Clinical trials: Antibody Mediated
Warm Autoimmune Hemolytic Anemia
ALXN1830 in Patients With Warm Autoimmune Hemolytic Anemia
The main objective of the study is to evaluate the safety and efficacy of ALXN1830 compared to placebo in adult participants with warm autoimmune hemolytic anemia (WAIHA).
- Trial name
- NCT04256148
- Testing
- ALXN1830
- Where
- United States
- Sponsor
- Alexion Pharmaceuticals, Inc.
Transplant Rejection
BIVV020 (SAR445088) in Prevention and Treatment of Antibody-mediated Rejection (AMR)
Primary Objectives: Cohort A: To evaluate the efficacy of BIVV020 in prevention of AMR Cohort B: To evaluate the efficacy of BIVV020 in treatment of active AMR Secondary Objectives: To assess the overall efficacy of BIVV020 in…
- Trial name
- NCT05156710
- Testing
- BIVV020 (SAR445088), Intravenous immunoglobulin (IVIg), Rituximab or biosimilar
- Where
- 27 sites in United States, Canada and 5 more
- Volunteers
- 48 people
- Sponsor
- Sanofi
Rheumatoid Arthritis
Drug Concentration, Immunogenicity, and Efficacy Study in Patients With Rheumatoid Arthritis Currently Treated With Etanercept, Adalimumab, or Infliximab
The purpose of this study is to examine the relationship between anti-drug antibodies, serum drug concentrations, and clinical response for rheumatoid arthritis patients being treated with etanercept, adalimumab or infliximab.
- Trial name
- ANTIBODY-RA (NCT01981473)
- Testing
- no intervention
- Where
- 54 sites in United States, Argentina and 3 more
- Volunteers
- 605 people
- Sponsor
- Pfizer
Acute Antibody-Mediated Rejection (AMR)
A Multicenter Study to Evaluate the Efficacy and Safety of Cinryze® for the Treatment of Acute Antibody-mediated Rejection in Participants With Kidney Transplant
The main purpose of the study is to evaluate the efficacy of CINRYZE administered with plasmapheresis, plasma exchange, or immune adsorption treatments and sucrose-free immunoglobulin (IVIg) for the treatment of acute…
- Trial name
- NCT02547220
- Testing
- Cinryze®
- Where
- 47 sites in United States, Canada and 4 more
- Volunteers
- 39 people
- Sponsor
- Shire
Graft Rejection, Kidney Transplantation
Recombinant Human C1 Inhibitor for the Treatment of Early Antibody-Mediated Rejection in Renal Transplantation
The purpose of this study will be to assess the safety, tolerability, and efficacy of rhC1INH in renal transplant recipients with biopsy-confirmed antibody-mediated rejection (AMR) within 30 days of renal transplantation.
- Trial name
- NCT01035593
- Testing
- plasmapheresis and IVIG, recombinant C1 inhibitor
- Where
- United States
- Sponsor
- Pharming Technologies B.V.
SLE - Systemic Lupus Erythematosus, Systemic Sclerosis
CD19/BCMA-Targeted Universal CAR-T Cell Injection for the Treatment of Autoimmune Diseases
This is a single-arm, open-label, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with autoantibody-mediated autoimmune…
- Conditions
- SLE - Systemic Lupus Erythematosus, Systemic Sclerosis, ANCA Associated Vasculitis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT07596680
- Testing
- RD06-05 CAR-T Cell Injection
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.
Antibody-Mediated Graft Rejection
Cell-based Assays for Antibody-mediated Transplant Rejection
Goal: The goal of this study is to validate blood tests, which can detect antibody-mediated rejection (ABMR) after renal transplantation.
- Trial name
- NCT03916822
- Testing
- Alloantigen-specific B-cells
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Plexision
Peanut Allergy
Efficacy and Safety of Viaskin Peanut in Children With Immunoglobulin E (IgE)-Mediated Peanut Allergy
The PEPITES study evaluates the efficacy and safety of Viaskin Peanut 250 µg peanut protein to induce desensitization to peanut in peanut-allergic children 4 through 11 years of age after a 12-month treatment by epicutaneous…
- Trial name
- PEPITES (NCT02636699)
- Testing
- Viaskin Peanut 250mcg
- Where
- 31 sites in United States, Australia and 3 more
- Volunteers
- 500 people
- Sponsor
- DBV Technologies
Cow's Milk Allergy
Evaluation of Tolerance, Efficacy and Safety of an Hydrolyzed Formula in Infants With IgE/Non-IgE Mediated CMA.
The aim of this interventional study is to assess the hypoallergenicity of a new formula in infants having a cow milk allergy (CMA), whatever the type of CMA, meaning in both IgE-mediated and non-IgE-mediated CMA patients.
- Trial name
- MERLIN (NCT06481280)
- Testing
- Test Formula
- Where
- 2 sites in Belgium, Italy
- Volunteers
- 70 people
- Sponsor
- United Pharmaceuticals
Antibody-mediated Rejection
Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection (AMR) in Adult Renal Transplant Recipients
This is a double-blind, randomized-withdrawal, placebo-controlled study in kidney transplant patients with AMR to evaluate the efficacy and safety of human plasma-derived C1-esterase inhibitor as add-on to standard of care (IVIG).
- Trial name
- NCT03221842
- Testing
- C1-esterase inhibitor
- Where
- 26 sites in United States, Belgium and 5 more
- Volunteers
- 63 people
- Sponsor
- CSL Behring
IgA Nephropathy (IgAN), Membranous Nephropathy
A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in the Treatment of Immune-mediated Kidney Diseases
This study is a single-arm, open-label, dose-escalation and dose-expansion clinical trial, divided into two phases: the first phase is the dose-escalation phase, and the second phase is the dose-expansion phase.
- Conditions
- IgA Nephropathy (IgAN), Membranous Nephropathy, ANCA-associated Vasculitis (AAV)/ANCA-associated Glomerulonephritis (AAGN), Refractory Podocytopathy
- Trial name
- NCT07389499
- Testing
- CD19-targeted iNKT Cell Injection
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Grit Biotechnology
Chronic Kidney Disease, Inflammation
Trial to Evaluate Reduction in Inflammation in Patients With Advanced Chronic Renal Disease Utilizing Antibody Mediated IL-6 Inhibition in Japan.
The purpose of this research study is to compare the safety and effectiveness of 2 different doses of a study drug called ziltivekimab to placebo (an inactive substance) in reducing inflammation and improving some of the bad…
- Conditions
- Chronic Kidney Disease, Inflammation, Cardiovascular Risk
- Trial name
- RESCUE-2 (NCT04626505)
- Testing
- Ziltivekimab
- Where
- Japan
- Volunteers
- 36 people
- Sponsor
- Novo Nordisk A/S
Graft Rejection
A Pilot Study to Evaluate the Use of C1 Esterase Inhibitor (Human) in Patients With Acute Antibody-Mediated Rejection
The purpose of this research study is to evaluate the safety, effect, and pharmacology of C1 Esterase Inhibitor (human) in kidney transplant patients with acute Antibody-Mediated Rejection (AMR).
- Trial name
- NCT01147302
- Testing
- C1 Esterase Inhibitor (Human)
- Where
- 5 sites in United States, Germany
- Volunteers
- 18 people
- Sponsor
- Shire
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
This is a Phase 1/2, open-label, multi-center, multi-cohort, non-randomized dose escalation and dose expansion basket study to determine the safety and tolerability of NKX019 (allogeneic CAR NK cells targeting CD19) in…
- Conditions
- Systemic Sclerosis, Idiopathic Inflammatory Myopathies, Antineutrophil Cytoplasmic Antibody-Associated Vasculitis, Rheumatoid Arthritis
- Trial name
- NCT06733935
- Testing
- NKX019, Fludarabine, Cyclophosphamide
- Where
- 12 sites in United States
- Volunteers
- 240 people
- Sponsor
- Nkarta, Inc.
Antibody-mediated Rejection
Clazakizumab for the Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients
This trial investigates the efficacy and safety of clazakizumab [an anti-interleukin (IL)-6 monoclonal antibody (mAb)] for the treatment of CABMR in recipients of a kidney transplant.
- Trial name
- IMAGINE (NCT03744910)
- Testing
- Clazakizumab, Physiologic saline solution
- Where
- 142 sites in United States, Australia and 13 more
- Volunteers
- 194 people
- Sponsor
- CSL Behring
SLE, Sclerosis
A Study of RD06-04 in Patients With Active Autoimmune Diseases
This is an open-label, Phase I, investigator-initiated trial (IIT) aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with autoimmune diseases mediated by…
- Conditions
- SLE, Sclerosis, ANCA Associated Vasculitis, IIM
- Trial name
- NCT06548620
- Testing
- RD06-04 cell infusion
- Where
- China
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.