Clinical trials: Monoclonal
Cryopyrin-associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome
Efficacy and Safety Study of Canakinumab Administered for 6 Months (24 Weeks) in Japanese Patients With Cryopyrin-associated Periodic Syndromes Followed by an Extension Phase
To date there are no approved effective therapies for the treatment of cryopyrin-associated periodic syndromes (CAPS) including Familial Cold Autoinflammatory Syndrome (FCAS), Muckle-Wells Syndrome (MWS), or Neonatal Onset…
- Conditions
- Cryopyrin-associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, Neonatal Onset Multisystem Inflammatory Disease
- Trial name
- NCT00991146
- Testing
- canakinumab
- Where
- 3 sites in Japan
- Volunteers
- 19 people
- Sponsor
- Novartis Pharmaceuticals
Liver Transplantation
Comparing Efficacy & Safety of Tacrolimus With/Without MMF or Monoclonal Anti-IL2R Antibody in Liver Transplantation.
To compare the efficacy and safety of two regimens containing tacrolimus and minimal steroids together with either monoclonal anti-IL2R antibodies (daclizumab) or mycophenolate mofetil.
- Trial name
- MARSILEA (NCT00295594)
- Testing
- tacrolimus
- Where
- 41 sites in Belgium, Denmark and 9 more
- Volunteers
- 627 people
- Sponsor
- Astellas Pharma Inc
Healthy Volunteers
A Study to Determine the Safety of AV-1, an Antibody Being Developed for Treatment of Dengue, in Healthy Volunteers
AV-1 is a human monoclonal antibody (mAb) being investigated as a potential therapy for dengue, a mosquito-borne viral disease with extensive global public health impact.
- Trial name
- NCT04273217
- Testing
- AV-1
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- AbViro LLC
LIVER TRANSPLANTATION
Tacrolimus and Daclizumab Versus Tacrolimus and Steroids in Liver Recipients Receiving Sub-optimal Grafts
The purpose of the study is to compare the safety and efficacy of two different tacrolimus based immunosuppressive regimens, one in combination with daclizumab, the other in combination with steroids, in recipients of suboptimal…
- Trial name
- PANTERA (NCT00321074)
- Testing
- TACROLIMUS
- Where
- 9 sites in Italy
- Volunteers
- 101 people
- Sponsor
- Astellas Pharma Inc
Severe Asthma
A Long-Term Safety and Efficacy Study of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALOUR)
The primary purpose of this study is to evaluate the long-term safety and efficacy of verekitug (UPB-101) in participants who complete the VALIANT study (NCT06196879).
- Trial name
- NCT06966479
- Testing
- Verekitug
- Where
- 102 sites in United States, Argentina and 13 more
- Volunteers
- 396 people
- Sponsor
- Upstream Bio Inc.
Breast Cancer, Hypercalcemia of Malignancy
Monoclonal Antibody Compared With Zoledronate in Treating Women With Breast Cancer and Bone Metastases
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Zoledronate may prevent bone loss and stop the growth of tumor cells in bone.
- Conditions
- Breast Cancer, Hypercalcemia of Malignancy, Metastatic Cancer, Pain
- Trial name
- NCT00060138
- Testing
- monoclonal antibody CAL, zoledronic acid
- Where
- United States
- Sponsor
- Chugai Pharmaceutical
Biliary Tract Cancer
Durvalumab With Chemotherapy as First Line Treatment in Patients With Advanced Biliary Tract Cancers (aBTCs)
A study to assess the safety and efficacy of durvalumab in combination with gemcitabine-based chemotherapy regimens in participants with aBTC.
- Trial name
- TOURMALINE (NCT05771480)
- Testing
- Durvalumab, Gemcitabine monotherapy, Gemcitabine + cisplatin
- Where
- 34 sites in United States, France and 6 more
- Volunteers
- 142 people
- Sponsor
- AstraZeneca
Atopic Dermatitis
Study of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Atopic Dermatitis
The study is to reflect the effectiveness and safety of MG-K10 humanized monoclonal antibody injection in patients with moderate to severe atopic dermatitis.administered every 4 weeks for 52 week
- Trial name
- NCT06026891
- Where
- China
- Volunteers
- 498 people
- Sponsor
- Shanghai Mabgeek Biotech.Co.Ltd
B Cell Lymphoma
A Study to Compare the Bioequivalence and Safety of JHL1101 and Rituximab in CD20 Positive B Cell Lymphoma Patients
This is a multicenter, randomized, double-blind, parallel group study to compare the PK, safety, tolerability, immunogenicity and PD of JHL1101 vs Rituxan in subjects with CD20-positive B cell lymphoma.
- Trial name
- NCT03670888
- Testing
- JHL1101, Rituximab
- Where
- 2 sites in China
- Volunteers
- 1 people
- Sponsor
- JHL Biotech, Inc.
Plasma Cell Myeloma
SAR650984 (Isatuximab), Lenalidomide, and Dexamethasone in Combination in RRMM Patients
Primary Objectives: To determine the maximum tolerated dose of SAR650984 (isatuximab) with lenalidomide and dexamethasone (LD) in patients with relapsed or refractory multiple myeloma.
- Trial name
- NCT01749969
- Testing
- isatuximab SAR650984, lenalidomide, dexamethasone
- Where
- 5 sites in United States
- Volunteers
- 57 people
- Sponsor
- Sanofi
Pharmacokinetics of ASKP1240, Healthy Volunteers
Study of ASKP1240 After a Single Intravenous Dose at Escalating Dose Levels in Healthy Subjects
The objective of this study is to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of ASKP1240 after a single intravenous dose at escalating dose levels in healthy subjects.
- Trial name
- NCT01565681
- Testing
- ASP1240
- Where
- United States
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Arthritis, Juvenile Idiopathic
Study of Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Idiopathic Arthritis (JIA)
This is a multicenter, Phase 3 randomized, placebo-controlled study designed to evaluate adalimumab in children 4 to 17 years old with polyarticular juvenile idiopathic arthritis (JIA) who are either methotrexate (MTX) treated or…
- Trial name
- NCT00048542
- Testing
- OLE BSA Adalimumab +/- MTX, OLE FD Adalimumab +/- MTX
- Where
- 31 sites in United States, Belgium and 6 more
- Volunteers
- 171 people
- Sponsor
- Abbott
Small-cell Lung Cancer, Neuroendocrine Carcinomas
A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer
This is Phase 1/2, multicenter, clinical study to evaluate the safety, efficacy, PK, and immunogenicity of IDE849 in subjects with DLL3-expressing tumors including SCLC.
- Conditions
- Small-cell Lung Cancer, Neuroendocrine Carcinomas, Solid Tumor Show to Express DLL3
- Trial name
- NCT07174583
- Testing
- IDE849, durvalumab, IDE161
- Where
- 13 sites in United States
- Volunteers
- 262 people
- Sponsor
- IDEAYA Biosciences
COVID-19
A Study of the Investigational Monoclonal Antibody, VYD2311, in Healthy Participants
A study to investigate the safety, tolerability, and pharmacokinetics of a SARS-CoV-2-directed monoclonal antibody in healthy participants
- Trial name
- NCT06523153
- Testing
- VYD2311
- Where
- Australia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Invivyd, Inc.
Neuroblastoma
ch14.18 Pharmacokinetic Study in High-risk Neuroblastoma
The purpose of this study is to compare the pharmacokinetics (blood levels) and safety of chimeric (ch) 14.18 manufactured by two independent drug makers (United Therapeutics [UTC] or the National Cancer Institute [NCI]).
- Trial name
- NCT01592045
- Testing
- ch14.18 -NCI, ch14.18-UTC, Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)
- Where
- 13 sites in United States
- Volunteers
- 28 people
- Sponsor
- United Therapeutics
Diffuse Large B Cell Lymphoma
A Study Comparing the Efficiency and Safety of S-CHOP(Cyclophosphamide, Hydroxydaunomycin, Oncovin, and Prednisone) Versus R-CHOP in Untreated CD20(Cluster of Differentiation Antigen 20)-Positive DLBCL Patients
The primary objective of the study is to assess the efficiency of SCT400 plus CHOP versus Rituximab plus CHOP in untreated CD20-positive DLBCL Patients.
- Trial name
- NCT02772822
- Testing
- SCT400 plus CHOP, Rituximab plus CHOP
- Where
- China
- Volunteers
- 330 people
- Sponsor
- Sinocelltech Ltd.
Hepatitis B, Chronic
A Study of Cetrelimab in Participants With Chronic Hepatitis B Virus Infection
The purpose of the study is to characterize the pharmacokinetic (PK) profile of cetrelimab administered subcutaneous (SC) and optionally intravenous (IV) in chronic hepatitis B (CHB) participants.
- Trial name
- NCT05242445
- Testing
- Cetrelimab
- Where
- 13 sites in Belgium, France and 3 more
- Volunteers
- 11 people
- Sponsor
- Janssen Research & Development, LLC
Rheumatoid Arthritis, Polyarthritis
The Use of Anti-CD4 Monoclonal Antibody (mAb)-Fragment for the Imaging of Chronic Inflammation in Patients With Active Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a disease with a large economic impact due to the long lasting disabling nature of the disease. Furthermore, diagnosis of the disease is difficult and only a scheme with different symptoms is used to…
- Conditions
- Rheumatoid Arthritis, Polyarthritis, Rheumatism, Autoimmune Disease
- Trial name
- NCT00372177
- Testing
- Fab-fragment of Anti-human CD4
- Where
- Germany
- Volunteers
- 5 people
- Sponsor
- Biotectid GmbH
Esophageal Squamous Cell Carcinoma
A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma(PANKU-Esophagus01)
This study is a registered phase Ill, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with recurrent or metastatic esophageal squamous cell carcinoma after failure of…
- Trial name
- NCT06304974
- Testing
- BL-B01D1, Irinotecan, paclitaxel
- Where
- China
- Volunteers
- 497 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Arthritis, Rheumatoid
Long-term Efficacy and Safety of Repeated Ofatumumab Treatment Courses in RA Patients Who Previously Received Ofatumumab or Placebo in Trial Hx-CD20-403
A 3-year open-label trial for patients who previously participated in Trial Hx-CD20-403 and who fulfill the eligibility criteria for this trial (GEN413) .
- Trial name
- NCT00655824
- Testing
- ofatumumab
- Where
- 10 sites in United States, Denmark and 3 more
- Volunteers
- 124 people
- Sponsor
- GlaxoSmithKline
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