Clinical trials: Proof of Concept
Acne Vulgaris
A Proof of Concept Study to Evaluate the Efficacy and Tolerability of Microneedling With SkinPen in Female and Male Subjects With Facial Acne Vulgaris, Ages 18 Through 45
This single-center, proof of concept trial is being conducted over the course of 42 days followed by a 2-month post-last treatment visit in order to assess the efficacy and tolerability of the Sponsor's SkinPen device in treating…
- Trial name
- NCT05071274
- Testing
- Skinpen Prescision System
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Crown Laboratories, Inc.
Intracerebral Hemorrhage
A Study to Evaluate the Safety, Tolerability and the Effects of Ixodes Ricinus-Contact Phase Inhibitor (Ir-CPI) in Adult Patients With Spontaneous Intracerebral Haemorrhage
The purpose of the study is to provide a first assessment of safety, tolerability and efficacy of Ir-CPI, administered on top of standard-of-care, on secondary brain injury in patients with spontaneous intracerebral haemorrhage.
- Trial name
- BIRCH (NCT05970224)
- Testing
- Ir-CPI
- Where
- 8 sites in Belgium
- Volunteers
- 23 people
- Sponsor
- Bioxodes S.A.
Osteoarthritis
Safety and Biologic Activity Study of Gevokizumab to Treat Erosive Osteoarthritis of the Hand
The purpose of this proof-of-concept study is to determine whether gevokizumab is effective in the treatment of inflammatory erosive osteoarthritis of the hand.
- Trial name
- NCT01882491
- Testing
- gevokizumab
- Where
- 23 sites in United States
- Volunteers
- 91 people
- Sponsor
- XOMA (US) LLC
Colitis, Ulcerative
A Study in Patients With Mild or Moderate Ulcerative Colitis Who Take a TNF Inhibitor. The Study Investigates Whether Bowel Inflammation Improves When Patients Take BI 655130 in Addition to Their Current Therapy
The objectives of this trial are safety and efficacy (proof-of-concept) of induction of mucosal healing by BI 655130 add-on therapy in patients with mild or moderate ulcerative colitis and persisting endoscopic activity despite…
- Trial name
- NCT03123120
- Testing
- Spesolimab
- Where
- 16 sites in Denmark, Germany and 4 more
- Volunteers
- 22 people
- Sponsor
- Boehringer Ingelheim
Relapsed or Plateau-Phase Multiple Myeloma
Open-Label, Phase 2, Proof of Concept Study in Multiple Myeloma - Denosumab
The purpose of this study is to determine if denosumab is effective in the treatment of relapsed or plateau-phase multiple myeloma.
- Trial name
- NCT00259740
- Testing
- DENOSUMAB
- Volunteers
- 96 people
- Sponsor
- Amgen
Healthy Volunteers, Atopic Dermatitis
A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton Syndrome
The study is divided in 3 parts, starting with the safety assessment of BPR277 ointment in Healthy volunteers (Part 1). If found to be well tolerated in Part 1, BPR277 ointment will be assessed in two different patients groups to…
- Conditions
- Healthy Volunteers, Atopic Dermatitis, Netherton Syndrome
- Trial name
- 3 (NCT01428297)
- Testing
- BPR277 ointment (controlled application), BPR277 ointment, BPR277
- Where
- 4 sites in United States, Netherlands
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Primary Biliary Cholangitis
Safety, Tolerability, and Efficacy of Etrasimod (APD334) in Participants With Primary Biliary Cholangitis
The purpose of this open-label, pilot, proof of concept study is to evaluate the safety, tolerability, and efficacy of oral etrasimod (APD334) in participants with primary biliary cholangitis (PBC).
- Trial name
- NCT03155932
- Testing
- APD334
- Where
- 9 sites in United States, Australia and 1 more
- Volunteers
- 2 people
- Sponsor
- Arena Pharmaceuticals
Giant Cell Arteritis
A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis
The primary purpose of this study is to evaluate the efficacy of guselkumab compared to placebo, in combination with a 26-week glucocorticoid (GC) taper regimen, in adult participants with new-onset or relapsing giant cell…
- Trial name
- THEIA (NCT04633447)
- Testing
- Guselkumab
- Where
- 30 sites in United States, Belgium and 7 more
- Volunteers
- 53 people
- Sponsor
- Janssen Research & Development, LLC
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.
Diabetes Mellitus, Type 2, Metabolic Syndrome X
A Phase IIa Proof-of-concept Study of NC-503 in Patients With Type II Diabetes
The main objectives of the current study are to establish the safety and clinical proof-of-concept of NC-503 in inadequately controlled patients with Type 2 diabetes and features of metabolic syndrome treated with either…
- Trial name
- NCT00675857
- Testing
- NC-503 (eprodisate disodium)
- Where
- 21 sites in Canada
- Volunteers
- 200 people
- Sponsor
- Bellus Health Inc. - a GSK company
Cognition, Cognitive Function
A Clinical Trial to Investigate the Safety and Efficacy of AP-Brain on Cognitive Function at Varying Dosages in Healthy Younger Adults With Self-reported Attention Problems
The goal of this clinical trial is to investigate the safety and efficacy of AP-Brain on cognitive function at varying dosages in healthy younger adults with self-reported attention problems.
- Trial name
- NCT07388576
- Testing
- AP-Brain (1g), AP-Brain (3g), AP-Brain (5g)
- Where
- 2 sites in Canada
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Rousselot BVBA
Multiple Sclerosis
ATX-MS-1467 in Multiple Sclerosis
This is a multi-center, open-label, single arm, baseline-controlled Phase 2a trial to evaluate the clinical and biological effects of ATX-MS-1467 in subjects with relapsing multiple sclerosis (MS) and to assess the maintenance of…
- Trial name
- NCT01973491
- Testing
- ATX-MS-1467
- Where
- Germany
- Volunteers
- 37 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Gastroesophageal Reflux
Comparison of Vonoprazan to Esomeprazole in Participants With Symptomatic GERD Who Responded Partially to a High Dose of Proton Pump Inhibitor (PPI)
The purpose of this study is to determine the effect of vonoprazan compared to esomeprazole for preventing heartburn symptoms over a 4-week treatment period in participants who have a partial response to treatment with…
- Trial name
- NCT02743949
- Testing
- Vonoprazan, Esomeprazole
- Where
- 39 sites in Belgium, Bulgaria and 4 more
- Volunteers
- 256 people
- Sponsor
- Takeda
Acute Anterior Uveitis
Proof of Concept Study to Evaluate Safety and Efficacy of LME636 in the Treatment of Acute Anterior Uveitis
The purpose of the study is to determine whether topical ocular administration of LME636 60 mg/mL is efficacious in resolving the ocular inflammation in the anterior chamber (AC) associated with acute anterior uveitis (AAU).
- Trial name
- NCT02482129
- Testing
- LME636 60 mg/mL ophthalmic solution, Dexamethasone 0.1% ophthalmic solution, LME636 Vehicle
- Volunteers
- 45 people
- Sponsor
- Alcon Research
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
Acute Ischemic Stroke
A Safety and Efficacy Study of Intravenous (IV) Elezanumab Assessing Change in Neurologic Function in Adult Participants With Acute Ischemic Stroke
Stroke is one of the leading causes death and major functional disability worldwide. Treatment options for acute stroke are limited with many patients having residual neurologic impairment.
- Trial name
- EAISE (NCT04309474)
- Testing
- Elezanumab
- Where
- 42 sites in United States, Australia and 4 more
- Volunteers
- 121 people
- Sponsor
- AbbVie
Diabetic Foot Ulcer
Oral BBR-012 in the Treatment of Diabetic Foot Ulcers, Proof of Concept Study
The aim of this Clinical Proof of Principle study is to evaluate the effect of BBR-012 on the healing of complicated diabetic foot ulcers.
- Trial name
- BBR-012 (NCT01342497)
- Testing
- isoniazide
- Where
- 11 sites in United Kingdom
- Volunteers
- 60 people
- Sponsor
- Bridge BioResearch Ltd.
Basal Cell Carcinoma
Placebo Microneedles in Healthy Volunteers (Part I) and Efficacy/Safety of Doxorubicin Microneedles in Basal Cell Cancer Subjects (Part II)
Part I is designed as a study of P-MNA application in healthy human volunteers. The goal of Part I is to determine several factors possibly affecting the rate and extent of microneedle array dissolution, such as anatomic…
- Trial name
- NCT04928222
- Testing
- Doxorubicin-containing MNA
- Where
- 2 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- SkinJect, Inc.
Autoimmune Encephalitis
Safety and Efficacy of IGIV 10% in Patients With Autoimmune Encephalitis:
The purpose of this study is to evaluate the safety and efficacy of IGIV 10% in patients with autoimmune encephalitis
- Trial name
- NCT04175522
- Testing
- Immunoglobulin G
- Where
- South Korea
- Volunteers
- 23 people
- Sponsor
- Green Cross Corporation
Lactose Intolerance
Effect of a Combination of Lactase and L. Salivarius DSM 34078 in Individuals With Lactose Intolerance
The goal of this clinical trial is to test whether a new combination of lactase and bacterial strain (L. Salivarius DSM 34078) can provide longer lasting beneficial effects on lactose digestion and gastrointestinal symptoms…
- Trial name
- NCT06107088
- Testing
- Active 1, Active 2, Active 3
- Where
- Germany
- Volunteers
- 76 people
- Sponsor
- Novozymes A/S