Clinical trials: Proof of Concept
Rheumatoid Arthritis
Efficacy and Safety Study of CC-292 Versus Placebo as Co-therapy With Methotrexate in Active Rheumatoid Arthritis
CC-292 is an oral agent that is under clinical development for the treatment of rheumatoid arthritis an autoimmune inflammatory disorder.
- Trial name
- NCT01975610
- Testing
- CC-292
- Where
- 27 sites in United States
- Volunteers
- 47 people
- Sponsor
- Celgene
GVHD
Proof-of-concept Trial of Apraglutide in Acute Graft Versus Host Disease (aGVHD)
The aim of this trial is to assess safety and efficacy of apraglutide in subjects with steroid refractory gastrointestinal aGVHD.
- Trial name
- NCT05415410
- Testing
- Apraglutide
- Where
- 13 sites in United States, Germany and 2 more
- Volunteers
- 31 people
- Sponsor
- VectivBio AG
Colo-rectal Cancer
Colorectal Analysis for Signature Cancer Assessment Using Delta-HLD
CASCADE (Colorectal Analysis for Signature Cancer Assessment Using delta-HLD Technology) is a proof-of-concept case-control study designed to evaluate the performance of delta-HLD, Epiliquid's proprietary liquid biopsy…
- Trial name
- CASCADE (NCT07148297)
- Where
- Argentina
- Volunteers
- 600 people
- Sponsor
- Epiliquid Holding, Inc
Atopic Dermatitis
A Safety Study to Evaluate the Use and Effectiveness of a Topical Ointment to Treat Adults With Atopic Dermatitis
The purpose of this study is to investigate the pharmacokinetics and safety of OPA-15406 in adult subjects with atopic dermatitis
- Trial name
- NCT01702181
- Testing
- OPA-15406, Tacrolimus
- Where
- 12 sites in United States
- Volunteers
- 92 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Sleep Apnea, Sleep Apnea, Obstructive
A Study to Determine the Flow Changes And/or AHI Reduction When Stimulating Two Targets (neural And/or Muscular) for the Treatment of Obstructive Sleep Apnea in Adult Subjects
This Proof-of-Concept study will collect acute and sub-acute flow and/or AHI data following the placement of lead arrays under direct vision.
- Conditions
- Sleep Apnea, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Sleep Disorder
- Trial name
- NCT06635265
- Testing
- Target Stimulation (HGN, AC, GG, Strap muscles)
- Where
- Australia
- Volunteers
- 3 people
- Sponsor
- Invicta Medical Inc.
Systemic Sclerosis
Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis
Primary Objective: To evaluate, in comparison with placebo, the efficacy of SAR156597 administered subcutaneously for 24 weeks on skin fibrosis in participants with diffuse cutaneous systemic sclerosis (dcSSc).
- Trial name
- NCT02921971
- Testing
- SAR156597
- Where
- 44 sites in United States, Argentina and 11 more
- Volunteers
- 97 people
- Sponsor
- Sanofi
Major Depressive Disorder
A Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 in Major Depressive Disorder
This is a multicenter, Phase 2, double-blind, randomized, parallel-arm, placebo-controlled clinical trial to evaluate the efficacy, safety, and tolerability of XEN1101 in subjects with Major Depressive Disorder.
- Trial name
- X-NOVA (NCT05376150)
- Testing
- XEN1101 10 mg, XEN1101 20 mg
- Where
- 20 sites in United States
- Volunteers
- 168 people
- Sponsor
- Xenon Pharmaceuticals Inc.
Osteoarthritis, Knee
Study of FX005 for the Treatment of Pain in Patients With Osteoarthritis of the Knee
The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of FX005 for the treatment of pain in patients with osteoarthritis of the knee.
- Trial name
- NCT01291914
- Testing
- FX005
- Where
- 13 sites in Austria, Canada and 2 more
- Volunteers
- 140 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Hemophilic Arthropathy
A Proof-of-Concept Study of AC-201 Controlled-Release Tablet (CR Tablet) in Patients With Hemophilic Arthropathy
Repeated joint bleeding leads to hemophilic arthropathy (HA), which manifests with chronic synovitis, cartilage damage and bony destruction.
- Trial name
- NCT02994147
- Testing
- AC-201CR
- Where
- Taiwan
- Volunteers
- 22 people
- Sponsor
- TWi Biotechnology, Inc.
Sars-CoV2
Rhu-pGSN for Severe Covid-19 Pneumonia
Study Objectives: Primary To assess the efficacy (survival without organ failure on Day 14) of three doses of rhu-pGSN administered intravenously (IV) plus standard of care (SOC) to hospitalized subjects with a primary diagnosis…
- Trial name
- NCT04358406
- Testing
- Recombinant human plasma gelsolin (Rhu-pGSN)
- Where
- 3 sites in Romania, Spain
- Volunteers
- 64 people
- Sponsor
- BioAegis Therapeutics Inc.
Fecal Incontinence
Implantation of BioSphincter TM for Treatment of Severe Passive Fecal Incontinence
This is first-in-human prospective Phase I study of the immediate and long-term safety of an implanted internal anal sphincter (IAS) bioengineered from autologous cells to treat subjects with severe passive FI who have failed…
- Trial name
- NCT05616208
- Testing
- Bioengineered Internal Anal Sphincter
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Cellf Bio LLC
Ulcerative Colitis
Efficacy and Safety of GLPG1205 in Subjects With Active Ulcerative Colitis
Approximately 60 patients suffering from moderate to severe ulcerative colitis will be evaluated for improvement of disease activity (efficacy) when taking GLPG1205 or matching placebo once daily for 12 weeks in addition to their…
- Trial name
- ORIGIN (NCT02337608)
- Testing
- GLPG1205
- Where
- 39 sites in Belgium, Czechia and 4 more
- Volunteers
- 64 people
- Sponsor
- Lakefront Biotherapeutics NV
Autism Spectrum Disorder
A Study of RG7314 to Investigate Efficacy and Safety in Individuals With Autism Spectrum Disorders (ASD)
This multi-center, randomized, double-blind, parallel group, placebo-controlled, proof of concept study will investigate the efficacy and safety of RG7314 in adult participants with ASD.
- Trial name
- NCT01793441
- Testing
- RG7314
- Where
- 56 sites in United States
- Volunteers
- 223 people
- Sponsor
- Hoffmann-La Roche
Exocrine Pancreatic Insufficiency
Oral CDX-7108 in Healthy Adults and EPI Subjects
Phase 1a/1b single and multiple ascending dose study of oral CDX-7108 in healthy adult subjects and a single dose proof-of-concept study of oral CDX-7108 in subjects with exocrine pancreatic insufficiency.
- Trial name
- NCT05082051
- Testing
- Part A, Part B, Part C
- Where
- 4 sites in Australia, New Zealand
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Chronic Rhinitis, Chronic Sinus Congestion
Proof-of-Concept Interventional Study With a Nasal Spray of JT-1 in Patients With Chronic Rhinitis or Chronic Sinusitis
Proof-of-concept study with a novel nasal spray in chronic rhinitis or chronic sinusitis. The study will involve 25 patients completing the study for a per protocol analysis.
- Trial name
- NCT05331222
- Testing
- JT-1
- Where
- Switzerland
- Volunteers
- 3 people
- Sponsor
- Jantar GmbH
Alzheimer Disease
Proof-of-concept Study of New Imaging Diagnostic in Patients With Suspected Alzheimer's Disease
This study is a Phase 1, first-in-human, multi-center study to establish safety of ADx-001 in healthy volunteers, and safety and proof of concept in patients with confirmed amyloid plaques in the brain (confirmed by amyloid…
- Trial name
- NCT05453539
- Testing
- DSPE-DOTA-Gd Liposomal Injection
- Where
- 2 sites in Germany
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Alzeca Biosciences, Inc.
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
A Study of ARGX-110 in Combination With Azacytidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) or High Risk Myelodysplatic Syndrome (MDS)
The purpose of this study is to determine the maximum tolerated dose (MTD) of ARGX-110 and/or the recommended Phase II dose (RP2D) in combination with a standard dose of azacytidine (AZA) in Phase 1; and to evaluate efficacy of…
- Trial name
- NCT03030612
- Testing
- ARGX-110, AZA
- Where
- 7 sites in France, Switzerland
- Volunteers
- 38 people
- Sponsor
- OncoVerity, Inc.
Non-segmental Vitiligo
Phase 2 Study to Evaluate EI-001 in Non-segmental Vitiligo Patients
The primary purpose of this study is to evaluate whether the drug EI-001 can help improve vitiligo symptoms. EI-001 is a novel antibody drug that affects the immune system to decrease uncontrolled inflammation.
- Trial name
- NCT07223229
- Testing
- EI-001
- Where
- 8 sites in United States, Taiwan
- Volunteers
- 45 people
- Sponsor
- Elixiron Immunotherapeutics (Hong Kong) Ltd.
Healthy
Pharmacokinetic Comparison of XS003 and Tasigna
The study will assess bioavailability of XS003 given as a single oral dose compared to Tasigna® given as a single oral dose in healthy male subjects.
- Trial name
- NCT02068898
- Testing
- XS003, Tasigna
- Where
- United Kingdom
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- XSpray Microparticles
Osteoarthritis, Knee
A Study of LY2828360 in Patients With Osteoarthritic Knee Pain
To investigate the safety, efficacy and pharmacokinetics of single daily oral dose of LY2828360 in male and female subjects with osteoarthritic knee pain
- Trial name
- NCT01319929
- Testing
- LY2828360
- Where
- Denmark
- Volunteers
- 39 people
- Sponsor
- Eli Lilly and Company