Clinical trials: Proof of Concept
Basal Cell Nevus Syndrome
Trial of Patidegib Gel 2%, 4%, and Vehicle to Decrease the Number of Surgically Eligible Basal Cell Carcinomas in Gorlin Syndrome Patients
Multicenter, double-blind, randomized, vehicle-controlled study that evaluates the efficacy and safety of patidegib gel 2% and 4% in comparison with vehicle in participants at least 18 years of age that meet the diagnostic…
- Trial name
- NCT02762084
- Testing
- Patidegib, Vehicle gel
- Where
- 2 sites in United Kingdom
- Volunteers
- 17 people
- Sponsor
- PellePharm, Inc.
Postpartum Depression
Evaluate SAGE-547 in Female Participants With Severe Postpartum Depression
This is an open-label proof-of-concept study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SAGE-547 Injection in adult female participants diagnosed with severe postpartum depression (PPD).
- Trial name
- NCT02285504
- Testing
- SAGE-547
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Supernus Pharmaceuticals, Inc.
Stasis Dermatitis
Study Evaluating Efficacy and Safety of Crisaborole in Adults With Stasis Dermatitis
This is a Phase 2a, randomized, double blind, vehicle controlled, parallel group, proof of concept study that will include participants with stasis dermatitis without active skin ulceration, who will receive crisaborole ointment…
- Trial name
- NCT04091087
- Testing
- crisaborole ointment, vehicle ointment
- Where
- 4 sites in United States
- Volunteers
- 66 people
- Sponsor
- Pfizer
Age-Related Macular Degeneration, Diabetic Retinopathy
Comfortable and Stabilizing Chin & Forehead Rest Attachment for Slit Lamp Configurations
In this study, participants will be imaged using two Optical Coherence Tomography (OCT) devices: device N, a standard conventional OCT device with an invention (comfortable chin and forehead rest that can be adjusted to fit each…
- Conditions
- Age-Related Macular Degeneration, Diabetic Retinopathy, Central Serous Chorioretinopathy, Glaucoma
- Trial name
- NCT05686421
- Testing
- OCT Imaging Using Device N, OCT Imaging Using Device C
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- NYU Langone Health
Advanced Cancers
Phase II Study of Ilorasertib (ABT348) in Patients With CDKN2A Deficient Solid Tumors
The goal of this clinical research study is to learn if ilorasertib (ABT-348) can help to control CDKN2A-deficient cancer. CDKN2A deficiency is a type of mutation (a genetic change). The safety of this drug will also be studied.
- Trial name
- NCT02478320
- Testing
- Ilorasertib
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- M.D. Anderson Cancer Center
IgG4-related Disease
Safety and Efficacy of Abatacept in IgG4-Related Disease
This is a Phase 2, single center, proof of concept clinical trial in subjects with active IgG4-Related Disease (IgG4-RD). Approximately 10 subjects with active IgG4-RD will be enrolled into this study.
- Trial name
- NCT03669861
- Testing
- Abatacept
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Massachusetts General Hospital
Atopic Dermatitis
LEO 29102 Cream in the Treatment of Atopic Dermatitis
This is a proof of concept and dose finding Phase II trial comparing 5 dose strengths with vehicle and an active comparator (Elidel cream 10 mg/g) in a 4 week, twice daily treatment regimen in mild to moderate atopic dermatitis…
- Trial name
- NCT01037881
- Testing
- LEO 29102, Elidel®
- Where
- 3 sites in Canada, Finland and 1 more
- Volunteers
- 183 people
- Sponsor
- LEO Pharma
Chronic Obstructive Pulmonary Disease, Emphysema
Belimumab Treatment of Emphysema Patients With Anti-GRP78 Autoantibodies
This is intended to be an initial "proof-of-concept" study to show feasibility, validate assays and approaches, and explore dosing and safety of belimumab in pulmonary emphysema patients who have clinically relevant (and…
- Trial name
- BOTEGA (NCT03244059)
- Testing
- Belimumab
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- University of Alabama at Birmingham
Squamous Cell Carcinoma of the Head and Neck
Study of the Combination of Acalabrutinib (ACP-196) and Pembrolizumab in Advanced Head and Neck Squamous Cell Carcinoma
Study of the combination of acalabrutinib (ACP-196) and pembrolizumab in subjects with advanced head and neck squamous cell carcinoma.
- Trial name
- KEYNOTE147 (NCT02454179)
- Testing
- pembrolizumab, Acalabrutinib
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- Acerta Pharma BV
Acute-On-Chronic Liver Failure, Ascites
Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)®
A Phase 2, multi-center, randomized, controlled, open-label study to evaluate the effects of the intraperitoneal, liposomal formulation VS-01 in patients with an acute episode of hepatic and/or extrahepatic organ dysfunctions and…
- Trial name
- NCT05900050
- Testing
- VS-01 on top of SOC, SOC (Control Group)
- Where
- 26 sites in United States, Belgium and 5 more
- Volunteers
- 15 people
- Sponsor
- Genfit
Tuberculosis, HIV Infections
Efficacy Against TB Disease, Safety, and Immunogenicity of MVA85A/AERAS-485 in HIV-Infected Adults (C-030-485)
This is a phase II, proof of concept, randomized, double-blind, placebo-controlled study to evaluate the protective efficacy against TB disease, safety, and immunogenicity of MVA85A/AERAS-485 in healthy, HIV-infected adults.
- Trial name
- NCT01151189
- Testing
- MVA85A/AERAS-485
- Where
- 2 sites in Senegal, South Africa
- Volunteers
- 650 people
- Sponsor
- Aeras
Idiopathic Normal Pressure Hydrocephalus (INPH)
A Placebo-Controlled Effectiveness in INPH Shunting (PENS) Trial
The Placebo-Controlled Effectiveness in Idiopathic Normal Pressure Hydrocephalus (iNPH) Shunting (PENS) trial is a multi-center blinded, randomized, placebo-controlled design investigation of cerebrospinal fluid (CSF) shunt…
- Trial name
- PENS (NCT03350750)
- Testing
- programmable CSF shunt valve
- Where
- 7 sites in United States, Canada and 1 more
- Volunteers
- 18 people
- Sponsor
- Johns Hopkins University
Geographic Atrophy
A Multicenter, Proof-Of-Concept Study Of Intravitreal AL-78898A In Patients With Geographic Atrophy (GA) Associated With Age-Related Macular Degeneration (AMD)
The purpose of this study was to to demonstrate superiority of AL-78898A intravitreal (IVT) injections compared to sham injections by assessing mean geographic atrophy (GA) lesion size change from baseline at Month 12.
- Trial name
- NCT01603043
- Testing
- Al-78898A
- Volunteers
- 10 people
- Sponsor
- Alcon Research
Healthy, Stress, Psychological
Stress & Anxiety Dampening Effects of a Probiotic Supplement Compared to Placebo in Healthy Subjects
The aim of this study is to assess whether a 5 week intake of a probiotic (Lpc-37) can modulate stress and anxiety experienced by healthy subjects during and after an acute stressor compared to placebo.
- Trial name
- NCT03494725
- Testing
- Lpc-37
- Where
- Germany
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Daacro
Ankylosing Spondylitis
Double Blind, Placebo Controlled Study to Assess Efficacy of AIN457 in Moderate to Severe Ankylosing Spondylitis
Evaluate the safety, tolerability and pharmacokinetics of AIN457 when administered as treatment of moderate to severe ankylosing spondylitis (AS).
- Trial name
- NCT00809159
- Testing
- AIN457
- Where
- 20 sites in United States, Germany and 2 more
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals
Graft-versus-host-disease, GVHD
A Proof of Concept Pilot Trial of Alpha-1-Antitrypsin for Pre-Emption Of Steroid-Refractory Acute GVHD
Bone marrow transplant (BMT) patients can develop graft-versus-host disease (GVHD), a serious and potentially fatal complication.
- Trial name
- NCT03459040
- Testing
- Alpha 1-Antitrypsin
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- John Levine
Nontuberculous Mycobacterium Infection
A Proof of Concept Study of Inhaled Nitric Oxide for Adults With Pulmonary Non-Tuberculous Mycobacterial Infection
The purpose of this study is to evaluate the efficacy and safety of open-label exposure of gNO in patients with NTM lung disease. Subjects will receive the study drug by inhaling through a nasal mask.
- Trial name
- NCT03748992
- Testing
- gNO
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Medical University of South Carolina
Healthy
Evaluating the Availability of Berry Phytonutrients Post-consumption of Fresh and Processed Blueberry by Healthy Adults
This study will evaluate the availability of phytonutrients in two blueberry varieties, chosen for their phytonutrient levels. This will be compared to phytonutrient-matched processed protein bar and a macronutrient-matched…
- Trial name
- BAM (NCT04175106)
- Testing
- a non-traditional (i.e., not typically available in the supermarket) blueberry cultivar bred using natural plant breeding techniques and established as having enhanced nutritive value, a standard commercially available blueberry variety (i.e., cultivar), a "minimally processed" blueberry-rich protein bar
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- North Carolina State University
Sjögren's Syndrome
A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sjögren's Syndrome
The purpose of the study is to evaluate the efficacy, safety, and tolerability of VIB4920 (formerly MEDI4920) in adult participants with Sjögren's Syndrome (SS).
- Trial name
- SS (NCT04129164)
- Testing
- VIB4920
- Where
- 62 sites in United States, Argentina and 10 more
- Volunteers
- 183 people
- Sponsor
- Amgen
Peanut Allergy
Study to Investigate Etokimab (ANB020) Activity in Adult Participants With Peanut Allergy
The purpose of this study is to determine etokimab safety, tolerability and activity in adult participants with peanut allergy.
- Trial name
- NCT02920021
- Testing
- Etokimab
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- AnaptysBio, Inc.