Clinical trials: Proof of Concept
Adenomyosis
Placebo-controlled Proof of Concept Study of Epelsiban in Women With Adenomyosis
The primary objective of the study is to assess the efficacy, safety, and tolerability of epelsiban compared with placebo in treatment of women with adenomyosis.
- Trial name
- NCT02794467
- Testing
- Epelsiban
- Where
- 13 sites in United States
- Sponsor
- GlaxoSmithKline
Sleep Disorders, Circadian Rhythm
Efficacy of Ramelteon on Speeding Up Sleep in Subjects With Delayed Sleep Phase Syndrome
The purpose of this study is to evaluate the ability of ramelteon, once daily (QD), to advance the timing of sleep in individuals with delayed sleep phase syndrome.
- Trial name
- NCT00593736
- Testing
- Ramelteon
- Where
- 42 sites in United States
- Volunteers
- 132 people
- Sponsor
- Takeda
Clinical Pharmacology
Study to Investigate the Natriuretic Effects, Safety, Tolerability and Pharmacokinetics of BAY94-8862
Pharmacodynamics, pharmacokinetics, safety, and tolerability will be investigated in this single dose study. In 5 treatment groups, different dosages of BAY94-8862 will be given in healthy male subjects.
- Trial name
- NCT01473108
- Testing
- Finerenone (BAY 94-8862) PEG solution, Finerenone (BAY 94-8862) immediate release tablet, Eplerenone (Inspra®)
- Where
- Germany
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Bayer
Primary Sjögren's Syndrome
UCB Proof of Concept Study in Patients With Primary Sjögren's Syndrome
This is a Phase 2, multicenter, double-blind, placebo-controlled, 12-week proof-of-concept study to assess the efficacy, safety, and tolerability of UCB5857 in subjects with primary Sjögren's Syndrome (pSS).
- Trial name
- NCT02610543
- Testing
- UCB5857
- Where
- 14 sites in France, Italy and 3 more
- Volunteers
- 27 people
- Sponsor
- UCB Celltech
Covid19
A Study to Evaluate Change in Viral Load After OPN-019 in Adults With COVID-19
The purpose of this study is to determine both the magnitude and duration of viral load (copies/mL) reduction after a single dose of OPN-019.
- Trial name
- NCT05035576
- Testing
- OPN-019
- Where
- Mexico
- Volunteers
- 8 people
- Sponsor
- Optinose US Inc.
Post-Menopausal Osteoporosis
Proof of Concept (Bone Resorption/Bone Mineral Density) Study (0429-005)
A study to asses the safety and efficacy of MK0429 in postmenopausal women with osteoporosis.
- Trial name
- NCT00533650
- Testing
- MK0429
- Volunteers
- 227 people
- Sponsor
- Merck Sharp & Dohme LLC
Psoriasis
An Ascending Multiple Dose Study With VTP-43742 in Healthy Volunteers
This is Part 1 of a two-part, randomized, double-blind, placebo-controlled study in which VTP-43742 was administered to participants; Part 1 in healthy volunteers and Part 2 in psoriatic participants.
- Trial name
- NCT03724292
- Testing
- VTP-43742
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Vitae Pharmaceuticals Inc., an Allergan affiliate
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
ABG Oxidative Stress Study Protocol-1
This is a proof of concept study that evaluates the response to oxidative stress in healthy men after taking plant concentrates.
- Trial name
- NCT02213523
- Testing
- Plant concentrate A, Plant concentrate B, Plant concentrate C
- Where
- 2 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Access Business Group
Hereditary Hemorrhagic Telangiectasia (HHT), Osler Weber Rendu Disease
Harmony-HHT: ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT)
This is a 2-part study evaluating ATV-1601 in participants with moderate to severe HHT. Part 1 is a randomized, double-blind, placebo-controlled study evaluating 3 dosing regimens of ATV-1601.
- Trial name
- NCT07601425
- Testing
- ATV-1601
- Where
- 8 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Atavistik Bio, Inc
COVID-19
JINZHEN for Treatment of Mild to Moderate COVID-19
JINZHEN is a botanical drug that contains eight chemical constituents extracted from plant, mineral and animal origin raw materials.
- Trial name
- NCT05092503
- Testing
- JINZHEN Granules for Oral Solution
- Where
- 10 sites in United States
- Volunteers
- 60 people
- Sponsor
- Lianyungang Kanion Group, Ltd.
Alcohol Associated Hepatitis
FXR Effect on Severe Alcohol-Associated Hepatitis (FRESH) Study
The purpose of this trial is to assess dose related safety, efficacy, and pharmacokinetics (PK) of INT-787 in participants with severe alcohol-associated hepatitis (sAH).
- Trial name
- FRESH (NCT05639543)
- Testing
- INT-787
- Where
- 29 sites in United States, France and 1 more
- Volunteers
- 67 people
- Sponsor
- Intercept Pharmaceuticals
Cerebrovascular Accident
Proof of Concept (POC) in Patients With Ischaemic Stroke
Study MAG104615, a Proof of Concept Study for GSK249320 versus placebo in Stroke Patients.
- Trial name
- NCT01808261
- Testing
- GSK249320 100/mg
- Where
- 36 sites in United States, Canada and 2 more
- Volunteers
- 134 people
- Sponsor
- GlaxoSmithKline
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
Osteoarthritis of the Knee
Proof-of Concept Study of Topical 3%-Diclofenac-Nano-Emulsion Cream for Knee OA Pain
This study valuates the safety and efficacy of treatment with 3% Diclofenac Nano-Emulsion Cream versus Placebo in subjects with osteoarthritis of the knee.
- Trial name
- NCT00484120
- Testing
- 3%-Diclofenac-Nano-Emulsion Cream
- Where
- 4 sites in Israel
- Volunteers
- 123 people
- Sponsor
- Pharmos
Thyroid Eye Disease, Graves Ophthalmopathy
A Study to Evaluate the Efficacy and Safety of LASN01 in Patients With Thyroid Eye Disease
LASN01 is a novel, fully human antibody directed against the human IL-11 receptor being developed for treatment of patients with thyroid eye disease (TED).
- Conditions
- Thyroid Eye Disease, Graves Ophthalmopathy, Graves Orbitopathy, Thyroid Associated Ophthalmopathy
- Trial name
- NCT06226545
- Testing
- LASN01
- Where
- 15 sites in United States, Spain and 1 more
- Volunteers
- 41 people
- Sponsor
- Lassen Therapeutics Inc.
Heartburn
Proof of Concept Study Efficacy of an Antacid/Lansoprazole Combination for Relief of Heartburn
This study will investigate the safety and efficacy of an antacid/Lansoprazole combination product for the relief of heartburn after consuming a heartburn-inducing meal.
- Trial name
- NCT01037452
- Testing
- Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg, Lansoprazole, Calcium carbonate/magnesium hydroxide
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Novartis
Gastroparesis
Study to Assess the Efficacy of VLY-686 in Relieving Symptoms of Gastroparesis
This is a multicenter, randomized, double-blind, placebo-controlled study to be conducted in the United States. One hundred fifty (150) subjects diagnosed with gastroparesis, who satisfy the selection criteria for the study, will…
- Trial name
- NCT02970968
- Testing
- VLY-686 (Tradipitant)
- Where
- 38 sites in United States
- Volunteers
- 152 people
- Sponsor
- Vanda Pharmaceuticals
Hepatitis C
Proof of Concept Study for Safety and Efficacy of EDP239 in Hepatitis C Subjects
The purpose of this study is, to assess whether EDP239 can reduce the HCV viral load in HCV gentotype-1 in chronically infected subjects and to further evaluate the safety profile of EDP239.
- Trial name
- NCT01856426
- Testing
- EDP239
- Where
- 5 sites in United States, Germany
- Volunteers
- 28 people
- Sponsor
- Enanta Pharmaceuticals, Inc
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