Clinical trials: Proof of Concept
Active Rheumatoid Arthritis
Study Evaluating Multiple Doses Of ATN-103 In Subjects With Active Rheumatoid Arthritis
The purpose of this study is to evaluate the safety and efficacy of ATN-103 when administered to subjects with active rheumatoid arthritis compared with placebo. All subjects must be on a stable dose and route of methotrexate.
- Trial name
- NCT00959036
- Testing
- ATN-103, Methotrexate
- Where
- 67 sites in United States, Belgium and 7 more
- Volunteers
- 252 people
- Sponsor
- Ablynx, a Sanofi company
Basal Cell Carcinomas
Clinical Trial of Patidegib Gel 2%, 4%, and Vehicle Applied Once or Twice Daily to Decrease the GLI1 Biomarker in Sporadic Nodular Basal Cell Carcinomas
This is a double-blind, dose escalating, randomized, vehicle-controlled study designed to compare the efficacy and safety of patidegib gel 2% and 4% applied once or twice daily in comparison with that of vehicle in patients with…
- Trial name
- BCC (NCT02828111)
- Testing
- Patidegib, Vehicle gel
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- PellePharm, Inc.
Myasthenia Gravis, Neuromuscular Manifestations
Expediting Myasthenia Gravis (MG) Diagnostic Evaluation: A Novel, Proof-of-Concept for Undiagnosed, Symptomatic Patients That Uses Social Media Targeting and Self-Assessment
This is a fully remote, site-less, prospective, observational study enrolling adults in the United States (excluding U.S. territories) with undiagnosed neuromuscular symptoms.
- Conditions
- Myasthenia Gravis, Neuromuscular Manifestations, Neuromuscular Diseases
- Trial name
- NCT06381284
- Testing
- Social media recruitment, Self-Assessment, Follow-up
- Where
- United States
- Volunteers
- 215 people, healthy volunteers welcome
- Sponsor
- ZS Associates
Infection, Human Immunodeficiency Virus
Phase Ib/IIa Clinical Study of ACC017 Tablets
ACC017 is an integrase inhibitor that will be evaluated for the treatment of HIV infection. This phase Ib/IIa, randomized, double-blind, parallel, dose ranging, placebo-controlled 'proof of concept' study is designed to evaluate…
- Trial name
- NCT06719310
- Testing
- ACC017+FTC/TAF
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Jiangsu Aidea Pharmaceutical Group Co., Ltd.
Follicular Lymphoma (FL), CLL
ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies
This study is evaluating the safety, pharmacodynamics (PD), and efficacy of acalabrutinib and pembrolizumab in hematologic malignancies.
- Conditions
- Follicular Lymphoma (FL), CLL, Small Lymphocytic Lymphoma (SLL), Richter's Syndrome
- Trial name
- KEYNOTE145 (NCT02362035)
- Testing
- Acalabrutinib, Pembrolizumab
- Where
- 19 sites in United States
- Volunteers
- 161 people
- Sponsor
- Acerta Pharma BV
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
Congenital Hyperinsulinism
HM15136 (Efpegerglucagon) Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)
This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of HM15136 when used as add-on therapy in subjects with CHI with persistent hypoglycemia while on standard of care treatment (SoC).
- Trial name
- NCT04732416
- Testing
- HM15136
- Where
- 7 sites in United States, Germany and 3 more
- Volunteers
- 17 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Sleep Disorders, Circadian Rhythm
Efficacy of Ramelteon on Speeding Up Sleep in Subjects With Delayed Sleep Phase Syndrome
The purpose of this study is to evaluate the ability of ramelteon, once daily (QD), to advance the timing of sleep in individuals with delayed sleep phase syndrome.
- Trial name
- NCT00593736
- Testing
- Ramelteon
- Where
- 42 sites in United States
- Volunteers
- 132 people
- Sponsor
- Takeda
AIDS/HIV - RelatedDisease Associated With AIDS, Vaccine-Preventable Diseases
Study to Evaluate the Safety and Immunogenicity of an HIV-1 Vaccine Regimen of Adjuvanted UVAX-1107 Followed by Adjuvanted UVAX-1107 or Adjuvanted UVAX-1197 in Healthy Subjects Aged 25-55 Years.
This is a first in human testing of novel HIV-1 protein nanoparticles vaccine candidates, UVAX-1107 and UVAX-1197 mixed with Aluminum Hydroxide (AH) and CpG 1018 adjuvants.
- Conditions
- AIDS/HIV - RelatedDisease Associated With AIDS, Vaccine-Preventable Diseases, HIV Infections
- Trial name
- NCT06541093
- Testing
- UVAX-1107, UVAX-1197
- Where
- Australia
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Uvax Bio LLC
NASH - Nonalcoholic Steatohepatitis, Diabetes Mellitus, Type 2
Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With SGLT2 Inhibitor EmpaGliflozin in patiEnts With NASH and Type 2 Diabetes Mellitus
The study in the T2DM population is intended to confirm the lanifibranor effect versus placebo on glycemic control and assess a positive effect of the combination of lanifibranor with an SGLT2 inhibitor on glycemic control.
- Trial name
- LEGEND (NCT05232071)
- Testing
- Lanifibranor, Empagliflozin
- Where
- 42 sites in United States, Belgium and 3 more
- Volunteers
- 39 people
- Sponsor
- Inventiva Pharma
Fabry Disesase
A proof-of Concept Study to Assess Safety and Tolerability of HM15421/GC1134A in Patients With Fabry Disease
This Phase 1/2 first-in-human (FIH) study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of HM15421 in patients with FD.
- Trial name
- NCT06858397
- Testing
- HM15421/GC1134A
- Where
- 10 sites in United States, Argentina and 1 more
- Volunteers
- 18 people
- Sponsor
- GC Biopharma Corp
Idiopathic Pulmonary Fibrosis (IPF)
AURA-IPF: A Randomized Phase 2 Study to Evaluate the Safety and Efficacy of AP02 (Nintedanib Solution) in IPF
This study will evaluate the impact Nintedanib Solution for Inhalation (AP02) has on lung function and key measures of fibrosis in adult patients with idiopathic pulmonary fibrosis (IPF) as well as assess its safety and…
- Trial name
- AURA-IPF (NCT07194382)
- Testing
- AP02
- Where
- 49 sites in Australia, Canada and 5 more
- Volunteers
- 160 people
- Sponsor
- Avalyn Pharma Inc.
Solid Tumor, Lymphoma
PROCLAIM-CX-072: A Trial to Find Safe and Active Doses of an Investigational Drug CX-072 for Patients With Solid Tumors or Lymphomas
The purpose of this first-in-human study of CX-072 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-072 administered intravenously (IV) as a single agent or in…
- Trial name
- NCT03013491
- Testing
- CX-072, ipilimumab, vemurafenib
- Where
- 31 sites in United States, Netherlands and 4 more
- Volunteers
- 196 people
- Sponsor
- CytomX Therapeutics
HIV-1 Infection
A Proof-of-concept Trial to Evaluate the Safety and Efficacy of UB-421 Plus Chidamide in Changing HIV Reservoirs
This is a phase II proof-of-concept trial study to assess the safety and efficacy of UB-421 monotherapy plus chidamide in changing the latent HIV reservoir among ART-treated HIV-1 adults with stably viral suppression who undergo…
- Trial name
- NCT05056974
- Testing
- UB-421, chidamide
- Where
- Taiwan
- Volunteers
- 11 people
- Sponsor
- United BioPharma
Vulvo Vaginal Atrophy (VVA)
Proof of Concept Study of Vaginal AZU-101 in Vulvovaginal Atrophy in Postmenopausal Women
Study Objectives: Primary: To assess the safety, tolerability, and systemic pharmacokinetics (PK) of AZU-101 Secondary: To evaluate efficacy of daily vaginal doses of AZU-101 in postmenopausal women on vaginal epithelium
- Trial name
- NCT06197568
- Testing
- Lasofoxifene Tartrate
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Azure Biotech Inc.
Colitis, Ulcerative
Budesonide 9 mg Capsules in Active UC
The purpose of the trial is to evaluate the efficacy of an 8 week treatment with once-daily 9 mg budesonide in patients with active ulcerative colitis
- Trial name
- TOPICAL-1 (NCT02550418)
- Testing
- Budesonide
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Dr. Falk Pharma GmbH
Graves Disease
A Proof-of-Concept Study to Assess Batoclimab in Participants With Graves' Disease
The purpose of this study is to assess the efficacy and safety of 24 weeks of treatment with batoclimab in adult participants with biochemically documented hyperthyroidism due to GD who have failed to achieve euthyroidism on…
- Trial name
- NCT05907668
- Testing
- IMVT-1401 (batoclimab)
- Where
- Germany
- Volunteers
- 32 people
- Sponsor
- Immunovant Sciences GmbH
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
SARS-CoV-2
Polio Vaccine (IPV) for SARS-CoV-2 and Prevention of Coronavirus Disease (COVID-19)
A total of 300 healthy volunteers between the ages of 18 and 80 with no previous history of COVID-19 will be entered into the study and will receive IPV by injection on Day 1.
- Trial name
- NCT04639375
- Testing
- Vaccinated with polio vaccine (IPV)
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- E-MO Biology Inc
Periorbital Edema
Energy-Based Lower Eyelid Rejuvenation - Proof of Concept for InMode AccuTite With or Without Morpheus8
1. To establish clinical efficacy, safety and patient satisfaction of reducing lower eyelid convexities or "bags" and/or malar crescents (festoons) with catheter-based injectable RF (InMode AccuTite) and variable depth Fractional…
- Trial name
- NCT04103619
- Testing
- AccuTite, AccuTite + Morpheus 8
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- InMode MD Ltd.