Clinical trials: Proof of Concept
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.
Proof of Concept
Dietary Intervention Detection in the Small Intestine
Proof of concept study to validate the ability of a capsule device to gather samples from the small bowel for microbiome analysis in adults and to detect dietary changes from simultaneous ingestion of a probiotic.
- Trial name
- NCT04489329
- Testing
- Ingestible Capsule, Probiotic
- Where
- Canada
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Nimble Science 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
Discoid Lupus Erythematosus
Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Discoid Lupus Erythematosus (DLE) Lesions
Lupus Erythematosus (LE) is an autoimmune disorder that includes a broad spectrum of clinical forms. One of these forms, Discoid Lupus Erythematosus (DLE) is a chronic disfiguring disease confined to the skin.
- Trial name
- NCT00625521
- Testing
- ASF 1096 0.5 % cream applied twice daily, Cream vehicle for ASF 1096 cream applied twice daily
- Where
- Sweden
- Volunteers
- 32 people
- Sponsor
- Astion Pharma A/S
Dentine Hypersensitivity
A Study to Evaluate the Dentinal Hypersensitivity Efficacy of Two Experimental Mouthwash Formulations
The aim of this study is to evaluate the clinical efficacy of two experimental mouthwash formulations, against a placebo mouthwash (without experimental ingredients).
- Trial name
- NCT07741032
- Testing
- 3% KNO3 Mouthwash, 2% HPC Mouthwash, 0% KNO3 Mouthwash
- Where
- Germany
- Volunteers
- 118 people
- Sponsor
- HALEON
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
Soft Tissue Mass Removal
Extraction of Stromal Vascular Fraction and Stem Cells From Fat Tissue
Human Adipose Tissue is considered as a new source for Stromal Stem Cells and offers a large therapeutic potential for many rare and common diseases that impacts millions of patients worldwide.
- Trial name
- NCT01399307
- Testing
- Liposuction
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- Antria
COVID-19
Efficacy and Safety of hzVSF-v13 in Patients With COVID-19 Pneumonia
Preliminarily investigate the safety and efficacy of two doses of hzVSF-v13 + SOC vs. placebo + SOC for the treatment of COVID-19 pneumonia.
- Trial name
- NCT04676971
- Testing
- hzVSF-v13
- Where
- 9 sites in Italy, Russia
- Volunteers
- 115 people
- Sponsor
- ImmuneMed, Inc.
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
Schizophrenia, Schizoaffective Disorder
Olanzapine Given in Combination With Zonisamide SR to Prevent Weight Gain in Schizophrenic Subjects
The purpose of this study is to determine if zonisamide SR will prevent weight gain in schizophrenic subjects who take olanzapine (Zyprexa)
- Conditions
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder
- Trial name
- NCT00734435
- Testing
- zonisamide SR plus olanzapine
- Where
- 9 sites in United States
- Volunteers
- 26 people
- Sponsor
- Orexigen Therapeutics, Inc
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
Pain
Naproxen Sodium/Acetaminophen Proof of Concept Dosing Study
Study assessing efficacy and safety of concomitantly dosed naproxen sodium with acetaminophen, compared with naproxen sodium, hydrocodone/acetaminophen and Placebo in a postoperative dental pain.
- Trial name
- NCT03879408
- Testing
- 440 mg naproxen sodium with 1000 mg acetaminophen, 220 mg naproxen sodium with 650 mg acetaminophen, 10 mg hydrocodone + 650 mg acetaminophen
- Where
- United States
- Volunteers
- 290 people
- Sponsor
- Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
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
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