Clinical trials: Proof of Concept
Antiphospholipid (aPL)-Positive
Phase IIa Trial of ALXN1007 for the Treatment of Non-criteria Manifestations of Antiphospholipid Syndrome
The primary purpose of this study was to evaluate the safety and tolerability of intravenous (IV) ALXN1007 in persistently antiphospholipid (aPL)-positive patients with at least 1 of the following non-criteria manifestations of…
- Trial name
- NCT02128269
- Testing
- Study Drug- ALXN1007
- Where
- 9 sites in United States, Brazil and 4 more
- Volunteers
- 9 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Alzheimer Disease
Proof-of-Concept Study of a Selective p38 MAPK Alpha Inhibitor, Neflamapimod, in Subjects With Mild Alzheimer's Disease
This is a phase 2b, double-blind, placebo controlled proof-of-concept study of a an oral small molecule selective inhibitor of p38 alpha kinase, neflamapimod, administered for 24 weeks in subjects with mild Alzheimer's disease.
- Trial name
- REVERSE-SD (NCT03402659)
- Testing
- neflamapimod
- Where
- 38 sites in United States, Czechia and 3 more
- Volunteers
- 161 people
- Sponsor
- EIP Pharma Inc
Pancreas Cancer, Metastatic, Pancreas Cancer, Stage IV
A Study of More Frequent Dosing of VCN-01 Combined With Standard Chemotherapy in Patients With Newly Diagnosed Metastatic Pancreatic Cancer
The goal of this clinical trial is to learn if the new administration regimen of VCN-01, given together with the standard chemotherapy drugs gemcitabine and nab-paclitaxel (GnP), is safe and well tolerated.
- Conditions
- Pancreas Cancer, Metastatic, Pancreas Cancer, Stage IV, Ductal Adenocarcinoma of the Pancreas
- Trial name
- VIRAGE2 (NCT07701486)
- Testing
- VCN-01 oncolytic adenovirus (zabilugene almadenorepvec), Nab-paclitaxel + Gemcitabine
- Where
- Spain
- Volunteers
- 6 people
- Sponsor
- Theriva Biologics SL
Pulmonary Disease, Chronic Obstructive
Proof of Concept Study Assessing Technology-Assisted Respiratory Adherence Prototype Version 3 in Individuals With COPD
The study's primary aim is to assess whether there is a clinically significant reduction in breathlessness in symptomatic individuals with chronic obstructive respiratory disease (IwCOPD) following engagement with…
- Trial name
- NCT04795323
- Testing
- TARA v3.1, only non-pharmacological self-management support, TARA v3.2, both non-pharmacological and pharmacological self-management support
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Boehringer Ingelheim
Pancreas Adenocarcinoma, Dysplasia
A Proof-of-Concept Study Evaluating LINFU™
The purpose of this research study is to study a method to detect pancreatic precancer and cancer (ductal adenocarcinoma) using ultrasound technology in those who are at significantly increased risk for developing pancreatic…
- Trial name
- NCT05161013
- Testing
- LINFU™
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Adenocyte, LLC
Treatment of PHN
3VM1001 Cream for the Treatment of Pain Associated With Post Herpetic Neuralgia (PHN)
Post-herpetic neuralgia (PHN) is pain following acute herpes zoster; defined as pain lasting longer than 3 months. Current first line management consists of tricyclic anti-depressants and anti-convulsants such as gabapentin and…
- Trial name
- PHN (NCT03421613)
- Testing
- 3VM1001
- Where
- 2 sites in United States
- Volunteers
- 28 people
- Sponsor
- CDA Research Group, Inc.
Primary Sjögren's Syndrome
A Study of the Safety and Effectiveness of Efgartigimod in Patients With Primary Sjögren's Syndrome (pSS)
The purpose of this study is to assess the efficacy and safety of human FcRn blocking therapy with efgartigimod compared to placebo, in participants with pSS.
- Trial name
- rho (NCT05817669)
- Testing
- Efgartigimod
- Where
- 17 sites in Belgium, Hungary and 2 more
- Volunteers
- 34 people
- Sponsor
- argenx
Proof of Concept
Dietary Intervention Detection in the Small Intestine
Proof of concept study to validate the ability of a capsule device to gather samples from the small bowel for microbiome analysis in adults and to detect dietary changes from simultaneous ingestion of a probiotic.
- Trial name
- NCT04489329
- Testing
- Ingestible Capsule, Probiotic
- Where
- Canada
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Nimble Science Ltd.
Acute Wounds
Investigation Evaluating Handling of Mepitel® One Used in Acute Wounds in Home Care
The primary objective is to evaluate the handling of Mepitel® One when used in acute wounds in home care. Secondary objective is to evaluate the comfort, conformability, stay-on ability, pain at removal, transparency of dressing…
- Trial name
- NCT01164982
- Testing
- Mepitel One
- Where
- Germany
- Sponsor
- Molnlycke Health Care AB
Overweight or Obesity
A Proof of Concept Trial in Overweight and Obese Patients, Investigating Effect of EMP16-02 on Body Weight (Primary)
This study is a proof of concept study to demonstrate that EMP16-02, a fixed dose combination (FDC) of orlistat and acarbose in an oral multiple-unit modified release (MR) formulation leads to a clinically relevant decrease in…
- Trial name
- NCT04521751
- Testing
- EMP16-02 120 mg orlistat/40 mg acarbose, EMP16-02 150 mg orlistat/50 mg acarbose
- Where
- 2 sites in Sweden
- Volunteers
- 156 people
- Sponsor
- Empros Pharma AB
Hip Prosthesis Infection, Knee Prosthesis Infection
Proof of Concept Study to Assess Safety and Efficacy of Phage Therapy in Hip or Knee Prosthetic Joint Infections Due to Staphylococcus Aureus Treated by DAIR.
Total joint replacements are effective for chronic pain but can lead to Prosthetic Joint Infections (PJI), primarily caused by Staphylococcus aureus and resistant to antibiotics.
- Trial name
- GLORIA (NCT06605651)
- Testing
- Anti-Staphylococcus aureus Bacteriophages (PP1493 and PP1815) intra-articular injection with 0.9% NaCl solution, 0.9% NaCl solution
- Volunteers
- 100 people
- Sponsor
- Phagenix
Ulcerative Colitis, Inflammatory Bowel Diseases
Proof of Concept Study Evaluating the Efficacy and Safety of ATH-063 Treatment in Patients With Relapsed/Refractory Moderately to Severely Active Ulcerative Colitis (UC)
The primary objective of this trial is to evaluate the clinical efficacy of ATH-063 in participants with biologic/advanced therapy relapsed/refractory moderately to severely active UC.
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Diseases, Autoimmune Diseases
- Trial name
- Aegean (NCT07513181)
- Testing
- ATH-063
- Where
- 4 sites in United States
- Volunteers
- 120 people
- Sponsor
- Athos Therapeutics Inc
Open-angle Glaucoma, Ocular Hypertension
Safety and Intraocular Pressure (IOP) Lowering Effect of AL-59412C
The purpose of this study was to assess the safety and efficacy of AL-59412C injected intravitreally relative to Vehicle.
- Trial name
- NCT01312454
- Testing
- AL-59412C injectable solution, Travoprost injectable solution, AL-59412C Vehicle
- Volunteers
- 4 people
- Sponsor
- Alcon Research
IBS - Irritable Bowel Syndrome
Effect of Lactibiane Tolerance® to Treat Leaky Gut in Irritable Bowel Syndrome With Predominant Diarrhea (IBS-D)Patients
This is a Phase IV, open-label, single-center, proof-of-concept, pilot study to evaluate the effect of Lactibiane Tolerance® in treating leaky gut in IBS-D patients.
- Trial name
- NCT04898257
- Testing
- Multistrain probiotic
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- Larena SAS
Premature Ejaculation
A Study To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Study in Men With Premature Ejaculation
To determine if an on demand dosing of 50 mg or 150 mg of GSK557296 demonstrates superior efficacy with respect to duration of intra vaginal ejaculatory latency time (IELT) during an 8 week study period compared to placebo in men…
- Trial name
- NCT01021553
- Testing
- GSK557296
- Where
- 8 sites in United States, Netherlands
- Volunteers
- 77 people
- Sponsor
- GlaxoSmithKline
Fecal Incontinence
Effect of Single Doses of 10 mg NRL001 Applied as a Suppository to the Anal Canal or Rectum
Study to assess the effects of 10mg NRL001 on mean anal resting pressure (MARP) when administered as a slow release suppository applied to the anal canal or rectum.
- Trial name
- NCT00893607
- Testing
- NRL001
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Norgine
PreDiabetes, Glucose Tolerance Impaired
A Study to Evaluate Efficacy and Safety of Distal Jejunal-release Dextrose Beads Formulation in Subjects With a Pathological Oral Glucose Tolerance Test
The primary purpose of the study is to evaluate the efficacy and safety of APHD-012 (distal jejunal-release dextrose [Aphaia technology, AT]) in participants with pre-diabetes (pathological Oral Glucose Tolerance Test (OGTT)).
- Trial name
- NCT05803772
- Testing
- APHD-012, APH-012P
- Where
- 3 sites in Slovakia
- Volunteers
- 31 people
- Sponsor
- Aphaia Pharma US LLC
Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
A Study of TAK-411 in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
CIDP is an autoimmune disease. This means that the body's germ fighting (immune) system attacks itself. In CIDP, the immune system attacks the protective covering around the nerves called myelin.
- Trial name
- CASCA (NCT06798012)
- Testing
- TAK-411
- Where
- 22 sites in United States, Canada and 1 more
- Volunteers
- 36 people
- Sponsor
- Takeda
Hyperkalemia
A Study Evaluating the Safety and Efficacy of RDX013 for the Treatment of Hyperkalemia
The purpose of this study is to evaluate the ability of RDX013 to lower serum potassium in patients with chronic kidney disease with elevated serum potassium levels
- Trial name
- Redukx (NCT04780841)
- Testing
- RDX013
- Where
- 6 sites in United States
- Volunteers
- 109 people
- Sponsor
- Ardelyx
Coronary Disease, Heart Valve Diseases
CTI-01 (Ethyl Pyruvate) Safety and Complication Prevention in Cardiac Surgery Patients on Cardiopulmonary Bypass (CPB)
Over 500,000 patients undergo cardiac surgery with CPB in the United States annually. Although mortality rates have decreased with advances in perioperative care, many patients are affected by postoperative organ dysfunction.
- Trial name
- NCT00107666
- Testing
- CTI-01 (ethyl pyruvate)
- Where
- 17 sites in United States
- Volunteers
- 150 people
- Sponsor
- Critical Therapeutics