Clinical trials: Proof of Concept
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
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
Fecal Incontinence
Effect of Single Doses of 10 mg NRL001 Applied as a Suppository to the Anal Canal or Rectum
Study to assess the effects of 10mg NRL001 on mean anal resting pressure (MARP) when administered as a slow release suppository applied to the anal canal or rectum.
- Trial name
- NCT00893607
- Testing
- NRL001
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Norgine
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
Tobacco Dependence
An Exploratory Study Comparing Two Nicotine Inhalers
Subjects will be screened within 28 days before the first study treatment to confirm that they meet the requirements to participate in the trial.
- Trial name
- NCT01478230
- Testing
- Nicotine
- Where
- Sweden
- Volunteers
- 36 people
- Sponsor
- McNeil AB
Psoriasis, Plaque Psoriasis
Proof of Concept Study of AX-158 in Patients With Mild to Moderate Plaque Psoriasis
Proof of concept study to assess the safety and tolerability of AX-158 in patients with mild to moderate psoriasis. Patients will be evaluated for a 28-day treatment period with either AX-158 or Placebo and then followed for an…
- Trial name
- NCT05725057
- Testing
- AX-158
- Where
- 6 sites in United Kingdom
- Volunteers
- 31 people
- Sponsor
- Artax Biopharma Inc
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
Retinitis Pigmentosa
A First-in-human, Proof of Concept Study of CPK850 in Patients With RLBP1 Retinitis Pigmentosa
The purpose of this first-in-human study is to explore the maximum tolerated dose (MTD) of CPK850 as determined by the single ascending dose ranging portion of the study.
- Trial name
- NCT03374657
- Testing
- CPK850
- Where
- Sweden
- Volunteers
- 12 people
- Sponsor
- Novartis Pharmaceuticals
Healthy
A Study of a Probiotic Food Supplement Containing B. Infantis (EVC001) in Healthy Breastfed Infants at Risk of Developing Atopic Dermatitis
The purpose of this study is to assess the effect of B. infantis (EVC001) versus placebo supplementation, in healthy breastfed infants at risk of developing atopic dermatitis (AD), on cumulative incidence of physician-diagnosed…
- Trial name
- NCT04662619
- Testing
- B. infantis
- Where
- Finland
- Volunteers
- 273 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
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
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.
Interstitial Cystitis, Painful Bladder Syndrome
An Effectiveness And Safety Study Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial Cystitis
The purpose of this study is to determine whether PD 0299685 is effective in the treatment of symptoms associated with interstitial cystitis/painful bladder syndrome, such as pain, urinary urgency and frequency.
- Trial name
- NCT00739739
- Testing
- PD 0299685 at 15mg BID, PD 0299685 at 30mg BID
- Where
- 44 sites in United States, Canada and 4 more
- Volunteers
- 161 people
- Sponsor
- Pfizer
Autism Spectrum Disorder
A Study of RG7314 to Investigate Efficacy and Safety in Individuals With Autism Spectrum Disorders (ASD)
This multi-center, randomized, double-blind, parallel group, placebo-controlled, proof of concept study will investigate the efficacy and safety of RG7314 in adult participants with ASD.
- Trial name
- NCT01793441
- Testing
- RG7314
- Where
- 56 sites in United States
- Volunteers
- 223 people
- Sponsor
- Hoffmann-La Roche
Parkinson Disease
Quality-of-Life Index (Q-Index)
The main objective of this observational study is to use commonly-used connected objects (smartphones and smartwatches) to remotely assess and monitor the health-related quality of life (HrQoL) of people with Parkinson's disease…
- Trial name
- NCT06209502
- Where
- 4 sites in Belgium
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- Koios Care
Healthy Volunteer
A Human Tick Kill Study to Investigate the Safety, Tolerability, and Whole Blood Concentration of TP-05
This is a Phase 2a, randomized, double-blind, proof-of-concept, single-center study evaluating the safety, tolerability, and whole blood concentration of TP-05 (lotilaner) in the killing of ticks after they have attached to human…
- Trial name
- NCT05387083
- Testing
- Low Dose TP-05, High Dose TP-05
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Tarsus Pharmaceuticals, Inc.
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.
Osteoarthritis, Knee
Study of FX005 for the Treatment of Pain in Patients With Osteoarthritis of the Knee
The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of FX005 for the treatment of pain in patients with osteoarthritis of the knee.
- Trial name
- NCT01291914
- Testing
- FX005
- Where
- 13 sites in Austria, Canada and 2 more
- Volunteers
- 140 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Crohn Disease
A Study of JNJ-64304500 as Add-on Therapy in Participants With Active Crohn's Disease
The purpose of this study is to evaluate the efficacy and safety of JNJ-64304500 as add-on therapy to standard of care (SOC) biologic treatment with anti-tumor necrosis factor alpha or anti-interleukin 12/23 inhibitors in…
- Trial name
- DUET (NCT04655807)
- Testing
- JNJ-64304500, Adalimumab, Ustekinumab
- Where
- United States
- Sponsor
- Janssen Research & Development, LLC