This is a Phase 1b, randomized, placebo/vehicle-controlled, double-blinded, multi-center trial. It is designed to assess the safety and efficacy of S. hominis A9 (ShA9) topical application as a treatment for atopic dermatitis (AD). The trial will enroll adults and adolescents with atopic dermatitis who are culture positive for S. aureus colonization.
The primary safety objective of this study is to compare the safety profile of ShA9 to placebo (vehicle) over 14 weeks of application, which includes an initial two-week period of co-treatment with topical corticosteroids (TCS). The primary efficacy objective of this study is to assess the ability of ShA9, compared to placebo (vehicle), to prolong the period of atopic dermatitis control over 12 weeks after conclusion of an initial two-week period of co-treatment with TCS.

开始日期2025-04-10

申办/合作机构

National Institute of Allergy & Infectious Diseases

[+2]

NCT06560151

/ Active, not recruiting临床2期IIT

Randomized, Double-Blind, Phase 2 Study to Assess Safety and Immunogenicity of A/H5 Inactivated Monovalent Influenza Vaccines At Different Antigen Dose Levels Adjuvanted with AS03® or MF59®

This BARDA-sponsored, randomized, double-blind, phase 2 study is designed to assess safety and immunogenicity of A/H5 inactivated monovalent influenza vaccines at different antigen dose levels adjuvanted with AS03 or MF59.

开始日期2024-08-21

申办/合作机构

Biomedical Advanced Research and Development Authority (BARDA)

[+2]

NCT06366087

/ Completed临床1期IIT

A Two-Period, Two-Sequence, Two-Treatment, Single-Dose Crossover Study of Atropine Sulfate Ophthalmic Solution (1%) Administered Sublingually vs Atropine Sulfate Administered Intramuscularly for Bioequivalence Determination

A randomized, two-period, two-sequence, crossover study to assess the bioequivalence, bioavailability, and pharmacokinetics (PK) of a single dose of atropine administered sublingually (SL) or intramuscularly (IM) in healthy adult volunteers.

开始日期2024-04-15

申办/合作机构

Biomedical Advanced Research and Development Authority (BARDA)

[+1]

100 项与 Rho Federal Systems Division, Inc. 相关的临床结果

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0 项与 Rho Federal Systems Division, Inc. 相关的专利（医药）

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项与 Rho Federal Systems Division, Inc. 相关的文献（医药）

2025-01-01·Journal of Allergy and Clinical Immunology

Dysregulation of airway and systemic interferon responses promotes asthma exacerbations in urban children

Article

作者: Gruchalla, Rebecca S ; Visness, Cynthia ; Gern, James E ; Zoratti, Edward M ; Altman, Matthew C ; Liu, Andrew H ; Kumar, Rajesh ; Gaberino, Courtney L ; Kattan, Meyer ; O'Connor, George T ; Bacharier, Leonard B ; Becker, Patrice M ; Jackson, Daniel J ; Gill, Michelle A ; Khurana Hershey, Gurjit K ; Togias, Alkis ; Teach, Stephen J ; Busse, William W

BACKGROUNDDetermining why some upper respiratory illnesses provoke asthma exacerbations remains an unmet need.OBJECTIVEWe sought to identify transcriptome-wide gene expression changes associated with colds that progress to exacerbation.METHODSTwo hundred eight urban children (6-17 years) with exacerbation-prone asthma were prospectively monitored for up to 2 cold illnesses. Exacerbation illnesses (Ex⁺), defined as colds leading to asthma exacerbations requiring systemic corticosteroids within 10 days, were compared to colds that resolved without exacerbation (Ex^-). Peripheral blood and nasal lavage samples were collected at baseline and during colds for RNA sequencing. Interferon gene expression was compared between Ex⁺ and Ex^- illnesses. Generalized additive modeling revealed interferon response kinetics. Multiple linear regression models compared interferon expression to clinical variables.RESULTSOne hundred six participants were evaluated during 154 colds. There was greater upregulation of differentially expressed interferon genes during Ex⁺ illnesses compared to Ex^-. Ex⁺ illnesses had greater average and steeper rise in interferon expression. Within 3 days of illness, interferon expression was positively associated with nasal rhinovirus quantity (nasal: adjusted R² = 0.48, P = .015; blood: adjusted R² = 0.22, P = .013), and interferon expression was negatively associated with percentage predicted forced expiratory volume in 1 second (nasal: β = -0.010, P = .048; blood: β = -0.008, P = .023). Participants with lower baseline interferon expression had shorter time to exacerbation, higher risk for exacerbation with viral illnesses, and greater increase in interferon expression during viral colds (nasal: β = -0.80, P < .0001; blood: β = -0.75, P < .0001).CONCLUSIONDysregulated interferon responses are important contributors to asthma exacerbation risk in children. Low baseline interferon expression followed by greater upregulation of interferon pathways in airway and blood during respiratory illnesses increased exacerbation risk. Targeting this pathway in at-risk individuals holds promise for the personalized prevention of asthma exacerbations.

2025-01-01·Journal of Allergy and Clinical Immunology

Rhinoconjunctivitis symptoms in children and adolescents with asthma: Longitudinal clustering analysis

Article

作者: Gergen, Peter J ; Togias, Alkis ; Busse, William W ; Wood, Robert A ; Calatroni, Agustin ; Bacharier, Leonard B ; Makhija, Melanie ; Visness, Cynthia M ; Liu, Andrew H ; Lamm, Carin ; Gern, James E ; Patel, Shilpa J ; Gruchalla, Rebecca S ; Jackson, Daniel J ; O'Connor, George T ; Kercsmar, Carolyn M ; Khurana Hershey, Gurjit K ; Kim, Haejin

BACKGROUNDRhinoconjunctivitis phenotypes are conventionally described on the basis of symptom severity, duration and seasonality, and aeroallergen sensitization. It is not known whether these phenotypes fully reflect the patterns of symptoms seen at a population level.OBJECTIVEWe sought to identify phenotypes of rhinoconjunctivitis on the basis of symptom intensity and seasonality using an unbiased approach and to compare their characteristics.METHODSA cohort of children with asthma in low-income urban environments was prospectively followed with a rhinoconjunctivitis activity questionnaire, and their upper and lower airway disease was managed for 12 months with every 2-month visit based on standardized algorithms. We identified individual rhinoconjunctivitis symptom trajectories and clusters of those trajectories and compared the clusters focusing on atopic characteristics.RESULTSData obtained from 619 children yielded 5 symptom clusters: 2 had high symptoms (22.5%) but differed in seasonal pattern, 1 had medium symptoms (13.6%), 1 had medium nasal congestion only (20.4%), and 1 had low symptoms (43.6%). The latter was further split into 2 subgroups if nasal corticosteroids were frequently prescribed (23.6%) or not (20.0%). Seasonal variation was absent in the low symptom clusters. The number of allergic sensitizations and family history of allergic airway disease were higher in the high symptom clusters, but allergic sensitization did not explain differences in seasonality.CONCLUSIONSThis study identified rhinoconjunctivitis phenotypes that have not been previously reported and were not differentiated by demographics or by measures of atopy and type 2 inflammation. Factors beyond allergy need to be investigated to better understand the pathobiology of rhinoconjunctivitis.

2024-08-01·Journal of Allergy and Clinical Immunology

Activated sputum eosinophils associated with exacerbations in children on mepolizumab

Article

作者: Knight, James ; Khurana Hershey, Gurjit K ; Visness, Cynthia ; Liu, Qing ; Yan, Xiting ; Stewart, Emma ; Wang, Xiaomei ; Jackson, Daniel J ; Becker, Patrice M ; Sanders, Joshua ; Altman, Matthew C ; Gill, Michelle ; Togias, Alkis ; Wilson, Gabriella E ; Busse, William W ; Shelar, Ashish ; Gruchalla, Rebecca ; Chupp, Geoffrey L ; Kattan, Meyer ; Liu, Andrew H ; Montgomery, Ruth R

BACKGROUNDMUPPITS-2 was a randomized, placebo-controlled clinical trial that demonstrated mepolizumab (anti-IL-5) reduced exacerbations and blood and airway eosinophils in urban children with severe eosinophilic asthma. Despite this reduction in eosinophilia, exacerbation risk persisted in certain patients treated with mepolizumab. This raises the possibility that subpopulations of airway eosinophils exist that contribute to breakthrough exacerbations.OBJECTIVEWe aimed to determine the effect of mepolizumab on airway eosinophils in childhood asthma.METHODSSputum samples were obtained from 53 MUPPITS-2 participants. Airway eosinophils were characterized using mass cytometry and grouped into subpopulations using unsupervised clustering analyses of 38 surface and intracellular markers. Differences in frequency and immunophenotype of sputum eosinophil subpopulations were assessed based on treatment arm and frequency of exacerbations.RESULTSMedian sputum eosinophils were significantly lower among participants treated with mepolizumab compared with placebo (58% lower, 0.35% difference [95% CI 0.01, 0.74], P = .04). Clustering analysis identified 3 subpopulations of sputum eosinophils with varied expression of CD62L. CD62L^int and CD62L^hi eosinophils exhibited significantly elevated activation marker and eosinophil peroxidase expression, respectively. In mepolizumab-treated participants, CD62L^int and CD62L^hi eosinophils were more abundant in participants who experienced exacerbations than in those who did not (100% higher for CD62L^int, 0.04% difference [95% CI 0.0, 0.13], P = .04; 93% higher for CD62L^hi, 0.21% difference [95% CI 0.0, 0.77], P = .04).CONCLUSIONSChildren with eosinophilic asthma treated with mepolizumab had significantly lower sputum eosinophils. However, CD62L^int and CD62L^hi eosinophils were significantly elevated in children on mepolizumab who had exacerbations, suggesting that eosinophil subpopulations exist that contribute to exacerbations despite anti-IL-5 treatment.

项与 Rho Federal Systems Division, Inc. 相关的新闻（医药）

2019-11-17

·BioSpace

Rho Awarded aNew Federal Contract from National Institute of Dental and Craniofacial Research

CRO to serve as the Clinical Research Management Support (CROMS) CRO to serve as the Clinical Research Management Support (CROMS) Research Triangle Park, NC ̶ November 14, 2019 – Rho , a full-service contract research organization (CRO) focused on bringing new products to market through a full range of product development services, announced today that it has been awarded a new federal contract from The National Institute of Dental and Craniofacial Research (NIDCR). The National Institutes of Health (NIH) has awarded the contract to Rho Federal Systems Division, Inc., a wholly-owned subsidiary of Rho, Inc., to serve as the Clinical Research Management Support (CROMS). The purpose of the CROMS is to provide comprehensive clinical research operations support, management, and data coordinating services for clinical research sponsored by NIDCR’s Extramural and Intramural Divisions. The CROMS also provides oversight tools and systems to assist in the effective administration and coordination of the NIDCR’s clinical research program. The award is for a base period of September 30, 2019 through September 29, 2020 at $5,095,737, with four annual options for a total value of $22,151,038. “We are pleased to continue our long and successful collaboration with the NIDCR in support of groundbreaking studies to further their mission to improve dental, oral, and craniofacial health,” said Laura Helms Reece, Dr. P.H., Chief Executive Officer for Rho. “Rho’s expertise and resources will help assure top-notch study design and execution, data management, statistical analysis, and regulatory compliance.” Rho’s CROMS group is led by Dr. Nancy Yovetich, Principal Investigator, who has served in this capacity for the last nine years, and Program Director Cathie Snyder, who has served in this role for the last seven years. Rho has partnered with Digital Infuzion, Inc., a data science industry leader in clinical and biomedical informatics based in Gaithersburg, Maryland, to establish a Clinical Research Management System (CRMS) to support efficient conduct and management of NIDCR’s research portfolio. As the NIDCR-CROMS contractor since 2008, Rho has previously provided similar support for hundreds of NIDCR studies. For additional details about Rho’s CROMS program, visit research . This project is funded in whole with federal funds from the National Institute of Dental and Craniofacial Research, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92019C00006. For more information about the National Institute of Dental and Craniofacial Research visit . About Rho Rho, a privately-held, contract research organization (CRO) located in Research Triangle Park, NC, provides a full range of clinical research services across the entire drug development process. For more than 35 years, Rho has been a trusted partner to some of the industry’s leading pharmaceutical, biotechnology, and medical device companies as well as academic and government organizations. Our commitment to excellence, our innovative technologies, and our therapeutic expertise accelerate time to market, maximize returns on investment, and lead to an exceptional customer experience. Please follow us on Facebook , LinkedIn and Twitter . # # #

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