Clinical trials: Steroid Refractory
GVHD,Acute
Mesenchymal Stem Cells (MSCs) for Steroid Refractory Acute GVHD (SR-aGVHD)
The objective of this clinical study is to demonstrate safety and feasibility of single-dose infusion of Ossium MSCs product (OSSM-001) to treat steroid refractory acute GVHD (SR-aGVHD).
- Trial name
- NCT05443464
- Testing
- OSSM-001
- Sponsor
- Ossium Health, Inc.
Steroid Refractory GVHD
Safety, PK, PD, Dosing, and Efficacy of RLS-0071for the Treatment of Hospitalized Patients With Steroid-Refractory Acute Graft-versus-Host Disease
This study is a Open Label Prospective Dose-Ranging Escalation and Expansion Trial to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Dosing, and Efficacy of RLS-0071 for the secondary treatment of acute…
- Trial name
- AURORA (NCT06343792)
- Testing
- RLS-0071
- Where
- 11 sites in United States, Germany and 1 more
- Volunteers
- 66 people
- Sponsor
- ReAlta Life Sciences, Inc.
Ulcerative Colitis
Basiliximab in Moderate to Severe Ulcerative Colitis
The purpose of this study is to assess the safety, effectiveness and pharmacokinetics of two levels of intravenous basiliximab in ulcerative colitis, compared to placebo.
- Trial name
- NCT00430898
- Testing
- Basiliximab
- Where
- 68 sites in United States, Belgium and 7 more
- Volunteers
- 181 people
- Sponsor
- Cerimon Pharmaceuticals
Steroid-refractory Acute Graft-versus-host Disease
A Phase I/II Trial of VUM02 Injection for Steroid-refractory Acute Graft-versus-host Disease (SR-aGvHD) Treatment
It is a phase I/II clinical study to evaluate the safety, tolerability and preliminary efficacy of VUM02 Injection in patients with acute graft-versus-host disease (aGvHD) who have failed systemic steroid therapy.
- Trial name
- ESTEVS-I/II (NCT06677255)
- Testing
- VUM02 Injection (UC-MSCs)+BAT, The control group with Best Available Therapy (BAT)
- Where
- China
- Volunteers
- 149 people
- Sponsor
- Wuhan Optics Valley Vcanbiopharma Co., Ltd.
Graft-versus-host Disease (GVHD)
An Expanded Access Program of Ruxolitinib for the Treatment of Graft-Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplant
To provide ruxolitinib through an expanded access program for the treatment of graft-versus-host disease (GVHD) in United States to patients who are ineligible or unable to participate in any actively enrolling Incyte-sponsored…
- Trial name
- NCT03147742
- Testing
- Ruxolitinib
- Where
- 33 sites in United States
- Sponsor
- Incyte Corporation
Inflammatory Diseases
Study of Efavaleukin Alfa in Healthy Chinese, Japanese, and Caucasian Participants
The primary objective of this study is to evaluate the pharmacokinetics (PK) of efavaleukin alfa after single subcutaneous (SC) administration in healthy Chinese, Japanese, and Caucasian participants.
- Trial name
- NCT04987333
- Testing
- Efavaleukin alfa
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Amgen
Ulcerative Colitis
Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study
The purpose of this study is to compare the efficacy, safety, pharmacokinetics, and immunogenicity in subjects retreated with visilizumab or placebo after a response in a prior visilizumab study.
- Trial name
- NCT00279435
- Testing
- visilizumab
- Where
- 39 sites in United States, Australia and 13 more
- Volunteers
- 25 people
- Sponsor
- Facet Biotech
Steroid Refractory GVHD
Evaluation of EFficacy and SaFEty of Leukotac (Inolimomab) in Pediatric Patients With SR-aGvHD
A Phase 3, Multicenter, open label, study to Evaluate the EFficacy and SaFEty of Leukotac® (inolimomab) in pediatric patients with steroid resistant acute Graft versus Host Disease (SR-aGvHD)
- Trial name
- EiFFEL (NCT04289103)
- Testing
- Inolimomab (Leukotac)
- Volunteers
- 65 people
- Sponsor
- ElsaLys Biotech
Steroid Refractory Graft Versus Host Disease
CK0802 for Treatment of Steroid Refractory Graft vs. Host Disease (GVHD)
The purpose of this study is to determine the efficacy and safety of CK0802 Tregs for treatment of refractory GVHD (graft-versus-host disease)
- Trial name
- NCT07576699
- Testing
- CK0802 (Allogeneic, Cryopreserved, Cord blood-derived T-regulatory cells, cells that are not HLA matched)
- Volunteers
- 12 people
- Sponsor
- Cellenkos, Inc.
Chronic Graft Versus Host Disease cGVHD
Safety and Efficacy of Efavaleukin Alfa in Subjects With Steroid Refractory Chronic Graft Versus Host Disease
Phase 1b: To evaluate the safety and tolerability of multiple ascending doses of efavaleukin alfa in subjects with steroid refractory chronic graft versus host disease (cGVHD).
- Trial name
- NCT03422627
- Testing
- Efavaleukin Alfa
- Where
- 14 sites in United States, Belgium and 2 more
- Volunteers
- 32 people
- Sponsor
- Amgen
Intravenous Steroid-Refractory Ulcerative Colitis
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis
To compare the efficacy of visilizumab at 5 mcg/kg/day administered intravenously (IV) on Days 1 and 2 to placebo in subjects with IVSR-UC.
- Trial name
- NCT00502294
- Testing
- Visilizumab (HuM291; Nuvion®)
- Volunteers
- 150 people
- Sponsor
- Facet Biotech
Sacroiliac Joint Somatic Dysfunction
Comparison of CornerLoc SI Joint Stabilization and Steroid Injections for Sacroiliac Joint Dysfunction
This study has been designed to compare the safety and effectiveness of the CornerLoc™ SI Joint Stabilization System to intra-articular sacroiliac joint steroid injection in patients with refractory sacroiliac joint dysfunction.
- Trial name
- COVI (NCT04218838)
- Testing
- CornerLoc SI Joint Stabilization Procedure, Intra-articular Sacroiliac Joint Steroid Injection
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- CornerLoc
Acute Graft Versus Host Disease
A Study of AbGn-168H in Patients With Steroid Refractory Acute Graft-vs-Host Disease After Donor Stem Cell Transplant
This study is to establish the safety, determine if there is an improvement in steroid refractory acute graft-vs-host disease (aGvHD) compared to historical cohorts, and determine the changes of aGvHD-associated T-cell clones in…
- Trial name
- NCT02436460
- Testing
- AbGn-168H
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- AbGenomics B.V Taiwan Branch
Ulcerative Colitis
CT to Assess the Efficacy and Safety of Adding GMA to Infliximab in Paediatric Patients With Steroid-refractory Ulcerative Colitis
The primary endpoint will be evaluated through the following variables: PUCAI score, IFX levels, and steroid treatment. Clinical response to IFX will be evaluated through the PUCAI score.
- Trial name
- NCT05430412
- Testing
- Adacolumn
- Where
- 10 sites in Portugal, Spain
- Volunteers
- 15 people
- Sponsor
- Adacyte Therapeutics SL
Acute Graft Versus Host Disease in Intestine, Steroid Refractory GVHD
MaaT013 As Salvage Therapy in Ruxolitinib Refractory GI-aGVHD Patients
MaaT013 showed interesting results in steroids and ruxolitinib-resistant aGVHD patients with gut involvement (55% ORR at D28) and 47% and 39% OS at 6 and 12 months respectively (Malard 2020), therefore warrant being tested as…
- Trial name
- ARES (NCT04769895)
- Testing
- MaaT013
- Where
- 50 sites in Austria, Belgium and 4 more
- Volunteers
- 66 people
- Sponsor
- MaaT Pharma
Chronic Graft-versus-host-disease
Efficacy and Safety of SCM-CGH in Patients With Steroid-Refractory or Dependent Chronic Graft-Versus-Host Disease
The purpose of this study is to evaluate efficacy of SCM-CGH in participants with steroid dependent/refractory chronic graft versus host disease (cGVHD) by measuring overall cGVHD response (complete response [CR] and partial…
- Trial name
- NCT04189432
- Testing
- SCM-CGH
- Where
- 11 sites in South Korea
- Volunteers
- 84 people
- Sponsor
- SCM Lifescience Co., LTD.
Colitis, Hepatitis
PHOENIX-ECP- Extracorporeal Photopheresis for Immune-related Colitis and/or Hepatitis in Advanced Melanoma With Inadequate Response to Steroid Exposure
Extracorporeal photopheresis (ECP) is an immunomodulatory therapy in which the photoactivating agent methoxsalen (also known as UVADEX) is used in combination with ultraviolet A (UVA) light.
- Conditions
- Colitis, Hepatitis, Melanoma (Skin Cancer)
- Trial name
- PHOENIX-ECP (NCT07619898)
- Testing
- methoxsalen, Extracorporeal photopheresis (ECP), Vedolizumab
- Volunteers
- 112 people
- Sponsor
- Therakos LLC
Graft vs Host Disease
A Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Participants With Steroid Dependent/Refractory Chronic Graft Versus Host Disease (cGVHD)
The purpose of this study is to evaluate efficacy of ibrutinib in Japanese participants with steroid dependent/refractory chronic graft versus host disease (cGVHD) by measuring overall cGVHD response (complete response [CR] and…
- Trial name
- NCT03474679
- Testing
- Ibrutinib
- Where
- 15 sites in Japan
- Volunteers
- 19 people
- Sponsor
- Janssen Pharmaceutical K.K.
Graft-versus-host Disease (GVHD)
Expanded Access of Ruxolitinib Cream to Treat a Single Patient With cGVHD
To provide ruxolitinib through an expanded access to treat a single patient with cGVHD
- Trial name
- NCT05722912
- Testing
- Ruxolitinib
- Sponsor
- Incyte Corporation
Chronic Graft vs Host Disease
A Study to Investigate the Comparative Effectiveness of Ibrutinib in Steroid Dependent/Refractory cGVHD Participants
The purpose of this study is to evaluate the effectiveness of ibrutinib compared to conventional salvage treatments in participants with steroid dependent/refractory chronic graft versus host disease (cGVHD) by measuring overall…
- Trial name
- NCT04852692
- Where
- 8 sites in South Korea
- Volunteers
- 15 people
- Sponsor
- Janssen Korea, Ltd., Korea