Clinical trials: Phase 3
Rifampicin-Resistant Pulmonary Tuberculosis, Multidrug-Resistant Pulmonary Tuberculosis
A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
This is a Phase 3, randomized, open-label, active-controlled, multicenter trial evaluating the efficacy, safety, and tolerability of quabodepistat-containing regimens for the treatment of rifampicin-resistant or…
- Trial name
- QUANTUM-TB (NCT07209761)
- Testing
- Bedaquiline, Quabodepistat, Pretomanid
- Where
- 42 sites in China, Georgia and 8 more
- Volunteers
- 532 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Non-small Cell Lung Cancer Stage IV
A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer
The goal of this clinical trial is to confirm that SB27 works in the same way as Keytruda in metastatic non-squamous non-small cell lung cancer (NSCLC) patients.
- Trial name
- NCT06348199
- Testing
- SB27, Keytruda
- Where
- 93 sites in Bosnia and Herzegovina, Brazil and 12 more
- Volunteers
- 555 people
- Sponsor
- Samsung Bioepis Co., Ltd.
Pneumococcal Disease
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
The purpose of this study is to learn about the safety of a new pneumococcal vaccine and how the new pneumococcal vaccine helps to fight against germs that can cause pneumonia (lung infections), meningitis (brain infections), and…
- Trial name
- NCT07573462
- Testing
- PG4, 20-valent pneumococcal conjugate vaccine (20vPnC)
- Where
- 78 sites in United States, Argentina and 8 more
- Volunteers
- 2,400 people, healthy volunteers welcome
- Sponsor
- Pfizer
Bipolar Disorder Type I With Mania
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I) The primary objective of the study is to evaluate the…
- Trial name
- NCT06929273
- Testing
- KarXT, Lithium, Valproate
- Where
- 184 sites in United States, Argentina and 18 more
- Volunteers
- 450 people
- Sponsor
- Bristol-Myers Squibb
Non-small Cell Lung Cancer
A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)
This is a study evaluating the efficacy and safety of calderasib with pembrolizumab as first-line treatment in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat…
- Trial name
- NCT06345729
- Testing
- Calderasib, Pembrolizumab
- Where
- 246 sites in United States, Argentina and 28 more
- Volunteers
- 348 people
- Sponsor
- Merck Sharp & Dohme LLC
SARS-CoV-2
A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease
The primary purpose of this study is to evaluate the efficacy and safety of secutrelvir in symptomatic nonhospitalized adult and adolescent participants with COVID-19 who are at high risk for progression to severe disease.
- Trial name
- NCT07743580
- Testing
- Secutrelvir
- Where
- 47 sites in United States, Bulgaria and 1 more
- Volunteers
- 2,000 people
- Sponsor
- Shionogi
Cancer
Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Durvalumab
The rationale of the ROSY-D study is to continue to provide study treatment for patients who have participated in a parent study with Durvalumab and who are continuing to derive clinical benefit from treatment at the end of such…
- Trial name
- ROSY-D (NCT05303532)
- Testing
- Durvalumab
- Where
- 123 sites in United States, Argentina and 29 more
- Volunteers
- 214 people
- Sponsor
- AstraZeneca
KRAS G12D-Mutant Advanced or Metastatic Pancreatic Cancer in the First-line Setting
HRS 4642 Injection Combined With AG Versus Placebo Combined With AG Therapy in First-Line Advanced or Metastatic Pancreatic Cancer
This study investigates the first-line treatment of advanced pancreatic cancer with KRAS G12D mutation. Patients were randomized 1:1 to receive either the experimental regimen HRS-4642 plus AG or the control regimen AG alone.
- Trial name
- NCT07232875
- Testing
- HRS-4642 + AG
- Where
- China
- Volunteers
- 588 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Metastatic Clear Cell Renal Cell Carcinoma, Advanced Clear Cell Renal Cell Carcinoma
Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma
The purpose of the study is to evaluate the progression-free survival (PFS) of casdatifan versus placebo when each is given in combination with cabozantinib for patients who received anti-PD-1 or anti-PD-L1 therapy as part of the…
- Trial name
- NCT07011719
- Testing
- Casdatifan, Cabozantinib
- Where
- 183 sites in United States, Argentina and 15 more
- Volunteers
- 720 people
- Sponsor
- Arcus Biosciences, Inc.
Guillain-Barre Syndrome
An Open Label Clinical Study to Evaluate Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (FORWARD Study)
The goal of this open label study is to measure pharmacokinetics, pharmacodynamics, early efficacy, and safety of tanruprubart in adult and pediatric participants, in the United States, Canada, and Europe.
- Trial name
- NCT07020819
- Testing
- Tanruprubart
- Where
- 30 sites in United States, Denmark and 3 more
- Volunteers
- 30 people
- Sponsor
- Annexon, Inc.
Paroxysmal Nocturnal Hemoglobinuria
A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors
A study designed to evaluate the safety of crovalimab with eculizumab in participants with PNH currently treated with complement inhibitors. This study will enroll approximately 190 participants.
- Trial name
- COMMODORE 1 (NCT04432584)
- Testing
- Crovalimab, Eculizumab
- Where
- 80 sites in United States, Belgium and 22 more
- Volunteers
- 190 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Investigation of Novel Surgical Imaging for Tumor Excision
This is a multi-center, two-arm randomized, blinded pivotal study to demonstrate the safety and efficacy of the LUM Imaging System (LUM015 imaging agent in conjunction with the LUM Imaging Device and decision software), in…
- Trial name
- INSITE (NCT03686215)
- Testing
- Study Device Arm
- Where
- 14 sites in United States
- Volunteers
- 406 people
- Sponsor
- Lumicell, Inc.
Relapsing Multiple Sclerosis
Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
The purpose of this Phase 3b study is to assess the efficacy, safety and tolerability of remibrutinib after switching from ocrelizumab and compared to continuous ocrelizumab treatment, in patients living with relapsing multiple…
- Trial name
- NCT06846281
- Testing
- Remibrutinib oral treatment, Ocrelizumab
- Where
- 131 sites in United States, Argentina and 17 more
- Volunteers
- 400 people
- Sponsor
- Novartis Pharmaceuticals
Chondral Defect, Articular Cartilage Defect
A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle
The objective of this study is to demonstrate the superiority of MACI (autologous cultured chondrocytes on porcine collagen membrane) versus Bone Marrow Stimulation in the treatment of patients aged 17 to 65 years with…
- Trial name
- MASCOT (NCT06915233)
- Testing
- autologous cultured chondrocytes on porcine collagen membrane, Bone Marrow Stimulation
- Where
- 9 sites in United States
- Volunteers
- 309 people
- Sponsor
- Vericel Corporation
Septic Shock, Sepsis
A Phase III, Open Label, Randomized, Controlled Study of VBI-S in the Treatment of Hypovolemia in Patients With Septic Shock (VBI-S-02)
This study is being conducted to evaluate the safety and effectiveness of VBI-S in elevating the blood pressure of septic shock patients with absolute or relative hypovolemia.
- Conditions
- Septic Shock, Sepsis, Hypovolemia
- Trial name
- VBI-S-02 (NCT06072430)
- Testing
- VBI-S
- Where
- 5 sites in United States
- Volunteers
- 39 people
- Sponsor
- Vivacelle Bio
Asthma Copd
A Multicenter, Randomized, Parallel, Two-Period, Non-Inferiority Study of EurofarmavsAlenia in Asthma and COPD Treatment
A phase III study, multicenter, randomized, parallel, open, two-period, comparative non-inferiority of Eurofarma versus Alenia® in the treatment of moderate to severe persistent asthma with and without obstructive pulmonary…
- Trial name
- ESPIRE (NCT04233190)
- Testing
- Alenia® 12mcg + 400mcg / Alenia® 6mcg + 200mcg
- Where
- Brazil
- Volunteers
- 472 people
- Sponsor
- Eurofarma Laboratorios S.A.
COVID-19, ARDS
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of EB05 + SOC vs. Placebo + SOC in Adult Hospitalized Patients With COVID-19
COVID-19 patients who develop severe disease often develop acute respiratory distress syndrome (ARDS) as a result of a dysregulated immune response.
- Trial name
- NCT04401475
- Testing
- SOC plus 15mg/kg EB05 IV
- Where
- 20 sites in United States, Canada
- Volunteers
- 278 people
- Sponsor
- Edesa Biotech Inc.
Alpha 1 Antitrypsin Deficiency
A Non-inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Doses of Weekly SC Alpha1-PI 15% Compared With Corresponding Standard IV Alpha1-PI in Participants With Alpha1-Antitrypsin Deficiency (AATD)
This study is designed to compare two different weekly doses of a medicine called Alpha1-Proteinase Inhibitor given by injection under the skin with the standard doses of the same medicine given through a vein.
- Trial name
- SWIFT-SC (NCT07555483)
- Testing
- Alpha-1 15%, Liquid Alpha1-PI
- Where
- 22 sites in United States, Denmark and 7 more
- Volunteers
- 40 people
- Sponsor
- Grifols Therapeutics LLC
Coronary Artery Disease
Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events
CKJX839D12303 is a research study to determine if the study treatment, called inclisiran, in comparison to placebo taken in addition to statin medication can effectively reduce the total amount of plaque formed in the heart's…
- Trial name
- V-PLAQUE (NCT05360446)
- Testing
- Inclisiran sodium 300 mg
- Where
- 89 sites in United States, Argentina and 16 more
- Volunteers
- 610 people
- Sponsor
- Novartis Pharmaceuticals
Pulmonary Hypertension, Interstitial Lung Disease
Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
The primary objective of this study is to evaluate the effect of 24-weeks of once daily treatment with TPIP versus placebo on exercise capacity in adults with PH-ILD.
- Trial name
- PALM-ILD (NCT07179380)
- Testing
- Treprostinil Palmitil Inhalation Powder
- Where
- 186 sites in United States, Argentina and 28 more
- Volunteers
- 344 people
- Sponsor
- Insmed Incorporated
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