Clinical trials: Proof of Concept
Ulcerative Colitis
Safety, Efficacy, and Tolerability Study of ASP3291 in Patients With Active Ulcerative Colitis
This is a Phase 2, randomized, double-blind, multicenter, parallel, placebo controlled study. Approximately 120 eligible patients with mild-to-moderate active ulcerative colitis will be randomized to double blind treatment of…
- Trial name
- NCT01612039
- Testing
- ASP3291
- Volunteers
- 112 people
- Sponsor
- Telsar Pharma Inc.
Systemic Lupus Erythematosus
Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus
The purpose of this study is to evaluate the safety and efficacy of repeated intravenous infusions of the study drug BT063 in patients with Systemic Lupus Erythematosus (SLE) compared with people who receive a placebo.
- Trial name
- BT063 in SLE (NCT02554019)
- Testing
- BT063
- Where
- 14 sites in Belarus, Georgia and 2 more
- Volunteers
- 36 people
- Sponsor
- Biotest
Sleep Initiation and Maintenance Disorders
Safety and Efficacy of Ramelteon and Doxepin in Subjects With Chronic Insomnia
The purpose of this study is to determine the efficacy of ramelteon, once daily (QD), combined with doxepin in treating subjects with insomnia.
- Trial name
- NCT00755495
- Testing
- Ramelteon and doxepin, Ramelteon, Doxepin
- Volunteers
- 472 people
- Sponsor
- Takeda
Vitiligo
Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo (NSV)
The purpose of this study is to look at the efficacy of afamelanotide, when combined with narrow-band ultraviolet B (NB-UVB) light, in patients with nonsegmental vitiligo.
- Trial name
- CUV102 (NCT01430195)
- Testing
- Afamelanotide, Narrow-Band UVB Light Treatment
- Where
- 2 sites in United States
- Volunteers
- 56 people
- Sponsor
- Clinuvel Pharmaceuticals Limited
Gallstones
Medical Dissolution of Cholesterol Gallstones Using Oral Aramchol - A Proof of Concept Phase IIa Study
This is a one center, Phase IIa, randomized, double blind, placebo controlled study designed to evaluate the efficacy and safety of two Aramchol doses in subjects 18 to 75 years of age, with newly formed cholesterol gallstones in…
- Trial name
- NCT02325492
- Testing
- Aramchol, Ultrasound
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- Galmed Pharmaceuticals Ltd
Alzheimer Disease, Dementia, Alzheimer Type
Dose-Finding Study To Evaluate Safety, Tolerability, and Efficacy of E2609 in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (Prodromal Alzheimer's Disease) and Mild to Moderate Dementia Due to Alzheimer's Disease
This is a Phase 2 study to evaluate safety and efficacy in participants with Mild Cognitive Impairment due to Alzheimer's Disease/Prodromal Alzheimer's Disease (referred to as MCI/Prodromal) and mild to moderate dementia due to…
- Trial name
- NCT02322021
- Testing
- E2609
- Where
- 21 sites in United States
- Volunteers
- 70 people
- Sponsor
- Eisai Inc.
Underactive Bladder
A Study of ASP8302 in Participants With Underactive Bladder
The study objectives of this study are to evaluate the efficacy of ASP8302 compared with placebo in participants with underactive bladder (UAB), to investigate the safety and tolerability of ASP8302 compared with placebo in…
- Trial name
- NCT03702777
- Testing
- ASP8302
- Where
- 29 sites in Germany, Japan and 4 more
- Volunteers
- 135 people
- Sponsor
- Astellas Pharma Europe B.V.
Urinary Tract Infections
Phase II Proof of Concept Study in Uncomplicated UTI
A study of the efficacy and safety of MPC-SHRC for the relief of symptoms associated with uncomplicated urinary tract infections.
- Trial name
- NCT03129295
- Testing
- MPC-SHRC
- Where
- 4 sites in United States
- Volunteers
- 200 people
- Sponsor
- Mission Pharmacal
Sleep Apnea, Sleep Apnea, Obstructive
Evaluation of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea
This proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can be stimulated using a small series of electrodes placed surgically via a percutaneous approach.
- Conditions
- Sleep Apnea, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Sleep Disorder
- Trial name
- NCT06283030
- Testing
- Hypoglossal nerve stimulation
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Invicta Medical Inc.
Plaque Psoriasis
A Study Comparing AIN457 to Placebo in Subjects With a Diagnosis of Moderate to Severe Stable Plaque Psoriasis
This is a two-arm, parallel group, double-blind, placebo-controlled proof-of-concept study comparing 3 mg/kg of AIN457 to placebo.
- Trial name
- NCT00669916
- Testing
- AIN457
- Volunteers
- 36 people
- Sponsor
- Novartis Pharmaceuticals
Alport Syndrome
Vonafexor ALPort Syndrome Efficacy & Safety TRIAl-1 (ALPESTRIA-1)
This study is a proof-of-concept trial of vonafexor safety, its effects on kidney function in subjects with at risk of progression Alport syndrome.
- Trial name
- ALPESTRIA-1 (NCT06425055)
- Testing
- Vonafexor
- Where
- 13 sites in United States, France and 1 more
- Volunteers
- 26 people
- Sponsor
- Enyo Pharma
Hypertension, Pulmonary, Pulmonary Disease, Chronic Obstructive
Single Dose Study in Patients With Chronic Obstructive Pulmonary Disease (COPD) Associated Pulmonary Hypertension.
This study is to demonstrate the safety, tolerability, pharmakokinetic and pharmacodynamic effect of a single oral dose of BAY63-2521 in patients with pulmonary hypertension due to chronic obstructive pulmonary disease (COPD).
- Trial name
- NCT00640315
- Testing
- Riociguat (Adempas, BAY63-2521) 1.0 mg, Riociguat (Adempas, BAY63-2521) 2.5 mg
- Where
- 7 sites in Germany
- Volunteers
- 23 people
- Sponsor
- Bayer
Basal Cell Carcinoma, Gorlin Syndrome
Efficacy, Safety and Pharmacokinetics of Oral LDE225 in Treatment of Patients With Nevoid Basal Cell Carcinoma Syndrome (NBCCS)
This was a phase II, double-blind, randomized, proof-of-concept, dose-ranging trial evaluating the efficacy, safety and pharmacokinetics of oral LDE225 in treatment of adult patients with NBCCS.
- Conditions
- Basal Cell Carcinoma, Gorlin Syndrome, Nevoid Basal Cell Carcinoma Syndrome
- Trial name
- NCT01350115
- Testing
- LDE225
- Where
- 6 sites in Austria, Belgium and 2 more
- Volunteers
- 10 people
- Sponsor
- Novartis Pharmaceuticals
Dyslipidaemias, Dyslipidaemia
GW501516 In Subjects Who Have Low Level Of High-Density Lipoprotein Cholesterol
The purpose of this clinical research study is to compare up to 3 doses of an investigational drug GW501516 to placebo (an inactive pill that looks like GW501516) to see if it is safe, well tolerated and effective in improving…
- Trial name
- NCT00158899
- Testing
- GW501516 oral tablets
- Where
- 64 sites in Belgium, Denmark and 9 more
- Volunteers
- 424 people
- Sponsor
- GlaxoSmithKline
Alopecia Areata
A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss)
The purpose of this study is to evaluate how well LY4005130 works in participants with severe alopecia areata (hair loss) when compared with placebo, and how well it's tolerated and what side effects may occur.
- Trial name
- NCT07533006
- Testing
- LY4005130
- Where
- 30 sites in United States, Canada and 5 more
- Volunteers
- 65 people
- Sponsor
- Eli Lilly and Company
Pulmonary Disease, Chronic Obstructive
A Study of UK-369,003 on the Safety and Efficacy in Patients With COPD
A randomised, controlled study investigating the effect of UK-369,003 on exercise tolerance in patients with COPD
- Trial name
- NCT00163098
- Testing
- UK-369,003
- Where
- 28 sites in Argentina, Australia and 3 more
- Volunteers
- 136 people
- Sponsor
- Pfizer
Rheumatoid Arthritis
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Participants With Rheumatoid Arthritis (MK-8457-010)
The purpose of this study is to assess the safety and efficacy of MK-8457 + Methotrexate (MTX) in participants with active rheumatoid arthritis (RA) and an inadequate response or intolerance to anti-tumor necrosis factor α…
- Trial name
- NCT01651936
- Testing
- MK-8457 100 mg, Methotrexate
- Volunteers
- 56 people
- Sponsor
- Merck Sharp & Dohme LLC
Acute Myeloid Leukemia, Myelodysplastic Syndrome
Safety and Proof-of-Concept Study of RPT1G in Adults With Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndromes
The main goals of this study are to learn if RPT1G is safe and tolerable and to determine the best dose and schedule of RPT1G for patients with relapsed or refractory acute myeloid leukemia (AML) and high-risk myelodysplastic…
- Trial name
- NCT07107126
- Testing
- RPT1G
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Remedy Plan, Inc.
Overactive Bladder
Clinical Study to Evaluate the Treatment Effect and Safety of BAY1817080 in Patients With Overactive Bladder (OAB)
The aim of the study is to determine how well the drug BAY1817080 works in OAB patients with urgency urinary incontinence (UUI), defined as involuntary leakage of urine, accompanied or immediately preceded by a sudden compelling…
- Trial name
- OVADER (NCT04545580)
- Testing
- BAY1817080
- Where
- 28 sites in Australia, Austria and 7 more
- Volunteers
- 99 people
- Sponsor
- Bayer
Cutaneous Warts
bLAC - Treatment of Cutaneous Warts in Immune Suppressed, Kidney Transplanted Patients
As many as 85 % of renal transplant patients may suffer from viral warts with a high degree of treatment resistance. Promising results of hLAC (human lactalbumin complex with lipid) point to a beneficial effect without noticeable…
- Trial name
- NCT00644579
- Testing
- bLAC
- Where
- 5 sites in Denmark
- Volunteers
- 120 people
- Sponsor
- NatImmune A/S