Clinical trials: Proof of Concept
Preeclampsia
Proof-of-Concept Trial on Selective Removal of sFlt-1 in Pregnant Women With Preeclampsia Via Apheresis
This clinical investigation is a medical device trial to examine the safety and efficacy of TheraSorb sFlt-1 adsorber treatment of pregnant patients with preeclampsia.
- Trial name
- SAVE (NCT02923206)
- Testing
- TheraSorb sFlt-1 adsorber
- Where
- 4 sites in Germany, United Kingdom
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Miltenyi Biomedicine GmbH
Psoriatic Arthritis (PsA)
Phase 2 Trial of FT2109 for the Treatment of Psoriatic Arthritis
This study will investigate if the study medicine FT2109 can treat symptoms of active Psoriatic Arthritis (PsA). This study assesses the safety and efficacy of FT2109 in adult participants with active PsA who may or may not have…
- Trial name
- NCT07869134
- Testing
- FT2109 Dosing Regimen 1, FT2109 Dosing Regimen 2
- Volunteers
- 210 people
- Sponsor
- Forward Therapeutics
Arthritis, Rheumatoid
A Study to Evaluate the Nipocalimab and Certolizumab Combination Therapy in Participants With Active Rheumatoid Arthritis
The purpose of this study is to evaluate the efficacy of combination therapy with nipocalimab and certolizumab compared to certolizumab monotherapy.
- Trial name
- DAISY (NCT06028438)
- Testing
- Nipocalimab, Certolizumab
- Where
- 32 sites in United States, Argentina and 4 more
- Volunteers
- 103 people
- Sponsor
- Janssen Research & Development, LLC
Lupus Nephritis
A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients With Lupus Nephritis (ZL-1103-013)
The purpose of the study is to evaluate the efficacy and safety of efgartigimod IV in Chinese patients with active lupus nephritis (LN).
- Trial name
- NCT05810948
- Testing
- efgartigimod IV
- Where
- 31 sites in China
- Volunteers
- 73 people
- Sponsor
- argenx
Dry Eye
Phase 2b Controlled Study of Dosing Techniques - Part B
Double-masked, dose-response of two concentrations of IVW-1001
- Trial name
- NCT07161011
- Testing
- IVW-1001 Ophthalmic Eyelid Wipe 0.2%, IVW-1001 Ophthalmic Eyelid Wipe 0.4%
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- IVIEW Therapeutics Inc.
Homozygous Familial Hypercholesterolemia
Study of REGN1500 in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
This is an open-label, single-arm study to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by REGN1500 in patients with homozygous familial hypercholesterolemia (HoFH).
- Trial name
- NCT02265952
- Testing
- REGN1500 250 mg SC/15 mg/kg IV/450 mg SC
- Where
- 5 sites in United States, Canada and 1 more
- Volunteers
- 9 people
- Sponsor
- Regeneron Pharmaceuticals
Proliferative Diabetic Retinopathy (PDR)
Multicenter 12 Months Clinical Study to Evaluate Efficacy and Safety of Ranibizumab Alone or in Combination With Laser Photocoagulation vs. Laser Photocoagulation Alone in Proliferative Diabetic Retinopathy (PRIDE)
The purpose of this study was to assess the efficacy and safety of the anti-Vascular Endothelial Growth Factor (VEGF) agent ranibizumab (0.5 mg) with or without Panretinal laser photocoagulation (PRP) compared to PRP alone in…
- Trial name
- PRIDE (NCT01594281)
- Testing
- Ranibizumab 0.5 mg, Panretinal laser photocoagulation
- Where
- 23 sites in Germany
- Volunteers
- 107 people
- Sponsor
- Novartis Pharmaceuticals
Panic Disorder
ELB139 Given Orally to Patients With Concurrent Panic Disorder, Challenged by CO2 Inhalation After a Single Dose and One Week of Treatment
This study is designed to investigate if 600 mg ELB139 given orally t.i.d. to patients suffering from panic disorder is effective in reducing anxiety evoked by inhalation of 35% CO2 measured by a visual analogue scale after the…
- Trial name
- NCT00322803
- Testing
- ELB139
- Where
- 3 sites in Germany, Netherlands
- Volunteers
- 24 people
- Sponsor
- elbion AG
Paroxysmal Nocturnal Hemoglobinuria
To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KP104
The purpose of this study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of KP104 in complement inhibitor-naïve participants with PNH.
- Trial name
- NCT05476887
- Testing
- KP104
- Where
- 4 sites in China
- Volunteers
- 35 people
- Sponsor
- Kira Pharmacenticals (US), LLC.
Pelvic Adhesions
A Clinical Study of Alanyl-Glutamine for Reduction of Post-Myomectomy Adhesions
This study evaluates whether L-Alanyl-L-Glutamine can reduce the incidence, extent and severity of adhesions after myomectomy. Half of the participants will receive L-Alanyl-L-Glutamine and the other half of participants will…
- Trial name
- NCT01701193
- Testing
- L-Alanyl/L-Glutamine, Physiologic saline
- Where
- Ukraine
- Volunteers
- 47 people
- Sponsor
- Temple Therapeutics BV
High-grade Glioma, Lung Cancer
A Proof-of-concept Study to Assess the Ability of [18F]AH-111585 PET Imaging to Detect Tumours and Angiogenesis
This proof-of-concept study is designed to assess the ability of [18F]AH-111585 PET imaging to detect tumors and angiogenesis. Up to 30 evaluable subjects are planned to be included at up to 2 study centers in the US.
- Conditions
- High-grade Glioma, Lung Cancer, Head & Neck Cancer, Sarcoma
- Trial name
- NCT00565721
- Testing
- Fluciclatide Injection - (AH111585 (F18))
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- GE Healthcare
LCA (Leber Congenital Amaurosis), RP (Retinitis Pigmentosa)
Safety/Proof of Concept Study of Oral QLT091001 in Subjects With Leber Congenital Amaurosis (LCA) or Retinitis Pigmentosa (RP) Due to Retinal Pigment Epithelial 65 Protein (RPE65) or Lecithin:Retinol Acyltransferase (LRAT) Mutations
The purpose of this study is: to evaluate the safety of oral QLT091001 to evaluate whether 7-day treatment with oral QLT091001 can improve visual function in subjects with LCA or RP due to RPE65 or LRAT mutations to evaluate…
- Trial name
- NCT01014052
- Testing
- QLT091001
- Where
- 7 sites in United States, Canada and 3 more
- Volunteers
- 32 people
- Sponsor
- QLT Inc.
Hepatitis B
Proof Of Concept : Immunogenicity and Safety of hepB Injection in the Dermis Using VAX-ID
A proof of concept (POC) study will be conducted in 44 volunteers that have been fully vaccinated against hepatitis B in the past (at least 5 years ago) to assess the safety and immunogenicity of intradermal vaccination with…
- Trial name
- POC_VAX-ID (NCT02186977)
- Testing
- VAX-ID, 1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD), 0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD)
- Where
- Belgium
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Novosanis NV
ALSP
A Study of VGL101 in Patients With Adult-Onset Leukoencephalopathy With Axonal Spheroids and Pigmented Glia
This is a multicenter, open-label study to assess the safety and tolerability of iluzanebart (also referred to as VGL101) in subjects with documentation of a gene mutation in the CSF1R gene for the treatment of adult-onset…
- Trial name
- NCT05677659
- Testing
- VGL101
- Where
- 10 sites in United States, France and 3 more
- Volunteers
- 20 people
- Sponsor
- Vigil Neuroscience, Inc.
Diabetes Mellitus, Gestational Diabetes Mellitus (GDM)
A Proof of Concept (PoC), Randomized, Controlled Study to Validate the Algorithm and Evaluate the Accuracy, Safety and Pain Level of the Smartest-AE in Comparison to Self-measure Blood Glucose Levels
The study is conducted in Israel so plain language for the study is exist in Hebrew only
- Conditions
- Diabetes Mellitus, Gestational Diabetes Mellitus (GDM), Pre Diabetes
- Trial name
- NCT06587087
- Testing
- Smartest-AE: The lancet that will be used will be the Vitrex Soft Lite lll 28G.
- Where
- Israel
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Smartest Technologies
C3 Glomerulopathy, C3 Glomerulonephritis
A Proof-of-Concept Study of Danicopan for 6 Months of Treatment in Participants With C3 Glomerulopathy (C3G)
The primary purpose of this proof-of-concept clinical study was to evaluate the efficacy and safety of the study drug, ACH-0144471 (also known as danicopan and ALXN2040), in participants with C3G who also had significant…
- Conditions
- C3 Glomerulopathy, C3 Glomerulonephritis, Dense Deposit Disease
- Trial name
- NCT03369236
- Testing
- Danicopan
- Where
- 7 sites in United States, United Kingdom
- Volunteers
- 13 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Atherosclerotic Cardiovascular Disease
Proof of Concept Study of BMS-823778 to Assess the Effects on Atherosclerosis
The purpose of the study is to assess the effect of BMS-823778 on reducing atherosclerotic plaque inflammation
- Trial name
- NCT01666704
- Testing
- BMS-823778
- Sponsor
- Bristol-Myers Squibb
Failed Lumbar Fusion
Study on Allogeneic Osteoblastic Cells Implantation in Rescue Interbody Fusion
Failed fusion and failure to relieve back pain following spinal fusion are still frequent, irrespective of the type of procedures or grafts used by the surgeon.
- Trial name
- NCT02328287
- Testing
- ALLOB®
- Where
- 3 sites in Belgium
- Volunteers
- 6 people
- Sponsor
- Bone Therapeutics S.A
Hip Fracture
A Proof-of-Concept Study Investigating the Safety and Efficacy of ZT-031 on Hip Fracture Healing in Men and Postmenopausal Women
The purpose of this research study is to test if an experimental drug called ZT-031 can help men over 30 years or post-menopausal women over 55 years of age with certain types of hip fracture to heal better or faster following…
- Trial name
- SHIFT (NCT00787358)
- Testing
- ZT-031
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Zelos Therapeutics
Acute-On-Chronic Liver Failure
TAK-242 in Patients With Acute Alcoholic Hepatitis
A phase 2a double-blind, randomized, placebo-controlled, multicenter, proof-of-concept study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of TAK-242 in subjects with acute decompensation of…
- Trial name
- NCT04620148
- Testing
- TAK-242
- Where
- 3 sites in United Kingdom
- Volunteers
- 4 people
- Sponsor
- Akaza Bioscience Ltd