Clinical trials: Proof of Concept
Diabetes Mellitus, Heart Failure
Results of Tc99m-Maraciclatide Scintigraphy in Subjects With Diabetes Mellitus and Heart Failure With Preserved Left Ventricular Ejection Fraction
The purpose of this study is to evaluate the results of 99mTc maraciclatide scintigraphy in diabetic subjects with HFPEF. A maximum of 20 subjects with Diabetes Mellitus (DM) and Heart Failure With Preserved Left Ventricular…
- Trial name
- NCT01440517
- Testing
- Tc99m-Maraciclatide
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- GE Healthcare
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
Post-traumatic Osteoarthritis of the Knee
Proof of Concept Study Comparing FX006 to Kenalog®-40 in Patients With Post-Traumatic Osteoarthritis of the Knee
This study was a double-blind, randomized, parallel group, proof of concept study comparing FX006 to Kenalog®-40 (triamcinolone acetonide injectable suspension, USP) in patients with post-traumatic osteoarthritis of the knee.
- Trial name
- NCT02468583
- Testing
- FX006 32 mg, TCA IR 40 mg
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Meibomian Glands, Dry Eye Syndromes
Safety and Efficacy of TrueTear™ for the Treatment of Meibomian Gland Disease
This study will compare the safety and efficacy of TrueTear™ to standardized moist heat compress (Thermalon® Dry Eye Compress) for the treatment of Meibomian Gland Disease (MGD).
- Trial name
- NCT03226769
- Testing
- TrueTear™, Thermalon Dry Eye Compress
- Where
- United States
- Volunteers
- 57 people
- Sponsor
- Allergan
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
Hidradenitis Suppurativa
A Study to Test the Efficacy and Safety of SAR442970 in Adults With Hidradenitis Suppurativa
This was a Phase 2 study in adult participants with moderate to severe hidradenitis suppurativa (HS). The purpose of the study was to evaluate the efficacy and safety of SAR442970 compared to placebo.
- Trial name
- HS OBTAIN (NCT05849922)
- Testing
- SAR442970
- Where
- 45 sites in United States, Australia and 13 more
- Volunteers
- 86 people
- Sponsor
- Sanofi
Dermatitis, Atopic
An Ascending Multiple Dose Study of VTP-38543 in Adult Participants With Mild to Moderate Atopic Dermatitis
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical efficacy of VTP-38543 administered as a cream, twice-daily, for 28 days in otherwise healthy adult…
- Trial name
- NCT02655679
- Testing
- VTP-38543, Vehicle with Transcutol®P, Vehicle without Transcutol®P
- Where
- 12 sites in United States, Canada
- Volunteers
- 104 people
- Sponsor
- Vitae Pharmaceuticals, Inc.
Healthy
A Healthy Volunteer Trial Investigating MR-enterography Image Quality of Lumentin® 44
A healthy volunteer, open, PoC single center trial investigating a new oral contrast agent for use in combination of MR examination of the abdomen and pelvis.
- Trial name
- NCT05781490
- Testing
- Lumentin® 44 Powder for oral foam
- Where
- Sweden
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Lument AB
Dysphagia, Oropharyngeal
AspiRATE: Novel Intervention to Acoustically Detect Silent Aspiration in Acquired Dysphagia.
This study will investigate whether silent aspiration during swallowing can reliably be detected using acoustic signal processing plus pulse oximetry.
- Trial name
- AspiRATE (NCT03676582)
- Testing
- Acoustic analysis plus pulse oximetry
- Where
- United Kingdom
- Volunteers
- 25 people
- Sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
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
Onchocerciasis
Study to Assess Adverse Events, Change in Disease Activity and How Oral ABBV-4083 Capsules When Given Alone or In Combination With Albendazole Capsules Moves in The Body of Adult Participants With Onchocerca Volvulus Infection
Onchocerciasis is a major public health problem in affected countries that causes disease-induced disability, and overall loss of economic productivity.
- Trial name
- NCT04913610
- Testing
- ABBV-4083, Albendazole
- Where
- 2 sites in Democratic Republic of the Congo
- Volunteers
- 153 people
- Sponsor
- AbbVie
Healthy
A Proof of Concept Study to Investigate the Use and Relevance of a Digital Platform for Infant Crying and Fussing
Primary: The rating by the primary caregivers on the use and relevance of data provided by the Language ENvironment Analysis (LENA) recorder and their level of engagement due to the content on the Cool mobile app.
- Trial name
- COOL (NCT03729960)
- Testing
- LENA recorder
- Where
- Singapore
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
Hypoglycemia, Complications of Bariatric Procedures
Delivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Hypoglycemia in Post-Bariatric Surgery Patients
The primary objective of this study is to test an optimized control system for sensor-guided (physician administered) delivery of glucagon, and test Proof-of-Concept (POC) in a clinical setting in patients with severe…
- Trial name
- NCT02733588
- Testing
- G-Pump™ (glucagon infusion)
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Xeris Pharmaceuticals
Non-Hodgkins Lymphoma, Multiple Myeloma
Acalabrutinib (ACP-196) in Combination With ACP-319, for Treatment of B-Cell Malignancies
This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy acalabrutinib and ACP 319 in B-cell malignancies.
- Conditions
- Non-Hodgkins Lymphoma, Multiple Myeloma, B-All
- Trial name
- NCT02328014
- Testing
- Acalabrutinib, ACP-319
- Where
- 7 sites in United States
- Volunteers
- 40 people
- Sponsor
- Acerta Pharma 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
NASH - Nonalcoholic Steatohepatitis
AVIATION Study: A Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of TERN-201 in Patients With Non-Cirrhotic Non-Alcoholic Steatohepatitis
This is a Phase 1b multi-center, randomized, double-blind, dose-ranging, placebo-controlled, adaptive study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) of TERN-201 in patients with non-cirrhotic NASH.
- Trial name
- NCT04897594
- Testing
- TERN-201
- Where
- 11 sites in United States
- Volunteers
- 52 people
- Sponsor
- Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Malaria, Malaria Vaccines
Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine in Tanzanian Infants
GSK Biologicals in partnership with the Malaria Vaccine Initiative at PATH is developing a candidate malaria vaccine GSK 257049 for the routine immunization of infants and children living in malaria endemic areas.
- Trial name
- NCT00289185
- Testing
- RTS,S/AS02D, Engerix-B®, TETRActHib™
- Where
- Tanzania
- Volunteers
- 340 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Lymphoma, Mantle-Cell, Lymphoma, Large B-Cell, Diffuse
An Efficacy and Safety Proof of Concept Study of Daratumumab in Relapsed/Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma
The purpose of this study is to assess overall response rate [ORR, including complete response (CR) and partial response (PR)], of daratumumab in participants with non-Hodgkin's lymphoma [a cancer of the lymph nodes (or…
- Conditions
- Lymphoma, Mantle-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular
- Trial name
- NCT02413489
- Testing
- Daratumumab
- Where
- 35 sites in United States, Australia and 5 more
- Volunteers
- 36 people
- Sponsor
- Janssen Research & Development, LLC
Macular Edema
Study Assessing AR-1105 in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)
This study will evaluate the safety, tolerability and efficacy of AR-1105 (dexamethasone implant) for the treatment of macular edema (ME) due to retinal vein occlusion (RVO).
- Trial name
- NCT03739593
- Testing
- AR-1105-CF1, AR-1105-CF2
- Where
- 11 sites in United States
- Volunteers
- 49 people
- Sponsor
- Aerie Pharmaceuticals
Sexual Dysfunction, Physiological
Estetrol for the Treatment of Female Sexual Arousal Disorder in Postmenopausal Women
This randomized, double-blind, placebo-controlled clinical trial investigated the effect of once daily oral administration of 20 mg estetrol monohydrate tablet for 12 weeks in postmenopausal women who experienced sexual arousal…
- Trial name
- NCT06308614
- Testing
- Estetrol
- Where
- 24 sites in United States
- Volunteers
- 82 people
- Sponsor
- Estetra