Clinical trials: CLE
Frozen Sections, Indocyanine Green (ICG)
A PROSPECTIVE, SINGLE-CENTERED, ASSESSOR-BLINDED STUDY TO EVALUATE THE CLINICAL EFFICACY OF THE PROPOSED CELL/TISSUE HISTOPATHOLOGY PROCESSOR CCELL (CONFOCAL FLUORESCENCE ENDOMICROSCOPY) FOR INTRAOPERATIVE DIAGNOSIS IN BRAIN TUMORS
The primary objective of this single-center study is to demonstrate the performance of cCeLL, used in real time, compared to frozen section analysis.
- Conditions
- Frozen Sections, Indocyanine Green (ICG), Brain Tumor
- Trial name
- NCT07254845
- Testing
- cCeLL In vivo, Indocyanine Green
- Volunteers
- 30 people
- Sponsor
- VPIX Medical
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
The Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HC022 Injection in Subjects With SLE/CLE
The primary objective of this phase Ib study is to evaluate the safety and tolerability of multiple-ascending, subcutaneous (SC) doses of HC022 in SLE/CLE subjects.
- Trial name
- NCT07306585
- Testing
- HC022
- Where
- China
- Volunteers
- 32 people
- Sponsor
- HC Biopharma Inc.
Systemic Lupus Erythematosus
The WILLOW Study With M5049 in SLE and CLE (SCLE and/or DLE) (WILLOW)
The purpose of this Proof of Concept (PoC) and Dose-finding (DF) basket study is to evaluate the efficacy and safety of orally administered Enpatoran over 24 weeks in systemic lupus erythematosus (SLE) and cutaneous lupus…
- Trial name
- NCT05162586
- Testing
- Enpatoran low dose, Enpatoran medium dose, Enpatoran high dose
- Where
- 153 sites in United States, Argentina and 20 more
- Volunteers
- 456 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus
A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE)
The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of IMVT-1402 in participants with Cutaneous Lupus Erythematosus.
- Trial name
- NCT06980805
- Testing
- IMVT-1402
- Where
- 86 sites in United States, Argentina and 11 more
- Volunteers
- 56 people
- Sponsor
- Immunovant Sciences GmbH
Alpha 1-Antitrypsin Deficiency
Alpha-1-Antitrypsin (AAT) To Treat Emphysema In AAT-Deficient Patients (EXACTLE)
The goal of this trial was to explore the utility of evaluating emphysema progression through CT scans measuring lung density during a 2 year period of weekly infusions of either placebo or human alpha-1-antitrypsin (AAT…
- Trial name
- NCT00263887
- Testing
- Alpha1-Proteinase Inhibitor (Human), Albumin (Human) 20%, United States Pharmacopeia (USP)
- Where
- 3 sites in Denmark, Sweden and 1 more
- Volunteers
- 77 people
- Sponsor
- Grifols Therapeutics LLC
Pancreatic Cyst, Pancreatic Neoplasms
Clinical Evaluation Of Needle-based Confocal Laser Endomicroscopy in The Lymph Nodes Along With Masses and Cystic Tumors of the Pancreas
This study focuses on three different lesions: pancreatic cysts, lymph nodes near the gastrointestinal tract and pancreatic masses.
- Conditions
- Pancreatic Cyst, Pancreatic Neoplasms, Pancreatic Adenoma, Pancreatic Cancer
- Trial name
- CONTACT (NCT01563133)
- Testing
- EUS-FNA, nCLE
- Where
- 3 sites in France
- Volunteers
- 330 people
- Sponsor
- Mauna Kea Technologies
Frozen Sections, Indocyanine Green
Multi-center Study on CCeLL-In Vivo's Clinical Efficacy for Intraoperative Brain Tumor Diagnosis.
The primary objective of this study is to demonstrate the non-inferiority of cCeLL compared to frozen section analysis. The investigational device is intended for use with indocyanine green (ICG) for fluorescence imaging as an…
- Conditions
- Frozen Sections, Indocyanine Green, Brain Tumor
- Trial name
- PRECISION (NCT06867978)
- Testing
- cCeLL In vivo, Indocyanine Green
- Volunteers
- 100 people
- Sponsor
- VPIX Medical
Cutaneous Lupus Erythematosus (CLE), Systemic Lupus Erythematosus
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus
The goal of this clinical trial is to learn if VENT-03 works to treat patients with cutaneous lupus erythematosus (CLE) who may or may not have systemic lupus erythematosus (SLE).
- Conditions
- Cutaneous Lupus Erythematosus (CLE), Systemic Lupus Erythematosus, SLE, SLE (Systemic Lupus)
- Trial name
- AERIS (NCT07260877)
- Testing
- VENT-03
- Where
- 34 sites in United States, Bulgaria and 6 more
- Volunteers
- 24 people
- Sponsor
- Ventus Therapeutics U.S., Inc.
Barrett Syndrome, Barrett's Syndrome
CLE for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia
This study focuses on demonstrating the value of probe-based Confocal Laser Endomicroscopy (pCLE) in guiding endoscopic therapeutic procedures in Barrett's Esophagus (BE).
- Conditions
- Barrett Syndrome, Barrett's Syndrome, Barrett's Esophagus, Barrett Esophagus
- Trial name
- CLEAN-MARGIN (NCT01032044)
- Testing
- Standard endoscopic evaluation, pCLE guided evaluation
- Where
- 6 sites in United States, France and 1 more
- Volunteers
- 164 people
- Sponsor
- Mauna Kea Technologies
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic…
- Trial name
- ELOWEN-1 (NCT07332481)
- Testing
- Enpatoran, Standard of care (SoC)
- Where
- 60 sites in United States, Australia and 14 more
- Volunteers
- 202 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus
Study of M5049 in CLE and SLE Participants
This study is to evaluate the safety, tolerability and pharmacokinetics (PK) of orally administered M5049 in participants with systemic lupus erythematosus (SLE) or cutaneous lupus erythematosus (CLE).
- Trial name
- NCT04647708
- Testing
- M5049
- Where
- 12 sites in Bulgaria, Germany and 4 more
- Volunteers
- 25 people
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Systematic Lupus Erythematosus, Cutaneous Lupus Erythematosus
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic…
- Trial name
- NCT07355218
- Testing
- Enpatoran, Standard of care (SoC)
- Where
- 57 sites in United States, Australia and 15 more
- Volunteers
- 202 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Cutaneous Lupus Erythematosus (CLE)
Evaluate the Efficacy and Safety of ICP-488 in Subjects With Cutaneous Lupus Erythematosus (CLE) Double-blind Study
This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study to evaluate the efficacy and safety of ICP-488 in subjects with cutaneous lupus erythematosus (CLE).
- Trial name
- NCT07440537
- Testing
- ICP-488 Tablets
- Where
- 27 sites in China
- Volunteers
- 105 people
- Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
Lung Neoplasms
Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy
This study is designed to evaluate the safety and feasibility of real-time needle-based confocal laser endomicroscopy (nCLE) in improving diagnostic accuracy of robotic-assisted bronchoscopy (RANB) biopsy performed with the…
- Trial name
- CLEAR (NCT05231278)
- Testing
- nCLE aided RANB biospy
- Where
- 4 sites in United States
- Volunteers
- 53 people
- Sponsor
- Johnson & Johnson Enterprise Innovation Inc.
Vanishing White Matter Disease
An Open-Label Exploratory Study of Fosigotifator in Participants With Vanishing White Matter Disease
Fosigotifator is an investigational drug being researched for the treatment of Vanishing White Matter disease in adult, pediatric and infant participants.
- Trial name
- NCT05757141
- Testing
- Fosigotifator
- Where
- 5 sites in United States, Canada and 1 more
- Volunteers
- 50 people
- Sponsor
- Calico Life Sciences LLC
Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus
A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis
The purpose of this study is to evaluate the safety and tolerability of escalating, multiple subcutaneous (SC) doses of VIB7734 in participants with Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)…
- Conditions
- Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis
- Trial name
- NCT03817424
- Testing
- VIB7734
- Where
- 30 sites in United States, Poland and 1 more
- Volunteers
- 31 people
- Sponsor
- Amgen
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
A Long-Term Extension (LTE) Study Of Enpatoran In Cutaneous Manifestations Of Lupus With Or Without Systemic Disease [Elowen-LTE]
The purpose of this study is to evaluate the long-term safety and efficacy of orally administered enpatoran in participants with cutaneous manifestations of lupus erythematosus who have completed the Elowen-1 (MS504908_0001)…
- Trial name
- NCT07840287
- Testing
- Enpatoran
- Where
- 2 sites in United States, Germany
- Volunteers
- 404 people
- Sponsor
- EMD Serono Research & Development Institute, Inc.
Cutaneous Lupus Erythematosus
Study to Evaluate Safety and Efficacy of Filgotinib and Lanraplenib in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)
The primary objective of this study is to evaluate the efficacy of filgotinib and lanraplenib (formerly GS-9876) in females with moderately-to-severely active cutaneous lupus erythematosus (CLE).
- Trial name
- NCT03134222
- Testing
- Lanraplenib, Filgotinib
- Where
- 16 sites in United States, Canada
- Volunteers
- 47 people
- Sponsor
- Gilead Sciences
Cervix Cancer, Endometrium Cancer
Probe-based and Needle-based Confocal Laser Endomicroscopy During Gynaecological Procedures.
The protocol aims at demonstrating the technical feasibility and safety of doing endomicroscopic imaging (both probe-based confocal laser endomicroscopy (pCLE) and needle-based confocal laser endomicroscopy, nCLE) during…
- Conditions
- Cervix Cancer, Endometrium Cancer, Ovarian Cancer, Carcinoma in Situ of Fallopian Tube
- Trial name
- NCT02221076
- Testing
- Confocal Laser Endomicroscopy (CLE)
- Where
- France
- Volunteers
- 16 people
- Sponsor
- Mauna Kea Technologies
Systemic Lupus Erythematosus (SLE) or Cutaneous Lupus Erythematosus
A Phase 1/2a Study of DB-2304 in Healthy Adults and SLE/CLE Participants
A Phase 1/2a Study of DB-2304 in Healthy Participants and Participants with Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus
- Trial name
- NCT06625671
- Testing
- DB-2304, Prednisone
- Where
- 7 sites in United States, Australia
- Volunteers
- 148 people, healthy volunteers welcome
- Sponsor
- DualityBio Inc.