.

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

A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects with Moderate-to-Severe Atopic Dermatitis

Date Added
October 29th, 2020
PRO Number
Pro00102620
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

Galderma has begun a study of an investigational drug called nemolizumab as a possible treatment for atopic dermatitis. Participants who had been previously enrolled in nemolizumab AD Phase 3 pivotal study will be eligible to enroll for the long term extension. Patients who have completed their initial 16 week treatment period who do not qualify for the maintenance period will be given the option to enroll immediately into the long term extension study. Additionally, subjects who complete the maintenance periods (week 48 visit) may also be eligible to enroll in the long term extension study.

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

A Phase 3b, open-label treatment extension study of upadacitinib for the treatment of adult subjects with moderate to severe atopic dermatitis who completed treatment in Study M16-046

Date Added
August 4th, 2020
PRO Number
Pro00100984
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

The purpose of this study is to provide an open label treatment extension study for the treatment of adult subjects (18-75 years of age at entry into the M16-046 study) with moderate to severe atopic dermatitis who completed treatment in the M16-046 study. These subjects should be determined to be eligible to continue treatment with upadacitinib by the Principal Investigator during the Baseline visit of this open label extension study.

The M19-850 Baseline visit will be the Week 24 visit of the M16-046 study. Subjects, who are eligible to enroll in the open label study, will receive daily oral doses of upadacitinib 30 mg from the Baseline visit up to the Week 52 visit.

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

Innovative Dermatology Real World Data and Research Collaborative

Date Added
June 23rd, 2020
PRO Number
Pro00100084
Researcher
Lara Wine Lee

List of Studies


Keywords
Immune System, Skin
Summary

This is a 2-year, longitudinal, observational study of adult patients (ages 18 and above) being treated for moderate to severe plaque psoriasis.

Patients being prescribed or initiating medical therapy with a new biologic drug (such as risankizumab, guselkumab, brodalumab, tildrakizumab, ixekizumab, adalimumab, etanercept, ustekinumab, secukinumab, certilizumab pegol, infliximab, or apremilast) for the treatment of plaque psoriasis will be eligible for enrollment. The study will be conducted to gather data from enrolled patients' electronic health records, prospective physician-reported information provided by the patients' dermatologists, and information collected from questionnaires and surveys completed by the enrolled patients.

Patients will be screened and enrolled at a regularly scheduled clinic visit. Retrospective medical records from patients who provide consent/assent and meet all inclusion and exclusion criteria will be obtained by the research site. Records will include but will not be limited to: hospitalizations, emergency room visits, procedures, and medical costs. Physician reported outcomes will be recorded at regularly scheduled visits. Patients will also be asked to complete patient reported outcome (PRO) surveys and questionnaires to record data regarding demographics, clinical characteristics of psoriatic disease, comorbidities, family history, occupation and lifestyle factors, use of PsO support programs, contact information, concomitant medication use, medication side effects, and symptom characteristics.

During the follow-up period, the research site will prospectively submit the research subjects' medical records approximately every 3 to 12 months, for up to 2 years. Patients will be asked to complete PRO surveys electronically at regular intervals during this follow-up period.

Institution
MUSC
Recruitment Contact
Virginia Barton
843-876-0110
bartonv@musc.edu

A PROSPECTIVE OBSERVATIONAL STUDY OF PATIENTS RECEIVING DUPIXENT® FOR ATOPIC DERMATITIS

Date Added
April 28th, 2020
PRO Number
Pro00095844
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This registry is observational study about patients who are 12 years or older who have Atopic Dermatitis (AD) that are initiating treatment with DUPIXENT.
Patients will be screened and enrolled at a regularly scheduled clinic visit. During the screening and enrollment period, patients will provide medical history, demographic information, complete patient reported outcome (PRO) surveys and physician assessments. During the follow-up period, patients will complete PRO surveys and physician assessments at regular intervals during this follow-up period. Participation in this study will involve at least 12 visits that will take place over a period of 5 years.

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

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Nemolizumab (CD14152) in Subjects with Moderate to- Severe Atopic Dermatitis

Date Added
April 7th, 2020
PRO Number
Pro00096947
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

Galderma has begun a study of an investigational drug called nemolizumab as a possible treatment for atopic dermatitis. Participants will be randomized to receive either Nemolizumab or placebo once every 4 weeks. Both Nemolizumab and Placebo will be given through a subcutaneous injection. At Visit 6 (Week 16), if the study doctor determines the participant is responding to the study treatment the participants will once again be randomized to either receive Nemolizumab and placebo or just placebo. At visit 6, if the participant is not responding to the medication the patient will have a follow up visit and their participation in the study will end.

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

A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Immune-Mediated Inflammatory Skin Conditions

Date Added
December 3rd, 2019
PRO Number
Pro00093832
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This is a 5-year, longitudinal, observational study of adult and pediatric patients (all ages) being treated for Immune-Mediated Inflammatory Skin Conditions. In addition to the study database, a biospecimen repository will be included in order to perform studies on biomarkers of response.

Patients being prescribed medical therapy for IMISC will be eligible for enrollment. Treatment algorithms will follow each site's local standard of care and no specific treatments, assessments, and/or laboratory tests will be dictated by enrollment in the main TARGET-DERM Program. Patients will be screened and enrolled at a regularly scheduled clinic visit. Up to three years of retrospective
medical records from patients who provide consent/assent and meet all inclusion and exclusion criteria will be obtained by the research site. Records will include but will not be limited to: hospitalizations, laboratory reports, clinic notes, telephone contact reports, medication lists, reasons for medication initiation and/or discontinuation, biopsy results, and imaging. Patients may
also be linked to external databases (such as patient support programs). Patients will also be asked to provide biological samples and complete patient reported outcome (PRO) surveys, although participation in these two portions is optional.

During the follow-up period, the research site will prospectively submit the research subjects' medical records approximately every 6 to 12 months, for up to 5 years. Patients/legal representatives ("parent proxy") will be asked to complete PRO surveys at regular intervals during this follow-up period.

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

EVALUATION OF BIOMARKERS OF ATOPIC DERMATITIS IN PEDIATRIC PATIENTS WHOSE DISEASE IS NOT ADEQUATELY CONTROLLED WITH TOPICAL PRESCRIPTION THERAPIES OR WHEN THOSE THERAPIES ARE NOT MEDICALLY ADVISABLE

Date Added
October 31st, 2019
PRO Number
Pro00089271
Researcher
Lara Wine Lee

List of Studies


Keywords
Pediatrics, Skin
Summary

This study will evaluate the biomarkers of children, younger than 12 years old, with moderate to severe eczema, also known as atopic dermatitis, whose disease is not adequately controlled with topical therapies (creams or lotions) or when those therapies are not medically advisable.

This is not a treatment study. This study is only recruiting volunteers who are enrolled into an atopic dermatitis registry known as Pedistad. Participation in this study will involve 6 visits every 12 months over a period of 5 years.The information collected in this study may lead to an improved understanding of atopic dermatitis and may provide healthcare providers with important information for treating atopic dermatitis in the future.

Institution
MUSC
Recruitment Contact
Susannah Wakefield
843-792-8352
dermresearch@musc.edu

Dermoscopic Features in Infantile Hemangiomas

Date Added
October 11th, 2019
PRO Number
Pro00091926
Researcher
Lara Wine Lee

List of Studies


Keywords
Cancer, Cancer/Skin, Healthy Volunteer Studies, Infant, Non-interventional, Pediatrics, Rare Diseases
Summary

The goal of the study is to characterize the features of Infantile Hemangiomas before and after treatment. Certain characteristics of the hemangioma can be seen more clearly with a closer and more resolute image of the lesion (abnormal vessels etc.). Developing a greater understanding of these characteristics​ may help clinicians better predict the course of infantile hemangiomas in children.

Specific aim 1: to correlate images seen on dermoscopy with regression of the hemangioma.
Specific aim 2: to provide features that may help to predict a better response to treatment.

Institution
MUSC
Recruitment Contact
Lara Wine Lee
8437922890
Winelee@musc.edu



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