Clinical trials: Phase 3, open to volunteers
Autosomal Recessive Polycystic Kidney (ARPKD)
A Study to See if Tolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)
To evaluate the pharmacodynamics and safety of tolvaptan in pediatric subjects with ARPKD
- Trial name
- NCT04782258
- Testing
- Tolvaptan Suspension, Tolvaptan Tablets
- Where
- 23 sites in United States, Belgium and 4 more
- Volunteers
- 20 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Alzheimer Disease
[18F]PI-2620 Phase 3 Histopathological Study
This study is an open-label, multi-center, non-randomized pivotal Phase 3 study to assess the efficacy and safety of PET imaging with [18F]PI-2620 for detection of tau deposition in subjects with Alzheimer's disease (AD) and…
- Trial name
- NCT05641688
- Testing
- [18F]PI-2620
- Where
- 25 sites in United States
- Volunteers
- 200 people
- Sponsor
- Lantheus Biosciences Ltd.
Breast Cancer
Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study
TOL2506A (OVELIA) is a Phase 3, single arm, open-label study evaluating the effectiveness of TOL2506 in suppressing ovarian function in premenopausal women with HR+, HER2-negative breast cancer and men with HR+ breast cancer.
- Trial name
- NCT05645536
- Testing
- TOL2506, Tamoxifen, Letrozole tablets
- Where
- 46 sites in United States, Argentina and 4 more
- Volunteers
- 250 people
- Sponsor
- Tolmar Inc.
Relapsing Multiple Sclerosis
Study to Evaluate Safety, Efficacy and Pharmacokinetics (PK) of a Modified Regimen of Ublituximab
The primary purpose of this phase 3b study is to assess the efficacy of a modified regimen of ublituximab in participants with relapsing multiple sclerosis (RMS) as measured by T1 Gadolinium (Gd)-enhancing lesions in Part A; PK…
- Trial name
- ENHANCE (NCT05877963)
- Testing
- Ublituximab
- Where
- 51 sites in United States, Poland
- Volunteers
- 800 people
- Sponsor
- TG Therapeutics, Inc.
Non-Small Cell Lung Cancer (NSCLC)
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum…
- Trial name
- NCT05920356
- Testing
- Sotorasib, Pembrolizumab
- Where
- 424 sites in United States, Argentina and 36 more
- Volunteers
- 750 people
- Sponsor
- Amgen
Primary Biliary Cholangitis (PBC)
A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis
The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) and cirrhosis (scarring of the liver). PBC is a slowly progressive disease, characterised by damage to the bile ducts in the liver, leading to a…
- Trial name
- ELFIDENCE (NCT06016842)
- Testing
- Elafibranor
- Where
- 198 sites in United States, Argentina and 26 more
- Volunteers
- 276 people
- Sponsor
- Ipsen
Influenza
A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts
This study consists of two parts: Part A Surveillance and Part B Transmission. The main purpose of Part A is to evaluate the prevalence of pre-dose and treatment-emergent amino acid substitutions in pediatric participants' <12…
- Trial name
- Pebblestone (NCT06094010)
- Testing
- Baloxavir Marboxil
- Where
- 51 sites in United States, Bulgaria and 2 more
- Volunteers
- 1,100 people
- Sponsor
- Hoffmann-La Roche
Phenylketonuria
A Study of Sepiapterin in Participants With Phenylketonuria (PKU)
The main purpose of this trial is to evaluate the long-term efficacy of sepiapterin on preserving neurocognitive functioning in children with PKU when treatment is initiated in early childhood.
- Trial name
- EPIPHENY (NCT06302348)
- Testing
- Sepiapterin
- Where
- 14 sites in United States, Australia and 5 more
- Volunteers
- 56 people
- Sponsor
- PTC Therapeutics
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.
- Trial name
- NCT06318169
- Testing
- Pegozafermin
- Where
- 370 sites in United States, Argentina and 25 more
- Volunteers
- 1,350 people
- Sponsor
- Hoffmann-La Roche
Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
The study will assess the efficacy and safety of pegozafermin administered in participants with biopsy-confirmed and clinically confirmed compensated cirrhosis due to MASH .
- Trial name
- NCT06419374
- Testing
- Pegozafermin
- Where
- 330 sites in United States, Argentina and 23 more
- Volunteers
- 1,800 people
- Sponsor
- Hoffmann-La Roche
Crohn's Disease
A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)
The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease.
- Trial name
- NCT06430801
- Testing
- IV Tulisokibart, SC Tulisokibart
- Where
- 499 sites in United States, Australia and 45 more
- Volunteers
- 1,200 people
- Sponsor
- Merck Sharp & Dohme LLC
Myelodysplastic Syndromes
A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions
The main aim of this study is to find out how well elritercept works in lowering the need for RBC transfusions. Other aims are to learn how well elritercept works in reducing the need for RBC transfusions over longer periods of…
- Trial name
- NCT06499285
- Testing
- Elritercept
- Where
- 182 sites in United States, Australia and 24 more
- Volunteers
- 225 people
- Sponsor
- Takeda
Non-small Cell Lung Cancer
A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 Expression ≥ 1%
The purpose of this study is to compare the efficacy of Nivolumab and Relatlimab in combination with chemotherapy to Pembrolizumab with Chemotherapy in participants with stage IV or recurrent Non-squamous Non-small Cell Lung…
- Trial name
- RELATIVITY1093 (NCT06561386)
- Testing
- Nivolumab, Relatlimab, Pembrolizumab
- Where
- 329 sites in United States, Argentina and 29 more
- Volunteers
- 1,000 people
- Sponsor
- Bristol-Myers Squibb
Pyoderma Gangrenosum
A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum
The purpose of this study is to find out whether a medicine called spesolimab helps people with pyoderma gangrenosum (PG). The main aim is to see whether spesolimab leads to closure of PG ulcers.
- Trial name
- NCT06624670
- Testing
- Spesolimab, Prednisone, Prednisolone
- Where
- 104 sites in United States, Argentina and 19 more
- Volunteers
- 90 people
- Sponsor
- LEO Pharma
Enthesitis-related Arthritis, Juvenile Psoriatic Arthritis
An Open-label Study to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-related Arthritis (Including Juvenile-onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
The purpose of this study is to assess plasma bimekizumab concentrations following subcutaneous (sc) bimekizumab administration.
- Trial name
- NCT06668181
- Testing
- Bimekizumab
- Where
- 23 sites in Canada, France and 4 more
- Volunteers
- 40 people
- Sponsor
- UCB Biopharma SRL
Non-small Cell Lung Cancer
Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer
This clinical trial is designed to assess the efficacy and safety of trastuzumab deruxtecan (T-DXd; Enhertu®) in combination with pembrolizumab versus platinum-based chemotherapy in combination with pembrolizumab in participants…
- Trial name
- DESTINY-Lung06 (NCT06899126)
- Testing
- Trastuzumab Deruxtecan, pembrolizumab, Pemetrexed
- Where
- 246 sites in United States, Argentina and 22 more
- Volunteers
- 686 people
- Sponsor
- Daiichi Sankyo
Attention Deficit Hyperactivity Disorder (ADHD)
A Long-term Trial of EB-1020 in Adult Patients With ADHD
The purpose of this study is to evaluate the safety of long-term administration of mainly high doses of EB-1020 over 52 weeks in patients who have completed the double-blind trial (405-102-00112) conducted in Japan
- Trial name
- NCT06926829
- Testing
- EB-1020 (Centanafadine) 164.4 mg, EB-1020 (Centanafadine) 328.8 mg
- Where
- Japan
- Volunteers
- 180 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Acromegaly
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
The primary purpose of this study is to assess the effect of Debio 4126 in the maintenance of the levels of insulin-like growth factor 1 (IGF-1) ≤1x upper limit of normal (ULN) in the double-blind period (Period 1) in comparison…
- Trial name
- OXTEND™-03 (NCT06930625)
- Testing
- Debio 4126
- Where
- 74 sites in United States, Austria and 19 more
- Volunteers
- 119 people
- Sponsor
- Debiopharm International SA
Attention Deficit Hyperactivity Disorder (ADHD)
Evaluation of the Efficacy and Safety of EB-1020 in Adult ADHD Patients
The purpose of this study is to evaluate the efficacy and examine the safety of two doses of EB-1020 QD XR capsule administered once daily orally in adult ADHD patients.
- Trial name
- NCT06931080
- Testing
- EB-1020 (Centanafadine) 164.4 mg, EB-1020 (Centanafadine) 328.8 mg
- Where
- Japan
- Volunteers
- 630 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Pancreatic Neuroendocrine Tumor (pNET), Extra-Pancreatic Neuroendocrine Tumor (epNET)
Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors
The primary purpose of this study is to assess the effectiveness of zanzalintinib compared to everolimus in participants with previously treated, unresectable, locally advanced or metastatic neuroendocrine tumors.
- Trial name
- STELLAR-311 (NCT06943755)
- Testing
- Zanzalintinib, Everolimus
- Where
- 133 sites in United States, Australia and 15 more
- Volunteers
- 440 people
- Sponsor
- Exelixis