A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus Save

Date Added
October 24th, 2018
PRO Number
Pro00077684
Researcher
Eric Zollars
Keywords
Autoimmune disease, Lupus, Skin
Summary

The purpose of this research study is to measure how well and how safe BMS-986165 is in treating patients with Systemic Lupus Erythematosus (SLE) and to determine the optimal dose level.

Lupus is an autoimmune disease, which means that your immune system not only attacks bacteria and viruses but also attacks your healthy cells and organs, affecting many parts of the body. Lupus can cause fever, joint pain, rash (redness of the skin), sensitivity of the skin to sunlight, as well as other symptoms, and may lead to inflammation and organ damage.

Current treatments for Lupus are mainly drugs that suppress the immune system such as cortisone-like drugs (such as prednisone) and cyclophosphamide (a potent drug sometimes used in treating certain types of cancer), and drugs commonly used to treat or prevent malaria (called antimalarials) such as hydroxychloroquine. Many of these treatments may have serious side effects if used for a long time.

Therefore, there is a need for new and effective treatments for Lupus.

Institution
MUSC
Recruitment Contact
Angela Robinson
843-792-6043
robia@musc.edu

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis Save

Date Added
July 10th, 2018
PRO Number
Pro00079009
Researcher
Edwin Smith
Keywords
Autoimmune disease, Drug Studies, Inflammation, Scleroderma, Skin, Stage III
Summary

SSc, which also can be called scleroderma, is a rare autoimmune disease. Autoimmune diseases such as SSc make your immune system over-active which causes chronic inflammation. This chronic inflammation leads to scar tissue, or fibrosis, of the skin and some internal organs.

The skin and involved internal organs with chronic inflammation from SSc become scarred over time, which makes them not work as well as they should. Lenabasum may help stop chronic inflammation, and stop scarring from getting worse without lowering the immune system.

This study is currently enrolling subjects who have scleroderma and are 18 years or older. Participation in the study will require you to complete 13 scheduled visits over the course of one year. After the completion of each visit, subjects will be compensated.

Institution
MUSC
Recruitment Contact
Trevor Faith
843-792-4844
faitht@musc.edu

A Phase 3 Randomized, Double-Blind, Multi-Center Long-Term Extension Study Investigating the Efficacy and Safety of PF-04965842 With or Without Topical Medications Administered to Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis Save

Date Added
June 12th, 2018
PRO Number
Pro00076498
Researcher
Lara Wine lee
Keywords
Skin
Summary

This study is to test the efficacy and safety of PF-04965842 with or without Topical Medications in subjects aged 12 years and older with moderate to severe atopic dermatitis and a body weight of greater than or equal to 40 kg.

Institution
MUSC
Recruitment Contact
Ricardo Cantu
843-792-8894
cantur@musc.edu

A PHASE 2/3 STUDY INVESTIGATING THE PHARMACOKINETICS, SAFETY, AND EFFICACY OF DUPILUMAB IN PATIENTS AGED ?6 MONTHS TO <6 YEARS WITH SEVERE ATOPIC DERMATITIS Save

Date Added
May 8th, 2018
PRO Number
Pro00074957
Researcher
Lara Wine lee
Keywords
Children's Health, Skin
Summary

This study is being conducted to determine how safe and effective an investigational drug called dupilumab (REGN668) is in reducing the signs and symptoms of eczema. This drug is investigational in that it is not yet approved by government agencies, such as the US Food and Drug Administration (FDA) for the treatment of children. Dupilumab is, however, approved by the FDA for the treatment of AD in adult patients.
Your child's participation in this study will require 8 visits to the study center over 3 months.

As part of this study, your child will have a physical exam, blood testing and an electrocardiogram or electrical testing of the heart performed. They will also be given the study drug (dupilumab).

Institution
MUSC
Recruitment Contact
Adrian Modzik
843-792-8385
modzik@musc.edu

A Phase 3 Randomized, Double-Blind, Placebo- Controlled, Parallel Group, Multi-Center Study to Evaluate The Efficacy And Safety of PF-04965842 Monotherapy in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis Save

Date Added
April 24th, 2018
PRO Number
Pro00075670
Researcher
Lara Wine lee
Keywords
Skin
Summary

The purpose of this research study is to compare the effects of the study drug, PF 04965842, with a placebo to find out which is better for treating atopic dermatitis.

Institution
MUSC
Recruitment Contact
Ricardo Cantu
843-792-8894
cantur@musc.edu

An International, Multicenter, Randomized, Double-Blind, Parallel-Group Phase 2 Study Evaluating the Safety and Efficacy of Diacerein 1% Ointment Topical Formulation in Subjects with Epidermolysis Bullosa Simplex (EBS) Save

Date Added
April 24th, 2018
PRO Number
Pro00076411
Researcher
Lara Wine lee
Keywords
Skin
Summary

This study is to treat patients with Epidermolysis Bullosa Simplex (EBS) for whom topical treatments have not been developed. This study will evaluate the safety and efficacy of systemic treatment with Diacerein 1% Cream.
Participation in the study will take about 8 visits over a period of about 22 weeks, with a 6 week screening period, 8 weeks of treatment and 8 weeks of no-treatment follow up).

Institution
MUSC
Recruitment Contact
Ricardo Cantu
843-792-8894
cantur@musc.edu

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF DUPILUMAB ADMINISTERED CONCOMITANTLY WITH TOPICAL CORTICOSTEROIDS IN PATIENTS, ?6 YEARS TO <12 YEARS OF AGE, WITH SEVERE ATOPIC DERMATITIS Save

Date Added
April 10th, 2018
PRO Number
Pro00075600
Researcher
Lara Wine lee
Keywords
Children's Health, Skin
Summary

This is a clinical research trial that will evaluate whether an investigational drug called dupilumab (given by injection) with corticosteroids is safe and effective in children with severe atopic dermatitis. Participation in the study will take about 13 visits to the clinic and 9 phone calls over a period of about 33 weeks.

Institution
MUSC
Recruitment Contact
Adrian Modzik
843-792-8385
cantur@musc.edu

Protocol I4V-MC-JAIW. A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients with Moderate to Severe Atopic Dermatitis Save

Date Added
February 27th, 2018
PRO Number
Pro00075349
Researcher
Lara Wine lee
Keywords
Skin
Summary

This study is to treat patients with moderate to severe atopic dermatitis for whom topical treatments have not been effective. This study will evaluate the safety and efficacy of systemic treatment with baricitinib.
Participation in the study will take about 16 visits over a period of about 26 months.

Institution
MUSC
Recruitment Contact
Abby Powell
843-792-6690
powab@musc.edu

Evaluation of Brentuximab Vedotin for Diffuse Cutaneous Systemic Sclerosis: A Phase 1/2 Multicenter Randomized, Double Blinded, Safety Study Save

Date Added
October 17th, 2017
PRO Number
Pro00070403
Researcher
Richard Silver
Keywords
Autoimmune disease, Drug Studies, Scleroderma, Skin
Summary

This study is being conducted in order to test the safety of Brentuximab Vedotin in subjects with Diffuse Cutaneous Systemic Sclerosis. The study involves a Screening visit, a Baseline visit and 12 study visits occurring every 3 to 4 weeks, with enrollment lasting approximately 52 weeks, during which enrolled subjects will receive either the study compound or placebo.

Institution
MUSC
Recruitment Contact
Kelley Kajdasz
843-792-5290
gibsonke@musc.edu

Protocol I1F-MC-RHCD Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of Ixekizumab in Patients from 6 to Less than 18 Years of Age with Moderate-to-Severe Plaque Psoriasis Save

Date Added
June 27th, 2017
PRO Number
Pro00064844
Researcher
Lara Wine lee
Keywords
Drug Studies, Pediatrics, Skin
Summary

This is a clinical research trial that will evaluate whether an investigational drug called ixekizumab (given by injection) is safe and effective in children and young adults, ages 6 to 17, with moderate to severe plaque psoriasis. For more information, please call Abby Powell at (843) 792-6690.

Institution
MUSC
Recruitment Contact
Abby Powell
843-792-6690
powab@musc.edu

Change_preferences

-- OR --

Create_login