A Randomized, Active-Controlled, Efficacy Assessor-Blinded Study to Evaluate Pharmacokinetics, Safety and Efficacy of Risankizumab in Patients from 6 to Less than 18 Years of Age with Moderate to Severe Plaque Psoriasis

Date Added
September 14th, 2021
PRO Number
Pro00111592
Researcher
Colleen Cotton

List of Studies

Keywords
Children's Health, Drug Studies, Pediatrics, Skin
Summary

The purpose of this study is to test and compare the effects of investigational drug risankizumab to the active control, ustekinumab, on pediatric plaque psoriasis. Subjects that meet all eligibility criteria will be randomized 2:1 to receive 150 mg dose of risankizumab and 45mg or 90 mg dose of ustekinumab - both drug dosages are determined by weight. At Week 16, subjects receiving ustekinumab or are unresponsive to risankizumab, will be switched to or continue to receive 150 mg risankizumab every 12 weeks. Subjects that are responsive to risankizumab at Week 16, will be re-randomized 1:1 to continue risankizumab or withdrawal from the study drug. Subjects randomized to withdrawal will receive no study drug until a flare occurs, after which they will enter a 16-week re-treatment period.

Institution
MUSC
Recruitment Contact
Alyson Winter
8438763209
wintera@musc.edu

A PHASE 3B, MULTI CENTER, OPEN-LABEL LONG-TERM EXTENSION STUDY OF APREMILAST (CC-10004) IN PEDIATRIC SUBJECTS FROM 6 THROUGH 17 YEARS OF AGE WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Date Added
July 13th, 2021
PRO Number
Pro00105940
Researcher
Lara Wine Lee

List of Studies


Keywords
Children's Health, Skin
Summary

The purpose of this study is to evaluate the long-term safety of apremilast in children and adolescents (ages 6 though 17). Pediatric subjects, who have completed Week 52 (end of Apremilast Extension Phase) in study CC-10004-PPSO-003 are eligible to enroll in this study. Apremilast will be provided in bottles throughout the entire study. Apremilast will be provided as 20 or 30 mg tablets, based on body weight category, by the study sponsor, Amgen Inc. and will be taken orally twice daily, approximately 12 hours apart.

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

A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.05% Administered QD in Subjects with Atopic Dermatitis

Date Added
July 6th, 2021
PRO Number
Pro00111522
Researcher
Colleen Cotton

List of Studies

Keywords
Children's Health, Skin
Summary

This study is being done to evaluate the safety and efficacy of ARQ-151 cream in subjects with mild to moderate eczema (atopic dermatitis) after application once every day for a month. Results will be compared against a vehicle (placebo). The vehicle is a dummy drug made from the same base product used to make ARQ-151 cream, but it does not contain any active study drug. ARQ-151 is a cream that contains the active ingredient roflumilast. Roflumilast is marketed in Canada, the United States, and other countries as a tablet (pill taken by mouth) for flares of a specific chronic lung disease. You will apply the study drug on your eczema lesions once a day for 28 days. The study doctor will tell you which lesions to treat. Any newly appearing eczema lesions that arise during the study must also be treated.

Institution
MUSC
Recruitment Contact
Lauren Parsons
843-792-1436
parsonla@musc.edu

A Phase 3, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.15% and ARQ-151 Cream 0.05% in Subjects with Atopic Dermatitis

Date Added
June 17th, 2021
PRO Number
Pro00110858
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Children's Health, Skin
Summary

This study is being done to evaluate the long term safety of ARQ-151 cream 0.15% and ARQ-151 cream 0.5% in subjects with mild to moderate eczema (atopic dermatitis). Eligible subjects will enroll in the long term safety study after they have successfully completed the preceding study. Study medication will be applied topically for 52 weeks at home. All affected areas, except on the scalp, will be treated. For the first 4 weeks of study, all subjects will apply study medication once a day in the areas identified and treated during the preceded study. Beginning at the Week 4 visit, any subject who achieves vIGA-AD of ‘0-clear' as confirmed by the Investigator at a scheduled or unscheduled clinic visit, will switch to twice weekly (BIW) maintenance treatment. For maintenance therapy, study medication will be applied on two nonconsecutive days per week.

Institution
MUSC
Recruitment Contact
Lauren Parsons
(843) 792-1436
parsonla@musc.edu

A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.15% Administered QD in Subjects with Atopic Dermatitis

Date Added
May 11th, 2021
PRO Number
Pro00108253
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Children's Health, Skin
Summary

This study is being done to evaluate the safety and efficacy of ARQ-151 cream in subjects with mild to moderate eczema (atopic dermatitis) after application once every day for a month. Results will be compared against a vehicle (placebo). The vehicle is a dummy drug made from the same base product used to make ARQ-151 cream, but it does not contain any active study drug. ARQ-151 is a cream that contains the active ingredient roflumilast. Roflumilast is marketed in Canada, the United States, and other countries as a tablet (pill taken by mouth) for flares of a specific chronic lung disease. You will apply the study drug on your eczema lesions once a day for 28 days. The study doctor will tell you which lesions to treat. Any newly appearing eczema lesions that arise during the study must also be treated.

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

Using a Cold Atmospheric Plasma Device to Treat Molluscum Contagiosum and Verruca Vulgaris in Pediatric Patients

Date Added
May 4th, 2021
PRO Number
Pro00106689
Researcher
Lara Wine Lee

List of Studies


Keywords
Children's Health, Pediatrics, Skin
Summary

This study is going to test a cold atmospheric plasma device (CAP), in particular a floating electrode-dielectric barrier device (FE-DBD), to treat warts and molluscum. The treatment device in this study generates cold atmospheric plasma (gaseous ionized molecules) to rid the virus from the body. Based on the successes of previous dermatologic studies, FE-DBD is being tested for this study to treat warts and molluscum. Patients will be enrolled to test the efficacy and safety of this device. 

Patients aged between 4-21 years are eligible to participate. The duration of the study is 4-12 weeks depending on treatment clearance. The number of lesions will be chosen by the dermatologist. Patients will receive standard of care therapy and/or NTAP depending on the number of lesions. Safety profile and patient tolerability will be measured, as well as changes in size, pain and appearance. Photographs and clinical impression will be used to measure treatment response. Pain and tolerability will be assessed by a visual analogue scale and tolerability assessment scale.

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

A randomized, double blind, parallel-group, placebo controlled study to evaluate the efficacy and safety of IBP-9414 in premature infants 500-1500g birth weight in the prevention of necrotizing enterocolitis – The Connection study

Date Added
February 23rd, 2021
PRO Number
Pro00105738
Researcher
Carol Wagner

List of Studies


Keywords
Children's Health, Infant, Pediatrics
Summary

Babies that are born extremely prematurely are at higher risk of developing a serious inflammatory condition, called necrotizing enterocolitis (NEC), that damages parts of the intestines. It is the most common cause of illness of the intestinal tract in premature infants in the first few weeks of life. It is a very serious condition that can lead to death in up to half of affected infants.The main purpose of this study is to see if IBP-9414 ( a probiotic) can prevent NEC and if it is safe and tolerable.

IBP-9414 (Lactobacillus reuteri) is a live bacterial therapy given to infant's through a feeding tube or it is given by mouth once daily starting at or before 48 hours of life. IBP-9414 will be given daily until the infant reaches 34 weeks + 6 days Post-Menstrual Age (PMA) (the the baby's gestational age at birth plus the postnatal days of life), or until treatment is permanently discontinued if earlier.

Institution
MUSC
Recruitment Contact
Della MacNicholas
843-792-8385
macnichd@musc.edu

Quality of Pediatric Resuscitation in a Multi-center Collaborative: an Observational Study

Date Added
February 18th, 2021
PRO Number
Pro00106721
Researcher
Allison Whalen

List of Studies


Keywords
Children's Health
Summary

This observational, multi-center cohort study of pediatric cardiac arrest management will contribute to a clinical CPR Learning Laboratory. The objectives of this study are to characterize the quality of CPR and post-cardiac arrest care delivered to children across a broad spectrum of hospitals, to determine the association between quantitative CPR quality measures (depth, rate, compression release, flow fraction) and survival to hospital discharge, and to determine the association of survival with site-specific post-cardiac arrest care (PCAC). The study will enroll pediatric cardiac arrests requiring chest compressions for ≥1 minute identified as part of standard clinical operations. The CPR quantitative measures, defibrillator data (when available), monitor data (when available), and post-arrest care will be de-identified and submitted to a central database.

Institution
MUSC
Recruitment Contact
Allison Whalen
8438761361
whalen@musc.edu

Training in Exercise Activities and Motion for Growth (TEAM 4 Growth): A Randomized Clinical Trial

Date Added
December 7th, 2020
PRO Number
Pro00084526
Researcher
Frances Woodard

List of Studies


Keywords
Cardiovascular, Children's Health, Heart
Summary

This is a Phase III randomized controlled trial of a passive ROM exercise program that will be performed in infants with HLHS and other single right ventricle anomalies following the Norwood procedure at PHN and Auxiliary Centers.

Institution
MUSC
Recruitment Contact
Mary Freeman
8437925762
freemanme@musc.edu

A Phase II Study of Metronomic and Targeted Anti-Angiogenesis Therapy for Children With Recurrent/Progressive Medulloblastoma

Date Added
September 1st, 2020
PRO Number
Pro00091939
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Brain, Brain Tumor, Cancer, Central Nervous System, Children's Health, Drug Studies, Pediatrics, Spinal Cord
Summary

This study is for patients with recurrent/progressive medulloblastoma, which is a type of childhood brain tumor. Participants in this study will receive intravenous (IV, into the veins) bevacizumab and intrathecal (into the spinal fluid) or intraventricular (into the fluid surrounding the brain) etoposide and cytarabine in combination with five oral (taken by mouth) chemotherapy drugs as a possible treatment for recurrent/progressive medulloblastoma. Total study duration is about 1 year and depending on how well a participant tolerates the medications and the response of the disease, the patient may continue the treatment after the first year.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trails@musc.edu



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