Clinical trials: Systemic Disease
Microscopic Polyangiitis (MPA), Granulomatosis With Polyangiitis (GPA)
Special Drug Use-results Survey for Long-term Use（Avacopan）
The purpose of this survey is evaluating the safety and efficacy of long-term administration of avacopan for Japanese patients with microscopic polyangiitis or granulomatosis with polyangiitis under actual conditions of use.
- Trial name
- NCT06758271
- Testing
- Avacopan
- Where
- Japan
- Volunteers
- 250 people
- Sponsor
- Kissei Pharmaceutical Co., Ltd.
Lupus Nephritis
A Study of Telitacicept in Lupus Nephritis
The purpose of this study is to evaluate the safety and efficacy of Telitacicept in adult patients with active lupus nephritis.
- Trial name
- NCT05680480
- Testing
- Telitacicept 240 mg, Telitacicept 160 mg
- Where
- 45 sites in China
- Volunteers
- 120 people
- Sponsor
- RemeGen Co., Ltd.
Post-Operative Confusion
Braindex Cerebral Tissue Oxygen Saturation (SctO2) Measurement Algorithm Assessment and Improvement
The objective of this clinical trial is to optimize Braindex brain tissue oxygen saturation (SctO2) measurement algorithm compared to a mixed reference value of jugular venous and systemic arterial saturation, during proven…
- Trial name
- POC-SctO2 (NCT05897060)
- Testing
- Venus Jugular O2 Saturation optical fiber
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Braindex
Systemic Sclerosis
A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis
The purpose of this study is to compare the efficacy and safety of BMS-986353 versus standard of care in participants with active Systemic Sclerosis
- Trial name
- Breakfree-SSc (NCT07335562)
- Testing
- BMS-986353, Fludarabine, Cyclophosphamide
- Where
- 56 sites in United States, Belgium and 8 more
- Volunteers
- 92 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Healthy, Lupus Nephritis
Functional MRI in Lupus Nephritis
The primary objectives of the study are as follows: To develop and optimize a renal functional magnetic resonance imaging (MRI) protocol consisting of Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI), Blood-Oxygen…
- Trial name
- NCT01731054
- Where
- 4 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Biogen
Digital Ulcers
Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients
The DUAL-2 study is designed as a multicenter, double-blind two-period study with an initial fixed 16-week Period 1, followed by a Period 2 of variable duration.
- Trial name
- DUAL-2 (NCT01474122)
- Testing
- Macitentan 3 mg, Macitentan 10 mg
- Volunteers
- 265 people
- Sponsor
- Actelion
Severe Sepsis, Coagulopathy
Phase 3 Safety and Efficacy Study of ART-123 in Subjects With Severe Sepsis and Coagulopathy
The purpose of the study is to evaluate if ART-123 given to patients who have severe sepsis can decrease mortality.
- Trial name
- NCT01598831
- Testing
- ART-123
- Where
- 161 sites in United States, Argentina and 22 more
- Volunteers
- 816 people
- Sponsor
- Asahi Kasei Pharma America Corporation
Systemic Lupus Erythematosus
A Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Participants With Systemic Lupus Erythematosus
The primary objective of this study is to evaluate the long term safety and tolerability of repeated administration of subcutaneous (SC) CEP-33457 for injection every 4 weeks over 72 weeks (18 doses) in participants with systemic…
- Trial name
- NCT01240694
- Testing
- CEP-33457
- Where
- 85 sites in United States, Belgium and 9 more
- Volunteers
- 136 people
- Sponsor
- Cephalon, Inc.
Systemic Lupus Erythematosus
Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease
The primary objective of the study is to assess the dose response and the dose frequency of epratuzumab in patients with SLE.
- Trial name
- NCT00624351
- Testing
- Epratuzumab
- Where
- 53 sites in United States, Belgium and 9 more
- Volunteers
- 227 people
- Sponsor
- UCB Pharma
Diffuse Cutaneous Systemic Sclerosis
Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc)
This is a prospective, multicenter, randomized, open-label, crossover study to investigate the safety, tolerability, and pharmacokinetics of IgPro20 in participants with diffuse cutaneous systemic sclerosis (dcSSc).
- Trial name
- NCT04137224
- Testing
- IgPro20, IgPro10
- Where
- 9 sites in Australia, Germany and 3 more
- Volunteers
- 27 people
- Sponsor
- CSL Behring
Schizophrenia, Alzheimer Disease
Study of Systemic and Ocular Safety and Pharmacokinetics of BI 409306 in Patients With Schizophrenia, Alzheimer's Disease, and Healthy Volunteers
Single site, parallel-group, double-blind trial of low or high dose of BI 409306 to evaluate the ocular and systemic safety and pharmacokinetics during 14 day treatment period in patients with schizophrenia, Alzheimer's disease…
- Trial name
- NCT02392468
- Testing
- BI 409306 25 mg, BI 409306 50 mg
- Where
- 3 sites in United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome
Universal CAR-T Cells (BRL-301) in Relapse or Refractory Autoimmune Diseases
This is an investigator initiated trial to assess the efficacy and safety of BRL-301 in the relapse or refractory autoimmune diseases of China.
- Conditions
- Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome, Systemic Sclerosis, Inflammatory Myopathy
- Trial name
- NCT05859997
- Testing
- BRL-301
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Bioray Laboratories
Membranous Nephropathy, Lupus Nephritis (LN)
A Study to Evaluate the Efficacy, Safety, and Tolerability of Human Sialidase Fusion Protein (HLX79) in Combination With Rituximab Injection Versus Placebo in Patients With Active Glomerulonephritis
The primary objectives of this clinical trial is to evaluate the safety and tolerability of HLX79 in combination with HLX01 versus placebo in combination with HLX01 in the treatment of glomerulonephritis.
- Trial name
- NCT07038382
- Where
- 17 sites in China
- Volunteers
- 24 people
- Sponsor
- Shanghai Henlius Biotech
Lupus Nephritis
Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of Ixazomib in Lupus Nephritis (LN)
The purpose of this study is to characterize the safety and tolerability of ixazomib when administered as multiple oral doses at escalating dose levels in participants with lupus nephritis.
- Trial name
- NCT02176486
- Testing
- Ixazomib
- Where
- 35 sites in United States, France and 5 more
- Volunteers
- 12 people
- Sponsor
- Takeda
Metastatic Colorectal Cancer, Colon Cancer
A Study of CTX-009 in Adult Patients With Metastatic Colorectal Cancer
This study is designed as an open-label, adaptive Simon Two-Stage study to evaluate the efficacy of CTX-009 in patients with metastatic colorectal cancer.
- Conditions
- Metastatic Colorectal Cancer, Colon Cancer, Rectal Cancer
- Trial name
- COMPANION-003 (NCT05513742)
- Testing
- CTX-009
- Where
- 7 sites in United States
- Volunteers
- 49 people
- Sponsor
- Compass Therapeutics
Neoplasms, Breast
Lapatinib for Brain Metastases In ErbB2-Positive Breast Cancer
Determine how safe and effective lapatinib is when used to treat patients with ErbB2 overexpressing breast cancer that has spread to the brain and is still progressing there even after radiation treatment using WBRT (whole brain…
- Trial name
- NCT00263588
- Testing
- lapatinib
- Where
- 74 sites in United States, Australia and 15 more
- Volunteers
- 242 people
- Sponsor
- Novartis Pharmaceuticals
Atrial Fibrillation, Atrial Flutter
Combined Use of BIOTRONIK Home Monitoring and Predefined Anticoagulation to Reduce Stroke Risk
The IMPACT Study will investigate the potential clinical benefit of the combined use of BIOTRONIK Home Monitoring (HM) technology and a predefined anticoagulation plan compared to conventional device evaluation and…
- Conditions
- Atrial Fibrillation, Atrial Flutter, Stroke, Embolism, Systemic Arterial
- Trial name
- IMPACT (NCT00559988)
- Testing
- Home Monitoring Guided OAC, Physician-Directed OAC
- Where
- 80 sites in United States, Australia and 4 more
- Volunteers
- 2,718 people
- Sponsor
- Biotronik, Inc.
System; Lupus Erythematosus
Individual Patient Expanded Access IND of Autologous HB-adMSCs for the Treatment of Systemic Lupus Erythematosus (SLE)
This protocol is part of an FDA Individual Patient Expanded Access IND. This study is to be conducted according to US and International Standards of Good Clinical Practice (FDA Title 21 part 312 and International Conference on…
- Trial name
- NCT04907175
- Testing
- HB-adMSCs
- Where
- United States
- Sponsor
- Hope Biosciences Research Foundation
Eosinophilic Granulomatosis With Polyangiitis (EGPA), Hypereosinophilia Syndrome (HES)
A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
The main purpose of study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of benralizumab.
- Trial name
- CLIPS (NCT06512883)
- Testing
- Benralizumab
- Where
- 15 sites in United States, Brazil and 8 more
- Volunteers
- 14 people
- Sponsor
- AstraZeneca
Systemic Lupus Erythematosus
Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus
International trial to evaluate the biological activity and safety of cenerimod (ACT-334441) in systemic lupus erythematosus (SLE) patients.
- Trial name
- NCT02472795
- Testing
- Cenerimod
- Where
- 18 sites in United States, Belarus and 4 more
- Volunteers
- 105 people
- Sponsor
- Viatris Innovation GmbH