Clinical trials: Proof of Concept
Hematologic Malignancy, Hematopoietic/Lymphoid Cancer
A Proof-of-Concept Trial of a Positive Psychology Intervention for Allogeneic Stem Cell Transplant Patients
The goal of this research study is to find out if a novel phone-based positive psychology intervention that focuses on improving health behaviors and positive emotions can help improve mood, health related quality of life, and…
- Conditions
- Hematologic Malignancy, Hematopoietic/Lymphoid Cancer, Blood Cancer
- Trial name
- NCT03654404
- Testing
- Positive Psychology Intervention
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Brigham and Women's Hospital
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
Fibromyalgia Syndrome
Assessing Efficacy and Safety of Lacosamide Compared to Placebo in Reducing Signs and Symptoms of Fibromyalgia Syndrome.
This trial investigated the efficacy and safety of 400mg/day of lacosamide as compared to placebo in reducing the signs and symptoms of fibromyalgia syndrome.
- Trial name
- NCT00401830
- Testing
- Lacosamide
- Where
- 25 sites in United States
- Volunteers
- 159 people
- Sponsor
- UCB Pharma
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
Malaria, Falciparum
MMV390048 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Participants
A single-centre, open-label, study using induced blood stage malaria infection to characterize the activity of MMV390048 against early Plasmodium falciparum blood stage infection.
- Trial name
- NCT02281344
- Testing
- MMV390048 20mg
- Where
- Australia
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Tourette Syndrome, Chronic Tic Disorder
Proof of Concept Study of an Oral Orthotic to Reduce Tic Severity in Chronic Tic Disorder and Tourette Syndrome
The purpose of this study is to assess the feasibility of a trial on an oral orthotic for reducing tic severity in children ages 7-25 years with Tourette syndrome (TS) or Chronic Tic Disorder (CTD).
- Trial name
- NCT02067819
- Testing
- Active Oral Orthotic Treatment
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Weill Medical College of Cornell University
Metastatic Pancreatic Cancer
Phase 2, Nab Paclitaxel/Gemcitabine Alone and in Combination With ACP-196 in Subjects With Metastatic Pancreatic Cancer
To evaluate the safety and efficacy of ACP-196 and nab paclitaxel/gemcitabine in subjects with previously untreated metastatic pancreatic cancer using standard response criteria
- Trial name
- NCT02570711
- Testing
- ACP-196, Nab-paclitaxel, Gemcitabine
- Where
- 10 sites in United States
- Volunteers
- 3 people
- Sponsor
- Acerta Pharma BV
Fatty Liver, Nonalcoholic, NAFLD
A Study of HTD1801 in Adults With Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)
Randomized, double-blind, placebo-controlled, parallel-group study comparing multiple doses of HTD1801 to placebo.
- Conditions
- Fatty Liver, Nonalcoholic, NAFLD, Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
- Trial name
- NCT03656744
- Testing
- HTD1801
- Where
- 17 sites in United States
- Volunteers
- 101 people
- Sponsor
- HighTide Therapeutics (Hong Kong) Limited
Arthritis, Rheumatoid
A Proof-of-concept Study of the Efficacy and Safety of Nipocalimab in Participants With Active Rheumatoid Arthritis
The purpose of this study is to evaluate the efficacy and safety of nipocalimab versus placebo in participants with moderate to severe active rheumatoid arthritis (RA).
- Trial name
- NCT04991753
- Testing
- Nipocalimab
- Where
- 28 sites in United States, Germany and 3 more
- Volunteers
- 53 people
- Sponsor
- Janssen Research & Development, LLC
HIV Infections
A Proof of Concept Study of GSK3640254 in Human Immunodeficiency Virus-1 (HIV-1) Infected Treatment-naive Adults
Infection with HIV-1 continues to be a serious health threat throughout the world. Chronic exposure to combination anti-retroviral therapy identified anti-retroviral associated long-term toxicities.
- Trial name
- NCT03784079
- Testing
- GSK3640254
- Where
- 23 sites in United States, France and 4 more
- Volunteers
- 34 people
- Sponsor
- ViiV Healthcare
Prostate Cancer
Safety, Pharmacokinetic and Proof-of-Concept Study of ARN-509 (Apalutamide) in Castration-Resistant Prostate Cancer (CRPC)
The purpose of this study is to assess the safety and activity of ARN-509 in men with advanced castration resistant prostate cancer.
- Trial name
- NCT01171898
- Testing
- ARN-509 (Phase 1), ARN-509 (Phase 2)
- Where
- 15 sites in United States
- Volunteers
- 127 people
- Sponsor
- Aragon Pharmaceuticals, Inc.
Skin Care
A Proof of Concept Clinical Study to Investigate the Effects of an Experimental Cosmetic Moisturiser on the Barrier Function of Human Skin on the Face and Forearm
The objective of this POC clinical study is to investigate the impact of the test product (Developmental Cosmetic Moisturising Cream) on skin barrier function and skin moisturisation on the forearm and face after 4 weeks of twice…
- Trial name
- NCT03216265
- Testing
- Test product (Moisturising cream), Positive control (Commercial market place moisturising cream), No treatment
- Where
- Germany
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Exudative Age-Related Macular Degeneration
LHA510 Proof-of-Concept Study as a Maintenance Therapy for Patients With Wet Age-Related Macular Degeneration
The purpose of this study is to evaluate the efficacy of 84 successive days of topically administered LHA510 compared to vehicle in reducing the number of patients requiring intravitreal (IVT) anti-vascular endothelial growth…
- Trial name
- NCT02355028
- Testing
- LHA510 ophthalmic suspension, LHA510 vehicle, Ranibizumab ophthalmic solution
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- Alcon, a Novartis Company
Chronic Hepatitis D Infection
Lonafarnib Boosted With Ritonavir With and Without Peginterferon Alfa-2a (PEG IFN-a) in HDV (LOWR-2)
An Open-label, Dose-ranging Study to Evaluate the Safety and Efficacy of Lonafarnib with Ritonavir Boosting +/- Peginterferon alfa-2a in Patients Chronically Infected with Delta Hepatitis (HDV) (LOWR-2).
- Trial name
- LOWR-2 (NCT02430194)
- Testing
- lonafarnib, ritonavir, Pegylated interferon-alfa-2a
- Where
- Turkey (Türkiye)
- Volunteers
- 55 people
- Sponsor
- EIT Pharma, Inc.
Type 2 Diabetes Mellitus, Diabetic Peripheral Neuropathy
Evaluation of Exenatide in Patients With Diabetic Neuropathy
This study will look at whether or not the medication exenatide improves signs and symptoms of diabetic peripheral neuropathy in people with type 2 diabetes and mild to moderate diabetic peripheral neuropathy.
- Trial name
- NCT00855439
- Testing
- Exenatide, Glargine
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- University of Michigan
Crohn's Disease
Efficacy, Safety and Tolerability of AIN457 in Moderate to Severe Active Crohn's Disease
This study will assess the safety and efficacy of AIN457 in patients with moderate to severe active Crohn's disease.
- Trial name
- NCT00584740
- Testing
- AIN457
- Where
- 2 sites in Germany
- Volunteers
- 59 people
- Sponsor
- Novartis Pharmaceuticals
Healthy
Healthy Volunteer Short Chain Fatty Acid Study
The purpose of this study is to evaluate the production of short chain fatty acids (fatty acids are part of your diet) in stool through the measurement of fecal inulin after a one-time ingestion of 10-gram dose of inulin among…
- Trial name
- NCT05254340
- Testing
- Inulin
- Where
- United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Indiana University
Rheumatoid Arthritis
ACP-196 Versus Placebo in Subjects With Rheumatoid Arthritis on Background Methotrexate
This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate.
- Trial name
- NCT02387762
- Testing
- acalabrutinib
- Where
- 17 sites in United States
- Volunteers
- 31 people
- Sponsor
- Acerta Pharma BV