Clinical trials: Chronic Graft vs Host Disease
- Condition Chronic Graft vs Host Disease
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Chronic Graft Versus Host Disease
A Study to Investigate Safety of Belumosudil in Participants Aged 12 Years and Above, With Chronic Graft-versus-host Disease (cGVHD)
This is an interventional phase IV clinical study which is single-arm study for assessing the safety of belumosudil in Indian patients who are12 years and older.
- Trial name
- NCT07135973
- Testing
- Belumosudil
- Volunteers
- 26 people
- Sponsor
- Sanofi
Chronic Graft Versus Host Disease
A Study to Test an Oral Medicine, Belumosudil, in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease.
This is a parallel, Phase 3, two-arm study for the treatment of newly diagnosed moderate or severe chronic GVHD. The study duration for a participant includes up to 4 weeks for screening; a treatment period until clinically…
- Trial name
- ROCKnrol-1 (NCT06143891)
- Testing
- Belumosudil, Prednisone, Prednisolone
- Where
- 151 sites in United States, Argentina and 22 more
- Volunteers
- 260 people
- Sponsor
- Sanofi
Chronic Graft-versus-host-disease
A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease
This study will be conducted to determine the preliminary efficacy of axatilimab in combination with ruxolitinib and to assess the contribution of axatilimab to the combination treatment effect in participants with cGVHD.
- Trial name
- NCT06388564
- Testing
- Axatilimab, Ruxolitinib, Corticosteroids
- Where
- 68 sites in United States, Belgium and 5 more
- Volunteers
- 130 people
- Sponsor
- Incyte Corporation
Chronic Graft-versus-host-disease
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
This study will be conducted to compare the efficacy of axatilimab versus placebo in combination with corticosteroids as initial treatment for moderate or severe chronic graft-versus-host disease (cGVHD).
- Trial name
- AXemplify-357 (NCT06585774)
- Testing
- INCA034176, Corticosteroids
- Where
- 131 sites in United States, Australia and 11 more
- Volunteers
- 240 people
- Sponsor
- Incyte Corporation
Chronic Graft-versus-host-disease
A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256)
This study will be conducted to compare Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy.
- Trial name
- NCT07124078
- Testing
- INCA034176, Best available Treatment (BAT)
- Where
- 41 sites in United States, Belgium and 4 more
- Volunteers
- 60 people
- Sponsor
- Incyte Corporation
Chronic Graft-versus-host-disease
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Axatilimab Monotherapy in Japanese Participants With Recurrent or Refractory Active Chronic Graft-Versus-Host Disease
This study will be conducted to determine the clinical efficacy of axatilimab in Japanese participants with chronic graft-versus-host disease (cGVHD).
- Trial name
- NCT06263478
- Testing
- INCA034176
- Where
- 16 sites in Japan
- Volunteers
- 21 people
- Sponsor
- Incyte Biosciences Japan GK
Chronic Graft Versus Host Disease
A Study of Belumosudil in Children With Chronic Graft Versus Host Disease (schoolROCK)
This is an open-label, single group, Phase 1/2, 1-arm study for treatment of children aged 1 to <18 years with active moderate-to-severe cGVHD that is refractory to or recurred after at least 2 prior lines of systemic therapy for…
- Trial name
- schoolROCK (NCT07116031)
- Testing
- Belumosudil
- Where
- 35 sites in United States, Belgium and 11 more
- Volunteers
- 37 people
- Sponsor
- Sanofi
Chronic Graft Versus Host Disease
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Participants will be randomized 1:1 to receive either belumosudil or Best Available Therapy (BAT), with stratification based on baseline cGVHD severity as defined by the 2014◦NIH consensus criteria (moderate versus severe), use…
- Trial name
- NCT07771439
- Testing
- Belumosudil, Best available therapy (BAT)
- Volunteers
- 356 people
- Sponsor
- Sanofi
Chronic Graft-versus-host-disease
A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy
This study will be conducted to compare Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy.
- Trial name
- NCT06821542
- Testing
- INCA034176, Best Available Therapy (BAT)
- Where
- 130 sites in Austria, Belgium and 14 more
- Volunteers
- 9 people
- Sponsor
- Incyte Corporation
Chronic Graft-versus-host-disease
A Ph1b/2 Study of Axatilimab Monotherapy in Chinese Participants With Recurrent or Refractory cGVHD
This study will be conducted to evaluate the safety, efficacy, and pharmacokinetics of axatilimab monotherapy in Chinese participants with recurrent or refractory active chronic graft-versus-host disease after systemic therapy.
- Trial name
- NCT06843408
- Testing
- INCA034176
- Where
- 9 sites in China
- Volunteers
- 32 people
- Sponsor
- Incyte Corporation
Chronic Graft Vs. Host Disease
Expanded Access of Axatilimab to Treat a Single Patient With Chronic Graft Versus Host Disease (GVHD)
This program is being offered on a patient by patient basis and will require company, Institutional Review Board/Independent Ethics Committee and Single Patient IND approval.
- Trial name
- NCT05544032
- Testing
- axatilimab
- Sponsor
- Incyte Corporation
Chronic Graft-versus-host-disease
A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)
This is a Phase 2 study to evaluate the efficacy, safety, and tolerability of axatilimab at 3 different dose levels in participants with recurrent or refractory active chronic graft versus host disease (cGVHD) who have received…
- Trial name
- AGAVE-201 (NCT04710576)
- Testing
- Axatilimab
- Where
- 121 sites in United States, Australia and 14 more
- Volunteers
- 296 people
- Sponsor
- Syndax Pharmaceuticals
Graft vs. Host Disease, Chronic Graft vs. Host Disease
Study of Efficacy and Safety of Ruxolitinib in Chinese Participants With Corticosteroid-refractory Chronic Graft vs. Host Disease
The purpose of the study is to assess the efficacy and safety of ruxolitinib in Chinese adult and pediatric participants aged 12 years or older with corticosteroid-refractory chronic graft vs. host disease (SR-cGvHD).
- Conditions
- Graft vs. Host Disease, Chronic Graft vs. Host Disease, Corticosteroid-refractory Chronic Graft vs. Host Disease
- Trial name
- NCT06824103
- Testing
- Ruxolitinib
- Where
- 22 sites in China
- Volunteers
- 50 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Graft Versus Host Disease
A Clinical Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Belumosudil in Chinese Adolescents With cGVHD Who Have Had an Inadequate Response to Glucocorticoids or Other Systemic Therapies
This is a single group, Phase 4, single-arm post-marketing study for treatment. The purpose of this study is to verify the pharmacokinetics, efficacy, and safety of belumosudil mesylate tablets in Chinese adolescent participants…
- Trial name
- NCT06616415
- Testing
- Belumosudil
- Where
- 2 sites in China
- Volunteers
- 6 people
- Sponsor
- Sanofi
Chronic Graft Versus Host Disease
Safety and Efficacy of Oral Belumosudil in Black or African American, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander Male and Female Participants Aged 12 Years and Above With Chronic Graft Versus Host Disease (cGVHD) After At Least 2 Prior Lines of Systemic Therapy
The purpose of this study is to measure safety and efficacy of oral belumosudil in Black or African American, American Indian or Alaska Native, and Native Hawaiian or Other Pacific Islander male and female participants with cGVHD…
- Trial name
- NCT05567406
- Testing
- Belumosudil
- Sponsor
- Kadmon, a Sanofi Company
Primary Myelofibrosis (PMF), Post Polycythemia Myelofibrosis (PPV MF)
Managed Access Programs for INC424, Ruxolitinib
The purpose of this registration is to list Managed Access Programs (MAPs) related to INC424, Ruxolitinib
- Conditions
- Primary Myelofibrosis (PMF), Post Polycythemia Myelofibrosis (PPV MF), Thrombocythemia Myelofibrosis (PET-MF), Severe/Very Severe COVID-19 Illness
- Trial name
- NCT04745637
- Testing
- Ruxolitinib
- Sponsor
- Novartis Pharmaceuticals
Chronic Graft Versus Host Disease
Phase 1/2 Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects With Chronic Graft Versus Host Disease (cGVHD)
Dose Finding and Safety Study of Ibrutinib in Pediatric Subjects with Chronic Graft Versus Host Disease (cGVHD)
- Trial name
- NCT03790332
- Testing
- Ibrutinib
- Where
- 48 sites in United States, Australia and 11 more
- Volunteers
- 59 people
- Sponsor
- Pharmacyclics LLC.
Chronic Graft-versus-host-disease
A Phase 1/2 Study to Evaluate Axatilimab in Participants With Active cGVHD
This is a Phase 1/2, Open-label, Dose Escalation study to investigate axatilimab in participants with active chronic graft versus host disease (cGVHD).
- Trial name
- NCT03604692
- Testing
- axatilimab
- Where
- 11 sites in United States
- Volunteers
- 41 people
- Sponsor
- Syndax Pharmaceuticals
Chronic Graft-versus-host-disease
Efficacy and Safety of KD025 in Subjects With cGVHD After At Least 2 Prior Lines of Systemic Therapy
This is a Phase 2, randomized, multicenter study to evaluate the efficacy and safety of KD025 in subjects with Chronic Graft Versus Host Disease (cGVHD) after at least 2 prior lines of systemic therapy
- Trial name
- NCT03640481
- Testing
- Belumosudil (KD025)
- Where
- 35 sites in United States
- Volunteers
- 159 people, healthy volunteers welcome
- Sponsor
- Kadmon, a Sanofi Company
Chronic Graft Versus Host Disease
Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New Onset Chronic Graft Versus Host Disease (cGVHD)
To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects with newly diagnosed moderate to severe cGVHD.
- Trial name
- iNTEGRATE (NCT02959944)
- Testing
- ibrutinib, Prednisone
- Where
- 102 sites in United States, Australia and 13 more
- Volunteers
- 193 people
- Sponsor
- Pharmacyclics LLC.