Clinical trials: Steroid Refractory
Acute Graft Versus Host Disease
Dose-finding Study Using Pentostatin for Injection in the Treatment of Steroid-refractory aGvHD
To determine a safe and effective dose of pentostatin in steroid-refractory aGvHD and to identify the minimal effective dose of pentostatin defined as the lowest dose that produces a response in 20% or more of patients while…
- Trial name
- NCT00032773
- Testing
- pentostatin for injection
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Astex Pharmaceuticals, Inc.
Intestinal GVHD, Steroid Refractory GVHD
Prospective Interventional Study Exploring the Microbiota Recolonization in SR-GvHD Patients Receiving MaaT013
The objective of the ORION study is to explore the changes of gut microbiota composition following MaaT013 administration and its impact on the immune system in GVHD patients.
- Trial name
- ORION (NCT05017688)
- Testing
- Blood and stool sample collection
- Where
- 9 sites in France
- Volunteers
- 40 people
- Sponsor
- MaaT Pharma
Graft vs Host Disease
Safety and Efficacy Study of T-Guard to Treat Steroid-resistant Acute GVHD
In this study, a combination of two antibodies both conjugated to a cell-killing toxin (so-called immunotoxins) will be evaluated.
- Trial name
- NCT02027805
- Testing
- T-Guard
- Where
- 2 sites in Germany, Netherlands
- Volunteers
- 20 people
- Sponsor
- Xenikos
Immune Thrombocytopenic Purpura (ITP)
A Study to Assess the Ability of Eltrombopag to Induce Sustained Response Off Treatment in Subjects With ITP
The purpose of this trial was to assess the ability of eltrombopag to induce sustained treatment-free remission in immune thrombocytopenia purpura (ITP) subjects who relapsed or failed to respond to an initial treatment with…
- Trial name
- TAPER (NCT03524612)
- Testing
- eltrombopag
- Where
- 32 sites in United States, Austria and 13 more
- Volunteers
- 105 people
- Sponsor
- Novartis Pharmaceuticals
Asthma
Mepolizumab Steroid-Sparing Study in Subjects With Severe Refractory Asthma
This is a randomised, double-blind, placebo-controlled, parallel-group, multicenter study of mepolizumab in comparison with placebo in reducing Oral Corticosteroid (OCS) use in subjects with severe refractory asthma.
- Trial name
- NCT01691508
- Testing
- Mepolizumab, OCS (prednisone/prednisolone)
- Where
- 47 sites in United States, Australia and 8 more
- Volunteers
- 135 people
- Sponsor
- GlaxoSmithKline
Graft vs Host Disease
A Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Chronic Graft Versus Host Disease
This study was been conducted to evaluate the safety, tolerability, and activity of belumosudil (formerly known as KD025) in adult participants with chronic graft versus host disease (cGVHD).
- Trial name
- NCT02841995
- Testing
- Belumosudil (KD025)
- Where
- 7 sites in United States
- Volunteers
- 54 people
- Sponsor
- Kadmon, a Sanofi Company
Steroid-Refractory Acute Graft Versus Host Disease
A Study to Compare T-Guard vs Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-vs-Host Disease (BMT CTN 2002)
This is an open-label, randomized, Phase 3, multicenter trial, which has been designed to compare the efficacy and safety of T-Guard to ruxolitinib in patients with Grade III or IV Steroid-Refractory acute Graft-Versus-Host…
- Trial name
- 2002 (NCT04934670)
- Testing
- T-Guard, Ruxolitinib
- Where
- 48 sites in United States, Belgium and 7 more
- Volunteers
- 12 people
- Sponsor
- Xenikos
Acute-graft-versus-host Disease
ASC930 in Patients With Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD)
Acute GVHD following allogeneic HCT is an immune-triggered process, leading to profound immune dysregulation and organ dysfunction.
- Trial name
- NCT04883918
- Testing
- ASC930
- Volunteers
- 60 people
- Sponsor
- ASC Therapeutics
Ulcerative Colitis
An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis
To assess the effects of visilizumab on the safety of subsequent salvage therapies in subjects who experienced disease progression in a previous visilizumab study and subsequently received salvage therapy.
- Trial name
- NCT00355901
- Testing
- Visilizumab (Nuvion®; HuM291)
- Where
- 40 sites in United States, Australia and 12 more
- Volunteers
- 300 people
- Sponsor
- PDL BioPharma, Inc.
Allogeneic Hematopoietic Stem Cell Transplantation
A Dose-Finding Study of Vedolizumab for Treatment of Steroid-Refractory Acute Intestinal Graft-Versus-Host Disease (GvHD) in Participants Who Have Undergone Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)
The purpose of this study is to assess the initial activity, tolerability, safety and to identify a recommended dose and regimen of vedolizumab intravenous (IV) administered for treatment of steroid-refractory acute intestinal…
- Trial name
- NCT02993783
- Testing
- Vedolizumab
- Where
- 15 sites in United States, Belgium and 3 more
- Volunteers
- 17 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Steroid-refractory Acute Graft-versus-host Disease
Treatment Of Steroid-Refractory Acute Graft-versus-host Disease With Mesenchymal Stromal Cells Versus Best Available Therapy
The primary purpose of this trial is to demonstrate the superiority of MC0518 compared to the first used best available therapy (BAT) with respect to overall response rate (ORR) at Day 28 and/or overall survival (OS) until Visit…
- Trial name
- IDUNN (NCT04629833)
- Testing
- MC0518, BAT
- Where
- 42 sites in France, Germany and 3 more
- Volunteers
- 210 people
- Sponsor
- medac GmbH
GVHD - Graft-Versus-Host Disease
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Trial of Remestemcel-L-rknd Added to Ruxolitinib for Grade III-IV Steroid-Refractory Acute Graft-Versus-Host Disease
This study is a randomized, double-blind, placebo-controlled, multicenter Phase III trial to compare the efficacy and safety of remestemcel-L-rknd (remestemcel-L), ex-vivo cultured adult human mesenchymal stromal cells (MSC)…
- Trial name
- NCT07568535
- Testing
- Remestemcel-L-rknd
- Volunteers
- 180 people
- Sponsor
- Mesoblast, Ltd.
Steroid-refractory Acute Graft-versus-host Disease
Trial of Efficacy and Safety of MC0518 Versus Best Available Therapy in Participants With Steroid-Refractory Acute Graft Versus Host Disease
The purpose of this trial is the comparative evaluation of overall response rate (ORR) in paediatric participants with steroid-refractory acute graft-versus-host disease (SR-aGvHD) at Visit Day 28 after treatment with MC0518 or…
- Trial name
- BALDER (NCT06075706)
- Testing
- MC0518, BAT
- Where
- 36 sites in France, Germany and 3 more
- Volunteers
- 49 people
- Sponsor
- medac GmbH
Acute Graft-Versus-Host Disease
A Study of Jaktinib for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease.
This is an single-arm, Phase II multi-center study. The purpose of this study is to assess the efficacy and safety of Jaktinib in subjects with Grades II to IV steroid-refractory acute graft-versus-host disease.
- Trial name
- NCT04971551
- Testing
- Jaktinib Hydrochloride Tablets
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Acute Graft Versus Host Disease in Intestine, Steroid Refractory GVHD
Early Access Program With MaaT013 in Steroid-refractory Acute Gastrointestinal Graft Versus Host Disease
MaaT013 is still in clinical development phase and is not approved yet for marketing in any region. During the development program, MaaT Pharma has undertaken initial development with closely related product candidates, leading…
- Trial name
- ATLAS (NCT04768907)
- Testing
- MaaT013
- Where
- 46 sites in Austria, Belgium and 6 more
- Sponsor
- MaaT Pharma
Ulcerative Colitis, Active Moderate
Adacolumn in Refractory UC Patients Trial
The objectives of the study are to observe and document the efficacy and safety of 5 or more Adacolumn treatments, administered once weekly over 5 or more weeks, in a specific subset of ulcerative colitis patients.
- Trial name
- ART (NCT01481142)
- Testing
- (GMA) Adsorptive Apheresis
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Otsuka Pharmaceutical Europe Ltd
Autoimmune Encephalitis
Phase III Clinical Study of NPB-01 in Patients With Autoimmune Encephalitis
To compare the efficacy and safety of NPB-01 in patients with autoimmune encephalitis refractory to steroid pulse therapy using steroid pulse therapy as a control.
- Trial name
- NCT05177939
- Testing
- NPB-01, NPB-01-ME
- Where
- Japan
- Volunteers
- 40 people
- Sponsor
- Nihon Pharmaceutical Co., Ltd
Steroid-refractory aGvHD Subsequent to Allogeneic Hematopoietic Cell Transplantation
A Study Evaluating the Efficacy and Safety of Neihulizumab vs "Conventional Treatment" to Treat Sr-aGvHD
This study is to assess the efficacy of Neihulizumab versus "conventional therapy" and to evaluate safety, pharmacokinetics and immunogenicity in treating steroid-refractory acute Graft-vs-Host Disease
- Trial name
- NCT02694770
- Testing
- Neihulizumab Treatment, Conventional Treatment
- Where
- 2 sites in United States
- Sponsor
- AbGenomics B.V Taiwan Branch
Steroid Refractory Acute Graft Versus Host Disease
Methoxsalen and Extracorporeal Photopheresis (ECP) for the Treatment of Pediatric Participants With Steroid Refractory Acute Graft Versus Host Disease
This is a single-arm, open-label, multicenter study of the efficacy of UVADEX® (methoxsalen) Sterile Solution in conjunction with THERAKOS® CELLEX® Photopheresis Systems (ECP) in pediatric participants with steroid-refractory…
- Trial name
- NCT02524847
- Testing
- Methoxsalen, Extracorporeal Photopheresis (ECP)
- Where
- 32 sites in United States, Austria and 6 more
- Volunteers
- 29 people
- Sponsor
- Therakos, Inc., a Mallinckrodt Company
GVHD
Proof-of-concept Trial of Apraglutide in Acute Graft Versus Host Disease (aGVHD)
The aim of this trial is to assess safety and efficacy of apraglutide in subjects with steroid refractory gastrointestinal aGVHD.
- Trial name
- NCT05415410
- Testing
- Apraglutide
- Where
- 13 sites in United States, Germany and 2 more
- Volunteers
- 31 people
- Sponsor
- VectivBio AG