A US Phase 3b, Multi-center, Randomized, Double-blind, Double-Dummy Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults with Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-Antihistamines

Date Added
February 10th, 2026
PRO Number
Pro00146309
Researcher
Kelli Williams

List of Studies


Keywords
Allergy, Autoimmune disease, Skin
Summary

This is a randomized, double-blind, multicenter Phase IIIb study comparing remibrutinib tablets with dupilumab injections in adults with chronic spontaneous urticaria (CSU) that is not well controlled by second-generation H1-antihistamines. Participants will receive either remibrutinib or dupilumab for 12 weeks, alongside their usual antihistamine. The goal is to see which treatment works faster and better at reducing symptoms like hives and itching. If remibrutinib is not yet available commercially after the study, participants may continue taking it in an optional extension phase.

Institution
MUSC
Recruitment Contact
Emma McLeod
843-792-8008
mcleodem@musc.edu

Ehlers Danlos Syndrome Research Biorepository and Database

Date Added
January 9th, 2026
PRO Number
Pro00147160
Researcher
Russell Norris

List of Studies


Keywords
Allergy, Chronic Fatigue, Genetics, Nervous System, Pain, Rare Diseases, Sleep Disorders, Surgery
Summary

This study aims to create a long-term Ehlers-Danlos syndrome (EDS) biorepository and clinical research database to support gene and biomolecular discovery. The repository will serve as a sustainable resource for advancing EDS-related research by collecting both clinical data and biological samples. Participants who consent will be included in the EDS registry, which stores demographic and operative information, contact details, and biological specimens for current and future studies. Enrolled patients may also choose to be recontacted for future research opportunities. The database will link participants across specialties using identifiers such as name, date of birth, and medical record number. Data collected will include information from electronic health records, such as clinical notes, diagnoses, medications, labs, imaging, anthropometric measures, and procedure reports.

Institution
MUSC
Recruitment Contact
Tayler Goectau
8437921544
goectau@musc.edu

A Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of BLU-808, a Wild Type KIT Inhibitor, in Chronic Inducible Urticaria and Chronic Spontaneous Urticaria

Date Added
October 23rd, 2025
PRO Number
Pro00145633
Researcher
Kelli Williams

List of Studies


Keywords
Allergy, Autoimmune disease, Skin
Summary

The purpose of this study is evaluate safety and effectiveness of an investigational drug in adults diagnosed with chronic urticaria (hives). The investigational drug is known as BLU-808 and will be taken daily orally. Participation in the study is expected to be approximately 18 weeks.

Institution
MUSC
Recruitment Contact
Emma McLeod
843-792-8008
mcleodem@musc.edu

A Randomized, Double-blind, Multicenter, Parallel-group, Phase IIIb 52 Week Study Evaluating the Efficacy and Safety of PT027 Compared with PT007 Administered As Needed in Participants 12 to < 18 Years of Age with Asthma (ACADIA)

Date Added
February 6th, 2025
PRO Number
Pro00140063
Researcher
Kelli Williams

List of Studies


Keywords
Allergy, Asthma, Pediatrics
Summary

This is a randomized, double-blind, multicenter, parallel-group Phase IIIb study with a fixed treatment period of 52 weeks. The purpose of this study is to compare BDA MDI with AS MDI on severe asthma exacerbations in adolescent participants aged 12 to < 18 years with a documented clinical diagnosis of asthma and at least one severe exacerbation in the prior year. Participants will administer randomized IMP as needed as they normally would with their own prescribed rescue inhaler.

Institution
MUSC
Recruitment Contact
Sydnee Pearson
8437926690
pearsosy@musc.edu



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